INTERLACE induction carboplatin and paclitaxel · Locally advanced cervical cancer · Evidence checklist for increased five-year progression-free survival

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 conditionWhat are the selected question, verdict record and parent context?Required	The selected existing question is improved 5-year progression-free survival; the question and its existing verdict record are preserved separately. The parent explains both coprimary survival results, while this table concerns the selected result itself. R01	Some information in the stored summary was linked for preparation. The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.	Original question/record and links to parent/related outcomes	Proposal: If new materials for the same question are supplied, link them while preserving the existing record and original wording
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow are original subclaim B/note, parent B76 and absent score/axes separated?Required	Original subclaim grade B and note '72% versus 64%, HR 0.65' are retained. Selected subclaim score, status and axes are absent; parent B, 76, Caution and axes remain parent history. R01	Some preserved-summary information has been linked. Direct selected-subclaim score, status and axes values are absent. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	A preserved copy separating the subclaim verdict/note from parent score/axes	Proposal: If a subclaim correction is actually supplied, record the complete original text, event and change decision separately
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionDo both tables, PFS, OS and safety concern the same trial?Required	1 original evidence entry and 1 citation entry link McCormack et al. 2024 GCIG INTERLACE, PMID39419054. PFS, OS, safety and both existing tables share results from the same trial and 500-person, 250/250 population. R01	Some preserved-summary information has been linked. Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Relationships among reports, registration, trial families, outcomes/time points and shared populations	Proposal: If follow-up or other materials are supplied, distinguish shared reports/populations/outcomes from separate families
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhich preserved summary and external original materials have currently been read?Required	The complete designated preserved summary was read for production and its original bytes preserved. The original PubMed URL is linked unchanged; external abstracts, papers, registration and plans remain unread. R01	Some preserved-summary information has been linked. External availability/acquisition, current content, link operation and access success were not verified in this work. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Existence, acquisition, reading status and original locations of the preserved summary and external materials	Proposal: When obtaining follow-up materials is authorized, record actual reading level and distinguish historical from current dates
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat were the actual population and selection scope for locally advanced cervical cancer?Required	The preserved parent question concerns locally advanced cervical cancer in the 500-person INTERLACE trial. Specific recruitment/exclusion and baseline composition lie beyond the summary. R01	Some preserved-summary information has been linked. Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original eligibility/exclusion, stage and baseline-characteristic tables	Proposal: Use materials from the same trial specifying original recruitment conditions, or suitable separate population research
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat do 32 centers, the international multicenter design and population distribution describe?Required	The original research description states that INTERLACE assigned 500 people at 32 centers, 250 per group; the evidence design is an international multicenter randomized phase 3 trial. R01	Some preserved-summary information has been linked. Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Center/region and recruitment distribution, baseline balance and treatment-delivery materials	Proposal: Use supplementary same-trial materials reporting actual regional conditions and results
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat are the sequence of induction chemotherapy before radiation and the comparator strategy?Required	The trial compares adding 6 weeks of induction carboplatin-paclitaxel before standard concurrent chemoradiotherapy with standard concurrent chemoradiotherapy alone. The original citation title and Korean/English texts are linked unchanged. R01	Some preserved-summary information has been linked. Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original protocols, shared treatment, sequencing and delivery for both strategies	Proposal: Use reports/appendices defining the original comparison of induction addition and standard CCRT
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionHow are nominal induction exposure and actual administered amounts separated?Required	Original study exposure was carboplatin AUC 2 and paclitaxel 80 mg/m², once weekly (1 administration per week) for 6 weeks. Original units/frequency are preserved only as historical study conditions. R01	Some preserved-summary information has been linked. Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original nominal/actual exposure, changes, adherence, formulation and route materials	Proposal: Link actual administration/stopping and results from the same study
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat was the median interval from induction completion to CCRT?Required	The original study-condition description gives a median interval of 7 days. It is preserved together with the research description that CCRT began approximately 1 week later. R01	Some preserved-summary information has been linked. Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original interval, delay, non-delivery, actual schedule and completion tables	Proposal: Link same-study sequencing, interval distributions and treatment delivery
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat were the randomized/ITT denominators and arm allocations?Required	Original sample wording is 500 randomized and 500 ITT participants (250/250). The original history describes both outcomes as analyses of this same allocated population. R01	Some preserved-summary information has been linked. Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original 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 and endpoint/time-specific safety denominators	Proposal: Distinguish analysis, risk sets and actual exposure within the same allocated population
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat were allocation, concealment and baseline balance?Required	The original quote states, 'Allocation was done by minimisation, using a central electronic system'. The central-electronic-system minimisation record is preserved. R01	Some preserved-summary information has been linked. Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Allocation algorithm/concealment, operational roles and baseline tables	Proposal: Use plans/original reports disclosing actual allocation procedures
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionWhat is the scope of no masking and investigator-assessed PFS?Required	The original quote states, 'No blinding or masking was performed', and identifies investigator-assessed PFS and all-cause death. Wording that masking was infeasible for the induction sequence remains historical context. R01	Some preserved-summary information has been linked. Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Endpoint-specific measurement, assessors, masking/confirmation, schedules and original appendices	Proposal: Link same-trial PFS and OS measurement limitations to each outcome
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhat are the original ITT and censoring records for event-free patients?Required	The original statement 'Analyses were by intention-to-treat (ITT)' and censoring of event-free patients at the last known alive date are preserved. R01	Some preserved-summary information has been linked. Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Endpoint-specific ITT/censoring, missingness, sensitivity and analysis-population definitions	Proposal: Link event/censoring/loss flow and original analysis from the same trial
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionHow were adherence, supportive/follow-up treatment and treatment changes handled?Required	The original allocated-strategy comparison is induction chemotherapy followed by CCRT versus CCRT alone. The two drugs/radiation sequence must be distinguished from actual delivery and subsequent interventions. R01	Some preserved-summary information has been linked. Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Actual arm-specific treatment, follow-up/salvage treatment, adherence and handling	Proposal: Use original reports distinguishing allocated-strategy effects from actual treatment delivery
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat were coprimary PFS/OS and the registration history?Required	The original quote 'The primary endpoints were overall survival and investigator-assessed progression-free survival' and stated agreement with NCT01566240 are preserved. The evidence registration entry is NCT01566240 · EudraCT 2011-001300-35. R01	Some preserved-summary information has been linked. Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original NCT/EudraCT versions, protocol, SAP and coprimary endpoint/time-point comparisons	Proposal: If original plans are supplied, link coprimary endpoints, amendment times and reporting scope
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhy did the planned sample change from 700 to 500?Required	The original counterview states that the planned sample decreased from 700 to 500 because of slow recruitment, rather than stopping early at an efficacy boundary. R01	Some preserved-summary information has been linked. Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original sample/planning changes, events, approvals, statistical assumptions and versions	Proposal: Use original reports/plans specifying recruitment/planning changes and final-analysis scope
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionDo median follow-up of 67 months, five-year outcomes and exposure duration differ?Required	The original rationale reports 5-year PFS/OS at median follow-up of 67 months. 6 weeks of induction, a median 7-day interval and 5-year endpoints are distinct time values. R01	Some preserved-summary information has been linked. Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Follow-up distributions, data cutoff, risk sets and time-specific tables	Proposal: Use original same-trial materials clarifying follow-up and each endpoint's time points
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionAre between-arm HR/five-year proportions distinguished from within-arm change and adjustment?Required	Original numbers are between-arm HR, CI and P and each arm's 5-year survival proportion. They are not written as individual survival-time gains or within-arm change from baseline. R01	Some preserved-summary information has been linked. HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	SAP, statistical models, definitions of each estimate/interval and original tables	Proposal: Link original models, adjustment, assumptions and between-arm results
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionCan direct effects of dose, sequence and subgroups be stated?Supplementary; required for extension	The original comparison adds a specific 6-week weekly induction combination-chemotherapy sequence. The summary does not state that individual drug contributions, other intervals/doses or subgroup superiority were directly compared. R01	Some preserved-summary information has been linked. Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Direct comparisons, prespecified subgroups, interactions and actual exposure materials	Proposal: If suitable direct comparisons specifying population/exposure are supplied, distinguish them from the original strategy
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionHow are report/registration history, original evidence date and current production date separated?Required	The original citation is the 2024 Lancet report and the original evidence date is 2026-08-26. Empty corrections/deliberation and historical Korean/English quotes are preserved. The current timestamp marks content production. R01	Some preserved-summary information has been linked. Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Publication/registration changes, evidence date, search/correction history and production events	Proposal: If materials are supplied, preserve original versions and additional dates/correction events separately
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionWhich events and assessors define the selected PFS outcome?Required	The selected question is improved 5-year progression-free survival, and the original coprimary endpoint is investigator-assessed PFS. The original research description states progression or death as the endpoint. R01	Some preserved-summary information has been linked. Detailed progression criteria, imaging/clinical assessment, schedules, handling of death/unmeasured cases and time origin remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original PFS definition, progression assessment, death/censoring, time origin and measurement	Proposal: Use same-trial original reports/appendices disclosing actual PFS assessment and analysis rules
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionWhat time point and original units do five-year PFS of 72% versus 64% describe?Required	5-year PFS with the induction strategy versus CCRT alone was 72% versus 64%. The original core/synthesis wording of an 8%p increase for each outcome is preserved as an existing value. R01	Some preserved-summary information has been linked. Five-year proportion estimation, CI, time-specific risk sets and censoring/assessment denominators remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original five-year PFS proportions/CI, risk sets, curves and result tables	Proposal: Use same-PFS materials disclosing proportions and time-to-event definitions/denominators together
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionWhat are the original PFS HR, 95% CI, P and direction?Required	PFS HR 0.65 (95% CI 0.46~0.91), P=.013, is preserved from the original rationale/evidence. The original parent and subclaim describe increased survival. R01	Some preserved-summary information has been linked. HR models, proportional-hazards/adjustment, stratification, testing plans and absolute-importance criteria remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original PFS HR tables, models/SAP, intervals and testing definitions	Proposal: Link original analysis assumptions/plans to this HR
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionWhat were PFS events, five-year risk sets and denominators?Required	The original allocation/ITT denominator is 500 (250/250). 5-year PFS proportions and time-to-event analyses share this same population. R01	Required direct details were not verified within the current preserved-summary and externally unread scope. Separate progression/death event counts, composition/overlap, five-year risk sets and imaging omissions/censoring are absent from the original summary. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original PFS event/time-specific tables, risk sets, censoring and assessable/analyzed denominators	Proposal: Distinguish progression/death and observed/censored data within the same allocated population
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionHow is overlap among progression, death and OS marked?Required	Original PFS concerns progression or death; OS concerns all-cause death. Both outcomes share patients and some death events and belong to one clinical family. R01	Some preserved-summary information has been linked. Progression/death components, simultaneous/first-event handling, person-level linkage and original event counts remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Composite PFS event definitions, components, timing and relationships with OS death	Proposal: Use original same-trial result tables reporting PFS components and OS separately
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionWhat measurement gaps follow from unmasked progression assessment?Required	The original trial performed no blinding/masking and used investigator-assessed PFS. These original measurement conditions are attributed to the outcome. R01	Some preserved-summary information has been linked. Progression criteria/imaging frequency, central confirmation, assessor differences and arm-specific detection/follow-up differences remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original PFS assessment, masking/confirmation, assessment frequency and measurement limitations	Proposal: Use same-trial materials disclosing original PFS measurement and omission/confirmation procedures
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionWhat are the original details of PFS censoring, time origin and the ITT estimand?Required	The original states ITT analysis and censoring of event-free patients at the last known alive date. This scope is distinguished from specific investigator-assessed PFS rules. R01	Required direct details were not verified within the current preserved-summary and externally unread scope. PFS time origin, missed assessments/subsequent treatment, unconfirmable progression, sensitivity and administrative-censoring details remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	PFS SAP, censoring/missingness, time origin and sensitivity results	Proposal: Use original same-PFS materials specifying actual censoring and observation losses
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionWhat are reported intervals, clinical importance and planned PFS criteria?Required	Original HR/95% CI, 5-year proportions and the 8%p wording are preserved at distinct estimation levels. Parent B76 remains a historical verdict and supplies no new importance threshold. R01	Some preserved-summary information has been linked. Prespecified important differences, power/event counts, coprimary alpha/multiplicity and proportion CI remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	PFS important differences, joint testing, planning changes and original interval definitions	Proposal: If original plans are disclosed, link justified importance criteria and intervals together
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionHow does same-trial OS differ from the selected PFS question?Required	The related overall-survival table reports a separate coprimary 5-year OS result: 80% versus 72%, HR0.60 (95% CI0.40~0.91), P=.015. It shares the same 500-person, 250/250 population and median follow-up of 67 months. R01	Some preserved-summary information has been linked. OS death confirmation/censoring, original event counts, risk sets and detailed component relationships with PFS remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original same-trial PFS/OS definitions, time points, populations and models	Proposal: Use INTERLACE materials disclosing both coprimary outcomes' actual analysis scope separately
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionDoes PFS also answer tumor-response, symptom and quality-of-life questions?Supplementary; required for extension	The selected question concerns 5-year PFS for progression or death; the positive OS result is preserved separately. The summary contains no direct tumor-response percentages or patient-reported symptom/quality-of-life values. R01	Required direct details were not verified within the current preserved-summary and externally unread scope. Response rates, post-progression burden, quality of life, symptoms, long-term function and patient-preference materials remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Patient-centered/response outcomes separate from PFS, with definitions, denominators and time points	Proposal: Use same-trial or suitable additional research disclosing other patient outcomes separately
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWhat are the people, denominators and proportions for grade 3 or worse adverse events?Required	The original counterview records 147/250 (59%) versus 120/250 (48%), an 11%p increase. These original numbers are safety results for the same strategy, with endpoints separate from efficacy/survival. R01	Some preserved-summary information has been linked. Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original safety tables, populations, periods, classification/overlap and comparative statistics	Proposal: Link severe adverse events in the same exposed population to definitions, denominators and periods
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat window and relatedness apply to deaths within 30 days of treatment completion?Required	The original study-condition description records 1 versus 2 deaths within 30 days of treatment completion, all unrelated to treatment. This is relatedness wording within a limited original window. R01	Some preserved-summary information has been linked. Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original treatment-completion, 30-day window, cause/relatedness and denominator tables	Proposal: Use original materials disclosing the limited safety window separately from deaths across full follow-up
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionAre individual original results available for marrow suppression, infection and neuropathy?Required	The original safety description mentions chemotherapy-toxicities such as marrow suppression, infection and neuropathy. Individual event counts/proportions for these types are not provided in the summary. R01	Required direct details were not verified within the current preserved-summary and externally unread scope. Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original adverse-event type tables, definitions, collection/timing and denominators	Proposal: Use original materials reporting type-specific safety under the same study exposure
34	Unverified	Full text not readStored summary read	N34 · Evidence conditionWhat are safety-exposure, onset/recovery and stopping times?Required	6 weeks of induction, a median 7-day interval to CCRT, median follow-up of 67 months and 30 days after treatment completion are distinct original time contexts. The entire severe-adverse-event collection window is separately needed. R01	Required direct details were not verified within the current preserved-summary and externally unread scope. Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Phase-specific safety windows, exposure/stopping/recovery and arm-specific materials	Proposal: Link period-specific harms to treatment delivery under the same strategy
35	Partly verified	Full text not readStored summary read	N35 · Evidence conditionHow are original disease, CCRT, concomitant treatment and harm attribution distinguished?Required	Locally advanced cervical cancer and the two-drug-plus-CCRT sequence are original study conditions. Severe adverse events compare combined strategies; causal contributions form a separate question. R01	Some preserved-summary information has been linked. Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Baseline risk, phase/concomitant exposure, event attribution and analysis materials	Proposal: Use original safety materials distinguishing combined exposure and alternative causes
36	Unverified	Full text not readStored summary read	N36 · Evidence conditionWhat is the scope of safety omissions, dropout and selective follow-up?Required	Original wording records ITT500 and severe adverse events of 147/250 versus 120/250. Each original denominator is preserved, without equating it to complete collection of all events at all times. R01	Required direct details were not verified within the current preserved-summary and externally unread scope. Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Safety-analysis definitions, flow/missingness and event collection/detection	Proposal: Use same-trial reports/appendices specifying actual omissions and safety follow-up
37	Unverified	Full text not readStored summary read	N37 · Evidence conditionDo long-term, rare and vulnerable-population harms require separate direct materials?Supplementary; required for that extension	5-year survival outcomes and median follow-up of 67 months concern efficacy follow-up. The original records severe toxicity and a limited 30-day death window but does not supply all long-term, rare or population-specific harms. R01	Required direct details were not verified within the current preserved-summary and externally unread scope. Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Long-term/rare/population-specific safety, exposure/follow-up and direct comparisons	Proposal: If suitable materials for these scopes are supplied, distinguish them from the currently selected effects/harms
38	Partly verified	Full text not readStored summary read	N38 · Evidence conditionWhere was original public/nonprofit funding reported?Required	Cancer Research UK and University College London–UCLH Biomedical Research Centre support is recorded in the original funding and research descriptions. Parent I2 remains a historical axis. R01	Some preserved-summary information has been linked. Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original funding/COI, sponsor/author-role declarations and data access	Proposal: Link complete original declarations of actual funding, roles and disclosures
39	Partly verified	Full text not readStored summary read	N39 · Evidence conditionWhat is the scope of no reported company provision of free study drugs?Required	The original research description states that free company study-drug provision was not reported. This is historical parent-authoring wording and does not establish current products or complete contracts. R01	Some preserved-summary information has been linked. Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Study-drug/in-kind supply and original interest/role declarations	Proposal: If original declarations are supplied, distinguish unreported matters from actual absence or provision
40	Partly verified	Full text not readStored summary read	N40 · Evidence conditionHow are independent replication and the two coprimary outcomes distinguished?Required	The parent preserves the historical statement that the same strategy lacked independent replication and records R1. Positive PFS/OS are results from the same INTERLACE trial, rather than two separate confirmatory trials. R01	Some preserved-summary information has been linked. Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Family relationships among reports, trials, populations, exact strategies, sources, outcomes and harms	Proposal: If additional materials are supplied, link shared/separate trials and state the level at which independence was verified
41	Partly verified	Full text not readStored summary read	N41 · Evidence conditionWhat is the context of null OUTBACK/ACTLACC results under a different sequence?Required	The parent's research description/counterpoint states that post-radiation adjuvant chemotherapy in OUTBACK and ACTLACC did not improve survival and concerns a different sequencing question. They are not separate evidence/citation entries in this preserved summary. R01	Some preserved-summary information has been linked. Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Original study citations, exact sequences, populations, comparisons, results and same-strategy scope	Proposal: If relevant materials are supplied, distinguish sequencing scope without automatically treating it as direct refutation or superiority
42	Partly verified	Full text not readStored summary read	N42 · Evidence conditionHow are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved?Required	Parent B76/Caution, original axes B/H/R1/I2/E+/B0, unrecorded precision, coprimary-split false, large-hard-endpoint-RCT true, no-human-study false and empty override reason are preserved unchanged. Korean/English texts, historical synthesis/grade decision and cross-check wording remain parent history. R01	Some preserved-summary information has been linked. Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Separate copies of subclaim/parent values, axes/absences, Korean/English texts and historical verdicts	Proposal: If corrections are supplied, distinguish full original text, events/versions and decisions and record parent/subclaim scope
43	Partly verified	Full text not readStored summary read	N43 · Evidence conditionAt what level can survival and toxicity currently be described?Required	Both positive coprimary survival results, increased severe toxicity and the limited 30-day relatedness result are preserved within original scope. Parent Caution remains history and establishes neither personal treatment decisions nor safety certification. R01	Some preserved-summary information has been linked. Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Efficacy/safety definitions, denominators/periods, original statistics and extrapolation boundaries	Proposal: If original materials are added, update evidence gaps while distinguishing interpretation across outcomes and times
44	Partly verified	Full text not readStored summary read	N44 · Evidence conditionIs extrapolation to current treatment, dose or radiotherapy choices avoided?Supplementary; required for extension of applicability	This table presents the designated existing INTERLACE question and historical combination strategy, population, comparator, original values and gaps. Current individual treatment/suitability and other products/doses/sequences/techniques are separate questions. R01	Some preserved-summary information has been linked. Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.	Direct population/exposure/comparator, periods and effect/harm materials for extended questions	Proposal: If materials are supplied and scope authorized, update while distinguishing original materials from other application conditions

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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: Locally advanced cervical cancer; INTERLACE, 500 participants at 32 centers. Exact stage, age, eligibility and baseline characteristics are unverified.
Ingredient, formulation and route: The original combined strategy of six weeks of induction carboplatin and paclitaxel immediately before standard CCRT.
Dose: AUC 2, 80 mg/m², once weekly for six weeks and a median seven-day interval are historical study conditions; no conversion, use or dosing recommendations are provided.
Comparator: Standard concurrent chemoradiotherapy alone. Detailed chemotherapy and radiotherapy schedules and balance of supportive and subsequent treatment are unverified.
Measured outcome: Co-primary investigator-assessed PFS, defined by progression or death; five-year proportions and HR.
Duration: Five-year outcomes, median follow-up of 67 months, six weeks of induction, a median seven-day interval and deaths within 30 days of treatment completion are separate periods. Overall exposure, populations at risk and safety periods are unverified.
Questions outside this scope: Attribution of efficacy to either drug alone or to other doses, sequences, products or radiotherapy schedules.; Summing events or populations across PFS, OS, safety and the 30-day window.; New reduction percentages or NNT, or back-calculated participant counts from HR or five-year proportions.; Individual suitability, treatment selection, administration, dose conversion or treatment-substitution instructions.; Inheriting joint outcomes, public funding or parent B0/I2 as new certification of independence or completed review.

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 · McCormack M, Eminowicz G, Gallardo D, et al. Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE). Lancet. 2024;404:1525-1535. PMID: 39419054.

PubMed

Material type: Original summary of the same report from the international multicenter randomized phase 3 INTERLACE trial.
Materials actually read: Summary read; external abstracts, full papers and registries unread
Findings recorded in the stored summary: PFS HR 0.65 (95% CI 0.46~0.91), P=.013, is preserved from the original rationale/evidence. The original parent and subclaim describe increased survival.
Record level: Not recorded
Study overlap and independent replication: The two outcome tables share GCIG INTERLACE, PMID 39419054, NCT01566240 / EudraCT 2011-001300-35, 500 participants with 250 per arm, and follow-up of 67 months. PFS, OS, harms and the 30-day window are outcome-specific units and are not summed as independent evidence. OUTBACK and ACTLACC are retained only as named context in the preserved summary; no separate bibliographic entries or tables are created.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Complete preserved copy of the original summary	Preserved summary copy acquired; summary read	Summary read	The full parent record, two existing questions, Korean and English texts, and original values, bibliographic details and registry records were read for production. This was not reading the original paper or registry.
External abstract	External materials unread; access not attempted	Access not attempted; not acquired	Not read	The original PubMed bibliographic URL is retained; the abstract was not acquired or read, and the link was not tested.
External full text	External materials unread; access not attempted	Access not attempted; not acquired	Not read	The existing link connects bibliographic identity and does not certify full-text access or acquisition. Original plans, results, measurements and safety tables are needed.
External registration	External materials unread; access not attempted	Access not attempted; not acquired	Not read	Existing NCT01566240 and EudraCT 2011-001300-35 records and original statements of agreement are preserved; no URL absent from the existing review summary is created or accessed, and no date is inferred.
Required protocol	Not acquired; detailed existence unverified	Access not attempted; not acquired	Not read	Original plans and versions are needed for eligibility, nominal and actual treatment, measurement, co-primary endpoints and timepoints, and the change from 700 to 500.
Required analysis plan	Not acquired; detailed existence unverified	Access not attempted; not acquired	Not read	Original materials are needed for models and adjustment, joint alpha and multiplicity, censoring, populations at risk, sensitivity analyses and importance thresholds. No new intervals or numbers are generated.
Required result tables and safety material	Not acquired; detailed existence unverified	Access not attempted; not acquired	Not read	Original tables are needed for the five-year risk set and events, treatment delivery, safety by grade and time, the 30-day death window and attribution, follow-up and missingness.
Required funding and interests	Not acquired; detailed existence unverified	Access not attempted; not acquired	Not read	Public or nonprofit funding and unreported company-provided trial drugs are historical summary statements. Complete funding and product provision, contracts, author conflicts of interest, and design and publication roles remain unread.

Report counts versus independent study counts

The two outcome tables share GCIG INTERLACE, PMID 39419054, NCT01566240 / EudraCT 2011-001300-35, 500 participants with 250 per arm, and follow-up of 67 months. PFS, OS, harms and the 30-day window are outcome-specific units and are not summed as independent evidence. OUTBACK and ACTLACC are retained only as named context in the preserved summary; no separate bibliographic entries or tables are created.

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 · What are the selected question, verdict record and parent context?

Required materials and conditions: Original question/record and links to parent/related outcomes
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the selected question, verdict record and parent context" to their original locations. Historical candidate-boundary review pending status is preserved as history; existing content and question-boundary review remain incomplete.
Requirement and applicability: Required
Application exceptions: Historical candidate-boundary review pending status is preserved as history; existing content and question-boundary review remain incomplete. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the selected question, verdict record and parent context.
Referenced methods: Own question-specific application conditions informed by the preserved summary and family definition C01.

N02 · How are original subclaim B/note, parent B76 and absent score/axes separated?

Required materials and conditions: A preserved copy separating the subclaim verdict/note from parent score/axes
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are original subclaim B/note, parent B76 and absent score/axes separated" to their original locations. Direct selected-subclaim score, status and axes values are absent.
Requirement and applicability: Required
Application exceptions: A blanket D or the parent's score of 76 and axes are not inherited by the selected subclaim; no new grade or score is created.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are original subclaim B/note, parent B76 and absent score/axes separated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09.

N03 · Do both tables, PFS, OS and safety concern the same trial?

Required materials and conditions: Relationships among reports, registration, trial families, outcomes/time points and shared populations
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Do both tables, PFS, OS and safety concern the same trial" to their original locations. Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined.
Requirement and applicability: Required
Application exceptions: The two questions, survival curves, endpoints, centers or 500 participants with 250 per arm are not added as new independent replications or participants.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Do both tables, PFS, OS and safety concern the same trial.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.

N04 · Which preserved summary and external original materials have currently been read?

Required materials and conditions: Existence, acquisition, reading status and original locations of the preserved summary and external materials
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Which preserved summary and external original materials have currently been read" to their original locations. External availability/acquisition, current content, link operation and access success were not verified in this work.
Requirement and applicability: Required
Application exceptions: Summary reading is not labeled full-text or registry reading, and an access attempt that was not made is not changed to failed access or absent materials.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Which preserved summary and external original materials have currently been read.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C03.

N05 · What were the actual population and selection scope for locally advanced cervical cancer?

Required materials and conditions: Original eligibility/exclusion, stage and baseline-characteristic tables
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What were the actual population and selection scope for locally advanced cervical cancer" to their original locations. Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified.
Requirement and applicability: Required
Application exceptions: Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What were the actual population and selection scope for locally advanced cervical cancer.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E08.

N06 · What do 32 centers, the international multicenter design and population distribution describe?

Required materials and conditions: Center/region and recruitment distribution, baseline balance and treatment-delivery materials
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What do 32 centers, the international multicenter design and population distribution describe" to their original locations. Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary.
Requirement and applicability: Required
Application exceptions: The 32 centers are not labeled independent trials, and no country list or distribution is invented.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What do 32 centers, the international multicenter design and population distribution describe.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E01, E07.

N07 · What are the sequence of induction chemotherapy before radiation and the comparator strategy?

Required materials and conditions: Original protocols, shared treatment, sequencing and delivery for both strategies
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the sequence of induction chemotherapy before radiation and the comparator strategy" to their original locations. Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified.
Requirement and applicability: Required
Application exceptions: The study sequence is not written as an individual treatment plan, treatment selection or guidance for another sequence.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the sequence of induction chemotherapy before radiation and the comparator strategy.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02.

N08 · How are nominal induction exposure and actual administered amounts separated?

Required materials and conditions: Original nominal/actual exposure, changes, adherence, formulation and route materials
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are nominal induction exposure and actual administered amounts separated" to their original locations. Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified.
Requirement and applicability: Required
Application exceptions: AUC 2 is not converted to mg or mg/kg, and 80 mg/m² is not turned into an individual dose or instructions for use.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are nominal induction exposure and actual administered amounts separated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.

N09 · What was the median interval from induction completion to CCRT?

Required materials and conditions: Original interval, delay, non-delivery, actual schedule and completion tables
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What was the median interval from induction completion to CCRT" to their original locations. Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified.
Requirement and applicability: Required
Application exceptions: The median seven-day interval is not turned into an identical interval for every participant or a recommendation on when to start treatment.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What was the median interval from induction completion to CCRT.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.

N10 · What were the randomized/ITT denominators and arm allocations?

Required materials and conditions: Allocation-to-exposure-to-analysis flow and endpoint/time-specific safety denominators
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What were the randomized/ITT denominators and arm allocations" to their original locations. Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables.
Requirement and applicability: Required
Application exceptions: The ITT population of 500 is not changed to certification that everyone was observed at five years or had complete imaging, and participants in the two tables are not added together.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What were the randomized/ITT denominators and arm allocations.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.

N11 · What were allocation, concealment and baseline balance?

Required materials and conditions: Allocation algorithm/concealment, operational roles and baseline tables
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What were allocation, concealment and baseline balance" to their original locations. Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified.
Requirement and applicability: Required
Application exceptions: Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What were allocation, concealment and baseline balance.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01.

N12 · What is the scope of no masking and investigator-assessed PFS?

Required materials and conditions: Endpoint-specific measurement, assessors, masking/confirmation, schedules and original appendices
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What is the scope of no masking and investigator-assessed PFS" to their original locations. Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified.
Requirement and applicability: Required
Application exceptions: Absence of masking alone does not produce automatic failure or a new bias grade, and parent B0 is not inherited as verification of measurement for each outcome.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What is the scope of no masking and investigator-assessed PFS.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01, E03.

N13 · What are the original ITT and censoring records for event-free patients?

Required materials and conditions: Endpoint-specific ITT/censoring, missingness, sensitivity and analysis-population definitions
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the original ITT and censoring records for event-free patients" to their original locations. Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified.
Requirement and applicability: Required
Application exceptions: Original ITT and censoring statements are not labeled complete follow-up of every participant or completed current statistical review.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the original ITT and censoring records for event-free patients.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.

N14 · How were adherence, supportive/follow-up treatment and treatment changes handled?

Required materials and conditions: Actual arm-specific treatment, follow-up/salvage treatment, adherence and handling
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How were adherence, supportive/follow-up treatment and treatment changes handled" to their original locations. Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified.
Requirement and applicability: Required
Application exceptions: Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How were adherence, supportive/follow-up treatment and treatment changes handled.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E02, E04.

N15 · What were coprimary PFS/OS and the registration history?

Required materials and conditions: Original NCT/EudraCT versions, protocol, SAP and coprimary endpoint/time-point comparisons
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What were coprimary PFS/OS and the registration history" to their original locations. Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread.
Requirement and applicability: Required
Application exceptions: Registry IDs and original statements of agreement are not upgraded to registry access during this work or certification of prespecification.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What were coprimary PFS/OS and the registration history.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, C09.

N16 · Why did the planned sample change from 700 to 500?

Required materials and conditions: Original sample/planning changes, events, approvals, statistical assumptions and versions
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Why did the planned sample change from 700 to 500" to their original locations. Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified.
Requirement and applicability: Required
Application exceptions: The difference between the planned 700 and revised 500 is not calculated as dropout or an efficacy-stopping count; historical statements alone do not currently certify every plan amendment.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Why did the planned sample change from 700 to 500.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, E05, C07.

N17 · Do median follow-up of 67 months, five-year outcomes and exposure duration differ?

Required materials and conditions: Follow-up distributions, data cutoff, risk sets and time-specific tables
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Do median follow-up of 67 months, five-year outcomes and exposure duration differ" to their original locations. Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified.
Requirement and applicability: Required
Application exceptions: The 67 months are not labeled every participant's follow-up duration or treatment duration.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Do median follow-up of 67 months, five-year outcomes and exposure duration differ.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, H02.

N18 · Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment?

Required materials and conditions: SAP, statistical models, definitions of each estimate/interval and original tables
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment" to their original locations. HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified.
Requirement and applicability: Required
Application exceptions: HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.

N19 · Can direct effects of dose, sequence and subgroups be stated?

Required materials and conditions: Direct comparisons, prespecified subgroups, interactions and actual exposure materials
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Can direct effects of dose, sequence and subgroups be stated" to their original locations. Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified.
Requirement and applicability: Supplementary; required for extension
Application exceptions: Results for the combined two-drug sequence are not attributed to either drug alone or to a confirmed optimal dose or interval.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Can direct effects of dose, sequence and subgroups be stated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E08, E02.

N20 · How are report/registration history, original evidence date and current production date separated?

Required materials and conditions: Publication/registration changes, evidence date, search/correction history and production events
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are report/registration history, original evidence date and current production date separated" to their original locations. Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed.
Requirement and applicability: Required
Application exceptions: The 2024 report or registry numbers are not used to infer a registration date, and an empty correction list is not labeled current certification of no corrections.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are report/registration history, original evidence date and current production date separated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, C03.

N21 · Which events and assessors define the selected PFS outcome?

Required materials and conditions: Original PFS definition, progression assessment, death/censoring, time origin and measurement
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Which events and assessors define the selected PFS outcome" to their original locations. Detailed progression criteria, imaging/clinical assessment, schedules, handling of death/unmeasured cases and time origin remain unverified.
Requirement and applicability: Required
Application exceptions: Detailed progression criteria, imaging/clinical assessment, schedules, handling of death/unmeasured cases and time origin remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Which events and assessors define the selected PFS outcome.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E03, E04.

N22 · What time point and original units do five-year PFS of 72% versus 64% describe?

Required materials and conditions: Original five-year PFS proportions/CI, risk sets, curves and result tables
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What time point and original units do five-year PFS of 72% versus 64% describe" to their original locations. Five-year proportion estimation, CI, time-specific risk sets and censoring/assessment denominators remain unverified.
Requirement and applicability: Required
Application exceptions: No new proportion difference, responder count, NNT or survival duration is calculated beyond the original 8%p.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What time point and original units do five-year PFS of 72% versus 64% describe.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, E05.

N23 · What are the original PFS HR, 95% CI, P and direction?

Required materials and conditions: Original PFS HR tables, models/SAP, intervals and testing definitions
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the original PFS HR, 95% CI, P and direction" to their original locations. HR models, proportional-hazards/adjustment, stratification, testing plans and absolute-importance criteria remain unverified.
Requirement and applicability: Required
Application exceptions: HR is not converted to RR, an individual guarantee about recurrence or death, or a new relative reduction percentage.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the original PFS HR, 95% CI, P and direction.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.

N24 · What were PFS events, five-year risk sets and denominators?

Required materials and conditions: Original PFS event/time-specific tables, risk sets, censoring and assessable/analyzed denominators
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What were PFS events, five-year risk sets and denominators" to their original locations. Separate progression/death event counts, composition/overlap, five-year risk sets and imaging omissions/censoring are absent from the original summary.
Requirement and applicability: Required
Application exceptions: The 72% and 64% are not multiplied by 250 to back-calculate event or participant counts, and all 250 participants are not said to have been observed at five years.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What were PFS events, five-year risk sets and denominators.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.

N25 · How is overlap among progression, death and OS marked?

Required materials and conditions: Composite PFS event definitions, components, timing and relationships with OS death
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How is overlap among progression, death and OS marked" to their original locations. Progression/death components, simultaneous/first-event handling, person-level linkage and original event counts remain unverified.
Requirement and applicability: Required
Application exceptions: PFS and OS events, patients or tables are not added to produce a new total or independent replication.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How is overlap among progression, death and OS marked.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, C06, E09.

N26 · What measurement gaps follow from unmasked progression assessment?

Required materials and conditions: Original PFS assessment, masking/confirmation, assessment frequency and measurement limitations
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What measurement gaps follow from unmasked progression assessment" to their original locations. Progression criteria/imaging frequency, central confirmation, assessor differences and arm-specific detection/follow-up differences remain unverified.
Requirement and applicability: Required
Application exceptions: The parent's description of PFS as a hard endpoint is not changed to absence of all assessment bias, and lack of masking alone does not remove the result.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What measurement gaps follow from unmasked progression assessment.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E03.

N27 · What are the original details of PFS censoring, time origin and the ITT estimand?

Required materials and conditions: PFS SAP, censoring/missingness, time origin and sensitivity results
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the original details of PFS censoring, time origin and the ITT estimand" to their original locations. PFS time origin, missed assessments/subsequent treatment, unconfirmable progression, sensitivity and administrative-censoring details remain unverified.
Requirement and applicability: Required
Application exceptions: PFS time origin, missed assessments/subsequent treatment, unconfirmable progression, sensitivity and administrative-censoring details remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the original details of PFS censoring, time origin and the ITT estimand.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E04, C07.

N28 · What are reported intervals, clinical importance and planned PFS criteria?

Required materials and conditions: PFS important differences, joint testing, planning changes and original interval definitions
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are reported intervals, clinical importance and planned PFS criteria" to their original locations. Prespecified important differences, power/event counts, coprimary alpha/multiplicity and proportion CI remain unverified.
Requirement and applicability: Required
Application exceptions: A large sample, positive P value or parent B is not used as a new verdict that every effect size or individual benefit is sufficiently established.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are reported intervals, clinical importance and planned PFS criteria.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E05, E06.

N29 · How does same-trial OS differ from the selected PFS question?

Required materials and conditions: Original same-trial PFS/OS definitions, time points, populations and models
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How does same-trial OS differ from the selected PFS question" to their original locations. OS death confirmation/censoring, original event counts, risk sets and detailed component relationships with PFS remain unverified.
Requirement and applicability: Required
Application exceptions: OS values or intervals are not moved to PFS, and the two outcomes are not added as independent confirmatory trials.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How does same-trial OS differ from the selected PFS question.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C08, C02, E09.

N30 · Does PFS also answer tumor-response, symptom and quality-of-life questions?

Required materials and conditions: Patient-centered/response outcomes separate from PFS, with definitions, denominators and time points
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Does PFS also answer tumor-response, symptom and quality-of-life questions" to their original locations. Response rates, post-progression burden, quality of life, symptoms, long-term function and patient-preference materials remain unverified.
Requirement and applicability: Supplementary; required for extension
Application exceptions: Positive PFS or OS does not automatically extend to every symptom, quality of life or individual benefit.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Does PFS also answer tumor-response, symptom and quality-of-life questions.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E09, E08.

N31 · What are the people, denominators and proportions for grade 3 or worse adverse events?

Required materials and conditions: Original safety tables, populations, periods, classification/overlap and comparative statistics
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the people, denominators and proportions for grade 3 or worse adverse events" to their original locations. Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified.
Requirement and applicability: Required
Application exceptions: No new risk difference, ratio, CI, significance or individual harm incidence is calculated beyond the original 11%p.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the people, denominators and proportions for grade 3 or worse adverse events.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H01, H03, H04.

N32 · What window and relatedness apply to deaths within 30 days of treatment completion?

Required materials and conditions: Original treatment-completion, 30-day window, cause/relatedness and denominator tables
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What window and relatedness apply to deaths within 30 days of treatment completion" to their original locations. Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified.
Requirement and applicability: Required
Application exceptions: The historical absence of treatment-related deaths within 30 days is not changed to a safety guarantee for every time or harm.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What window and relatedness apply to deaths within 30 days of treatment completion.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H02, H04, H09.

N33 · Are individual original results available for marrow suppression, infection and neuropathy?

Required materials and conditions: Original adverse-event type tables, definitions, collection/timing and denominators
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Are individual original results available for marrow suppression, infection and neuropathy" to their original locations. Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified.
Requirement and applicability: Required
Application exceptions: Original toxicity examples are not asserted to be observed events or rates in particular individuals, and no new user instructions for management or administration are written.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Are individual original results available for marrow suppression, infection and neuropathy.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H04, E10.

N34 · What are safety-exposure, onset/recovery and stopping times?

Required materials and conditions: Phase-specific safety windows, exposure/stopping/recovery and arm-specific materials
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are safety-exposure, onset/recovery and stopping times" to their original locations. Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified.
Requirement and applicability: Required
Application exceptions: The median efficacy follow-up of 67 months is not repurposed as the observation or exposure duration for every harm.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are safety-exposure, onset/recovery and stopping times.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H02, H04.

N35 · How are original disease, CCRT, concomitant treatment and harm attribution distinguished?

Required materials and conditions: Baseline risk, phase/concomitant exposure, event attribution and analysis materials
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are original disease, CCRT, concomitant treatment and harm attribution distinguished" to their original locations. Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified.
Requirement and applicability: Required
Application exceptions: Original proportions for the combined strategy are not changed to harm or harmlessness of a particular drug alone, or instructions for adjustment.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are original disease, CCRT, concomitant treatment and harm attribution distinguished.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H05, E02, E10.

N36 · What is the scope of safety omissions, dropout and selective follow-up?

Required materials and conditions: Safety-analysis definitions, flow/missingness and event collection/detection
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What is the scope of safety omissions, dropout and selective follow-up" to their original locations. Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified.
Requirement and applicability: Required
Application exceptions: Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What is the scope of safety omissions, dropout and selective follow-up.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H06, H04, C07.

N37 · Do long-term, rare and vulnerable-population harms require separate direct materials?

Required materials and conditions: Long-term/rare/population-specific safety, exposure/follow-up and direct comparisons
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Do long-term, rare and vulnerable-population harms require separate direct materials" to their original locations. Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified.
Requirement and applicability: Supplementary; required for that extension
Application exceptions: Events not specified here are not filled in as zero or no occurrence.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Do long-term, rare and vulnerable-population harms require separate direct materials.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H08, E08.

N38 · Where was original public/nonprofit funding reported?

Required materials and conditions: Original funding/COI, sponsor/author-role declarations and data access
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Where was original public/nonprofit funding reported" to their original locations. Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified.
Requirement and applicability: Required
Application exceptions: Public or nonprofit funding and original I2 alone do not certify current independence, absence of bias or absence of all conflicts of interest.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Where was original public/nonprofit funding reported.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.

N39 · What is the scope of no reported company provision of free study drugs?

Required materials and conditions: Study-drug/in-kind supply and original interest/role declarations
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What is the scope of no reported company provision of free study drugs" to their original locations. Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread.
Requirement and applicability: Required
Application exceptions: A statement that something was not reported is not changed to current certification of no involvement or provision by any company.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What is the scope of no reported company provision of free study drugs.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.

N40 · How are independent replication and the two coprimary outcomes distinguished?

Required materials and conditions: Family relationships among reports, trials, populations, exact strategies, sources, outcomes and harms
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are independent replication and the two coprimary outcomes distinguished" to their original locations. Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search.
Requirement and applicability: Required
Application exceptions: The original absence of replication is not changed to zero current studies worldwide, and two tables or endpoints are not counted as new independent replications.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are independent replication and the two coprimary outcomes distinguished.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.

N41 · What is the context of null OUTBACK/ACTLACC results under a different sequence?

Required materials and conditions: Original study citations, exact sequences, populations, comparisons, results and same-strategy scope
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What is the context of null OUTBACK/ACTLACC results under a different sequence" to their original locations. Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread.
Requirement and applicability: Required
Application exceptions: Names alone do not create additional report entries or new independent trials, or establish direct superiority of one sequence over another or optimal timing.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What is the context of null OUTBACK/ACTLACC results under a different sequence.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C08, C02, E07, E08.

N42 · How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved?

Required materials and conditions: Separate copies of subclaim/parent values, axes/absences, Korean/English texts and historical verdicts
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved" to their original locations. Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review.
Requirement and applicability: Required
Application exceptions: Unrecorded precision is not filled in as zero, and parent scores or axes are not inherited by the subclaim or labeled a newly completed review.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09, E06.

N43 · At what level can survival and toxicity currently be described?

Required materials and conditions: Efficacy/safety definitions, denominators/periods, original statistics and extrapolation boundaries
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "At what level can survival and toxicity currently be described" to their original locations. Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified.
Requirement and applicability: Required
Application exceptions: Original increases are not changed to guarantees of individual benefit or harm, and absence of treatment-related deaths within 30 days is not extended to harmlessness.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: At what level can survival and toxicity currently be described.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H09, E10, C08, E09.

N44 · Is extrapolation to current treatment, dose or radiotherapy choices avoided?

Required materials and conditions: Direct population/exposure/comparator, periods and effect/harm materials for extended questions
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Is extrapolation to current treatment, dose or radiotherapy choices avoided" to their original locations. Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified.
Requirement and applicability: Supplementary; required for extension of applicability
Application exceptions: No new instructions are created for carboplatin or paclitaxel, dose calculation or administration, CCRT or radiotherapy schedules, treatment selection or substitution, suitability or management actions.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Is extrapolation to current treatment, dose or radiotherapy choices avoided.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, E08, 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: Existing content review is pending or remains 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

2026-10-10 · 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 · What are the selected question, verdict record and parent context?

Current findings: The selected existing question is improved 5-year progression-free survival; the question and its existing verdict record are preserved separately. The parent explains both coprimary survival results, while this table concerns the selected result itself.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some information in the stored summary was linked for preparation. The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.
Reason for missing information: The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.
Required materials and conditions: Original question/record and links to parent/related outcomes
Materials to obtain first: Original question/record and links to parent/related outcomes
Further research: Proposal: If new materials for the same question are supplied, link them while preserving the existing record and original wording
Remaining uncertainty: The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the selected question, verdict record and parent context" to their original locations. Historical candidate-boundary review pending status is preserved as history; existing content and question-boundary review remain incomplete.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the selected question, verdict record and parent context.
Application exceptions: Historical candidate-boundary review pending status is preserved as history; existing content and question-boundary review remain incomplete. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Referenced methods: Own question-specific application conditions informed by the preserved summary and family definition C01.

Related sources R01

N02 · How are original subclaim B/note, parent B76 and absent score/axes separated?

Current findings: Original subclaim grade B and note '72% versus 64%, HR 0.65' are retained. Selected subclaim score, status and axes are absent; parent B, 76, Caution and axes remain parent history.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Direct selected-subclaim score, status and axes values are absent. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: There are no direct values for the selected subclaim score, status or axes.
Required materials and conditions: A preserved copy separating the subclaim verdict/note from parent score/axes
Materials to obtain first: A preserved copy separating the subclaim verdict/note from parent score/axes
Further research: Proposal: If a subclaim correction is actually supplied, record the complete original text, event and change decision separately
Remaining uncertainty: There are no direct values for the selected subclaim score, status or axes.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are original subclaim B/note, parent B76 and absent score/axes separated" to their original locations. Direct selected-subclaim score, status and axes values are absent.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are original subclaim B/note, parent B76 and absent score/axes separated.
Application exceptions: A blanket D or the parent's score of 76 and axes are not inherited by the selected subclaim; no new grade or score is created.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09.

Related sources R01

N03 · Do both tables, PFS, OS and safety concern the same trial?

Current findings: 1 original evidence entry and 1 citation entry link McCormack et al. 2024 GCIG INTERLACE, PMID39419054. PFS, OS, safety and both existing tables share results from the same trial and 500-person, 250/250 population.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined.
Required materials and conditions: Relationships among reports, registration, trial families, outcomes/time points and shared populations
Materials to obtain first: Relationships among reports, registration, trial families, outcomes/time points and shared populations
Further research: Proposal: If follow-up or other materials are supplied, distinguish shared reports/populations/outcomes from separate families
Remaining uncertainty: Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Do both tables, PFS, OS and safety concern the same trial" to their original locations. Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Do both tables, PFS, OS and safety concern the same trial.
Application exceptions: The two questions, survival curves, endpoints, centers or 500 participants with 250 per arm are not added as new independent replications or 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 · Which preserved summary and external original materials have currently been read?

Current findings: The complete designated preserved summary was read for production and its original bytes preserved. The original PubMed URL is linked unchanged; external abstracts, papers, registration and plans remain unread.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. External availability/acquisition, current content, link operation and access success were not verified in 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, current content, link operation and access success were not verified in this work.
Required materials and conditions: Existence, acquisition, reading status and original locations of the preserved summary and external materials
Materials to obtain first: Existence, acquisition, reading status and original locations of the preserved summary and external materials
Further research: Proposal: When obtaining follow-up materials is authorized, record actual reading level and distinguish historical from current dates
Remaining uncertainty: External availability/acquisition, current content, link operation and access success were not verified in this work.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Which preserved summary and external original materials have currently been read" to their original locations. External availability/acquisition, current content, link operation and access success were not verified in this work.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Which preserved summary and external original materials have currently been read.
Application exceptions: Summary reading is not labeled full-text or registry reading, and an access attempt that was not made is not changed to failed access or absent materials.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C03.

Related sources R01

N05 · What were the actual population and selection scope for locally advanced cervical cancer?

Current findings: The preserved parent question concerns locally advanced cervical cancer in the 500-person INTERLACE trial. Specific recruitment/exclusion and baseline composition lie beyond the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified.
Required materials and conditions: Original eligibility/exclusion, stage and baseline-characteristic tables
Materials to obtain first: Original eligibility/exclusion, stage and baseline-characteristic tables
Further research: Proposal: Use materials from the same trial specifying original recruitment conditions, or suitable separate population research
Remaining uncertainty: Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What were the actual population and selection scope for locally advanced cervical cancer" to their original locations. Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What were the actual population and selection scope for locally advanced cervical cancer.
Application exceptions: Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E08.

Related sources R01

N06 · What do 32 centers, the international multicenter design and population distribution describe?

Current findings: The original research description states that INTERLACE assigned 500 people at 32 centers, 250 per group; the evidence design is an international multicenter randomized phase 3 trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary.
Required materials and conditions: Center/region and recruitment distribution, baseline balance and treatment-delivery materials
Materials to obtain first: Center/region and recruitment distribution, baseline balance and treatment-delivery materials
Further research: Proposal: Use supplementary same-trial materials reporting actual regional conditions and results
Remaining uncertainty: Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What do 32 centers, the international multicenter design and population distribution describe" to their original locations. Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What do 32 centers, the international multicenter design and population distribution describe.
Application exceptions: The 32 centers are not labeled independent trials, and no country list or distribution is invented.
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 are the sequence of induction chemotherapy before radiation and the comparator strategy?

Current findings: The trial compares adding 6 weeks of induction carboplatin-paclitaxel before standard concurrent chemoradiotherapy with standard concurrent chemoradiotherapy alone. The original citation title and Korean/English texts are linked unchanged.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified.
Required materials and conditions: Original protocols, shared treatment, sequencing and delivery for both strategies
Materials to obtain first: Original protocols, shared treatment, sequencing and delivery for both strategies
Further research: Proposal: Use reports/appendices defining the original comparison of induction addition and standard CCRT
Remaining uncertainty: Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the sequence of induction chemotherapy before radiation and the comparator strategy" to their original locations. Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the sequence of induction chemotherapy before radiation and the comparator strategy.
Application exceptions: The study sequence is not written as an individual treatment plan, treatment selection or guidance for another sequence.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02.

Related sources R01

N08 · How are nominal induction exposure and actual administered amounts separated?

Current findings: Original study exposure was carboplatin AUC 2 and paclitaxel 80 mg/m², once weekly (1 administration per week) for 6 weeks. Original units/frequency are preserved only as historical study conditions.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified.
Required materials and conditions: Original nominal/actual exposure, changes, adherence, formulation and route materials
Materials to obtain first: Original nominal/actual exposure, changes, adherence, formulation and route materials
Further research: Proposal: Link actual administration/stopping and results from the same study
Remaining uncertainty: Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are nominal induction exposure and actual administered amounts separated" to their original locations. Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are nominal induction exposure and actual administered amounts separated.
Application exceptions: AUC 2 is not converted to mg or mg/kg, and 80 mg/m² is not turned into an individual dose or instructions for use.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.

Related sources R01

N09 · What was the median interval from induction completion to CCRT?

Current findings: The original study-condition description gives a median interval of 7 days. It is preserved together with the research description that CCRT began approximately 1 week later.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified.
Required materials and conditions: Original interval, delay, non-delivery, actual schedule and completion tables
Materials to obtain first: Original interval, delay, non-delivery, actual schedule and completion tables
Further research: Proposal: Link same-study sequencing, interval distributions and treatment delivery
Remaining uncertainty: Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What was the median interval from induction completion to CCRT" to their original locations. Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What was the median interval from induction completion to CCRT.
Application exceptions: The median seven-day interval is not turned into an identical interval for every participant or a recommendation on when to start treatment.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.

Related sources R01

N10 · What were the randomized/ITT denominators and arm allocations?

Current findings: Original sample wording is 500 randomized and 500 ITT participants (250/250). The original history describes both outcomes as analyses of this same allocated population.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables.
Required materials and conditions: Allocation-to-exposure-to-analysis flow and endpoint/time-specific safety denominators
Materials to obtain first: Allocation-to-exposure-to-analysis flow and endpoint/time-specific safety denominators
Further research: Proposal: Distinguish analysis, risk sets and actual exposure within the same allocated population
Remaining uncertainty: Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What were the randomized/ITT denominators and arm allocations" to their original locations. Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What were the randomized/ITT denominators and arm allocations.
Application exceptions: The ITT population of 500 is not changed to certification that everyone was observed at five years or had complete imaging, and participants in the two tables are not added together.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.

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N11 · What were allocation, concealment and baseline balance?

Current findings: The original quote states, 'Allocation was done by minimisation, using a central electronic system'. The central-electronic-system minimisation record is preserved.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Original details of minimisation variables, random components, sequence access/operation and baseline balance 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 details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified.
Required materials and conditions: Allocation algorithm/concealment, operational roles and baseline tables
Materials to obtain first: Allocation algorithm/concealment, operational roles and baseline tables
Further research: Proposal: Use plans/original reports disclosing actual allocation procedures
Remaining uncertainty: Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What were allocation, concealment and baseline balance" to their original locations. Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What were allocation, concealment and baseline balance.
Application exceptions: Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01.

Related sources R01

N12 · What is the scope of no masking and investigator-assessed PFS?

Current findings: The original quote states, 'No blinding or masking was performed', and identifies investigator-assessed PFS and all-cause death. Wording that masking was infeasible for the induction sequence remains historical context.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment 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: Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified.
Required materials and conditions: Endpoint-specific measurement, assessors, masking/confirmation, schedules and original appendices
Materials to obtain first: Endpoint-specific measurement, assessors, masking/confirmation, schedules and original appendices
Further research: Proposal: Link same-trial PFS and OS measurement limitations to each outcome
Remaining uncertainty: Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What is the scope of no masking and investigator-assessed PFS" to their original locations. Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What is the scope of no masking and investigator-assessed PFS.
Application exceptions: Absence of masking alone does not produce automatic failure or a new bias grade, and parent B0 is not inherited as verification of measurement for each outcome.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01, E03.

Related sources R01

N13 · What are the original ITT and censoring records for event-free patients?

Current findings: The original statement 'Analyses were by intention-to-treat (ITT)' and censoring of event-free patients at the last known alive date are preserved.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified.
Required materials and conditions: Endpoint-specific ITT/censoring, missingness, sensitivity and analysis-population definitions
Materials to obtain first: Endpoint-specific ITT/censoring, missingness, sensitivity and analysis-population definitions
Further research: Proposal: Link event/censoring/loss flow and original analysis from the same trial
Remaining uncertainty: Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the original ITT and censoring records for event-free patients" to their original locations. Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the original ITT and censoring records for event-free patients.
Application exceptions: Original ITT and censoring statements are not labeled complete follow-up of every participant or completed current statistical review.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.

Related sources R01

N14 · How were adherence, supportive/follow-up treatment and treatment changes handled?

Current findings: The original allocated-strategy comparison is induction chemotherapy followed by CCRT versus CCRT alone. The two drugs/radiation sequence must be distinguished from actual delivery and subsequent interventions.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy 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: Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified.
Required materials and conditions: Actual arm-specific treatment, follow-up/salvage treatment, adherence and handling
Materials to obtain first: Actual arm-specific treatment, follow-up/salvage treatment, adherence and handling
Further research: Proposal: Use original reports distinguishing allocated-strategy effects from actual treatment delivery
Remaining uncertainty: Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How were adherence, supportive/follow-up treatment and treatment changes handled" to their original locations. Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How were adherence, supportive/follow-up treatment and treatment changes handled.
Application exceptions: Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E02, E04.

Related sources R01

N15 · What were coprimary PFS/OS and the registration history?

Current findings: The original quote 'The primary endpoints were overall survival and investigator-assessed progression-free survival' and stated agreement with NCT01566240 are preserved. The evidence registration entry is NCT01566240 · EudraCT 2011-001300-35.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread.
Required materials and conditions: Original NCT/EudraCT versions, protocol, SAP and coprimary endpoint/time-point comparisons
Materials to obtain first: Original NCT/EudraCT versions, protocol, SAP and coprimary endpoint/time-point comparisons
Further research: Proposal: If original plans are supplied, link coprimary endpoints, amendment times and reporting scope
Remaining uncertainty: Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What were coprimary PFS/OS and the registration history" to their original locations. Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What were coprimary PFS/OS and the registration history.
Application exceptions: Registry IDs and original statements of agreement are not upgraded to registry access during this work or certification of prespecification.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, C09.

Related sources R01

N16 · Why did the planned sample change from 700 to 500?

Current findings: The original counterview states that the planned sample decreased from 700 to 500 because of slow recruitment, rather than stopping early at an efficacy boundary.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details 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 amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified.
Required materials and conditions: Original sample/planning changes, events, approvals, statistical assumptions and versions
Materials to obtain first: Original sample/planning changes, events, approvals, statistical assumptions and versions
Further research: Proposal: Use original reports/plans specifying recruitment/planning changes and final-analysis scope
Remaining uncertainty: Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Why did the planned sample change from 700 to 500" to their original locations. Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Why did the planned sample change from 700 to 500.
Application exceptions: The difference between the planned 700 and revised 500 is not calculated as dropout or an efficacy-stopping count; historical statements alone do not currently certify every plan amendment.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, E05, C07.

Related sources R01

N17 · Do median follow-up of 67 months, five-year outcomes and exposure duration differ?

Current findings: The original rationale reports 5-year PFS/OS at median follow-up of 67 months. 6 weeks of induction, a median 7-day interval and 5-year endpoints are distinct time values.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified.
Required materials and conditions: Follow-up distributions, data cutoff, risk sets and time-specific tables
Materials to obtain first: Follow-up distributions, data cutoff, risk sets and time-specific tables
Further research: Proposal: Use original same-trial materials clarifying follow-up and each endpoint's time points
Remaining uncertainty: Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Do median follow-up of 67 months, five-year outcomes and exposure duration differ" to their original locations. Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Do median follow-up of 67 months, five-year outcomes and exposure duration differ.
Application exceptions: The 67 months are not labeled every participant's follow-up duration or treatment duration.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, H02.

Related sources R01

N18 · Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment?

Current findings: Original numbers are between-arm HR, CI and P and each arm's 5-year survival proportion. They are not written as individual survival-time gains or within-arm change from baseline.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity 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/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified.
Required materials and conditions: SAP, statistical models, definitions of each estimate/interval and original tables
Materials to obtain first: SAP, statistical models, definitions of each estimate/interval and original tables
Further research: Proposal: Link original models, adjustment, assumptions and between-arm results
Remaining uncertainty: HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment" to their original locations. HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment.
Application exceptions: HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.

Related sources R01

N19 · Can direct effects of dose, sequence and subgroups be stated?

Current findings: The original comparison adds a specific 6-week weekly induction combination-chemotherapy sequence. The summary does not state that individual drug contributions, other intervals/doses or subgroup superiority were directly compared.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified.
Required materials and conditions: Direct comparisons, prespecified subgroups, interactions and actual exposure materials
Materials to obtain first: Direct comparisons, prespecified subgroups, interactions and actual exposure materials
Further research: Proposal: If suitable direct comparisons specifying population/exposure are supplied, distinguish them from the original strategy
Remaining uncertainty: Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Can direct effects of dose, sequence and subgroups be stated" to their original locations. Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Can direct effects of dose, sequence and subgroups be stated.
Application exceptions: Results for the combined two-drug sequence are not attributed to either drug alone or to a confirmed optimal dose or interval.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E08, E02.

Related sources R01

N20 · How are report/registration history, original evidence date and current production date separated?

Current findings: The original citation is the 2024 Lancet report and the original evidence date is 2026-08-26. Empty corrections/deliberation and historical Korean/English quotes are preserved. The current timestamp marks content production.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed.
Required materials and conditions: Publication/registration changes, evidence date, search/correction history and production events
Materials to obtain first: Publication/registration changes, evidence date, search/correction history and production events
Further research: Proposal: If materials are supplied, preserve original versions and additional dates/correction events separately
Remaining uncertainty: Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are report/registration history, original evidence date and current production date separated" to their original locations. Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are report/registration history, original evidence date and current production date separated.
Application exceptions: The 2024 report or registry numbers are not used to infer a registration date, and an empty correction list is not labeled current certification of no corrections.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, C03.

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N21 · Which events and assessors define the selected PFS outcome?

Current findings: The selected question is improved 5-year progression-free survival, and the original coprimary endpoint is investigator-assessed PFS. The original research description states progression or death as the endpoint.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Detailed progression criteria, imaging/clinical assessment, schedules, handling of death/unmeasured cases and time origin remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Detailed progression criteria, imaging/clinical assessment, schedules, handling of death/unmeasured cases and time origin remain unverified.
Required materials and conditions: Original PFS definition, progression assessment, death/censoring, time origin and measurement
Materials to obtain first: Original PFS definition, progression assessment, death/censoring, time origin and measurement
Further research: Proposal: Use same-trial original reports/appendices disclosing actual PFS assessment and analysis rules
Remaining uncertainty: Detailed progression criteria, imaging/clinical assessment, schedules, handling of death/unmeasured cases and time origin remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Which events and assessors define the selected PFS outcome" to their original locations. Detailed progression criteria, imaging/clinical assessment, schedules, handling of death/unmeasured cases and time origin remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Which events and assessors define the selected PFS outcome.
Application exceptions: Detailed progression criteria, imaging/clinical assessment, schedules, handling of death/unmeasured cases and time origin remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E03, E04.

Related sources R01

N22 · What time point and original units do five-year PFS of 72% versus 64% describe?

Current findings: 5-year PFS with the induction strategy versus CCRT alone was 72% versus 64%. The original core/synthesis wording of an 8%p increase for each outcome is preserved as an existing value.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Five-year proportion estimation, CI, time-specific risk sets and censoring/assessment denominators remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Five-year proportion estimation, CI, time-specific risk sets and censoring/assessment denominators remain unverified.
Required materials and conditions: Original five-year PFS proportions/CI, risk sets, curves and result tables
Materials to obtain first: Original five-year PFS proportions/CI, risk sets, curves and result tables
Further research: Proposal: Use same-PFS materials disclosing proportions and time-to-event definitions/denominators together
Remaining uncertainty: Five-year proportion estimation, CI, time-specific risk sets and censoring/assessment denominators remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What time point and original units do five-year PFS of 72% versus 64% describe" to their original locations. Five-year proportion estimation, CI, time-specific risk sets and censoring/assessment denominators remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What time point and original units do five-year PFS of 72% versus 64% describe.
Application exceptions: No new proportion difference, responder count, NNT or survival duration is calculated beyond the original 8%p.
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 original PFS HR, 95% CI, P and direction?

Current findings: PFS HR 0.65 (95% CI 0.46~0.91), P=.013, is preserved from the original rationale/evidence. The original parent and subclaim describe increased survival.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. HR models, proportional-hazards/adjustment, stratification, testing plans and absolute-importance criteria 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, proportional-hazards/adjustment, stratification, testing plans and absolute-importance criteria remain unverified.
Required materials and conditions: Original PFS HR tables, models/SAP, intervals and testing definitions
Materials to obtain first: Original PFS HR tables, models/SAP, intervals and testing definitions
Further research: Proposal: Link original analysis assumptions/plans to this HR
Remaining uncertainty: HR models, proportional-hazards/adjustment, stratification, testing plans and absolute-importance criteria remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the original PFS HR, 95% CI, P and direction" to their original locations. HR models, proportional-hazards/adjustment, stratification, testing plans and absolute-importance criteria remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the original PFS HR, 95% CI, P and direction.
Application exceptions: HR is not converted to RR, an individual guarantee about recurrence or death, or a new relative reduction percentage.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.

Related sources R01

N24 · What were PFS events, five-year risk sets and denominators?

Current findings: The original allocation/ITT denominator is 500 (250/250). 5-year PFS proportions and time-to-event analyses share this same population.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details were not verified within the current preserved-summary and externally unread scope. Separate progression/death event counts, composition/overlap, five-year risk sets and imaging omissions/censoring 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: Separate progression/death event counts, composition/overlap, five-year risk sets and imaging omissions/censoring are absent from the original summary.
Required materials and conditions: Original PFS event/time-specific tables, risk sets, censoring and assessable/analyzed denominators
Materials to obtain first: Original PFS event/time-specific tables, risk sets, censoring and assessable/analyzed denominators
Further research: Proposal: Distinguish progression/death and observed/censored data within the same allocated population
Remaining uncertainty: Separate progression/death event counts, composition/overlap, five-year risk sets and imaging omissions/censoring are absent from the original summary.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What were PFS events, five-year risk sets and denominators" to their original locations. Separate progression/death event counts, composition/overlap, five-year risk sets and imaging omissions/censoring are absent from the original summary.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What were PFS events, five-year risk sets and denominators.
Application exceptions: The 72% and 64% are not multiplied by 250 to back-calculate event or participant counts, and all 250 participants are not said to have been observed at five years.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.

Related sources R01

N25 · How is overlap among progression, death and OS marked?

Current findings: Original PFS concerns progression or death; OS concerns all-cause death. Both outcomes share patients and some death events and belong to one clinical family.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Progression/death components, simultaneous/first-event handling, person-level linkage and original event counts 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/death components, simultaneous/first-event handling, person-level linkage and original event counts remain unverified.
Required materials and conditions: Composite PFS event definitions, components, timing and relationships with OS death
Materials to obtain first: Composite PFS event definitions, components, timing and relationships with OS death
Further research: Proposal: Use original same-trial result tables reporting PFS components and OS separately
Remaining uncertainty: Progression/death components, simultaneous/first-event handling, person-level linkage and original event counts remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How is overlap among progression, death and OS marked" to their original locations. Progression/death components, simultaneous/first-event handling, person-level linkage and original event counts remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How is overlap among progression, death and OS marked.
Application exceptions: PFS and OS events, patients or tables are not added to produce a new total or independent replication.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, C06, E09.

Related sources R01

N26 · What measurement gaps follow from unmasked progression assessment?

Current findings: The original trial performed no blinding/masking and used investigator-assessed PFS. These original measurement conditions are attributed to the outcome.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Progression criteria/imaging frequency, central confirmation, assessor differences and arm-specific detection/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: Progression criteria/imaging frequency, central confirmation, assessor differences and arm-specific detection/follow-up differences remain unverified.
Required materials and conditions: Original PFS assessment, masking/confirmation, assessment frequency and measurement limitations
Materials to obtain first: Original PFS assessment, masking/confirmation, assessment frequency and measurement limitations
Further research: Proposal: Use same-trial materials disclosing original PFS measurement and omission/confirmation procedures
Remaining uncertainty: Progression criteria/imaging frequency, central confirmation, assessor differences and arm-specific detection/follow-up differences remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What measurement gaps follow from unmasked progression assessment" to their original locations. Progression criteria/imaging frequency, central confirmation, assessor differences and arm-specific detection/follow-up differences remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What measurement gaps follow from unmasked progression assessment.
Application exceptions: The parent's description of PFS as a hard endpoint is not changed to absence of all assessment bias, and lack of masking alone does not remove the result.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E03.

Related sources R01

N27 · What are the original details of PFS censoring, time origin and the ITT estimand?

Current findings: The original states ITT analysis and censoring of event-free patients at the last known alive date. This scope is distinguished from specific investigator-assessed PFS rules.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details were not verified within the current preserved-summary and externally unread scope. PFS time origin, missed assessments/subsequent treatment, unconfirmable progression, sensitivity and administrative-censoring details remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: PFS time origin, missed assessments/subsequent treatment, unconfirmable progression, sensitivity and administrative-censoring details remain unverified.
Required materials and conditions: PFS SAP, censoring/missingness, time origin and sensitivity results
Materials to obtain first: PFS SAP, censoring/missingness, time origin and sensitivity results
Further research: Proposal: Use original same-PFS materials specifying actual censoring and observation losses
Remaining uncertainty: PFS time origin, missed assessments/subsequent treatment, unconfirmable progression, sensitivity and administrative-censoring details remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the original details of PFS censoring, time origin and the ITT estimand" to their original locations. PFS time origin, missed assessments/subsequent treatment, unconfirmable progression, sensitivity and administrative-censoring details remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the original details of PFS censoring, time origin and the ITT estimand.
Application exceptions: PFS time origin, missed assessments/subsequent treatment, unconfirmable progression, sensitivity and administrative-censoring details remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E04, C07.

Related sources R01

N28 · What are reported intervals, clinical importance and planned PFS criteria?

Current findings: Original HR/95% CI, 5-year proportions and the 8%p wording are preserved at distinct estimation levels. Parent B76 remains a historical verdict and supplies no new importance threshold.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Prespecified important differences, power/event counts, coprimary alpha/multiplicity and proportion CI 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 important differences, power/event counts, coprimary alpha/multiplicity and proportion CI remain unverified.
Required materials and conditions: PFS important differences, joint testing, planning changes and original interval definitions
Materials to obtain first: PFS important differences, joint testing, planning changes and original interval definitions
Further research: Proposal: If original plans are disclosed, link justified importance criteria and intervals together
Remaining uncertainty: Prespecified important differences, power/event counts, coprimary alpha/multiplicity and proportion CI remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are reported intervals, clinical importance and planned PFS criteria" to their original locations. Prespecified important differences, power/event counts, coprimary alpha/multiplicity and proportion CI remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are reported intervals, clinical importance and planned PFS criteria.
Application exceptions: A large sample, positive P value or parent B is not used as a new verdict that every effect size or individual benefit is sufficiently established.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E05, E06.

Related sources R01

N29 · How does same-trial OS differ from the selected PFS question?

Current findings: The related overall-survival table reports a separate coprimary 5-year OS result: 80% versus 72%, HR0.60 (95% CI0.40~0.91), P=.015. It shares the same 500-person, 250/250 population and median follow-up of 67 months.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. OS death confirmation/censoring, original event counts, risk sets and detailed component relationships with PFS remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: OS death confirmation/censoring, original event counts, risk sets and detailed component relationships with PFS remain unverified.
Required materials and conditions: Original same-trial PFS/OS definitions, time points, populations and models
Materials to obtain first: Original same-trial PFS/OS definitions, time points, populations and models
Further research: Proposal: Use INTERLACE materials disclosing both coprimary outcomes' actual analysis scope separately
Remaining uncertainty: OS death confirmation/censoring, original event counts, risk sets and detailed component relationships with PFS remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How does same-trial OS differ from the selected PFS question" to their original locations. OS death confirmation/censoring, original event counts, risk sets and detailed component relationships with PFS remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How does same-trial OS differ from the selected PFS question.
Application exceptions: OS values or intervals are not moved to PFS, and the two outcomes are not added as independent confirmatory trials.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C08, C02, E09.

Related sources R01

N30 · Does PFS also answer tumor-response, symptom and quality-of-life questions?

Current findings: The selected question concerns 5-year PFS for progression or death; the positive OS result is preserved separately. The summary contains no direct tumor-response percentages or patient-reported symptom/quality-of-life values.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details were not verified within the current preserved-summary and externally unread scope. Response rates, post-progression burden, quality of life, symptoms, long-term function and patient-preference 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: Response rates, post-progression burden, quality of life, symptoms, long-term function and patient-preference materials remain unverified.
Required materials and conditions: Patient-centered/response outcomes separate from PFS, with definitions, denominators and time points
Materials to obtain first: Patient-centered/response outcomes separate from PFS, with definitions, denominators and time points
Further research: Proposal: Use same-trial or suitable additional research disclosing other patient outcomes separately
Remaining uncertainty: Response rates, post-progression burden, quality of life, symptoms, long-term function and patient-preference materials remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Does PFS also answer tumor-response, symptom and quality-of-life questions" to their original locations. Response rates, post-progression burden, quality of life, symptoms, long-term function and patient-preference materials remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Does PFS also answer tumor-response, symptom and quality-of-life questions.
Application exceptions: Positive PFS or OS does not automatically extend to every symptom, quality of life or individual benefit.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E09, E08.

Related sources R01

N31 · What are the people, denominators and proportions for grade 3 or worse adverse events?

Current findings: The original counterview records 147/250 (59%) versus 120/250 (48%), an 11%p increase. These original numbers are safety results for the same strategy, with endpoints separate from efficacy/survival.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified.
Required materials and conditions: Original safety tables, populations, periods, classification/overlap and comparative statistics
Materials to obtain first: Original safety tables, populations, periods, classification/overlap and comparative statistics
Further research: Proposal: Link severe adverse events in the same exposed population to definitions, denominators and periods
Remaining uncertainty: Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are the people, denominators and proportions for grade 3 or worse adverse events" to their original locations. Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are the people, denominators and proportions for grade 3 or worse adverse events.
Application exceptions: No new risk difference, ratio, CI, significance or individual harm incidence is calculated beyond the original 11%p.
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 window and relatedness apply to deaths within 30 days of treatment completion?

Current findings: The original study-condition description records 1 versus 2 deaths within 30 days of treatment completion, all unrelated to treatment. This is relatedness wording within a limited original window.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified.
Required materials and conditions: Original treatment-completion, 30-day window, cause/relatedness and denominator tables
Materials to obtain first: Original treatment-completion, 30-day window, cause/relatedness and denominator tables
Further research: Proposal: Use original materials disclosing the limited safety window separately from deaths across full follow-up
Remaining uncertainty: Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What window and relatedness apply to deaths within 30 days of treatment completion" to their original locations. Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What window and relatedness apply to deaths within 30 days of treatment completion.
Application exceptions: The historical absence of treatment-related deaths within 30 days is not changed to a safety guarantee for every time or harm.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H02, H04, H09.

Related sources R01

N33 · Are individual original results available for marrow suppression, infection and neuropathy?

Current findings: The original safety description mentions chemotherapy-toxicities such as marrow suppression, infection and neuropathy. Individual event counts/proportions for these types are not provided in the summary.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details were not verified within the current preserved-summary and externally unread scope. Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping 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: Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified.
Required materials and conditions: Original adverse-event type tables, definitions, collection/timing and denominators
Materials to obtain first: Original adverse-event type tables, definitions, collection/timing and denominators
Further research: Proposal: Use original materials reporting type-specific safety under the same study exposure
Remaining uncertainty: Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Are individual original results available for marrow suppression, infection and neuropathy" to their original locations. Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Are individual original results available for marrow suppression, infection and neuropathy.
Application exceptions: Original toxicity examples are not asserted to be observed events or rates in particular individuals, and no new user instructions for management or administration are written.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H04, E10.

Related sources R01

N34 · What are safety-exposure, onset/recovery and stopping times?

Current findings: 6 weeks of induction, a median 7-day interval to CCRT, median follow-up of 67 months and 30 days after treatment completion are distinct original time contexts. The entire severe-adverse-event collection window is separately needed.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details were not verified within the current preserved-summary and externally unread scope. Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified.
Required materials and conditions: Phase-specific safety windows, exposure/stopping/recovery and arm-specific materials
Materials to obtain first: Phase-specific safety windows, exposure/stopping/recovery and arm-specific materials
Further research: Proposal: Link period-specific harms to treatment delivery under the same strategy
Remaining uncertainty: Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What are safety-exposure, onset/recovery and stopping times" to their original locations. Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What are safety-exposure, onset/recovery and stopping times.
Application exceptions: The median efficacy follow-up of 67 months is not repurposed as the observation or exposure duration for every harm.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H02, H04.

Related sources R01

N35 · How are original disease, CCRT, concomitant treatment and harm attribution distinguished?

Current findings: Locally advanced cervical cancer and the two-drug-plus-CCRT sequence are original study conditions. Severe adverse events compare combined strategies; causal contributions form a separate question.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-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: Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified.
Required materials and conditions: Baseline risk, phase/concomitant exposure, event attribution and analysis materials
Materials to obtain first: Baseline risk, phase/concomitant exposure, event attribution and analysis materials
Further research: Proposal: Use original safety materials distinguishing combined exposure and alternative causes
Remaining uncertainty: Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are original disease, CCRT, concomitant treatment and harm attribution distinguished" to their original locations. Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are original disease, CCRT, concomitant treatment and harm attribution distinguished.
Application exceptions: Original proportions for the combined strategy are not changed to harm or harmlessness of a particular drug alone, or instructions for adjustment.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H05, E02, E10.

Related sources R01

N36 · What is the scope of safety omissions, dropout and selective follow-up?

Current findings: Original wording records ITT500 and severe adverse events of 147/250 versus 120/250. Each original denominator is preserved, without equating it to complete collection of all events at all times.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details were not verified within the current preserved-summary and externally unread scope. Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types 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-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified.
Required materials and conditions: Safety-analysis definitions, flow/missingness and event collection/detection
Materials to obtain first: Safety-analysis definitions, flow/missingness and event collection/detection
Further research: Proposal: Use same-trial reports/appendices specifying actual omissions and safety follow-up
Remaining uncertainty: Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What is the scope of safety omissions, dropout and selective follow-up" to their original locations. Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What is the scope of safety omissions, dropout and selective follow-up.
Application exceptions: Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H06, H04, C07.

Related sources R01

N37 · Do long-term, rare and vulnerable-population harms require separate direct materials?

Current findings: 5-year survival outcomes and median follow-up of 67 months concern efficacy follow-up. The original records severe toxicity and a limited 30-day death window but does not supply all long-term, rare or population-specific harms.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details were not verified within the current preserved-summary and externally unread scope. Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified.
Required materials and conditions: Long-term/rare/population-specific safety, exposure/follow-up and direct comparisons
Materials to obtain first: Long-term/rare/population-specific safety, exposure/follow-up and direct comparisons
Further research: Proposal: If suitable materials for these scopes are supplied, distinguish them from the currently selected effects/harms
Remaining uncertainty: Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Do long-term, rare and vulnerable-population harms require separate direct materials" to their original locations. Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Do long-term, rare and vulnerable-population harms require separate direct materials.
Application exceptions: Events not specified here are not filled in as zero or no occurrence.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H08, E08.

Related sources R01

N38 · Where was original public/nonprofit funding reported?

Current findings: Cancer Research UK and University College London–UCLH Biomedical Research Centre support is recorded in the original funding and research descriptions. Parent I2 remains a historical axis.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified.
Required materials and conditions: Original funding/COI, sponsor/author-role declarations and data access
Materials to obtain first: Original funding/COI, sponsor/author-role declarations and data access
Further research: Proposal: Link complete original declarations of actual funding, roles and disclosures
Remaining uncertainty: Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Where was original public/nonprofit funding reported" to their original locations. Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Where was original public/nonprofit funding reported.
Application exceptions: Public or nonprofit funding and original I2 alone do not certify current independence, absence of bias or absence of all conflicts of interest.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.

Related sources R01

N39 · What is the scope of no reported company provision of free study drugs?

Current findings: The original research description states that free company study-drug provision was not reported. This is historical parent-authoring wording and does not establish current products or complete contracts.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Original product supply, financial/in-kind provision, author employment/patents and full support roles 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 product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread.
Required materials and conditions: Study-drug/in-kind supply and original interest/role declarations
Materials to obtain first: Study-drug/in-kind supply and original interest/role declarations
Further research: Proposal: If original declarations are supplied, distinguish unreported matters from actual absence or provision
Remaining uncertainty: Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What is the scope of no reported company provision of free study drugs" to their original locations. Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What is the scope of no reported company provision of free study drugs.
Application exceptions: A statement that something was not reported is not changed to current certification of no involvement or provision by any company.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.

Related sources R01

N40 · How are independent replication and the two coprimary outcomes distinguished?

Current findings: The parent preserves the historical statement that the same strategy lacked independent replication and records R1. Positive PFS/OS are results from the same INTERLACE trial, rather than two separate confirmatory trials.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search.
Required materials and conditions: Family relationships among reports, trials, populations, exact strategies, sources, outcomes and harms
Materials to obtain first: Family relationships among reports, trials, populations, exact strategies, sources, outcomes and harms
Further research: Proposal: If additional materials are supplied, link shared/separate trials and state the level at which independence was verified
Remaining uncertainty: Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are independent replication and the two coprimary outcomes distinguished" to their original locations. Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are independent replication and the two coprimary outcomes distinguished.
Application exceptions: The original absence of replication is not changed to zero current studies worldwide, and two tables or endpoints are not counted as new independent replications.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.

Related sources R01

N41 · What is the context of null OUTBACK/ACTLACC results under a different sequence?

Current findings: The parent's research description/counterpoint states that post-radiation adjuvant chemotherapy in OUTBACK and ACTLACC did not improve survival and concerns a different sequencing question. They are not separate evidence/citation entries in this preserved summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and 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: Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread.
Required materials and conditions: Original study citations, exact sequences, populations, comparisons, results and same-strategy scope
Materials to obtain first: Original study citations, exact sequences, populations, comparisons, results and same-strategy scope
Further research: Proposal: If relevant materials are supplied, distinguish sequencing scope without automatically treating it as direct refutation or superiority
Remaining uncertainty: Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "What is the context of null OUTBACK/ACTLACC results under a different sequence" to their original locations. Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: What is the context of null OUTBACK/ACTLACC results under a different sequence.
Application exceptions: Names alone do not create additional report entries or new independent trials, or establish direct superiority of one sequence over another or optimal timing.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C08, C02, E07, E08.

Related sources R01

N42 · How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved?

Current findings: Parent B76/Caution, original axes B/H/R1/I2/E+/B0, unrecorded precision, coprimary-split false, large-hard-endpoint-RCT true, no-human-study false and empty override reason are preserved unchanged. Korean/English texts, historical synthesis/grade decision and cross-check wording remain parent history.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review.
Required materials and conditions: Separate copies of subclaim/parent values, axes/absences, Korean/English texts and historical verdicts
Materials to obtain first: Separate copies of subclaim/parent values, axes/absences, Korean/English texts and historical verdicts
Further research: Proposal: If corrections are supplied, distinguish full original text, events/versions and decisions and record parent/subclaim scope
Remaining uncertainty: Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved" to their original locations. Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved.
Application exceptions: Unrecorded precision is not filled in as zero, and parent scores or axes are not inherited by the subclaim or labeled a newly completed review.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09, E06.

Related sources R01

N43 · At what level can survival and toxicity currently be described?

Current findings: Both positive coprimary survival results, increased severe toxicity and the limited 30-day relatedness result are preserved within original scope. Parent Caution remains history and establishes neither personal treatment decisions nor safety certification.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.
Reason for missing information: Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified.
Required materials and conditions: Efficacy/safety definitions, denominators/periods, original statistics and extrapolation boundaries
Materials to obtain first: Efficacy/safety definitions, denominators/periods, original statistics and extrapolation boundaries
Further research: Proposal: If original materials are added, update evidence gaps while distinguishing interpretation across outcomes and times
Remaining uncertainty: Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "At what level can survival and toxicity currently be described" to their original locations. Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: At what level can survival and toxicity currently be described.
Application exceptions: Original increases are not changed to guarantees of individual benefit or harm, and absence of treatment-related deaths within 30 days is not extended to harmlessness.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H09, E10, C08, E09.

Related sources R01

N44 · Is extrapolation to current treatment, dose or radiotherapy choices avoided?

Current findings: This table presents the designated existing INTERLACE question and historical combination strategy, population, comparator, original values and gaps. Current individual treatment/suitability and other products/doses/sequences/techniques are separate questions.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some preserved-summary information has been linked. Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations 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 guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified.
Required materials and conditions: Direct population/exposure/comparator, periods and effect/harm materials for extended questions
Materials to obtain first: Direct population/exposure/comparator, periods and effect/harm materials for extended questions
Further research: Proposal: If materials are supplied and scope authorized, update while distinguishing original materials from other application conditions
Remaining uncertainty: Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified.
Conditions for verification: Link preserved values, definitions, denominators, periods and unverified matters relevant to "Is extrapolation to current treatment, dose or radiotherapy choices avoided" to their original locations. Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified.
Why this condition is needed: This condition is needed to separately document the selected five-year progression-free-survival question: Is extrapolation to current treatment, dose or radiotherapy choices avoided.
Application exceptions: No new instructions are created for carboplatin or paclitaxel, dose calculation or administration, CCRT or radiotherapy schedules, treatment selection or substitution, suitability or management actions.
Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, E08, H08, H09.

Related sources R01