Everolimus · advanced hepatocellular carcinoma after sorafenib · evidence check for increased disease control

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich existing question is being transferred to this sheet?Required	The selected existing question is increased disease control, with the question distinguished from its original verdict record. The parent overall-survival context is preserved in the complete copy; other subquestions are not separate clinical trials. R01	Some information for this item exists in the preserved summary and has been linked. The original candidate's boundary-review pending state is historical; review of the existing question boundary remains incomplete. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Preserved draft distinguishing the existing question, record location and parent and sibling scopes	Proposal: An updated draft retaining the original question and record relationship if additional reports for the same question are supplied
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow are the subclaim grade and note distinguished from the parent score and axes?Required	The selected subclaim grade is C. Its note states: 56.1% versus 45.1%, but a secondary endpoint after the primary survival endpoint failed. Subclaim score, status and axis fields are absent; parent grade D, 34 points and Caution safety status are parent history. R01	Some information for this item exists in the preserved summary and has been linked. Direct values for the subclaim score, status and axes are absent from the original. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Separate locations for the selected subclaim wording and parent verdict history	Proposal: A preserved copy separating complete original wording from the change event when the selected subclaim verdict itself is corrected
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionDo the two sheets concern the same EVOLVE-1 report, trial and population?Required	The parent's evidence and citation lists each contain 1 record linking Zhu AX et al. 2014 EVOLVE-1, PMID 25058218 and NCT01035229. The two existing outcomes, time to progression and safety share this preserved report's context. R01	Some information for this item exists in the preserved summary and has been linked. Other report versions, follow-up results and current unique study or participant totals have not been established. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Relationship table for bibliography, registration, shared cohort and individual outcomes	Proposal: An outcome-specific material list preserving the same-trial relationship when original or follow-up reports are supplied
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhat materials were actually read during this work?Required	The specified complete parent verdict summary was read for production and the original preserved. External articles, abstracts, registration and plans remain unread and access was not attempted. The PubMed URL is the existing citation link. R01	Some information for this item exists in the preserved summary and has been linked. External availability, acquisition, reading and link operation were not verified during this work. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Material records separating the preserved summary from external original materials	Proposal: Material records distinguishing reading level and dates when follow-up work that actually obtains new materials is authorized
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat is the selected population and previous sorafenib-treatment scope?Required	EVOLVE-1 concerned Child-Pugh A patients with advanced hepatocellular carcinoma who failed or could not tolerate sorafenib. This scope is not transferred to all other liver diseases or treatment lines. R01	Some information for this item exists in the preserved summary and has been linked. Age, sex, etiology, baseline tumor burden, specific inclusion or exclusion criteria and the respective proportions of failure and intolerance are absent from the preserved summary. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Recruitment criteria, baseline tables, previous treatment and distinctions between failure and intolerance	Proposal: Comparative materials specifying prespecified population-specific outcomes and scope in the same indication
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionHow are 17 countries, 121 centers and participant distributions related?Required	The preserved design is a randomized, double-blind, placebo-controlled phase 3 trial at 121 centers in 17 countries. Center and country counts are not participant or independent-trial counts. R01	Some information for this item exists in the preserved summary and has been linked. Recruitment counts by country or center, baseline balance, regional outcomes and follow-up differences remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Center, country and recruitment flow and baseline distribution tables	Proposal: Link prespecified subgroup materials on regional or selection differences as outcomes within the same trial when available
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat was the actual everolimus exposure and dose scope?Required	The original study compared everolimus 7.5 mg/day plus best supportive care with placebo. This value is recorded only as historical research exposure, not medication or treatment instructions. R01	Some information for this item exists in the preserved summary and has been linked. Original formulation, detailed administration route, exposure duration, actual cumulative dose, dose reduction, discontinuation and adherence materials remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Study product or formulation and nominal or actual exposure and change materials	Proposal: Research materials distinguishing exposure-specific results within the trial conditions when supplied
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionHow are placebo, supportive care and subsequent treatments distinguished?Required	The preserved summary records matching placebo and everolimus plus best supportive care as study conditions. Specific control-group and group-specific supportive care remain a separate scope to document. R01	Some information for this item exists in the preserved summary and has been linked. Actual supportive-care balance, subsequent anticancer or rescue therapy, departures, crossover and analysis handling remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Group-specific concomitant and subsequent treatments, departures and analysis handling tables	Proposal: Follow-up materials linking subsequent-treatment or crossover information to the original randomized comparison
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat were randomization, full-analysis and group denominators?Required	Preserve the recorded sample of 546 randomized and analyzed participants: 362 everolimus versus 184 placebo. The existing research description records 2:1 allocation and inclusion of everyone in the full analysis population. R01	Some information for this item exists in the preserved summary and has been linked. Endpoint-specific measurable, completed, followed and safety-analysis denominators require separate tables. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Allocation-to-exposure-to-analysis flow, endpoint denominators and exclusion reasons	Proposal: Original reports distinguishing analysis populations for each outcome within the same allocated population
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat is the scope of handling missingness, follow-up loss and discontinuation?Required	Preserve the original summary stating that all 546 participants were included in the full analysis population. Death, progression, medication discontinuation and loss to follow-up are different events. R01	Some information for this item exists in the preserved summary and has been linked. Group-specific follow-up loss, administrative censoring, missingness reasons, sensitivity analyses and observation after discontinuation are absent from the original summary. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Endpoint-specific missingness or censoring, discontinuation, analysis plans and sensitivity results	Proposal: Supplementary reports of missingness or follow-up materials based on actual flow and original analysis assumptions
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat original record describes the allocation process?Required	The existing research description preserves the quotation that participants were registered using an interactive voice- or web-response system and randomized. The 2:1 allocation is the group allocation ratio within the same trial. R01	Some information for this item exists in the preserved summary and has been linked. Original details of random-number generation, stratification variables, sequence access, operational roles and baseline balance remain externally unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original locations of allocation or concealment procedures and baseline tables	Proposal: Materials linking allocation history and original analysis when registration, protocols or reports are actually supplied
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionWhom and which procedures does the double-blinding record concern?Required	Preserve the original records ‘randomized, double-blind’ and ‘matching placebo’. A blinding description is not automatically identical to current outcome-specific measurement procedures. R01	Some information for this item exists in the preserved summary and has been linked. Specific blinding of participants, clinicians, outcome assessors and statisticians, unblinding, success and imaging interpretation remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Blinded parties, maintenance or unblinding and endpoint-specific assessment procedures	Proposal: Distinguish blinding scope through original materials reporting actual assessment conditions for each outcome
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionAre randomized design and current bias judgments separated?Required	The parent historically recorded a large randomized trial with a hard endpoint and four B0 evidence items. No RoB2 assessment or new bias grade is performed during this production work. R01	Some information for this item exists in the preserved summary and has been linked. Official outcome-specific risk assessment and original-document comparison remain within the user's review scope. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original details of design, allocation, missingness, measurement and selective reporting	Proposal: An updated draft documenting outcome-specific design information when additional original materials are supplied
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat is the effect of interest for adherence, treatment changes and the randomized comparison?Required	Preserved values concern the randomized everolimus-versus-placebo comparison. Nominal research exposure is distinguished from actual medication use and maintenance effects. R01	Some information for this item exists in the preserved summary and has been linked. PP or adherence effects, actual dose intensity and group-specific treatment-change or subsequent-treatment analyses remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Effect of interest, analysis population and handling of adherence or treatment changes	Proposal: Supplementary reports from the same trial explicitly linking analyses different from the randomized comparison
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionDo outcome collection and assessment procedures fit the actual endpoints?Required	Overall survival, disease control and time to progression are different measured outcomes within the same trial. The double-blind design is preserved, but outcome-specific interpretation or ascertainment methods are separately required. R01	Some information for this item exists in the preserved summary and has been linked. Death ascertainment routes, imaging criteria, assessment schedules, central review, assessor blinding and repeated assessments remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Endpoint-specific definitions, methods, assessors, schedules and missing measurements	Proposal: Original reports or appendices linking actual endpoint measurement procedures to reported values
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionCan analysis models, adjustment and between-group or within-group outcomes be distinguished?Required	Preserved numbers are between-group HR and P comparisons and group-specific medians or proportions. Group-specific medians or proportions are not written as within-group changes. R01	Some information for this item exists in the preserved summary and has been linked. HR models, adjustment variables, stratification, assumptions, proportion-comparison tests and sensitivity analyses remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Estimate definitions in statistical methods, SAP and original outcome tables	Proposal: Additional materials publishing original models and distinguishing adjusted from unadjusted outcomes
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhat is the history of prespecified primary overall survival and registration?Required	Preserve the existing research description's quotation ‘The primary end point was overall survival’ and recorded agreement with NCT01035229. The registration number is the original identifier in the existing evidence list. R01	Some information for this item exists in the preserved summary and has been linked. Current registration documents, change history, protocol and SAP were not read or compared. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original locations of primary endpoints, analyses and times in registration versions, protocol, SAP and report	Proposal: A linked draft distinguishing prespecification and reasons for changes in follow-up work that receives actual plan materials
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhat is the scope of secondary positivity after primary failure and multiplicity?Required	The existing reader answer and counterview record positive secondary disease control after failure of primary overall survival. Preserve the parent's primary-failed-secondary-positive marker as true. R01	Some information for this item exists in the preserved summary and has been linked. Complete secondary endpoint lists, hierarchical testing, multiplicity adjustment, prespecified confirmatory status and changes remain externally unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Complete primary or secondary outcome lists and multiplicity plans in protocol, SAP and registration	Proposal: A draft distinguishing the statistical scope of secondary outcomes when plan and result materials from the same trial are supplied
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionAre direct materials available for subgroups, responders, dose and persistence questions?Supplementary; required for extension	The parent's population is Child-Pugh A after sorafenib failure or intolerance, and research exposure is 7.5 mg/day. Molecular selection, responders and other-dose or persistence effects are not separately supplied. R01	Some information for this item exists in the preserved summary and has been linked. Prespecified subgroups, interactions, molecular markers, direct dose comparisons and outcomes after treatment discontinuation remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Prespecified subgroup, interaction and exposure-specific original outcomes and plans	Proposal: Link additional research materials with explicit population or exposure, distinguishing the same from separate study families
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionCan this scope be extended to other liver function, treatment lines or long-term harms?Supplementary; required for extension	The current draft is limited to historical EVOLVE-1: Child-Pugh A advanced hepatocellular carcinoma after sorafenib. Other liver function, populations, treatment lines and current strategies are outside this direct result's scope. R01	Direct details of this condition were not verified within the current preserved-summary and externally unread scope. No new search was conducted for direct materials on other populations or exposures, longer observation, rare harms or current treatment combinations. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Direct comparisons and safety materials by extended population, exposure and duration	Proposal: Link materials for separate indications or durations with explicit differences in applicability from the existing results when supplied
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionWhat are the definition and secondary hierarchy of disease control?Required	The selected existing question is increased disease control, grade C. Its note states 56.1% versus 45.1%, but a secondary endpoint after the primary survival endpoint failed. R01	Some information for this item exists in the preserved summary and has been linked. Response or stable-disease components, imaging assessment criteria, duration conditions and definitions of comparable assessed populations remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	DCR definition, response criteria, primary or secondary plans and result tables	Proposal: Original reports or appendices from the same trial specifying disease-control definitions and analysis scope
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionWhat original between-group values are 56.1% versus 45.1% and P=.01?Required	Disease control for everolimus versus placebo was 56.1% versus 45.1% (P=.01). The existing counterpoint description of an 11%p difference is preserved as a value already in the preserved summary. R01	Some information for this item exists in the preserved summary and has been linked. The summary does not contain CI for the estimate, analysis methods for the proportion difference, adjustments or multiplicity handling. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original DCR result tables, denominators, CI and testing or adjustment methods	Proposal: The same DCR report jointly presenting proportions, effect intervals and plans
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionWhat are the DCR denominators and numbers of people with disease control?Required	The overall randomized and analyzed denominator was 546 participants (362/184). These are the parent original sample records; DCR assessable or analysis denominators and participant counts are not separately given in the original summary. R01	Direct details of this condition were not verified within the current preserved-summary and externally unread scope. Group-specific DCR denominators, numerators, completed imaging assessments, missing assessments and analysis-inclusion rules remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original DCR sample and event tables, assessment flow and analysis-population definitions	Proposal: Original result tables distinguishing randomized, analyzed, assessable and disease-control denominators
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionHow are non-assessment, death, progression and stable disease handled in DCR?Required	DCR is a proportion outcome, while overall survival is a time-to-death outcome. The original record that everyone was included in the full analysis population does not mean that every DCR imaging or response status was known. R01	Direct details of this condition were not verified within the current preserved-summary and externally unread scope. Classification, missing-data handling and sensitivity analyses for non-assessment, early death, progression and incomplete imaging remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	DCR analysis rules, response classification and missing-data or death-handling tables	Proposal: Materials specifying original DCR analyses for non-assessment, death or discontinuation
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionWhat are the DCR assessment times and minimum duration?Required	The original materials give disease control of 56.1% versus 45.1%, but do not separately state the assessment time or duration for that proportion. R01	Direct details of this condition were not verified within the current preserved-summary and externally unread scope. Whether this was best overall response or a particular time point, minimum stable-disease duration, imaging intervals and data cutoff remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	DCR definition, assessment schedule, minimum duration and data-cutoff date	Proposal: Materials from the same trial linking time-specific or duration-specific DCR to original analyses
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWhat is the scope of imaging interpretation, central or local assessment and assessor blinding?Required	The original trial design was double-blind with matching placebo. Separate information is needed on who interpreted disease-control imaging and how. R01	Direct details of this condition were not verified within the current preserved-summary and externally unread scope. Tumor-assessment criteria, measurement error, central or local interpretation, assessor blinding and response confirmation remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	DCR imaging criteria, assessors, original interpretation methods and appendices	Proposal: Materials from the same trial reporting actual DCR measurement or interpretation procedures and their agreement or differences
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionWhat are DCR effect intervals, clinical importance and multiplicity?Required	The preserved DCR values and P=.01 are original records of a secondary result. The hierarchy restriction of positivity after survival failure is preserved alongside them. R01	Some information for this item exists in the preserved summary and has been linked. CI for the DCR effect, prespecified importance, hierarchical or multiplicity adjustment and confirmatory status remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	DCR effect intervals, SAP, primary or secondary testing order and importance criteria	Proposal: Materials linking planned and reported DCR intervals and testing scope
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre positive DCR and the null primary overall-survival result distinguished?Required	In the same trial, median OS was 7.6 versus 7.3 months, with 303/362 (83.7%) versus 151/184 (82.1%) deaths; HR 1.05 (95% CI 0.86 to 1.27; P=.68). The parent verdict and overall-survival sheet preserve the failure to increase survival. R01	Some information for this item exists in the preserved summary and has been linked. External materials directly verifying differences in models, times or denominators between the two endpoints and the DCR-OS relationship remain unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Definitions, denominators, estimates and plans for each endpoint and their same-trial relationship	Proposal: Original same-trial result tables presenting DCR and OS together without merging them
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionWhat are the units and directions of time to progression and DCR?Required	TTP was a separate result of 3.0 versus 2.6 months, HR 0.93 (95% CI 0.75 to 1.15). DCR proportions and TTP time or HR use different units and analyses. R01	Some information for this item exists in the preserved summary and has been linked. Progression assessment, censoring or death handling, denominators, P and links to DCR assessment times remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	TTP definition and original results, DCR definition and separation of the two analyses	Proposal: The same report linking original tumor assessments to progression-time definitions and follow-up
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionDoes disease control answer questions about patient symptoms, quality of life or long-term outcomes?Required	The existing central explanation states that a higher tumor-control proportion did not translate into longer life. The selected question concerns DCR itself; survival, symptoms and quality of life are separate. R01	Some information for this item exists in the preserved summary and has been linked. This summary does not contain patient-reported symptoms, quality of life, tumor-control duration, individual benefit or mediation or surrogate validation. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Direct DCR and patient-centered outcome materials, times, denominators and original analyses	Proposal: Materials separately reporting tumor control and patient-centered outcomes in the same or an appropriate separate study
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWhat was the original all-grade stomatitis comparison?Required	The original record reports all-grade stomatitis of 39.6% versus 4.9%. This is a safety outcome distinct from tumor control or survival. R01	Some information for this item exists in the preserved summary and has been linked. Stomatitis event counts, safety denominators, collection or classification, times, CI and P remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original stomatitis tables, safety population, grading criteria and duration	Proposal: Original safety materials linking stomatitis in the same exposed population with denominators and duration
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat were the grade 3 or 4 anemia comparison and original statistical level?Required	Grade 3 or 4 anemia was 7.8% versus 3.3%, with the original safety comparison recorded as descriptive statistics. R01	Some information for this item exists in the preserved summary and has been linked. Anemia event counts, denominators, baseline anemia, grading criteria, between-group CI or P and timing remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Anemia safety tables, denominators or duration, classification and baseline status	Proposal: Materials publishing hematologic harms from the same trial at the original population, timing and analysis level
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionWhat were the original grade 3 or 4 asthenia and decreased-appetite values?Required	Preserve grade 3 or 4 asthenia of 7.8% versus 5.5% and decreased appetite of 6.1% versus 0.5% separately. Original safety comparisons were descriptive statistics. R01	Some information for this item exists in the preserved summary and has been linked. Event-specific denominators, participants versus event counts, co-occurring events, causes or timing, CI or P and classifications remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original tables, denominators, grading, collection and timing for each safety event	Proposal: Safety materials reporting asthenia and decreased appetite as separate events under the same exposure
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionHow are asymptomatic hepatitis B reactivation and discontinuation distinguished?Required	The original record reports asymptomatic hepatitis B reactivation by central laboratory testing in 29 versus 10 participants, and discontinuation in 3 everolimus participants. Asymptomatic test results and medication discontinuation are separate events. R01	Some information for this item exists in the preserved summary and has been linked. Reactivation criteria, baseline HBV or at-risk denominators, testing times, prophylaxis, discontinuation timing or attribution and CI or P remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	HBV testing criteria, populations at risk, group denominators or follow-up and original discontinuation tables	Proposal: Safety materials linking HBV reactivation and discontinuation under the same exposure with populations at risk
35	Unverified	Full text not readStored summary read	N35 · Evidence conditionWhat is the scope of safety denominators, exposure duration and complete collection?Required	The parent records stomatitis, hematologic or hepatic outcomes and Caution status. Distinguish the full randomized-analysis denominator from safety exposure or assessment denominators. R01	Direct details of this condition were not verified within the current preserved-summary and externally unread scope. Safety populations, actual exposure durations, event-specific populations at risk, collection or follow-up, post-discontinuation events, losses and rare harms remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Safety analysis definitions, exposure, all-event tables and collection or follow-up materials	Proposal: Original reports from the same trial specifying safety populations, timing and missingness
36	Partly verified	Full text not readStored summary read	N36 · Evidence conditionWhat are baseline disease, concurrent treatment and alternative causes of harms?Required	Advanced hepatocellular carcinoma, Child-Pugh A, prior sorafenib failure or intolerance and supportive care are the original population or exposure context. Detailed medication attribution of recorded events is separate. R01	Some information for this item exists in the preserved summary and has been linked. Baseline liver disease or HBV, anemia, concurrent medications, subsequent treatment, alternative causes and group-specific adjustment remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Baseline risks, concomitant or subsequent treatments, event attribution and original analyses	Proposal: Supplementary safety materials separately publishing baseline disease and exposure or event relationships
37	Partly verified	Full text not readStored summary read	N37 · Evidence conditionWho supplied research funding, study medication and placebo?Required	Preserve Novartis Pharmaceuticals sponsorship, study medication or placebo supply, data management, statistical analysis and writing support from original funding information and narrative. R01	Some information for this item exists in the preserved summary and has been linked. Original contracts, funding details, complete individual-interest disclosures and current changes remain externally unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original funding, product supply, contracts and disclosed interests	Proposal: Original materials publishing actual-report funding, product supply and roles together
38	Partly verified	Full text not readStored summary read	N38 · Evidence conditionHow did the sponsor participate in design, data collection and analysis?Required	The existing research description records Novartis participation in design, collection through its data-management system and analysis by its statistical team. R01	Some information for this item exists in the preserved summary and has been linked. Specific scope of full data access, original statistical responsibility, independent reanalysis and operational contracts remains unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Design, collection and analysis role declarations, data access and statistical responsibility	Proposal: Original declarations or supplementary materials specifying reported roles and the scope of actual analysis disclosure
39	Partly verified	Full text not readStored summary read	N39 · Evidence conditionWhat were employee-author, writing and submission-decision roles?Required	The preserved summary records employee authors participating in interpretation, writing and submission decisions, and Novartis paying ApotheCom's medical-writing costs. R01	Some information for this item exists in the preserved summary and has been linked. Complete individual-author COI, writing or approval and submission-authority contracts and role changes remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Author employment or COI, contributions, writing and publication-role declarations	Proposal: Materials linking original author or sponsor roles and disclosed interests
40	Partly verified	Full text not readStored summary read	N40 · Evidence conditionWhat is the actual scope of independent replication or separate safety materials?Required	The preserved evidence or citation list contains 1 EVOLVE-1 report record; parent replication R1 and independence I0 are historical axes. The two sheets or repeated safety citations are not counted as separate replications. R01	Some information for this item exists in the preserved summary and has been linked. No new search was conducted for independent trials, additional report or cohort lists, duplicate events or external safety or regulatory materials. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Reports, study families, COI, shared outcomes and contrary-material lists	Proposal: Relationship records specifying repeated citation, shared populations or separate populations when separate materials are actually supplied
41	Partly verified	Full text not readStored summary read	N41 · Evidence conditionAt what level are efficacy outcomes and descriptive harms described?Required	Retain null OS, positive secondary DCR and descriptive harms as their respective original results. Parent safety Caution is historical and does not confirm safety or absence of all harms. R01	Some information for this item exists in the preserved summary and has been linked. Current synthesis of event-specific comparative estimates, causal attribution and long-term or rare harms remains unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original efficacy and safety tables, definitions, denominators or times and interpretive scope	Proposal: Original reports separately specifying the different analysis levels for efficacy and harms
42	Partly verified	Full text not readStored summary read	N42 · Evidence conditionHow are parent grade, score, false or empty axis values and Korean or English drafts preserved?Required	Preserve parent D, 34, Caution and axes B/H/R1/I0/E0/B0/C0; coprimary split false, large hard-endpoint RCT true, no-human-study false, primary-failed-secondary-positive true and empty override reasons. Complete Korean and English drafts and historical synthesis or grade decisions are context. R01	Some information for this item exists in the preserved summary and has been linked. Original cross-checking, grades and axes were not automatically applied as current review completion or selected subclaim values. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Separate copies preserving subclaim and parent values, Korean or English drafts, axes and historical verdict	Proposal: Preserved records separating complete pre-change originals, events, versions and decisions when verdict corrections are actually supplied
43	Partly verified	Full text not readStored summary read	N43 · Evidence conditionDo the cutoff date, corrections and empty values differ from current production dates?Required	Preserve original cutoff 2026-08-26 and empty correction and deliberation values. Bibliography or registration-agreement descriptions in the original Korean and English drafts are historical, while the current writing time is a production event. R01	Some information for this item exists in the preserved summary and has been linked. Original additional-cutoff and detailed-classification fields are absent; no new search, registration, correction or retraction comparison or external reading was performed. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Distinguishing original cutoff, correction, retraction or search history from production events	Proposal: Update records distinguishing historical scope from current additional events when materials or corrections are actually supplied
44	Partly verified	Full text not readStored summary read	N44 · Evidence conditionIs the scope kept from extending to current applicability, products or treatment decisions?Supplementary; required for extending applicability	This sheet documents the specified existing claim and EVOLVE-1's historical comparison, outcomes and gaps. Other products or doses, current treatment lines and individual treatment choice are outside this production scope. R01	Some information for this item exists in the preserved summary and has been linked. Current clinical practice, product or regulatory status, individual suitability and direct superiority of other treatments were not verified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Appropriate direct materials for extended questions and applicability differences from the original trial	Proposal: Research-gap updates distinguishing selected scope, outcomes and harms when additional materials are authorized and supplied

No items match your search or filter.

44 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Child-Pugh A advanced hepatocellular carcinoma after sorafenib failure or intolerance; original selected population at 121 centers in 17 countries
Ingredient, formulation and route: Original trial intervention of everolimus plus best supportive care
Dose: Historical research exposure of 7.5 mg/day; nominal or actual exposure, formulation and route details remain unverified; not dosing instructions
Comparator: Original matching-placebo record; actual group-specific supportive or subsequent treatment remains unverified
Measured outcome: Secondary disease control after the primary survival endpoint failed; definition, assessment times, denominators and CI details remain unverified
Duration: Original median OS 7.6/7.3 months and TTP 3.0/2.6 months are endpoint time values; total follow-up or exposure and DCR assessment times remain unverified
Questions outside this scope: Transferring DCR or TTP into OS benefit; Certifying non-significant OS as zero effect, equivalence or safety; Extension to other Child-Pugh classes, treatment lines, doses, products or current treatment strategies; Medication, treatment-choice, substitution or discontinuation instructions; Adding the same two sheets or endpoints as new independent trials or participants

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Zhu AX, Kudo M, Assenat E, et al. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: the EVOLVE-1 randomized clinical trial. JAMA. 2014;312:57-67. PMID: 25058218.

PubMed

Material type: Original summary of the same randomized, double-blind, placebo-controlled phase 3 trial report
Materials actually read: Summary read; external abstracts, full texts and registrations unread
Findings recorded in the stored summary: Disease control for everolimus versus placebo was 56.1% versus 45.1% (P=.01). The existing counterpoint description of an 11%p difference is preserved as a value already in the preserved summary.
Record level: Not recorded
Study overlap and independent replication: The overall-survival and disease-control sheets share the same EVOLVE-1, PMID25058218, NCT01035229 and 546 participants (362/184). OS, DCR, TTP and safety are separated as outcome units; no additional trials or new participants are added.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Preserved complete summary copy	Preserved summary copy acquired; summary read	Summary read	Parent Korean and English drafts, two existing questions, bibliography, registration and original values were read for production; this is not reading clinical original materials.
External abstract	External material unread; no access attempts	Access not attempted; not obtained	Not read	The original PubMed bibliographic URL was linked. Abstract reading, material acquisition and operation tests were not performed.
External full text	External material unread; no access attempts	Access not attempted; not obtained	Not read	The original bibliographic URL links identity; it does not certify a direct full-text acquisition or reading URL.
External registration	External material unread; no access attempts	Access not attempted; not obtained	Not read	Preserve the registration-ID record and original agreement wording. No registration URL absent from the existing summary was constructed, and current registration was not read.
Required protocol	Not acquired; detailed existence unverified	Access not attempted; not obtained	Not read	Original details of OS definitions, DCR or progression criteria, assessment times, exposure and blinding are required. Lack of acquisition is not converted into confirmed non-registration or selective reporting.
Required analysis plan	Not acquired; detailed existence unverified	Access not attempted; not obtained	Not read	Original OS HR analysis, DCR intervals or tests, hierarchy, multiplicity and missing-data handling materials are required. No new CI or verdict is created.
Required result tables and safety material	Not acquired; detailed existence unverified	Access not attempted; not obtained	Not read	Original tables are required to distinguish allocation or full analysis from DCR assessment, OS censoring, safety or at-risk denominators and descriptive harms.
Required sponsorship and competing-interest materials	Not acquired; detailed existence unverified	Access not attempted; not obtained	Not read	Original sponsorship, design, collection, analysis, writing and submission-role descriptions are preserved; complete COI, contracts and original declarations remain unread.

Report counts versus independent study counts

The overall-survival and disease-control sheets share the same EVOLVE-1, PMID25058218, NCT01035229 and 546 participants (362/184). OS, DCR, TTP and safety are separated as outcome units; no additional trials or new participants are added.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which existing question is being transferred to this sheet?

Required materials and conditions: Preserved draft distinguishing the existing question, record location and parent and sibling scopes
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Which existing question is being transferred to this sheet" and link them to original locations. The original candidate's boundary-review pending state is historical; review of the existing question boundary remains incomplete.
Requirement and applicability: Required
Application exceptions: The original candidate's boundary-review pending state is historical; review of the existing question boundary remains incomplete. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Which existing question is being transferred to this sheet.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01.

N02 · How are the subclaim grade and note distinguished from the parent score and axes?

Required materials and conditions: Separate locations for the selected subclaim wording and parent verdict history
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are the subclaim grade and note distinguished from the parent score and axes" and link them to original locations. Direct values for the subclaim score, status and axes are absent from the original.
Requirement and applicability: Required
Application exceptions: Do not uniformly change subclaim C or D to D or inherit the parent's 34 points as a subclaim score.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are the subclaim grade and note distinguished from the parent score and axes.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09.

N03 · Do the two sheets concern the same EVOLVE-1 report, trial and population?

Required materials and conditions: Relationship table for bibliography, registration, shared cohort and individual outcomes
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Do the two sheets concern the same EVOLVE-1 report, trial and population" and link them to original locations. Other report versions, follow-up results and current unique study or participant totals have not been established.
Requirement and applicability: Required
Application exceptions: Do not add the two sheets' 546 participants, 362/184 or two questions as independent replications or new participants.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Do the two sheets concern the same EVOLVE-1 report, trial and population.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.

N04 · What materials were actually read during this work?

Required materials and conditions: Material records separating the preserved summary from external original materials
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What materials were actually read during this work" and link them to original locations. External availability, acquisition, reading and link operation were not verified during this work.
Requirement and applicability: Required
Application exceptions: Summary reading is not labeled as reading clinical original materials, and no access attempt is not converted into access failure.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What materials were actually read during this work.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C03.

N05 · What is the selected population and previous sorafenib-treatment scope?

Required materials and conditions: Recruitment criteria, baseline tables, previous treatment and distinctions between failure and intolerance
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the selected population and previous sorafenib-treatment scope" and link them to original locations. Age, sex, etiology, baseline tumor burden, specific inclusion or exclusion criteria and the respective proportions of failure and intolerance are absent from the preserved summary.
Requirement and applicability: Required
Application exceptions: Age, sex, etiology, baseline tumor burden, specific inclusion or exclusion criteria and the respective proportions of failure and intolerance are absent from the preserved summary. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the selected population and previous sorafenib-treatment scope.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E08.

N06 · How are 17 countries, 121 centers and participant distributions related?

Required materials and conditions: Center, country and recruitment flow and baseline distribution tables
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are 17 countries, 121 centers and participant distributions related" and link them to original locations. Recruitment counts by country or center, baseline balance, regional outcomes and follow-up differences remain unverified.
Requirement and applicability: Required
Application exceptions: Recruitment counts by country or center, baseline balance, regional outcomes and follow-up differences remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are 17 countries, 121 centers and participant distributions related.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E01, E07.

N07 · What was the actual everolimus exposure and dose scope?

Required materials and conditions: Study product or formulation and nominal or actual exposure and change materials
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What was the actual everolimus exposure and dose scope" and link them to original locations. Original formulation, detailed administration route, exposure duration, actual cumulative dose, dose reduction, discontinuation and adherence materials remain unverified.
Requirement and applicability: Required
Application exceptions: Nominal 7.5 mg/day is not converted into an individual dose or effects of other formulations or doses.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What was the actual everolimus exposure and dose scope.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.

N08 · How are placebo, supportive care and subsequent treatments distinguished?

Required materials and conditions: Group-specific concomitant and subsequent treatments, departures and analysis handling tables
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are placebo, supportive care and subsequent treatments distinguished" and link them to original locations. Actual supportive-care balance, subsequent anticancer or rescue therapy, departures, crossover and analysis handling remain unverified.
Requirement and applicability: Required
Application exceptions: Matching placebo alone does not establish that all concomitant and subsequent treatments were identical.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are placebo, supportive care and subsequent treatments distinguished.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02.

N09 · What were randomization, full-analysis and group denominators?

Required materials and conditions: Allocation-to-exposure-to-analysis flow, endpoint denominators and exclusion reasons
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What were randomization, full-analysis and group denominators" and link them to original locations. Endpoint-specific measurable, completed, followed and safety-analysis denominators require separate tables.
Requirement and applicability: Required
Application exceptions: The full-analysis description is not extended to complete observation of all imaging or safety data or current ITT certification.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What were randomization, full-analysis and group denominators.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.

N10 · What is the scope of handling missingness, follow-up loss and discontinuation?

Required materials and conditions: Endpoint-specific missingness or censoring, discontinuation, analysis plans and sensitivity results
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the scope of handling missingness, follow-up loss and discontinuation" and link them to original locations. Group-specific follow-up loss, administrative censoring, missingness reasons, sensitivity analyses and observation after discontinuation are absent from the original summary.
Requirement and applicability: Required
Application exceptions: Group-specific follow-up loss, administrative censoring, missingness reasons, sensitivity analyses and observation after discontinuation are absent from the original summary. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the scope of handling missingness, follow-up loss and discontinuation.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04, H06.

N11 · What original record describes the allocation process?

Required materials and conditions: Original locations of allocation or concealment procedures and baseline tables
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What original record describes the allocation process" and link them to original locations. Original details of random-number generation, stratification variables, sequence access, operational roles and baseline balance remain externally unread.
Requirement and applicability: Required
Application exceptions: Original details of random-number generation, stratification variables, sequence access, operational roles and baseline balance remain externally unread. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What original record describes the allocation process.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01.

N12 · Whom and which procedures does the double-blinding record concern?

Required materials and conditions: Blinded parties, maintenance or unblinding and endpoint-specific assessment procedures
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Whom and which procedures does the double-blinding record concern" and link them to original locations. Specific blinding of participants, clinicians, outcome assessors and statisticians, unblinding, success and imaging interpretation remain unverified.
Requirement and applicability: Required
Application exceptions: Specific blinding of participants, clinicians, outcome assessors and statisticians, unblinding, success and imaging interpretation remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Whom and which procedures does the double-blinding record concern.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01, E03.

N13 · Are randomized design and current bias judgments separated?

Required materials and conditions: Original details of design, allocation, missingness, measurement and selective reporting
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Are randomized design and current bias judgments separated" and link them to original locations. Official outcome-specific risk assessment and original-document comparison remain within the user's review scope.
Requirement and applicability: Required
Application exceptions: Parent B0 and the true large-hard-endpoint-RCT marker are not automatically inherited as fulfillment of conditions for both subclaims.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Are randomized design and current bias judgments separated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01, E03, E04, E06.

N14 · What is the effect of interest for adherence, treatment changes and the randomized comparison?

Required materials and conditions: Effect of interest, analysis population and handling of adherence or treatment changes
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the effect of interest for adherence, treatment changes and the randomized comparison" and link them to original locations. PP or adherence effects, actual dose intensity and group-specific treatment-change or subsequent-treatment analyses remain unverified.
Requirement and applicability: Required
Application exceptions: PP or adherence effects, actual dose intensity and group-specific treatment-change or subsequent-treatment analyses remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the effect of interest for adherence, treatment changes and the randomized comparison.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E02, E04.

N15 · Do outcome collection and assessment procedures fit the actual endpoints?

Required materials and conditions: Endpoint-specific definitions, methods, assessors, schedules and missing measurements
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Do outcome collection and assessment procedures fit the actual endpoints" and link them to original locations. Death ascertainment routes, imaging criteria, assessment schedules, central review, assessor blinding and repeated assessments remain unverified.
Requirement and applicability: Required
Application exceptions: Death ascertainment routes, imaging criteria, assessment schedules, central review, assessor blinding and repeated assessments remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Do outcome collection and assessment procedures fit the actual endpoints.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E03.

N16 · Can analysis models, adjustment and between-group or within-group outcomes be distinguished?

Required materials and conditions: Estimate definitions in statistical methods, SAP and original outcome tables
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Can analysis models, adjustment and between-group or within-group outcomes be distinguished" and link them to original locations. HR models, adjustment variables, stratification, assumptions, proportion-comparison tests and sensitivity analyses remain unverified.
Requirement and applicability: Required
Application exceptions: HR models, adjustment variables, stratification, assumptions, proportion-comparison tests and sensitivity analyses remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Can analysis models, adjustment and between-group or within-group outcomes be distinguished.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.

N17 · What is the history of prespecified primary overall survival and registration?

Required materials and conditions: Original locations of primary endpoints, analyses and times in registration versions, protocol, SAP and report
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the history of prespecified primary overall survival and registration" and link them to original locations. Current registration documents, change history, protocol and SAP were not read or compared.
Requirement and applicability: Required
Application exceptions: Original registration-agreement wording is not labeled as current registration reading or prespecification certification.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the history of prespecified primary overall survival and registration.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, C09.

N18 · What is the scope of secondary positivity after primary failure and multiplicity?

Required materials and conditions: Complete primary or secondary outcome lists and multiplicity plans in protocol, SAP and registration
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the scope of secondary positivity after primary failure and multiplicity" and link them to original locations. Complete secondary endpoint lists, hierarchical testing, multiplicity adjustment, prespecified confirmatory status and changes remain externally unread.
Requirement and applicability: Required
Application exceptions: P=.01 is not automatically promoted into confirmatory success, survival benefit or a new grade.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the scope of secondary positivity after primary failure and multiplicity.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, C08, E09.

N19 · Are direct materials available for subgroups, responders, dose and persistence questions?

Required materials and conditions: Prespecified subgroup, interaction and exposure-specific original outcomes and plans
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Are direct materials available for subgroups, responders, dose and persistence questions" and link them to original locations. Prespecified subgroups, interactions, molecular markers, direct dose comparisons and outcomes after treatment discontinuation remain unverified.
Requirement and applicability: Supplementary; required for extension
Application exceptions: Prespecified subgroups, interactions, molecular markers, direct dose comparisons and outcomes after treatment discontinuation remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Are direct materials available for subgroups, responders, dose and persistence questions.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E08, E07.

N20 · Can this scope be extended to other liver function, treatment lines or long-term harms?

Required materials and conditions: Direct comparisons and safety materials by extended population, exposure and duration
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Can this scope be extended to other liver function, treatment lines or long-term harms" and link them to original locations. No new search was conducted for direct materials on other populations or exposures, longer observation, rare harms or current treatment combinations.
Requirement and applicability: Supplementary; required for extension
Application exceptions: No new search was conducted for direct materials on other populations or exposures, longer observation, rare harms or current treatment combinations. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Can this scope be extended to other liver function, treatment lines or long-term harms.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E08, H08.

N21 · What are the definition and secondary hierarchy of disease control?

Required materials and conditions: DCR definition, response criteria, primary or secondary plans and result tables
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are the definition and secondary hierarchy of disease control" and link them to original locations. Response or stable-disease components, imaging assessment criteria, duration conditions and definitions of comparable assessed populations remain unverified.
Requirement and applicability: Required
Application exceptions: C is the selected subclaim's historical grade; it is not changed into parent D34 or a current clinical verdict.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are the definition and secondary hierarchy of disease control.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E06, E09.

N22 · What original between-group values are 56.1% versus 45.1% and P=.01?

Required materials and conditions: Original DCR result tables, denominators, CI and testing or adjustment methods
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What original between-group values are 56.1% versus 45.1% and P=.01" and link them to original locations. The summary does not contain CI for the estimate, analysis methods for the proportion difference, adjustments or multiplicity handling.
Requirement and applicability: Required
Application exceptions: Do not back-calculate new responder counts, differences, OR/RR or CI from rounded proportions.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What original between-group values are 56.1% versus 45.1% and P=.01.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, E05.

N23 · What are the DCR denominators and numbers of people with disease control?

Required materials and conditions: Original DCR sample and event tables, assessment flow and analysis-population definitions
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are the DCR denominators and numbers of people with disease control" and link them to original locations. Group-specific DCR denominators, numerators, completed imaging assessments, missing assessments and analysis-inclusion rules remain unverified.
Requirement and applicability: Required
Application exceptions: OS denominators 362/184 are not transferred into verified DCR denominators, and responder counts are not calculated from proportions.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are the DCR denominators and numbers of people with disease control.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.

N24 · How are non-assessment, death, progression and stable disease handled in DCR?

Required materials and conditions: DCR analysis rules, response classification and missing-data or death-handling tables
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are non-assessment, death, progression and stable disease handled in DCR" and link them to original locations. Classification, missing-data handling and sensitivity analyses for non-assessment, early death, progression and incomplete imaging remain unverified.
Requirement and applicability: Required
Application exceptions: Classification, missing-data handling and sensitivity analyses for non-assessment, early death, progression and incomplete imaging remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are non-assessment, death, progression and stable disease handled in DCR.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E04, C07.

N25 · What are the DCR assessment times and minimum duration?

Required materials and conditions: DCR definition, assessment schedule, minimum duration and data-cutoff date
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are the DCR assessment times and minimum duration" and link them to original locations. Whether this was best overall response or a particular time point, minimum stable-disease duration, imaging intervals and data cutoff remain unverified.
Requirement and applicability: Required
Application exceptions: Median OS of 7.6/7.3 months or TTP of 3.0/2.6 months are not used to fill DCR assessment periods.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are the DCR assessment times and minimum duration.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E03, E08.

N26 · What is the scope of imaging interpretation, central or local assessment and assessor blinding?

Required materials and conditions: DCR imaging criteria, assessors, original interpretation methods and appendices
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the scope of imaging interpretation, central or local assessment and assessor blinding" and link them to original locations. Tumor-assessment criteria, measurement error, central or local interpretation, assessor blinding and response confirmation remain unverified.
Requirement and applicability: Required
Application exceptions: The original double-blind design does not automatically certify completed central imaging interpretation or absence of measurement bias.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the scope of imaging interpretation, central or local assessment and assessor blinding.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E03.

N27 · What are DCR effect intervals, clinical importance and multiplicity?

Required materials and conditions: DCR effect intervals, SAP, primary or secondary testing order and importance criteria
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are DCR effect intervals, clinical importance and multiplicity" and link them to original locations. CI for the DCR effect, prespecified importance, hierarchical or multiplicity adjustment and confirmatory status remain unverified.
Requirement and applicability: Required
Application exceptions: P=.01 alone does not establish every effect size, current confirmatory success or individual clinical benefit.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are DCR effect intervals, clinical importance and multiplicity.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E05, E06.

N28 · Are positive DCR and the null primary overall-survival result distinguished?

Required materials and conditions: Definitions, denominators, estimates and plans for each endpoint and their same-trial relationship
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Are positive DCR and the null primary overall-survival result distinguished" and link them to original locations. External materials directly verifying differences in models, times or denominators between the two endpoints and the DCR-OS relationship remain unread.
Requirement and applicability: Required
Application exceptions: Positive DCR is not transferred into increased OS, and the null OS result does not justify deleting preserved DCR values.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Are positive DCR and the null primary overall-survival result distinguished.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C08, E09.

N29 · What are the units and directions of time to progression and DCR?

Required materials and conditions: TTP definition and original results, DCR definition and separation of the two analyses
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are the units and directions of time to progression and DCR" and link them to original locations. Progression assessment, censoring or death handling, denominators, P and links to DCR assessment times remain unverified.
Requirement and applicability: Required
Application exceptions: TTP is not converted into PFS, DCR duration or survival benefit, and no difference between medians is calculated.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are the units and directions of time to progression and DCR.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C08, E09.

N30 · Does disease control answer questions about patient symptoms, quality of life or long-term outcomes?

Required materials and conditions: Direct DCR and patient-centered outcome materials, times, denominators and original analyses
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Does disease control answer questions about patient symptoms, quality of life or long-term outcomes" and link them to original locations. This summary does not contain patient-reported symptoms, quality of life, tumor-control duration, individual benefit or mediation or surrogate validation.
Requirement and applicability: Required
Application exceptions: Survival success is not imposed as mandatory for DCR itself, but DCR is not automatically extended into other patient benefits.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Does disease control answer questions about patient symptoms, quality of life or long-term outcomes.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E09, E08.

N31 · What was the original all-grade stomatitis comparison?

Required materials and conditions: Original stomatitis tables, safety population, grading criteria and duration
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What was the original all-grade stomatitis comparison" and link them to original locations. Stomatitis event counts, safety denominators, collection or classification, times, CI and P remain unverified.
Requirement and applicability: Required
Application exceptions: Stomatitis event counts, safety denominators, collection or classification, times, CI and P remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What was the original all-grade stomatitis comparison.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H01, H03, H04.

N32 · What were the grade 3 or 4 anemia comparison and original statistical level?

Required materials and conditions: Anemia safety tables, denominators or duration, classification and baseline status
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What were the grade 3 or 4 anemia comparison and original statistical level" and link them to original locations. Anemia event counts, denominators, baseline anemia, grading criteria, between-group CI or P and timing remain unverified.
Requirement and applicability: Required
Application exceptions: Descriptive proportions are not newly calculated into significant risk increases, no-difference tests or incidence rates.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What were the grade 3 or 4 anemia comparison and original statistical level.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H01, H03, H04.

N33 · What were the original grade 3 or 4 asthenia and decreased-appetite values?

Required materials and conditions: Original tables, denominators, grading, collection and timing for each safety event
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What were the original grade 3 or 4 asthenia and decreased-appetite values" and link them to original locations. Event-specific denominators, participants versus event counts, co-occurring events, causes or timing, CI or P and classifications remain unverified.
Requirement and applicability: Required
Application exceptions: Do not merge the two symptoms into a new composite event, participant total or risk difference.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What were the original grade 3 or 4 asthenia and decreased-appetite values.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H03, H04, E10.

N34 · How are asymptomatic hepatitis B reactivation and discontinuation distinguished?

Required materials and conditions: HBV testing criteria, populations at risk, group denominators or follow-up and original discontinuation tables
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are asymptomatic hepatitis B reactivation and discontinuation distinguished" and link them to original locations. Reactivation criteria, baseline HBV or at-risk denominators, testing times, prophylaxis, discontinuation timing or attribution and CI or P remain unverified.
Requirement and applicability: Required
Application exceptions: Do not divide 29/10 or 3 discontinuations by full allocated denominators to calculate new proportions or risks.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are asymptomatic hepatitis B reactivation and discontinuation distinguished.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H02, H03, H04, H05.

N35 · What is the scope of safety denominators, exposure duration and complete collection?

Required materials and conditions: Safety analysis definitions, exposure, all-event tables and collection or follow-up materials
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the scope of safety denominators, exposure duration and complete collection" and link them to original locations. Safety populations, actual exposure durations, event-specific populations at risk, collection or follow-up, post-discontinuation events, losses and rare harms remain unverified.
Requirement and applicability: Required
Application exceptions: Safety populations, actual exposure durations, event-specific populations at risk, collection or follow-up, post-discontinuation events, losses and rare harms remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the scope of safety denominators, exposure duration and complete collection.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H02, H04, H06, H08.

N36 · What are baseline disease, concurrent treatment and alternative causes of harms?

Required materials and conditions: Baseline risks, concomitant or subsequent treatments, event attribution and original analyses
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are baseline disease, concurrent treatment and alternative causes of harms" and link them to original locations. Baseline liver disease or HBV, anemia, concurrent medications, subsequent treatment, alternative causes and group-specific adjustment remain unverified.
Requirement and applicability: Required
Application exceptions: Do not newly assert that other causes were absent or all events were caused by everolimus.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are baseline disease, concurrent treatment and alternative causes of harms.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H05, E02, E10.

N37 · Who supplied research funding, study medication and placebo?

Required materials and conditions: Original funding, product supply, contracts and disclosed interests
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Who supplied research funding, study medication and placebo" and link them to original locations. Original contracts, funding details, complete individual-interest disclosures and current changes remain externally unread.
Requirement and applicability: Required
Application exceptions: Original contracts, funding details, complete individual-interest disclosures and current changes remain externally unread. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Who supplied research funding, study medication and placebo.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.

N38 · How did the sponsor participate in design, data collection and analysis?

Required materials and conditions: Design, collection and analysis role declarations, data access and statistical responsibility
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How did the sponsor participate in design, data collection and analysis" and link them to original locations. Specific scope of full data access, original statistical responsibility, independent reanalysis and operational contracts remains unverified.
Requirement and applicability: Required
Application exceptions: Sponsor involvement alone does not justify deleting original numbers or deriving a new null effect or bias magnitude.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How did the sponsor participate in design, data collection and analysis.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10, E04.

N39 · What were employee-author, writing and submission-decision roles?

Required materials and conditions: Author employment or COI, contributions, writing and publication-role declarations
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What were employee-author, writing and submission-decision roles" and link them to original locations. Complete individual-author COI, writing or approval and submission-authority contracts and role changes remain unverified.
Requirement and applicability: Required
Application exceptions: Complete individual-author COI, writing or approval and submission-authority contracts and role changes remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What were employee-author, writing and submission-decision roles.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.

N40 · What is the actual scope of independent replication or separate safety materials?

Required materials and conditions: Reports, study families, COI, shared outcomes and contrary-material lists
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the actual scope of independent replication or separate safety materials" and link them to original locations. No new search was conducted for independent trials, additional report or cohort lists, duplicate events or external safety or regulatory materials.
Requirement and applicability: Required
Application exceptions: One literature record or two existing sheets are not converted into current worldwide trial totals or confirmed independent replication.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the actual scope of independent replication or separate safety materials.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, C10, E07, H07.

N41 · At what level are efficacy outcomes and descriptive harms described?

Required materials and conditions: Original efficacy and safety tables, definitions, denominators or times and interpretive scope
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "At what level are efficacy outcomes and descriptive harms described" and link them to original locations. Current synthesis of event-specific comparative estimates, causal attribution and long-term or rare harms remains unverified.
Requirement and applicability: Required
Application exceptions: Non-significant survival or positive DCR does not erase harms, and descriptive statistics alone do not create a new causal safety verdict.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: At what level are efficacy outcomes and descriptive harms described.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H09, C08.

N42 · How are parent grade, score, false or empty axis values and Korean or English drafts preserved?

Required materials and conditions: Separate copies preserving subclaim and parent values, Korean or English drafts, axes and historical verdict
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are parent grade, score, false or empty axis values and Korean or English drafts preserved" and link them to original locations. Original cross-checking, grades and axes were not automatically applied as current review completion or selected subclaim values.
Requirement and applicability: Required
Application exceptions: The parent's 34 points, B0/C0 or cross-check-applied history are not inherited as subclaim scores or axes, new fulfillment or review completion.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are parent grade, score, false or empty axis values and Korean or English drafts preserved.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09, E06.

N43 · Do the cutoff date, corrections and empty values differ from current production dates?

Required materials and conditions: Distinguishing original cutoff, correction, retraction or search history from production events
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Do the cutoff date, corrections and empty values differ from current production dates" and link them to original locations. Original additional-cutoff and detailed-classification fields are absent; no new search, registration, correction or retraction comparison or external reading was performed.
Requirement and applicability: Required
Application exceptions: Empty correction history is not certified as no current corrections, and the original verification date is not changed into the current review date.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Do the cutoff date, corrections and empty values differ from current production dates.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, C03.

N44 · Is the scope kept from extending to current applicability, products or treatment decisions?

Required materials and conditions: Appropriate direct materials for extended questions and applicability differences from the original trial
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Is the scope kept from extending to current applicability, products or treatment decisions" and link them to original locations. Current clinical practice, product or regulatory status, individual suitability and direct superiority of other treatments were not verified.
Requirement and applicability: Supplementary; required for extending applicability
Application exceptions: No new medication or dosing instructions, substitution or discontinuation of sorafenib or other treatments, or anticancer-treatment choices are created.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Is the scope kept from extending to current applicability, products or treatment decisions.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, E08, E09, H08, H09.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Review of existing content or actual review incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

2026-10-11 · Public page/material version 1.0

A public view and materials were prepared from the existing 44 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which existing question is being transferred to this sheet?

Current findings: The selected existing question is increased disease control, with the question distinguished from its original verdict record. The parent overall-survival context is preserved in the complete copy; other subquestions are not separate clinical trials.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. The original candidate's boundary-review pending state is historical; review of the existing question boundary remains incomplete. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: The original candidate's boundary-review pending state is historical; review of the existing question boundary remains incomplete.
Required materials and conditions: Preserved draft distinguishing the existing question, record location and parent and sibling scopes
Materials to obtain first: Preserved draft distinguishing the existing question, record location and parent and sibling scopes
Further research: Proposal: An updated draft retaining the original question and record relationship if additional reports for the same question are supplied
Remaining uncertainty: The original candidate's boundary-review pending state is historical; review of the existing question boundary remains incomplete.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Which existing question is being transferred to this sheet" and link them to original locations. The original candidate's boundary-review pending state is historical; review of the existing question boundary remains incomplete.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Which existing question is being transferred to this sheet.
Application exceptions: The original candidate's boundary-review pending state is historical; review of the existing question boundary remains incomplete. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01.

Related sources R01

N02 · How are the subclaim grade and note distinguished from the parent score and axes?

Current findings: The selected subclaim grade is C. Its note states: 56.1% versus 45.1%, but a secondary endpoint after the primary survival endpoint failed. Subclaim score, status and axis fields are absent; parent grade D, 34 points and Caution safety status are parent history.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Direct values for the subclaim score, status and axes are absent from the original. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Direct values for the subclaim score, status and axes are absent from the original.
Required materials and conditions: Separate locations for the selected subclaim wording and parent verdict history
Materials to obtain first: Separate locations for the selected subclaim wording and parent verdict history
Further research: Proposal: A preserved copy separating complete original wording from the change event when the selected subclaim verdict itself is corrected
Remaining uncertainty: Direct values for the subclaim score, status and axes are absent from the original.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are the subclaim grade and note distinguished from the parent score and axes" and link them to original locations. Direct values for the subclaim score, status and axes are absent from the original.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are the subclaim grade and note distinguished from the parent score and axes.
Application exceptions: Do not uniformly change subclaim C or D to D or inherit the parent's 34 points as a subclaim score.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09.

Related sources R01

N03 · Do the two sheets concern the same EVOLVE-1 report, trial and population?

Current findings: The parent's evidence and citation lists each contain 1 record linking Zhu AX et al. 2014 EVOLVE-1, PMID 25058218 and NCT01035229. The two existing outcomes, time to progression and safety share this preserved report's context.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Other report versions, follow-up results and current unique study or participant totals have not been established. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Other report versions, follow-up results and current unique study or participant totals have not been established.
Required materials and conditions: Relationship table for bibliography, registration, shared cohort and individual outcomes
Materials to obtain first: Relationship table for bibliography, registration, shared cohort and individual outcomes
Further research: Proposal: An outcome-specific material list preserving the same-trial relationship when original or follow-up reports are supplied
Remaining uncertainty: Other report versions, follow-up results and current unique study or participant totals have not been established.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Do the two sheets concern the same EVOLVE-1 report, trial and population" and link them to original locations. Other report versions, follow-up results and current unique study or participant totals have not been established.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Do the two sheets concern the same EVOLVE-1 report, trial and population.
Application exceptions: Do not add the two sheets' 546 participants, 362/184 or two questions as independent replications or new participants.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.

Related sources R01

N04 · What materials were actually read during this work?

Current findings: The specified complete parent verdict summary was read for production and the original preserved. External articles, abstracts, registration and plans remain unread and access was not attempted. The PubMed URL is the existing citation link.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. External availability, acquisition, reading and link operation were not verified during this work. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: External availability, acquisition, reading and link operation were not verified during this work.
Required materials and conditions: Material records separating the preserved summary from external original materials
Materials to obtain first: Material records separating the preserved summary from external original materials
Further research: Proposal: Material records distinguishing reading level and dates when follow-up work that actually obtains new materials is authorized
Remaining uncertainty: External availability, acquisition, reading and link operation were not verified during this work.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What materials were actually read during this work" and link them to original locations. External availability, acquisition, reading and link operation were not verified during this work.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What materials were actually read during this work.
Application exceptions: Summary reading is not labeled as reading clinical original materials, and no access attempt is not converted into access failure.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C03.

Related sources R01

N05 · What is the selected population and previous sorafenib-treatment scope?

Current findings: EVOLVE-1 concerned Child-Pugh A patients with advanced hepatocellular carcinoma who failed or could not tolerate sorafenib. This scope is not transferred to all other liver diseases or treatment lines.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Age, sex, etiology, baseline tumor burden, specific inclusion or exclusion criteria and the respective proportions of failure and intolerance are absent from the preserved summary. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Age, sex, etiology, baseline tumor burden, specific inclusion or exclusion criteria and the respective proportions of failure and intolerance are absent from the preserved summary.
Required materials and conditions: Recruitment criteria, baseline tables, previous treatment and distinctions between failure and intolerance
Materials to obtain first: Recruitment criteria, baseline tables, previous treatment and distinctions between failure and intolerance
Further research: Proposal: Comparative materials specifying prespecified population-specific outcomes and scope in the same indication
Remaining uncertainty: Age, sex, etiology, baseline tumor burden, specific inclusion or exclusion criteria and the respective proportions of failure and intolerance are absent from the preserved summary.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the selected population and previous sorafenib-treatment scope" and link them to original locations. Age, sex, etiology, baseline tumor burden, specific inclusion or exclusion criteria and the respective proportions of failure and intolerance are absent from the preserved summary.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the selected population and previous sorafenib-treatment scope.
Application exceptions: Age, sex, etiology, baseline tumor burden, specific inclusion or exclusion criteria and the respective proportions of failure and intolerance are absent from the preserved summary. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E08.

Related sources R01

N06 · How are 17 countries, 121 centers and participant distributions related?

Current findings: The preserved design is a randomized, double-blind, placebo-controlled phase 3 trial at 121 centers in 17 countries. Center and country counts are not participant or independent-trial counts.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Recruitment counts by country or center, baseline balance, regional outcomes and follow-up differences remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Recruitment counts by country or center, baseline balance, regional outcomes and follow-up differences remain unverified.
Required materials and conditions: Center, country and recruitment flow and baseline distribution tables
Materials to obtain first: Center, country and recruitment flow and baseline distribution tables
Further research: Proposal: Link prespecified subgroup materials on regional or selection differences as outcomes within the same trial when available
Remaining uncertainty: Recruitment counts by country or center, baseline balance, regional outcomes and follow-up differences remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are 17 countries, 121 centers and participant distributions related" and link them to original locations. Recruitment counts by country or center, baseline balance, regional outcomes and follow-up differences remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are 17 countries, 121 centers and participant distributions related.
Application exceptions: Recruitment counts by country or center, baseline balance, regional outcomes and follow-up differences remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E01, E07.

Related sources R01

N07 · What was the actual everolimus exposure and dose scope?

Current findings: The original study compared everolimus 7.5 mg/day plus best supportive care with placebo. This value is recorded only as historical research exposure, not medication or treatment instructions.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Original formulation, detailed administration route, exposure duration, actual cumulative dose, dose reduction, discontinuation and adherence materials remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Original formulation, detailed administration route, exposure duration, actual cumulative dose, dose reduction, discontinuation and adherence materials remain unverified.
Required materials and conditions: Study product or formulation and nominal or actual exposure and change materials
Materials to obtain first: Study product or formulation and nominal or actual exposure and change materials
Further research: Proposal: Research materials distinguishing exposure-specific results within the trial conditions when supplied
Remaining uncertainty: Original formulation, detailed administration route, exposure duration, actual cumulative dose, dose reduction, discontinuation and adherence materials remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What was the actual everolimus exposure and dose scope" and link them to original locations. Original formulation, detailed administration route, exposure duration, actual cumulative dose, dose reduction, discontinuation and adherence materials remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What was the actual everolimus exposure and dose scope.
Application exceptions: Nominal 7.5 mg/day is not converted into an individual dose or effects of other formulations or doses.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.

Related sources R01

N08 · How are placebo, supportive care and subsequent treatments distinguished?

Current findings: The preserved summary records matching placebo and everolimus plus best supportive care as study conditions. Specific control-group and group-specific supportive care remain a separate scope to document.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Actual supportive-care balance, subsequent anticancer or rescue therapy, departures, crossover and analysis handling remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Actual supportive-care balance, subsequent anticancer or rescue therapy, departures, crossover and analysis handling remain unverified.
Required materials and conditions: Group-specific concomitant and subsequent treatments, departures and analysis handling tables
Materials to obtain first: Group-specific concomitant and subsequent treatments, departures and analysis handling tables
Further research: Proposal: Follow-up materials linking subsequent-treatment or crossover information to the original randomized comparison
Remaining uncertainty: Actual supportive-care balance, subsequent anticancer or rescue therapy, departures, crossover and analysis handling remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are placebo, supportive care and subsequent treatments distinguished" and link them to original locations. Actual supportive-care balance, subsequent anticancer or rescue therapy, departures, crossover and analysis handling remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are placebo, supportive care and subsequent treatments distinguished.
Application exceptions: Matching placebo alone does not establish that all concomitant and subsequent treatments were identical.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02.

Related sources R01

N09 · What were randomization, full-analysis and group denominators?

Current findings: Preserve the recorded sample of 546 randomized and analyzed participants: 362 everolimus versus 184 placebo. The existing research description records 2:1 allocation and inclusion of everyone in the full analysis population.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Endpoint-specific measurable, completed, followed and safety-analysis denominators require separate tables. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Endpoint-specific measurable, completed, followed and safety-analysis denominators require separate tables.
Required materials and conditions: Allocation-to-exposure-to-analysis flow, endpoint denominators and exclusion reasons
Materials to obtain first: Allocation-to-exposure-to-analysis flow, endpoint denominators and exclusion reasons
Further research: Proposal: Original reports distinguishing analysis populations for each outcome within the same allocated population
Remaining uncertainty: Endpoint-specific measurable, completed, followed and safety-analysis denominators require separate tables.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What were randomization, full-analysis and group denominators" and link them to original locations. Endpoint-specific measurable, completed, followed and safety-analysis denominators require separate tables.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What were randomization, full-analysis and group denominators.
Application exceptions: The full-analysis description is not extended to complete observation of all imaging or safety data or current ITT certification.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.

Related sources R01

N10 · What is the scope of handling missingness, follow-up loss and discontinuation?

Current findings: Preserve the original summary stating that all 546 participants were included in the full analysis population. Death, progression, medication discontinuation and loss to follow-up are different events.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Group-specific follow-up loss, administrative censoring, missingness reasons, sensitivity analyses and observation after discontinuation are absent from the original summary. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Group-specific follow-up loss, administrative censoring, missingness reasons, sensitivity analyses and observation after discontinuation are absent from the original summary.
Required materials and conditions: Endpoint-specific missingness or censoring, discontinuation, analysis plans and sensitivity results
Materials to obtain first: Endpoint-specific missingness or censoring, discontinuation, analysis plans and sensitivity results
Further research: Proposal: Supplementary reports of missingness or follow-up materials based on actual flow and original analysis assumptions
Remaining uncertainty: Group-specific follow-up loss, administrative censoring, missingness reasons, sensitivity analyses and observation after discontinuation are absent from the original summary.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the scope of handling missingness, follow-up loss and discontinuation" and link them to original locations. Group-specific follow-up loss, administrative censoring, missingness reasons, sensitivity analyses and observation after discontinuation are absent from the original summary.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the scope of handling missingness, follow-up loss and discontinuation.
Application exceptions: Group-specific follow-up loss, administrative censoring, missingness reasons, sensitivity analyses and observation after discontinuation are absent from the original summary. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04, H06.

Related sources R01

N11 · What original record describes the allocation process?

Current findings: The existing research description preserves the quotation that participants were registered using an interactive voice- or web-response system and randomized. The 2:1 allocation is the group allocation ratio within the same trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Original details of random-number generation, stratification variables, sequence access, operational roles and baseline balance remain externally unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Original details of random-number generation, stratification variables, sequence access, operational roles and baseline balance remain externally unread.
Required materials and conditions: Original locations of allocation or concealment procedures and baseline tables
Materials to obtain first: Original locations of allocation or concealment procedures and baseline tables
Further research: Proposal: Materials linking allocation history and original analysis when registration, protocols or reports are actually supplied
Remaining uncertainty: Original details of random-number generation, stratification variables, sequence access, operational roles and baseline balance remain externally unread.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What original record describes the allocation process" and link them to original locations. Original details of random-number generation, stratification variables, sequence access, operational roles and baseline balance remain externally unread.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What original record describes the allocation process.
Application exceptions: Original details of random-number generation, stratification variables, sequence access, operational roles and baseline balance remain externally unread. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01.

Related sources R01

N12 · Whom and which procedures does the double-blinding record concern?

Current findings: Preserve the original records ‘randomized, double-blind’ and ‘matching placebo’. A blinding description is not automatically identical to current outcome-specific measurement procedures.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Specific blinding of participants, clinicians, outcome assessors and statisticians, unblinding, success and imaging interpretation remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Specific blinding of participants, clinicians, outcome assessors and statisticians, unblinding, success and imaging interpretation remain unverified.
Required materials and conditions: Blinded parties, maintenance or unblinding and endpoint-specific assessment procedures
Materials to obtain first: Blinded parties, maintenance or unblinding and endpoint-specific assessment procedures
Further research: Proposal: Distinguish blinding scope through original materials reporting actual assessment conditions for each outcome
Remaining uncertainty: Specific blinding of participants, clinicians, outcome assessors and statisticians, unblinding, success and imaging interpretation remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Whom and which procedures does the double-blinding record concern" and link them to original locations. Specific blinding of participants, clinicians, outcome assessors and statisticians, unblinding, success and imaging interpretation remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Whom and which procedures does the double-blinding record concern.
Application exceptions: Specific blinding of participants, clinicians, outcome assessors and statisticians, unblinding, success and imaging interpretation remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01, E03.

Related sources R01

N13 · Are randomized design and current bias judgments separated?

Current findings: The parent historically recorded a large randomized trial with a hard endpoint and four B0 evidence items. No RoB2 assessment or new bias grade is performed during this production work.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Official outcome-specific risk assessment and original-document comparison remain within the user's review scope. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Official outcome-specific risk assessment and original-document comparison remain within the user's review scope.
Required materials and conditions: Original details of design, allocation, missingness, measurement and selective reporting
Materials to obtain first: Original details of design, allocation, missingness, measurement and selective reporting
Further research: Proposal: An updated draft documenting outcome-specific design information when additional original materials are supplied
Remaining uncertainty: Official outcome-specific risk assessment and original-document comparison remain within the user's review scope.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Are randomized design and current bias judgments separated" and link them to original locations. Official outcome-specific risk assessment and original-document comparison remain within the user's review scope.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Are randomized design and current bias judgments separated.
Application exceptions: Parent B0 and the true large-hard-endpoint-RCT marker are not automatically inherited as fulfillment of conditions for both subclaims.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01, E03, E04, E06.

Related sources R01

N14 · What is the effect of interest for adherence, treatment changes and the randomized comparison?

Current findings: Preserved values concern the randomized everolimus-versus-placebo comparison. Nominal research exposure is distinguished from actual medication use and maintenance effects.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. PP or adherence effects, actual dose intensity and group-specific treatment-change or subsequent-treatment analyses remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: PP or adherence effects, actual dose intensity and group-specific treatment-change or subsequent-treatment analyses remain unverified.
Required materials and conditions: Effect of interest, analysis population and handling of adherence or treatment changes
Materials to obtain first: Effect of interest, analysis population and handling of adherence or treatment changes
Further research: Proposal: Supplementary reports from the same trial explicitly linking analyses different from the randomized comparison
Remaining uncertainty: PP or adherence effects, actual dose intensity and group-specific treatment-change or subsequent-treatment analyses remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the effect of interest for adherence, treatment changes and the randomized comparison" and link them to original locations. PP or adherence effects, actual dose intensity and group-specific treatment-change or subsequent-treatment analyses remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the effect of interest for adherence, treatment changes and the randomized comparison.
Application exceptions: PP or adherence effects, actual dose intensity and group-specific treatment-change or subsequent-treatment analyses remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E02, E04.

Related sources R01

N15 · Do outcome collection and assessment procedures fit the actual endpoints?

Current findings: Overall survival, disease control and time to progression are different measured outcomes within the same trial. The double-blind design is preserved, but outcome-specific interpretation or ascertainment methods are separately required.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Death ascertainment routes, imaging criteria, assessment schedules, central review, assessor blinding and repeated assessments remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Death ascertainment routes, imaging criteria, assessment schedules, central review, assessor blinding and repeated assessments remain unverified.
Required materials and conditions: Endpoint-specific definitions, methods, assessors, schedules and missing measurements
Materials to obtain first: Endpoint-specific definitions, methods, assessors, schedules and missing measurements
Further research: Proposal: Original reports or appendices linking actual endpoint measurement procedures to reported values
Remaining uncertainty: Death ascertainment routes, imaging criteria, assessment schedules, central review, assessor blinding and repeated assessments remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Do outcome collection and assessment procedures fit the actual endpoints" and link them to original locations. Death ascertainment routes, imaging criteria, assessment schedules, central review, assessor blinding and repeated assessments remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Do outcome collection and assessment procedures fit the actual endpoints.
Application exceptions: Death ascertainment routes, imaging criteria, assessment schedules, central review, assessor blinding and repeated assessments remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E03.

Related sources R01

N16 · Can analysis models, adjustment and between-group or within-group outcomes be distinguished?

Current findings: Preserved numbers are between-group HR and P comparisons and group-specific medians or proportions. Group-specific medians or proportions are not written as within-group changes.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. HR models, adjustment variables, stratification, assumptions, proportion-comparison tests and sensitivity analyses remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: HR models, adjustment variables, stratification, assumptions, proportion-comparison tests and sensitivity analyses remain unverified.
Required materials and conditions: Estimate definitions in statistical methods, SAP and original outcome tables
Materials to obtain first: Estimate definitions in statistical methods, SAP and original outcome tables
Further research: Proposal: Additional materials publishing original models and distinguishing adjusted from unadjusted outcomes
Remaining uncertainty: HR models, adjustment variables, stratification, assumptions, proportion-comparison tests and sensitivity analyses remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Can analysis models, adjustment and between-group or within-group outcomes be distinguished" and link them to original locations. HR models, adjustment variables, stratification, assumptions, proportion-comparison tests and sensitivity analyses remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Can analysis models, adjustment and between-group or within-group outcomes be distinguished.
Application exceptions: HR models, adjustment variables, stratification, assumptions, proportion-comparison tests and sensitivity analyses remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.

Related sources R01

N17 · What is the history of prespecified primary overall survival and registration?

Current findings: Preserve the existing research description's quotation ‘The primary end point was overall survival’ and recorded agreement with NCT01035229. The registration number is the original identifier in the existing evidence list.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Current registration documents, change history, protocol and SAP were not read or compared. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Current registration documents, change history, protocol and SAP were not read or compared.
Required materials and conditions: Original locations of primary endpoints, analyses and times in registration versions, protocol, SAP and report
Materials to obtain first: Original locations of primary endpoints, analyses and times in registration versions, protocol, SAP and report
Further research: Proposal: A linked draft distinguishing prespecification and reasons for changes in follow-up work that receives actual plan materials
Remaining uncertainty: Current registration documents, change history, protocol and SAP were not read or compared.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the history of prespecified primary overall survival and registration" and link them to original locations. Current registration documents, change history, protocol and SAP were not read or compared.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the history of prespecified primary overall survival and registration.
Application exceptions: Original registration-agreement wording is not labeled as current registration reading or prespecification certification.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, C09.

Related sources R01

N18 · What is the scope of secondary positivity after primary failure and multiplicity?

Current findings: The existing reader answer and counterview record positive secondary disease control after failure of primary overall survival. Preserve the parent's primary-failed-secondary-positive marker as true.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Complete secondary endpoint lists, hierarchical testing, multiplicity adjustment, prespecified confirmatory status and changes remain externally unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Complete secondary endpoint lists, hierarchical testing, multiplicity adjustment, prespecified confirmatory status and changes remain externally unread.
Required materials and conditions: Complete primary or secondary outcome lists and multiplicity plans in protocol, SAP and registration
Materials to obtain first: Complete primary or secondary outcome lists and multiplicity plans in protocol, SAP and registration
Further research: Proposal: A draft distinguishing the statistical scope of secondary outcomes when plan and result materials from the same trial are supplied
Remaining uncertainty: Complete secondary endpoint lists, hierarchical testing, multiplicity adjustment, prespecified confirmatory status and changes remain externally unread.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the scope of secondary positivity after primary failure and multiplicity" and link them to original locations. Complete secondary endpoint lists, hierarchical testing, multiplicity adjustment, prespecified confirmatory status and changes remain externally unread.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the scope of secondary positivity after primary failure and multiplicity.
Application exceptions: P=.01 is not automatically promoted into confirmatory success, survival benefit or a new grade.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, C08, E09.

Related sources R01

N19 · Are direct materials available for subgroups, responders, dose and persistence questions?

Current findings: The parent's population is Child-Pugh A after sorafenib failure or intolerance, and research exposure is 7.5 mg/day. Molecular selection, responders and other-dose or persistence effects are not separately supplied.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Prespecified subgroups, interactions, molecular markers, direct dose comparisons and outcomes after treatment discontinuation remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Prespecified subgroups, interactions, molecular markers, direct dose comparisons and outcomes after treatment discontinuation remain unverified.
Required materials and conditions: Prespecified subgroup, interaction and exposure-specific original outcomes and plans
Materials to obtain first: Prespecified subgroup, interaction and exposure-specific original outcomes and plans
Further research: Proposal: Link additional research materials with explicit population or exposure, distinguishing the same from separate study families
Remaining uncertainty: Prespecified subgroups, interactions, molecular markers, direct dose comparisons and outcomes after treatment discontinuation remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Are direct materials available for subgroups, responders, dose and persistence questions" and link them to original locations. Prespecified subgroups, interactions, molecular markers, direct dose comparisons and outcomes after treatment discontinuation remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Are direct materials available for subgroups, responders, dose and persistence questions.
Application exceptions: Prespecified subgroups, interactions, molecular markers, direct dose comparisons and outcomes after treatment discontinuation remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E08, E07.

Related sources R01

N20 · Can this scope be extended to other liver function, treatment lines or long-term harms?

Current findings: The current draft is limited to historical EVOLVE-1: Child-Pugh A advanced hepatocellular carcinoma after sorafenib. Other liver function, populations, treatment lines and current strategies are outside this direct result's scope.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details of this condition were not verified within the current preserved-summary and externally unread scope. No new search was conducted for direct materials on other populations or exposures, longer observation, rare harms or current treatment combinations. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: No new search was conducted for direct materials on other populations or exposures, longer observation, rare harms or current treatment combinations.
Required materials and conditions: Direct comparisons and safety materials by extended population, exposure and duration
Materials to obtain first: Direct comparisons and safety materials by extended population, exposure and duration
Further research: Proposal: Link materials for separate indications or durations with explicit differences in applicability from the existing results when supplied
Remaining uncertainty: No new search was conducted for direct materials on other populations or exposures, longer observation, rare harms or current treatment combinations.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Can this scope be extended to other liver function, treatment lines or long-term harms" and link them to original locations. No new search was conducted for direct materials on other populations or exposures, longer observation, rare harms or current treatment combinations.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Can this scope be extended to other liver function, treatment lines or long-term harms.
Application exceptions: No new search was conducted for direct materials on other populations or exposures, longer observation, rare harms or current treatment combinations. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E08, H08.

Related sources R01

N21 · What are the definition and secondary hierarchy of disease control?

Current findings: The selected existing question is increased disease control, grade C. Its note states 56.1% versus 45.1%, but a secondary endpoint after the primary survival endpoint failed.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Response or stable-disease components, imaging assessment criteria, duration conditions and definitions of comparable assessed populations remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Response or stable-disease components, imaging assessment criteria, duration conditions and definitions of comparable assessed populations remain unverified.
Required materials and conditions: DCR definition, response criteria, primary or secondary plans and result tables
Materials to obtain first: DCR definition, response criteria, primary or secondary plans and result tables
Further research: Proposal: Original reports or appendices from the same trial specifying disease-control definitions and analysis scope
Remaining uncertainty: Response or stable-disease components, imaging assessment criteria, duration conditions and definitions of comparable assessed populations remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are the definition and secondary hierarchy of disease control" and link them to original locations. Response or stable-disease components, imaging assessment criteria, duration conditions and definitions of comparable assessed populations remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are the definition and secondary hierarchy of disease control.
Application exceptions: C is the selected subclaim's historical grade; it is not changed into parent D34 or a current clinical verdict.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E06, E09.

Related sources R01

N22 · What original between-group values are 56.1% versus 45.1% and P=.01?

Current findings: Disease control for everolimus versus placebo was 56.1% versus 45.1% (P=.01). The existing counterpoint description of an 11%p difference is preserved as a value already in the preserved summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. The summary does not contain CI for the estimate, analysis methods for the proportion difference, adjustments or multiplicity handling. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: The summary does not contain CI for the estimate, analysis methods for the proportion difference, adjustments or multiplicity handling.
Required materials and conditions: Original DCR result tables, denominators, CI and testing or adjustment methods
Materials to obtain first: Original DCR result tables, denominators, CI and testing or adjustment methods
Further research: Proposal: The same DCR report jointly presenting proportions, effect intervals and plans
Remaining uncertainty: The summary does not contain CI for the estimate, analysis methods for the proportion difference, adjustments or multiplicity handling.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What original between-group values are 56.1% versus 45.1% and P=.01" and link them to original locations. The summary does not contain CI for the estimate, analysis methods for the proportion difference, adjustments or multiplicity handling.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What original between-group values are 56.1% versus 45.1% and P=.01.
Application exceptions: Do not back-calculate new responder counts, differences, OR/RR or CI from rounded proportions.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, E05.

Related sources R01

N23 · What are the DCR denominators and numbers of people with disease control?

Current findings: The overall randomized and analyzed denominator was 546 participants (362/184). These are the parent original sample records; DCR assessable or analysis denominators and participant counts are not separately given in the original summary.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details of this condition were not verified within the current preserved-summary and externally unread scope. Group-specific DCR denominators, numerators, completed imaging assessments, missing assessments and analysis-inclusion rules remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Group-specific DCR denominators, numerators, completed imaging assessments, missing assessments and analysis-inclusion rules remain unverified.
Required materials and conditions: Original DCR sample and event tables, assessment flow and analysis-population definitions
Materials to obtain first: Original DCR sample and event tables, assessment flow and analysis-population definitions
Further research: Proposal: Original result tables distinguishing randomized, analyzed, assessable and disease-control denominators
Remaining uncertainty: Group-specific DCR denominators, numerators, completed imaging assessments, missing assessments and analysis-inclusion rules remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are the DCR denominators and numbers of people with disease control" and link them to original locations. Group-specific DCR denominators, numerators, completed imaging assessments, missing assessments and analysis-inclusion rules remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are the DCR denominators and numbers of people with disease control.
Application exceptions: OS denominators 362/184 are not transferred into verified DCR denominators, and responder counts are not calculated from proportions.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.

Related sources R01

N24 · How are non-assessment, death, progression and stable disease handled in DCR?

Current findings: DCR is a proportion outcome, while overall survival is a time-to-death outcome. The original record that everyone was included in the full analysis population does not mean that every DCR imaging or response status was known.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details of this condition were not verified within the current preserved-summary and externally unread scope. Classification, missing-data handling and sensitivity analyses for non-assessment, early death, progression and incomplete imaging remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Classification, missing-data handling and sensitivity analyses for non-assessment, early death, progression and incomplete imaging remain unverified.
Required materials and conditions: DCR analysis rules, response classification and missing-data or death-handling tables
Materials to obtain first: DCR analysis rules, response classification and missing-data or death-handling tables
Further research: Proposal: Materials specifying original DCR analyses for non-assessment, death or discontinuation
Remaining uncertainty: Classification, missing-data handling and sensitivity analyses for non-assessment, early death, progression and incomplete imaging remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are non-assessment, death, progression and stable disease handled in DCR" and link them to original locations. Classification, missing-data handling and sensitivity analyses for non-assessment, early death, progression and incomplete imaging remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are non-assessment, death, progression and stable disease handled in DCR.
Application exceptions: Classification, missing-data handling and sensitivity analyses for non-assessment, early death, progression and incomplete imaging remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E04, C07.

Related sources R01

N25 · What are the DCR assessment times and minimum duration?

Current findings: The original materials give disease control of 56.1% versus 45.1%, but do not separately state the assessment time or duration for that proportion.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details of this condition were not verified within the current preserved-summary and externally unread scope. Whether this was best overall response or a particular time point, minimum stable-disease duration, imaging intervals and data cutoff remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Whether this was best overall response or a particular time point, minimum stable-disease duration, imaging intervals and data cutoff remain unverified.
Required materials and conditions: DCR definition, assessment schedule, minimum duration and data-cutoff date
Materials to obtain first: DCR definition, assessment schedule, minimum duration and data-cutoff date
Further research: Proposal: Materials from the same trial linking time-specific or duration-specific DCR to original analyses
Remaining uncertainty: Whether this was best overall response or a particular time point, minimum stable-disease duration, imaging intervals and data cutoff remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are the DCR assessment times and minimum duration" and link them to original locations. Whether this was best overall response or a particular time point, minimum stable-disease duration, imaging intervals and data cutoff remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are the DCR assessment times and minimum duration.
Application exceptions: Median OS of 7.6/7.3 months or TTP of 3.0/2.6 months are not used to fill DCR assessment periods.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E03, E08.

Related sources R01

N26 · What is the scope of imaging interpretation, central or local assessment and assessor blinding?

Current findings: The original trial design was double-blind with matching placebo. Separate information is needed on who interpreted disease-control imaging and how.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details of this condition were not verified within the current preserved-summary and externally unread scope. Tumor-assessment criteria, measurement error, central or local interpretation, assessor blinding and response confirmation remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Tumor-assessment criteria, measurement error, central or local interpretation, assessor blinding and response confirmation remain unverified.
Required materials and conditions: DCR imaging criteria, assessors, original interpretation methods and appendices
Materials to obtain first: DCR imaging criteria, assessors, original interpretation methods and appendices
Further research: Proposal: Materials from the same trial reporting actual DCR measurement or interpretation procedures and their agreement or differences
Remaining uncertainty: Tumor-assessment criteria, measurement error, central or local interpretation, assessor blinding and response confirmation remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the scope of imaging interpretation, central or local assessment and assessor blinding" and link them to original locations. Tumor-assessment criteria, measurement error, central or local interpretation, assessor blinding and response confirmation remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the scope of imaging interpretation, central or local assessment and assessor blinding.
Application exceptions: The original double-blind design does not automatically certify completed central imaging interpretation or absence of measurement bias.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E03.

Related sources R01

N27 · What are DCR effect intervals, clinical importance and multiplicity?

Current findings: The preserved DCR values and P=.01 are original records of a secondary result. The hierarchy restriction of positivity after survival failure is preserved alongside them.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. CI for the DCR effect, prespecified importance, hierarchical or multiplicity adjustment and confirmatory status remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: CI for the DCR effect, prespecified importance, hierarchical or multiplicity adjustment and confirmatory status remain unverified.
Required materials and conditions: DCR effect intervals, SAP, primary or secondary testing order and importance criteria
Materials to obtain first: DCR effect intervals, SAP, primary or secondary testing order and importance criteria
Further research: Proposal: Materials linking planned and reported DCR intervals and testing scope
Remaining uncertainty: CI for the DCR effect, prespecified importance, hierarchical or multiplicity adjustment and confirmatory status remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are DCR effect intervals, clinical importance and multiplicity" and link them to original locations. CI for the DCR effect, prespecified importance, hierarchical or multiplicity adjustment and confirmatory status remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are DCR effect intervals, clinical importance and multiplicity.
Application exceptions: P=.01 alone does not establish every effect size, current confirmatory success or individual clinical benefit.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E05, E06.

Related sources R01

N28 · Are positive DCR and the null primary overall-survival result distinguished?

Current findings: In the same trial, median OS was 7.6 versus 7.3 months, with 303/362 (83.7%) versus 151/184 (82.1%) deaths; HR 1.05 (95% CI 0.86 to 1.27; P=.68). The parent verdict and overall-survival sheet preserve the failure to increase survival.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. External materials directly verifying differences in models, times or denominators between the two endpoints and the DCR-OS relationship remain unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: External materials directly verifying differences in models, times or denominators between the two endpoints and the DCR-OS relationship remain unread.
Required materials and conditions: Definitions, denominators, estimates and plans for each endpoint and their same-trial relationship
Materials to obtain first: Definitions, denominators, estimates and plans for each endpoint and their same-trial relationship
Further research: Proposal: Original same-trial result tables presenting DCR and OS together without merging them
Remaining uncertainty: External materials directly verifying differences in models, times or denominators between the two endpoints and the DCR-OS relationship remain unread.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Are positive DCR and the null primary overall-survival result distinguished" and link them to original locations. External materials directly verifying differences in models, times or denominators between the two endpoints and the DCR-OS relationship remain unread.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Are positive DCR and the null primary overall-survival result distinguished.
Application exceptions: Positive DCR is not transferred into increased OS, and the null OS result does not justify deleting preserved DCR values.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C08, E09.

Related sources R01

N29 · What are the units and directions of time to progression and DCR?

Current findings: TTP was a separate result of 3.0 versus 2.6 months, HR 0.93 (95% CI 0.75 to 1.15). DCR proportions and TTP time or HR use different units and analyses.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Progression assessment, censoring or death handling, denominators, P and links to DCR assessment times remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Progression assessment, censoring or death handling, denominators, P and links to DCR assessment times remain unverified.
Required materials and conditions: TTP definition and original results, DCR definition and separation of the two analyses
Materials to obtain first: TTP definition and original results, DCR definition and separation of the two analyses
Further research: Proposal: The same report linking original tumor assessments to progression-time definitions and follow-up
Remaining uncertainty: Progression assessment, censoring or death handling, denominators, P and links to DCR assessment times remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are the units and directions of time to progression and DCR" and link them to original locations. Progression assessment, censoring or death handling, denominators, P and links to DCR assessment times remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are the units and directions of time to progression and DCR.
Application exceptions: TTP is not converted into PFS, DCR duration or survival benefit, and no difference between medians is calculated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C08, E09.

Related sources R01

N30 · Does disease control answer questions about patient symptoms, quality of life or long-term outcomes?

Current findings: The existing central explanation states that a higher tumor-control proportion did not translate into longer life. The selected question concerns DCR itself; survival, symptoms and quality of life are separate.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. This summary does not contain patient-reported symptoms, quality of life, tumor-control duration, individual benefit or mediation or surrogate validation. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: This summary does not contain patient-reported symptoms, quality of life, tumor-control duration, individual benefit or mediation or surrogate validation.
Required materials and conditions: Direct DCR and patient-centered outcome materials, times, denominators and original analyses
Materials to obtain first: Direct DCR and patient-centered outcome materials, times, denominators and original analyses
Further research: Proposal: Materials separately reporting tumor control and patient-centered outcomes in the same or an appropriate separate study
Remaining uncertainty: This summary does not contain patient-reported symptoms, quality of life, tumor-control duration, individual benefit or mediation or surrogate validation.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Does disease control answer questions about patient symptoms, quality of life or long-term outcomes" and link them to original locations. This summary does not contain patient-reported symptoms, quality of life, tumor-control duration, individual benefit or mediation or surrogate validation.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Does disease control answer questions about patient symptoms, quality of life or long-term outcomes.
Application exceptions: Survival success is not imposed as mandatory for DCR itself, but DCR is not automatically extended into other patient benefits.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E09, E08.

Related sources R01

N31 · What was the original all-grade stomatitis comparison?

Current findings: The original record reports all-grade stomatitis of 39.6% versus 4.9%. This is a safety outcome distinct from tumor control or survival.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Stomatitis event counts, safety denominators, collection or classification, times, CI and P remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Stomatitis event counts, safety denominators, collection or classification, times, CI and P remain unverified.
Required materials and conditions: Original stomatitis tables, safety population, grading criteria and duration
Materials to obtain first: Original stomatitis tables, safety population, grading criteria and duration
Further research: Proposal: Original safety materials linking stomatitis in the same exposed population with denominators and duration
Remaining uncertainty: Stomatitis event counts, safety denominators, collection or classification, times, CI and P remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What was the original all-grade stomatitis comparison" and link them to original locations. Stomatitis event counts, safety denominators, collection or classification, times, CI and P remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What was the original all-grade stomatitis comparison.
Application exceptions: Stomatitis event counts, safety denominators, collection or classification, times, CI and P remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H01, H03, H04.

Related sources R01

N32 · What were the grade 3 or 4 anemia comparison and original statistical level?

Current findings: Grade 3 or 4 anemia was 7.8% versus 3.3%, with the original safety comparison recorded as descriptive statistics.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Anemia event counts, denominators, baseline anemia, grading criteria, between-group CI or P and timing remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Anemia event counts, denominators, baseline anemia, grading criteria, between-group CI or P and timing remain unverified.
Required materials and conditions: Anemia safety tables, denominators or duration, classification and baseline status
Materials to obtain first: Anemia safety tables, denominators or duration, classification and baseline status
Further research: Proposal: Materials publishing hematologic harms from the same trial at the original population, timing and analysis level
Remaining uncertainty: Anemia event counts, denominators, baseline anemia, grading criteria, between-group CI or P and timing remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What were the grade 3 or 4 anemia comparison and original statistical level" and link them to original locations. Anemia event counts, denominators, baseline anemia, grading criteria, between-group CI or P and timing remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What were the grade 3 or 4 anemia comparison and original statistical level.
Application exceptions: Descriptive proportions are not newly calculated into significant risk increases, no-difference tests or incidence rates.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H01, H03, H04.

Related sources R01

N33 · What were the original grade 3 or 4 asthenia and decreased-appetite values?

Current findings: Preserve grade 3 or 4 asthenia of 7.8% versus 5.5% and decreased appetite of 6.1% versus 0.5% separately. Original safety comparisons were descriptive statistics.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Event-specific denominators, participants versus event counts, co-occurring events, causes or timing, CI or P and classifications remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Event-specific denominators, participants versus event counts, co-occurring events, causes or timing, CI or P and classifications remain unverified.
Required materials and conditions: Original tables, denominators, grading, collection and timing for each safety event
Materials to obtain first: Original tables, denominators, grading, collection and timing for each safety event
Further research: Proposal: Safety materials reporting asthenia and decreased appetite as separate events under the same exposure
Remaining uncertainty: Event-specific denominators, participants versus event counts, co-occurring events, causes or timing, CI or P and classifications remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What were the original grade 3 or 4 asthenia and decreased-appetite values" and link them to original locations. Event-specific denominators, participants versus event counts, co-occurring events, causes or timing, CI or P and classifications remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What were the original grade 3 or 4 asthenia and decreased-appetite values.
Application exceptions: Do not merge the two symptoms into a new composite event, participant total or risk difference.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H03, H04, E10.

Related sources R01

N34 · How are asymptomatic hepatitis B reactivation and discontinuation distinguished?

Current findings: The original record reports asymptomatic hepatitis B reactivation by central laboratory testing in 29 versus 10 participants, and discontinuation in 3 everolimus participants. Asymptomatic test results and medication discontinuation are separate events.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Reactivation criteria, baseline HBV or at-risk denominators, testing times, prophylaxis, discontinuation timing or attribution and CI or P remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Reactivation criteria, baseline HBV or at-risk denominators, testing times, prophylaxis, discontinuation timing or attribution and CI or P remain unverified.
Required materials and conditions: HBV testing criteria, populations at risk, group denominators or follow-up and original discontinuation tables
Materials to obtain first: HBV testing criteria, populations at risk, group denominators or follow-up and original discontinuation tables
Further research: Proposal: Safety materials linking HBV reactivation and discontinuation under the same exposure with populations at risk
Remaining uncertainty: Reactivation criteria, baseline HBV or at-risk denominators, testing times, prophylaxis, discontinuation timing or attribution and CI or P remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are asymptomatic hepatitis B reactivation and discontinuation distinguished" and link them to original locations. Reactivation criteria, baseline HBV or at-risk denominators, testing times, prophylaxis, discontinuation timing or attribution and CI or P remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are asymptomatic hepatitis B reactivation and discontinuation distinguished.
Application exceptions: Do not divide 29/10 or 3 discontinuations by full allocated denominators to calculate new proportions or risks.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H02, H03, H04, H05.

Related sources R01

N35 · What is the scope of safety denominators, exposure duration and complete collection?

Current findings: The parent records stomatitis, hematologic or hepatic outcomes and Caution status. Distinguish the full randomized-analysis denominator from safety exposure or assessment denominators.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details of this condition were not verified within the current preserved-summary and externally unread scope. Safety populations, actual exposure durations, event-specific populations at risk, collection or follow-up, post-discontinuation events, losses and rare harms remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Safety populations, actual exposure durations, event-specific populations at risk, collection or follow-up, post-discontinuation events, losses and rare harms remain unverified.
Required materials and conditions: Safety analysis definitions, exposure, all-event tables and collection or follow-up materials
Materials to obtain first: Safety analysis definitions, exposure, all-event tables and collection or follow-up materials
Further research: Proposal: Original reports from the same trial specifying safety populations, timing and missingness
Remaining uncertainty: Safety populations, actual exposure durations, event-specific populations at risk, collection or follow-up, post-discontinuation events, losses and rare harms remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the scope of safety denominators, exposure duration and complete collection" and link them to original locations. Safety populations, actual exposure durations, event-specific populations at risk, collection or follow-up, post-discontinuation events, losses and rare harms remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the scope of safety denominators, exposure duration and complete collection.
Application exceptions: Safety populations, actual exposure durations, event-specific populations at risk, collection or follow-up, post-discontinuation events, losses and rare harms remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H02, H04, H06, H08.

Related sources R01

N36 · What are baseline disease, concurrent treatment and alternative causes of harms?

Current findings: Advanced hepatocellular carcinoma, Child-Pugh A, prior sorafenib failure or intolerance and supportive care are the original population or exposure context. Detailed medication attribution of recorded events is separate.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Baseline liver disease or HBV, anemia, concurrent medications, subsequent treatment, alternative causes and group-specific adjustment remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Baseline liver disease or HBV, anemia, concurrent medications, subsequent treatment, alternative causes and group-specific adjustment remain unverified.
Required materials and conditions: Baseline risks, concomitant or subsequent treatments, event attribution and original analyses
Materials to obtain first: Baseline risks, concomitant or subsequent treatments, event attribution and original analyses
Further research: Proposal: Supplementary safety materials separately publishing baseline disease and exposure or event relationships
Remaining uncertainty: Baseline liver disease or HBV, anemia, concurrent medications, subsequent treatment, alternative causes and group-specific adjustment remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What are baseline disease, concurrent treatment and alternative causes of harms" and link them to original locations. Baseline liver disease or HBV, anemia, concurrent medications, subsequent treatment, alternative causes and group-specific adjustment remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What are baseline disease, concurrent treatment and alternative causes of harms.
Application exceptions: Do not newly assert that other causes were absent or all events were caused by everolimus.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H05, E02, E10.

Related sources R01

N37 · Who supplied research funding, study medication and placebo?

Current findings: Preserve Novartis Pharmaceuticals sponsorship, study medication or placebo supply, data management, statistical analysis and writing support from original funding information and narrative.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Original contracts, funding details, complete individual-interest disclosures and current changes remain externally unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Original contracts, funding details, complete individual-interest disclosures and current changes remain externally unread.
Required materials and conditions: Original funding, product supply, contracts and disclosed interests
Materials to obtain first: Original funding, product supply, contracts and disclosed interests
Further research: Proposal: Original materials publishing actual-report funding, product supply and roles together
Remaining uncertainty: Original contracts, funding details, complete individual-interest disclosures and current changes remain externally unread.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Who supplied research funding, study medication and placebo" and link them to original locations. Original contracts, funding details, complete individual-interest disclosures and current changes remain externally unread.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Who supplied research funding, study medication and placebo.
Application exceptions: Original contracts, funding details, complete individual-interest disclosures and current changes remain externally unread. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.

Related sources R01

N38 · How did the sponsor participate in design, data collection and analysis?

Current findings: The existing research description records Novartis participation in design, collection through its data-management system and analysis by its statistical team.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Specific scope of full data access, original statistical responsibility, independent reanalysis and operational contracts remains unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Specific scope of full data access, original statistical responsibility, independent reanalysis and operational contracts remains unverified.
Required materials and conditions: Design, collection and analysis role declarations, data access and statistical responsibility
Materials to obtain first: Design, collection and analysis role declarations, data access and statistical responsibility
Further research: Proposal: Original declarations or supplementary materials specifying reported roles and the scope of actual analysis disclosure
Remaining uncertainty: Specific scope of full data access, original statistical responsibility, independent reanalysis and operational contracts remains unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How did the sponsor participate in design, data collection and analysis" and link them to original locations. Specific scope of full data access, original statistical responsibility, independent reanalysis and operational contracts remains unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How did the sponsor participate in design, data collection and analysis.
Application exceptions: Sponsor involvement alone does not justify deleting original numbers or deriving a new null effect or bias magnitude.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10, E04.

Related sources R01

N39 · What were employee-author, writing and submission-decision roles?

Current findings: The preserved summary records employee authors participating in interpretation, writing and submission decisions, and Novartis paying ApotheCom's medical-writing costs.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Complete individual-author COI, writing or approval and submission-authority contracts and role changes remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Complete individual-author COI, writing or approval and submission-authority contracts and role changes remain unverified.
Required materials and conditions: Author employment or COI, contributions, writing and publication-role declarations
Materials to obtain first: Author employment or COI, contributions, writing and publication-role declarations
Further research: Proposal: Materials linking original author or sponsor roles and disclosed interests
Remaining uncertainty: Complete individual-author COI, writing or approval and submission-authority contracts and role changes remain unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What were employee-author, writing and submission-decision roles" and link them to original locations. Complete individual-author COI, writing or approval and submission-authority contracts and role changes remain unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What were employee-author, writing and submission-decision roles.
Application exceptions: Complete individual-author COI, writing or approval and submission-authority contracts and role changes remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.

Related sources R01

N40 · What is the actual scope of independent replication or separate safety materials?

Current findings: The preserved evidence or citation list contains 1 EVOLVE-1 report record; parent replication R1 and independence I0 are historical axes. The two sheets or repeated safety citations are not counted as separate replications.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. No new search was conducted for independent trials, additional report or cohort lists, duplicate events or external safety or regulatory materials. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: No new search was conducted for independent trials, additional report or cohort lists, duplicate events or external safety or regulatory materials.
Required materials and conditions: Reports, study families, COI, shared outcomes and contrary-material lists
Materials to obtain first: Reports, study families, COI, shared outcomes and contrary-material lists
Further research: Proposal: Relationship records specifying repeated citation, shared populations or separate populations when separate materials are actually supplied
Remaining uncertainty: No new search was conducted for independent trials, additional report or cohort lists, duplicate events or external safety or regulatory materials.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "What is the actual scope of independent replication or separate safety materials" and link them to original locations. No new search was conducted for independent trials, additional report or cohort lists, duplicate events or external safety or regulatory materials.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: What is the actual scope of independent replication or separate safety materials.
Application exceptions: One literature record or two existing sheets are not converted into current worldwide trial totals or confirmed independent replication.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, C10, E07, H07.

Related sources R01

N41 · At what level are efficacy outcomes and descriptive harms described?

Current findings: Retain null OS, positive secondary DCR and descriptive harms as their respective original results. Parent safety Caution is historical and does not confirm safety or absence of all harms.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Current synthesis of event-specific comparative estimates, causal attribution and long-term or rare harms remains unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Current synthesis of event-specific comparative estimates, causal attribution and long-term or rare harms remains unverified.
Required materials and conditions: Original efficacy and safety tables, definitions, denominators or times and interpretive scope
Materials to obtain first: Original efficacy and safety tables, definitions, denominators or times and interpretive scope
Further research: Proposal: Original reports separately specifying the different analysis levels for efficacy and harms
Remaining uncertainty: Current synthesis of event-specific comparative estimates, causal attribution and long-term or rare harms remains unverified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "At what level are efficacy outcomes and descriptive harms described" and link them to original locations. Current synthesis of event-specific comparative estimates, causal attribution and long-term or rare harms remains unverified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: At what level are efficacy outcomes and descriptive harms described.
Application exceptions: Non-significant survival or positive DCR does not erase harms, and descriptive statistics alone do not create a new causal safety verdict.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H09, C08.

Related sources R01

N42 · How are parent grade, score, false or empty axis values and Korean or English drafts preserved?

Current findings: Preserve parent D, 34, Caution and axes B/H/R1/I0/E0/B0/C0; coprimary split false, large hard-endpoint RCT true, no-human-study false, primary-failed-secondary-positive true and empty override reasons. Complete Korean and English drafts and historical synthesis or grade decisions are context.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Original cross-checking, grades and axes were not automatically applied as current review completion or selected subclaim values. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Original cross-checking, grades and axes were not automatically applied as current review completion or selected subclaim values.
Required materials and conditions: Separate copies preserving subclaim and parent values, Korean or English drafts, axes and historical verdict
Materials to obtain first: Separate copies preserving subclaim and parent values, Korean or English drafts, axes and historical verdict
Further research: Proposal: Preserved records separating complete pre-change originals, events, versions and decisions when verdict corrections are actually supplied
Remaining uncertainty: Original cross-checking, grades and axes were not automatically applied as current review completion or selected subclaim values.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "How are parent grade, score, false or empty axis values and Korean or English drafts preserved" and link them to original locations. Original cross-checking, grades and axes were not automatically applied as current review completion or selected subclaim values.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: How are parent grade, score, false or empty axis values and Korean or English drafts preserved.
Application exceptions: The parent's 34 points, B0/C0 or cross-check-applied history are not inherited as subclaim scores or axes, new fulfillment or review completion.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09, E06.

Related sources R01

N43 · Do the cutoff date, corrections and empty values differ from current production dates?

Current findings: Preserve original cutoff 2026-08-26 and empty correction and deliberation values. Bibliography or registration-agreement descriptions in the original Korean and English drafts are historical, while the current writing time is a production event.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Original additional-cutoff and detailed-classification fields are absent; no new search, registration, correction or retraction comparison or external reading was performed. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Original additional-cutoff and detailed-classification fields are absent; no new search, registration, correction or retraction comparison or external reading was performed.
Required materials and conditions: Distinguishing original cutoff, correction, retraction or search history from production events
Materials to obtain first: Distinguishing original cutoff, correction, retraction or search history from production events
Further research: Proposal: Update records distinguishing historical scope from current additional events when materials or corrections are actually supplied
Remaining uncertainty: Original additional-cutoff and detailed-classification fields are absent; no new search, registration, correction or retraction comparison or external reading was performed.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Do the cutoff date, corrections and empty values differ from current production dates" and link them to original locations. Original additional-cutoff and detailed-classification fields are absent; no new search, registration, correction or retraction comparison or external reading was performed.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Do the cutoff date, corrections and empty values differ from current production dates.
Application exceptions: Empty correction history is not certified as no current corrections, and the original verification date is not changed into the current review date.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, C03.

Related sources R01

N44 · Is the scope kept from extending to current applicability, products or treatment decisions?

Current findings: This sheet documents the specified existing claim and EVOLVE-1's historical comparison, outcomes and gaps. Other products or doses, current treatment lines and individual treatment choice are outside this production scope.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information for this item exists in the preserved summary and has been linked. Current clinical practice, product or regulatory status, individual suitability and direct superiority of other treatments were not verified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Current clinical practice, product or regulatory status, individual suitability and direct superiority of other treatments were not verified.
Required materials and conditions: Appropriate direct materials for extended questions and applicability differences from the original trial
Materials to obtain first: Appropriate direct materials for extended questions and applicability differences from the original trial
Further research: Proposal: Research-gap updates distinguishing selected scope, outcomes and harms when additional materials are authorized and supplied
Remaining uncertainty: Current clinical practice, product or regulatory status, individual suitability and direct superiority of other treatments were not verified.
Conditions for verification: Distinguish preserved values, direct scope and unverified matters relevant to "Is the scope kept from extending to current applicability, products or treatment decisions" and link them to original locations. Current clinical practice, product or regulatory status, individual suitability and direct superiority of other treatments were not verified.
Why this condition is needed: This condition is needed to separately document the selected increased-disease-control question: Is the scope kept from extending to current applicability, products or treatment decisions.
Application exceptions: No new medication or dosing instructions, substitution or discontinuation of sorafenib or other treatments, or anticancer-treatment choices are created.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, E08, E09, H08, H09.

Related sources R01