CHAMGAP
MethodologyVerdictsExplanations (KO)Evidence CheckCitation KitMonitoring

PEGPH20 add-on therapy × improved overall survival — evidence sheet for hyaluronan-high metastatic pancreatic ductal adenocarcinoma

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Comparative efficacyWere the original overall-survival subclaim verdict and parent context preserved separately?Required
The selected original claim is improved overall survival, subclaim grade D, with a null-result note of HR 1.00 and P=.97. Parent D, 34 points and Caution are preserved as separate context.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Subclaim score, status and axes are absent and are not filled with parent values. This is not a new grade assessment.
Separate records of the original claim, grade, note and parent values
Proposal: Link additional materials separately to the selected survival question and parent context.
2 Partly verified Full text not readStored summary read N02 · Comparative efficacyWho were the hyaluronan-high, untreated stage IV pancreatic ductal adenocarcinoma participants?Required
The trial recruited previously untreated stage IV pancreatic ductal adenocarcinoma patients with stromal hyaluronan staining of at least 50%.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not automatically apply results to other expression levels, stages, treatment lines or cancers. Detailed eligibility and baseline conditions remain unread.
Original tumor, expression, treatment-history, stage, eligibility and denominator materials
Proposal: Obtain original eligibility, baseline characteristics, biomarker-assessment methods and denominators.
3 Partly verified Full text not readStored summary read N03 · Comparative efficacyWere PEGPH20 add-on therapy and shared anticancer treatment distinguished?Required
The intervention was PEGPH20 add-on therapy; both groups received nab-paclitaxel plus gemcitabine.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. The added drug's effect is not converted into the overall effect of shared anticancer treatment. Dose, schedule and actual-exposure details remain unread, and no treatment instructions are created.
Records of study drug, placebo, shared regimen, actual exposure and concomitant-treatment management
Proposal: Link original intervention, placebo, shared regimen, actual exposure and discontinuation materials.
4 Partly verified Full text not readStored summary read N04 · Comparative efficacyWhat were the shared research conditions for matching placebo and thrombosis prophylaxis?Required
Matching placebo was used, and both groups had mandatory enoxaparin prophylaxis because of thromboembolic risk.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Research conditions are not converted into prophylaxis or medication instructions for readers. The same results are not certified for other prophylaxis or exposure conditions.
Original placebo, shared prophylaxis, co-exposure and adherence materials
Proposal: Obtain original protocol materials on shared management, actual exposure, deviations and concomitant treatments.
5 Partly verified Full text not readStored summary read N05 · Comparative efficacyWere 494 randomized participants, 492 ITT participants and 2:1 allocation distinguished?Required
The record states that 492 of 494 participants randomized 2:1 were included in the ITT analysis.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not calculate group sizes from 2:1 or fill every endpoint and safety denominator with 492. Exclusion reasons and group-specific analysis sizes remain unread.
Group-specific allocation, ITT, exclusions and outcome-specific analysis denominators
Proposal: Obtain original participant flow, group allocation, ITT exclusions and outcome-specific denominators.
6 Partly verified Full text not readStored summary read N06 · Comparative efficacyWhat were the overall-survival definitions for start time, death ascertainment, follow-up and censoring?Required
The original primary endpoint was overall survival; 330 of 492 ITT participants died.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not create death-ascertainment methods, data cutoffs, censoring, group-specific deaths or follow-up details. Do not duplicate 330 as each group's event count.
Original survival-time, start-point, death, censoring, follow-up and denominator materials
Proposal: Obtain original survival definitions, death ascertainment, censoring, follow-up and group-specific event tables.
7 Partly verified Full text not readStored summary read N07 · Comparative efficacyWere median overall survival and HR, CI and P preserved as original values?Required
Median overall survival was 11.2 versus 11.5 months, HR 1.00 (95% CI 0.80 to 1.27), P=.97.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not calculate median differences, survival proportions, new HR, NNT or restricted means. Median CI and model details remain unread.
Group-specific medians, between-group HR, CI, tests, models and denominators
Proposal: Obtain original survival curves, median CI, models, group-specific denominators and tests.
8 Partly verified Full text not readStored summary read N08 · Comparative efficacyWere the null HR 1.00 result and remaining possible benefit distinguished?Required
The parent records D34 for null overall survival while stating that the CI retained possible benefit.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. A point estimate of 1.00 is not converted into certification of zero effect, equivalence or exclusion of meaningful benefit. Clinical-importance and success-HR threshold details remain unread.
Original CI, prespecified success or importance thresholds and effect interpretation
Proposal: Obtain original planned clinical-importance criteria, testing assumptions and effect CI.
9 Partly verified Full text not readStored summary read N09 · Comparative efficacyWere the prespecified 2019 amendment and sole primary overall-survival endpoint preserved?Required
The preserved summary records overall survival as the sole primary endpoint after a prespecified 2019 amendment and states agreement with NCT02715804.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not infer earlier endpoints, amendment dates or data-access circumstances. Registration and plans were not compared in this production.
Records of original registration, protocol, SAP, dates and decisions before and after amendment
Proposal: Obtain original registration history, protocol, SAP and amendment events separately.
10 Partly verified Full text not readStored summary read N10 · Comparative efficacyWhat was the response-rate hierarchy in fixed-sequence testing?Required
Overall survival had to be significant first before lower-order endpoints could be tested confirmatorily. The record states that response was interpreted as exploratory after survival failed.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Positive response does not replace primary survival success, and the testing hierarchy is not newly changed.
Original plans for OS, lower-order endpoints, testing sequence and multiplicity
Proposal: Obtain original SAP materials on fixed sequence, outcome lists, changes and endpoint-specific tests.
11 Partly verified Full text not readStored summary read N11 · Comparative efficacyWere objective response of 47% versus 36% and survival separated?Required
Original response was 47% versus 36%, ratio 1.29 (95% CI 1.03 to 1.63). Its exploratory lower-order status is preserved.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Response ratio and intervals are not copied into OS HR or CI. Responder counts, new proportion differences and P are not calculated.
Separate records of imaging-response definitions, denominators, ratio, CI and hierarchy
Proposal: Obtain original response definitions, assessments, denominators and hierarchy materials separately.
12 Partly verified Full text not readStored summary read N12 · Comparative efficacyWere the definitions and effects of progression-free and overall survival distinguished?Required
The record gives median PFS of 7.1 versus 7.1 months, HR 0.97 (95% CI 0.75 to 1.26).
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. PFS values and intervals are not transferred into OS values. PFS testing P, assessment procedures and hierarchy details remain unread.
PFS and OS events, times, denominators, effects and CI
Proposal: Obtain original PFS definitions, models, denominators, plans and tests separately.
13 Partly verified Full text not readStored summary read N13 · Comparative efficacyWhat was the scope of original allocation-concealment and blinding methods?Required
The original summary records 2:1 allocation through a central interactive response system and use of double-blinding with matching placebo.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not newly certify each assessor or analyst role, code breaking or actual implementation details. Parent B0 is historical.
Central allocation, concealment and participant, assessor or analyst procedures
Proposal: Obtain original methods, allocation, blinding roles and unblinding procedures.
14 Unverified Full text not readStored summary read N14 · Comparative efficacyWere gaps in ITT, missing-data, censoring and subsequent-treatment handling retained?Required
492 ITT participants and 330 deaths are preserved.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Complete follow-up, group-specific censoring, crossover, subsequent anticancer treatment and missing-data sensitivity are not newly specified.
Original analysis-population, model, censoring, deviation, subsequent-treatment and sensitivity materials
Proposal: Obtain original SAP, analysis-population, follow-up, censoring, subsequent-treatment and sensitivity materials.
15 Unverified Full text not readStored summary read N15 · Comparative efficacyIs there information on actual drug exposure, discontinuation and anticancer dose intensity?Required
Add-on therapy, shared anticancer treatment and mandatory prophylaxis conditions are preserved in the summary.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Exposure duration, dose intensity, discontinuation, crossover and adherence effects remain unread. Exposure is not converted into treatment recommendations.
Actual exposure, adherence and discontinuation for the added drug, shared regimen and prophylactic drug
Proposal: Obtain original exposure, discontinuation, group-specific concomitant-treatment and prespecified effect-of-interest materials.
16 Partly verified Full text not readStored summary read N16 · Comparative efficacyWas survival not filled in from mechanisms, hyaluronan selection or imaging response?Required
Selection for hyaluronan staining of at least 50% and improved imaging response appear in the preserved summary, but survival was null.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Mechanistic explanations, selected biomarkers and imaging changes do not replace OS benefit. No mechanistic numbers or additional subgroup effects are created.
Relationships between biomarker, mechanism, imaging and direct survival
Proposal: Link original mechanism and biomarker analysis plans separately to direct survival materials.
17 Unverified Full text not readStored summary read N17 · Comparative efficacyWere gaps in prespecified subgroups, sensitivity and long-term survival retained?Required
The selected high-expression population and overall ITT survival results are preserved as recorded.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not generate subgroup numbers, effects, P or long-term survival proportions absent from the original summary. Median survival is not converted into follow-up duration.
Original subgroup, interaction, follow-up, model, denominator and multiplicity materials
Proposal: Obtain original subgroup, interaction, long-term follow-up and sensitivity materials.
18 Partly verified Full text not readStored summary read N18 · Comparative efficacyWere the same HALO report, two outcomes and sibling sheets not added as independent evidence?Required
The two sheets share one HALO109-301 report and the 494/492-participant context. The parent wording that the originally confirmed efficacy evidence was one manufacturer development trial is retained.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not add sheets, endpoints or repeated participant displays as new independent trials or participants. Final independent and total-participant counts remain unrecorded.
Links among original trial, report, shared population, endpoints and times
Proposal: Link additional reports to the same registration and trial identifiers and their relationships.
19 Partly verified Full text not readStored summary read N19 · Comparative efficacyWere Halozyme funding, products, employee authors, management and writing roles separated?Required
Halozyme sponsorship and support, protocol, study drug or placebo and data management; 2 company-employee authors; and Paragon medical writing paid by Halozyme are preserved.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Paragon writing is not converted into outsourced analysis. Data-analysis roles and employee-identity details remain unread.
Separate records of cash support, drug or placebo supply, affiliations and external analysis or writing
Proposal: Obtain original disclosures separately for funding, supply, affiliations, data management, analysis and writing roles.
20 Partly verified Full text not readStored summary read N20 · Comparative efficacyWere original independence, R1 and I0 axes distinguished from new certification?Required
Parent R1 and I0 and the original manufacturer-development-trial context are preserved.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. No new external efficacy trial, independent replication or investigator certification is created. Original axes are not copied into absent subclaim values.
Preservation of original verdict, support, investigators and report relationships
Proposal: If other materials are provided, separately link only study, funding, author and denominator relationships.
21 Partly verified Full text not readStored summary read N21 · Supplementary harm evidenceWere original grade 3 or worse fatigue, muscle-spasm and hyponatremia proportions retained?Required
Fatigue of 16.0% versus 9.6%, muscle spasms of 6.5% versus 0.6% and hyponatremia of 8.0% versus 3.8% are original grade 3 or worse proportions.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not calculate new harm differences, RR, P, CI or event counts. Group-specific safety-analysis denominators, collection periods and relatedness details remain unread.
Original group-specific harm definitions, denominators, grades, relatedness and exposure tables
Proposal: Obtain original safety-population, group-specific event, denominator, grade and exposure tables.
22 Partly verified Full text not readStored summary read N22 · Supplementary harm evidenceWere descriptively more frequent harms and inferential-testing plans distinguished?Required
The preserved summary records descriptively more frequent harms in the PEGPH20 group and states that the protocol did not plan inferential safety testing.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Descriptive differences are not promoted into statistically significant harm or confirmed causality, and absence of testing is not converted into absence of harm.
Prespecified safety plans, tests, effects, intervals and relatedness
Proposal: Obtain original safety plans, descriptive tables, relatedness and follow-up materials separately.
23 Partly verified Full text not readStored summary read N23 · Supplementary harm evidenceWere thrombosis risk, shared enoxaparin and safety-applicability boundaries separated?Required
The original condition of mandatory prophylaxis in both groups because of thromboembolic risk is preserved.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. The same safety is not applied to conditions without prophylaxis, and no prophylactic-drug instructions are given to readers. Thrombosis event counts and CI are absent from the summary.
Risk management, shared prophylaxis, actual exposure, events and denominators
Proposal: Obtain original thrombosis-event, prophylactic-exposure, deviation and group-specific denominator materials.
24 Unverified Full text not readStored summary read N24 · Supplementary harm evidenceDo gaps remain in other, rare or long-term harms and discontinuation?Required
The current preserved summary focuses on some grade 3 or worse harms and prophylaxis conditions.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. This summary does not newly establish all harms, discontinuations, long-term harms or safety.
Original serious-event, discontinuation, exposure, follow-up and direct-harm materials
Proposal: Obtain complete original safety tables, exposure, discontinuation, serious or rare-event and long-term materials.
25 Unverified Full text not readStored summary read N25 · Supplementary harm evidenceWere effects or harms not generalized to other cancers, treatment lines or combinations?Required
The trial concerns add-on therapy in untreated high-expression stage IV pancreatic ductal adenocarcinoma with specified shared regimen and prophylaxis conditions.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not certify efficacy or harms for other cancers, treatment lines or prophylaxis conditions or create treatment or drug-substitution instructions.
Direct comparative and safety materials by population, exposure and combination
Proposal: Link direct materials on new populations or combinations to separate questions if provided.
26 Partly verified Full text not readStored summary read N26 · Comparative efficacyWere actual access to the preserved summary, external papers, registration and plans distinguished?Required
The entire parent preserved summary was read for production, and the original PubMed URL and NCT02715804 are preserved.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. No new URL is created from registration identifiers. Abstracts, full texts, registration, protocol and SAP remain unread, and no separate external link tests were performed.
Original source links, registration identifiers and material-specific reading states
Proposal: Link materials acquired by the user to individual types and access states.
27 Partly verified Full text not readStored summary read N27 · Comparative efficacyWere original dates, Korean and English drafts, false or missing values, empty values and verdict history preserved?Required
The date 2026-08-26, empty correction and deliberation values, original Korean and English drafts, D34, false or missing axis values and empty values, and the true marker for failure of the primary endpoint with a positive secondary result are preserved.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Historical cross-checking is not used as current review completion. Absent subclaim scores are not filled with parent scores.
Separate records of the complete preserved summary, subclaim verdict, parent values, corrections and history
Proposal: Link new materials or decisions to separate change events while preserving original text.
28 Partly verified Full text not readStored summary read N28 · Comparative efficacyWere production completion, incomplete existing-content review and independence status distinguished?Supplementary
Original review-pending and production-eligibility markers and boundary-review requirements are preserved as history. Existing content review remains incomplete; activation and completion markers for model, content and boundary review are false.
R01
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. No new verdict, split or independence certification exists; new units are 0 and the final independent total is not recorded.
Existing candidate history and current production or review states
Proposal: Reflect only user-provided materials or decisions as separate events.
No items match your search or filter.

28 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
Previously untreated stage IV pancreatic ductal adenocarcinoma with stromal hyaluronan staining of at least 50%; detailed eligibility remains unread
Ingredient, formulation and route
Historical research conditions for PEGPH20 add-on therapy; distinguished from shared nab-paclitaxel, gemcitabine and mandatory enoxaparin prophylaxis
Dose
Research-drug or prophylaxis doses, schedules and actual-exposure details remain unread; no treatment or medication instructions are created
Comparator
Original comparison with matching placebo and the same shared anticancer treatment and mandatory prophylaxis
Measured outcome
Selected primary overall survival; ORR, PFS and harms preserved separately
Duration
Original median OS of 11.2/11.5 months and PFS of 7.1/7.1 months are outcome values and are not used as intervention or follow-up duration; data-cutoff and actual-exposure or follow-up details remain unread
Questions outside this scope
Transferring ORR into OS, PFS or clinical-function benefit; Certifying exploratory lower-order results as confirmatory success under fixed-sequence testing; Certifying effects or harms in other cancers, treatment lines, combinations or prophylaxis conditions; Adding different endpoints, sibling sheets or the same people as independent evidence; Drug selection, use, prophylaxis, substitution or treatment recommendations

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 · Van Cutsem E, Tempero MA, Sigal D, et al. Randomized Phase III Trial of Pegvorhyaluronidase Alfa With Nab-Paclitaxel Plus Gemcitabine for Patients With Hyaluronan-High Metastatic Pancreatic Adenocarcinoma. J Clin Oncol. 2020;38:3185-3194. PMID: 32706635.

PubMed

Material type
HALO109-301 randomized phase 3 trial report
Materials actually read
Summary read; external materials not read
Findings recorded in the stored summary
Median OS 11.2 versus 11.5 months; HR 1.00 (95% CI 0.80 to 1.27), P=.97; 330 deaths
Record level
Preserved-summary results; ORR is linked from the body, and original evidence-list OS values are not changed into ORR
Study overlap and independent replication
HALO109-301 shares the same report, original trial, cohort and two subclaim outcomes; OS, ORR and PFS are not counted as separate new trials. A study-family identifier links relationships and does not certify unique trial counts; reports, endpoints, sibling sheets and the same participants are not newly added as independent evidence.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
local_summaryOriginal source link preservedSummary readSummary readPreserved parent verdict summary
abstractOriginal source link preservedNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
fulltextNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
registrationNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
protocol_sapNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review

Report counts versus independent study counts

HALO109-301 shares the same report, original trial, cohort and two subclaim outcomes; OS, ORR and PFS are not counted as separate new trials. A study-family identifier links relationships and does not certify unique trial counts; reports, endpoints, sibling sheets and the same participants are not newly added as independent evidence.

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 · Were the original overall-survival subclaim verdict and parent context preserved separately?
Required materials and conditions
Separate records of the original claim, grade, note and parent values
Conditions for verification
Separate records of the original claim, grade, note and parent values
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N02 · Who were the hyaluronan-high, untreated stage IV pancreatic ductal adenocarcinoma participants?
Required materials and conditions
Original tumor, expression, treatment-history, stage, eligibility and denominator materials
Conditions for verification
Original tumor, expression, treatment-history, stage, eligibility and denominator materials
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N03 · Were PEGPH20 add-on therapy and shared anticancer treatment distinguished?
Required materials and conditions
Records of study drug, placebo, shared regimen, actual exposure and concomitant-treatment management
Conditions for verification
Records of study drug, placebo, shared regimen, actual exposure and concomitant-treatment management
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N04 · What were the shared research conditions for matching placebo and thrombosis prophylaxis?
Required materials and conditions
Original placebo, shared prophylaxis, co-exposure and adherence materials
Conditions for verification
Original placebo, shared prophylaxis, co-exposure and adherence materials
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N05 · Were 494 randomized participants, 492 ITT participants and 2:1 allocation distinguished?
Required materials and conditions
Group-specific allocation, ITT, exclusions and outcome-specific analysis denominators
Conditions for verification
Group-specific allocation, ITT, exclusions and outcome-specific analysis denominators
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N06 · What were the overall-survival definitions for start time, death ascertainment, follow-up and censoring?
Required materials and conditions
Original survival-time, start-point, death, censoring, follow-up and denominator materials
Conditions for verification
Original survival-time, start-point, death, censoring, follow-up and denominator materials
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N07 · Were median overall survival and HR, CI and P preserved as original values?
Required materials and conditions
Group-specific medians, between-group HR, CI, tests, models and denominators
Conditions for verification
Group-specific medians, between-group HR, CI, tests, models and denominators
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N08 · Were the null HR 1.00 result and remaining possible benefit distinguished?
Required materials and conditions
Original CI, prespecified success or importance thresholds and effect interpretation
Conditions for verification
Original CI, prespecified success or importance thresholds and effect interpretation
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N09 · Were the prespecified 2019 amendment and sole primary overall-survival endpoint preserved?
Required materials and conditions
Records of original registration, protocol, SAP, dates and decisions before and after amendment
Conditions for verification
Records of original registration, protocol, SAP, dates and decisions before and after amendment
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N10 · What was the response-rate hierarchy in fixed-sequence testing?
Required materials and conditions
Original plans for OS, lower-order endpoints, testing sequence and multiplicity
Conditions for verification
Original plans for OS, lower-order endpoints, testing sequence and multiplicity
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N11 · Were objective response of 47% versus 36% and survival separated?
Required materials and conditions
Separate records of imaging-response definitions, denominators, ratio, CI and hierarchy
Conditions for verification
Separate records of imaging-response definitions, denominators, ratio, CI and hierarchy
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N12 · Were the definitions and effects of progression-free and overall survival distinguished?
Required materials and conditions
PFS and OS events, times, denominators, effects and CI
Conditions for verification
PFS and OS events, times, denominators, effects and CI
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N13 · What was the scope of original allocation-concealment and blinding methods?
Required materials and conditions
Central allocation, concealment and participant, assessor or analyst procedures
Conditions for verification
Central allocation, concealment and participant, assessor or analyst procedures
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N14 · Were gaps in ITT, missing-data, censoring and subsequent-treatment handling retained?
Required materials and conditions
Original analysis-population, model, censoring, deviation, subsequent-treatment and sensitivity materials
Conditions for verification
Original analysis-population, model, censoring, deviation, subsequent-treatment and sensitivity materials
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N15 · Is there information on actual drug exposure, discontinuation and anticancer dose intensity?
Required materials and conditions
Actual exposure, adherence and discontinuation for the added drug, shared regimen and prophylactic drug
Conditions for verification
Actual exposure, adherence and discontinuation for the added drug, shared regimen and prophylactic drug
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N16 · Was survival not filled in from mechanisms, hyaluronan selection or imaging response?
Required materials and conditions
Relationships between biomarker, mechanism, imaging and direct survival
Conditions for verification
Relationships between biomarker, mechanism, imaging and direct survival
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N17 · Were gaps in prespecified subgroups, sensitivity and long-term survival retained?
Required materials and conditions
Original subgroup, interaction, follow-up, model, denominator and multiplicity materials
Conditions for verification
Original subgroup, interaction, follow-up, model, denominator and multiplicity materials
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N18 · Were the same HALO report, two outcomes and sibling sheets not added as independent evidence?
Required materials and conditions
Links among original trial, report, shared population, endpoints and times
Conditions for verification
Links among original trial, report, shared population, endpoints and times
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N19 · Were Halozyme funding, products, employee authors, management and writing roles separated?
Required materials and conditions
Separate records of cash support, drug or placebo supply, affiliations and external analysis or writing
Conditions for verification
Separate records of cash support, drug or placebo supply, affiliations and external analysis or writing
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N20 · Were original independence, R1 and I0 axes distinguished from new certification?
Required materials and conditions
Preservation of original verdict, support, investigators and report relationships
Conditions for verification
Preservation of original verdict, support, investigators and report relationships
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N21 · Were original grade 3 or worse fatigue, muscle-spasm and hyponatremia proportions retained?
Required materials and conditions
Original group-specific harm definitions, denominators, grades, relatedness and exposure tables
Conditions for verification
Original group-specific harm definitions, denominators, grades, relatedness and exposure tables
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N22 · Were descriptively more frequent harms and inferential-testing plans distinguished?
Required materials and conditions
Prespecified safety plans, tests, effects, intervals and relatedness
Conditions for verification
Prespecified safety plans, tests, effects, intervals and relatedness
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N23 · Were thrombosis risk, shared enoxaparin and safety-applicability boundaries separated?
Required materials and conditions
Risk management, shared prophylaxis, actual exposure, events and denominators
Conditions for verification
Risk management, shared prophylaxis, actual exposure, events and denominators
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N24 · Do gaps remain in other, rare or long-term harms and discontinuation?
Required materials and conditions
Original serious-event, discontinuation, exposure, follow-up and direct-harm materials
Conditions for verification
Original serious-event, discontinuation, exposure, follow-up and direct-harm materials
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N25 · Were effects or harms not generalized to other cancers, treatment lines or combinations?
Required materials and conditions
Direct comparative and safety materials by population, exposure and combination
Conditions for verification
Direct comparative and safety materials by population, exposure and combination
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N26 · Were actual access to the preserved summary, external papers, registration and plans distinguished?
Required materials and conditions
Original source links, registration identifiers and material-specific reading states
Conditions for verification
Original source links, registration identifiers and material-specific reading states
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N27 · Were original dates, Korean and English drafts, false or missing values, empty values and verdict history preserved?
Required materials and conditions
Separate records of the complete preserved summary, subclaim verdict, parent values, corrections and history
Conditions for verification
Separate records of the complete preserved summary, subclaim verdict, parent values, corrections and history
Requirement and applicability
Required
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
N28 · Were production completion, incomplete existing-content review and independence status distinguished?
Required materials and conditions
Existing candidate history and current production or review states
Conditions for verification
Existing candidate history and current production or review states
Requirement and applicability
Supplementary
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Referenced methods
Improved overall survival
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
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

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
Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.
What the statuses mean
Partly verified
Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified
Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete
Review of existing content incomplete
Met
Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported
Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible
Not applied during this preparation because actual access was not tested
Not applicable
Use with a reason for non-applicability based on an explicit question boundary
Conflicting data
Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions
Do not use as a clinical grade encompassing currently unread materials

Change history

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

Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were 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 · Were the original overall-survival subclaim verdict and parent context preserved separately?

Current findings
The selected original claim is improved overall survival, subclaim grade D, with a null-result note of HR 1.00 and P=.97. Parent D, 34 points and Caution are preserved as separate context.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Subclaim score, status and axes are absent and are not filled with parent values. This is not a new grade assessment.
Reason for missing information
Subclaim score, status and axes are absent and are not filled with parent values. This is not a new grade assessment.
Required materials and conditions
Separate records of the original claim, grade, note and parent values
Materials to obtain first
Subclaim score, status and axes are absent and are not filled with parent values. This is not a new grade assessment.
Further research
Proposal: Link additional materials separately to the selected survival question and parent context.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Separate records of the original claim, grade, note and parent values
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N02 · Who were the hyaluronan-high, untreated stage IV pancreatic ductal adenocarcinoma participants?

Current findings
The trial recruited previously untreated stage IV pancreatic ductal adenocarcinoma patients with stromal hyaluronan staining of at least 50%.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not automatically apply results to other expression levels, stages, treatment lines or cancers. Detailed eligibility and baseline conditions remain unread.
Reason for missing information
Do not automatically apply results to other expression levels, stages, treatment lines or cancers. Detailed eligibility and baseline conditions remain unread.
Required materials and conditions
Original tumor, expression, treatment-history, stage, eligibility and denominator materials
Materials to obtain first
Do not automatically apply results to other expression levels, stages, treatment lines or cancers. Detailed eligibility and baseline conditions remain unread.
Further research
Proposal: Obtain original eligibility, baseline characteristics, biomarker-assessment methods and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original tumor, expression, treatment-history, stage, eligibility and denominator materials
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N03 · Were PEGPH20 add-on therapy and shared anticancer treatment distinguished?

Current findings
The intervention was PEGPH20 add-on therapy; both groups received nab-paclitaxel plus gemcitabine.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. The added drug's effect is not converted into the overall effect of shared anticancer treatment. Dose, schedule and actual-exposure details remain unread, and no treatment instructions are created.
Reason for missing information
The added drug's effect is not converted into the overall effect of shared anticancer treatment. Dose, schedule and actual-exposure details remain unread, and no treatment instructions are created.
Required materials and conditions
Records of study drug, placebo, shared regimen, actual exposure and concomitant-treatment management
Materials to obtain first
The added drug's effect is not converted into the overall effect of shared anticancer treatment. Dose, schedule and actual-exposure details remain unread, and no treatment instructions are created.
Further research
Proposal: Link original intervention, placebo, shared regimen, actual exposure and discontinuation materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Records of study drug, placebo, shared regimen, actual exposure and concomitant-treatment management
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N04 · What were the shared research conditions for matching placebo and thrombosis prophylaxis?

Current findings
Matching placebo was used, and both groups had mandatory enoxaparin prophylaxis because of thromboembolic risk.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Research conditions are not converted into prophylaxis or medication instructions for readers. The same results are not certified for other prophylaxis or exposure conditions.
Reason for missing information
Research conditions are not converted into prophylaxis or medication instructions for readers. The same results are not certified for other prophylaxis or exposure conditions.
Required materials and conditions
Original placebo, shared prophylaxis, co-exposure and adherence materials
Materials to obtain first
Research conditions are not converted into prophylaxis or medication instructions for readers. The same results are not certified for other prophylaxis or exposure conditions.
Further research
Proposal: Obtain original protocol materials on shared management, actual exposure, deviations and concomitant treatments.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original placebo, shared prophylaxis, co-exposure and adherence materials
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N05 · Were 494 randomized participants, 492 ITT participants and 2:1 allocation distinguished?

Current findings
The record states that 492 of 494 participants randomized 2:1 were included in the ITT analysis.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not calculate group sizes from 2:1 or fill every endpoint and safety denominator with 492. Exclusion reasons and group-specific analysis sizes remain unread.
Reason for missing information
Do not calculate group sizes from 2:1 or fill every endpoint and safety denominator with 492. Exclusion reasons and group-specific analysis sizes remain unread.
Required materials and conditions
Group-specific allocation, ITT, exclusions and outcome-specific analysis denominators
Materials to obtain first
Do not calculate group sizes from 2:1 or fill every endpoint and safety denominator with 492. Exclusion reasons and group-specific analysis sizes remain unread.
Further research
Proposal: Obtain original participant flow, group allocation, ITT exclusions and outcome-specific denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Group-specific allocation, ITT, exclusions and outcome-specific analysis denominators
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N06 · What were the overall-survival definitions for start time, death ascertainment, follow-up and censoring?

Current findings
The original primary endpoint was overall survival; 330 of 492 ITT participants died.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not create death-ascertainment methods, data cutoffs, censoring, group-specific deaths or follow-up details. Do not duplicate 330 as each group's event count.
Reason for missing information
Do not create death-ascertainment methods, data cutoffs, censoring, group-specific deaths or follow-up details. Do not duplicate 330 as each group's event count.
Required materials and conditions
Original survival-time, start-point, death, censoring, follow-up and denominator materials
Materials to obtain first
Do not create death-ascertainment methods, data cutoffs, censoring, group-specific deaths or follow-up details. Do not duplicate 330 as each group's event count.
Further research
Proposal: Obtain original survival definitions, death ascertainment, censoring, follow-up and group-specific event tables.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original survival-time, start-point, death, censoring, follow-up and denominator materials
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N07 · Were median overall survival and HR, CI and P preserved as original values?

Current findings
Median overall survival was 11.2 versus 11.5 months, HR 1.00 (95% CI 0.80 to 1.27), P=.97.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not calculate median differences, survival proportions, new HR, NNT or restricted means. Median CI and model details remain unread.
Reason for missing information
Do not calculate median differences, survival proportions, new HR, NNT or restricted means. Median CI and model details remain unread.
Required materials and conditions
Group-specific medians, between-group HR, CI, tests, models and denominators
Materials to obtain first
Do not calculate median differences, survival proportions, new HR, NNT or restricted means. Median CI and model details remain unread.
Further research
Proposal: Obtain original survival curves, median CI, models, group-specific denominators and tests.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Group-specific medians, between-group HR, CI, tests, models and denominators
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N08 · Were the null HR 1.00 result and remaining possible benefit distinguished?

Current findings
The parent records D34 for null overall survival while stating that the CI retained possible benefit.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. A point estimate of 1.00 is not converted into certification of zero effect, equivalence or exclusion of meaningful benefit. Clinical-importance and success-HR threshold details remain unread.
Reason for missing information
A point estimate of 1.00 is not converted into certification of zero effect, equivalence or exclusion of meaningful benefit. Clinical-importance and success-HR threshold details remain unread.
Required materials and conditions
Original CI, prespecified success or importance thresholds and effect interpretation
Materials to obtain first
A point estimate of 1.00 is not converted into certification of zero effect, equivalence or exclusion of meaningful benefit. Clinical-importance and success-HR threshold details remain unread.
Further research
Proposal: Obtain original planned clinical-importance criteria, testing assumptions and effect CI.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original CI, prespecified success or importance thresholds and effect interpretation
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N09 · Were the prespecified 2019 amendment and sole primary overall-survival endpoint preserved?

Current findings
The preserved summary records overall survival as the sole primary endpoint after a prespecified 2019 amendment and states agreement with NCT02715804.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not infer earlier endpoints, amendment dates or data-access circumstances. Registration and plans were not compared in this production.
Reason for missing information
Do not infer earlier endpoints, amendment dates or data-access circumstances. Registration and plans were not compared in this production.
Required materials and conditions
Records of original registration, protocol, SAP, dates and decisions before and after amendment
Materials to obtain first
Do not infer earlier endpoints, amendment dates or data-access circumstances. Registration and plans were not compared in this production.
Further research
Proposal: Obtain original registration history, protocol, SAP and amendment events separately.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Records of original registration, protocol, SAP, dates and decisions before and after amendment
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N10 · What was the response-rate hierarchy in fixed-sequence testing?

Current findings
Overall survival had to be significant first before lower-order endpoints could be tested confirmatorily. The record states that response was interpreted as exploratory after survival failed.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Positive response does not replace primary survival success, and the testing hierarchy is not newly changed.
Reason for missing information
Positive response does not replace primary survival success, and the testing hierarchy is not newly changed.
Required materials and conditions
Original plans for OS, lower-order endpoints, testing sequence and multiplicity
Materials to obtain first
Positive response does not replace primary survival success, and the testing hierarchy is not newly changed.
Further research
Proposal: Obtain original SAP materials on fixed sequence, outcome lists, changes and endpoint-specific tests.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original plans for OS, lower-order endpoints, testing sequence and multiplicity
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N11 · Were objective response of 47% versus 36% and survival separated?

Current findings
Original response was 47% versus 36%, ratio 1.29 (95% CI 1.03 to 1.63). Its exploratory lower-order status is preserved.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Response ratio and intervals are not copied into OS HR or CI. Responder counts, new proportion differences and P are not calculated.
Reason for missing information
Response ratio and intervals are not copied into OS HR or CI. Responder counts, new proportion differences and P are not calculated.
Required materials and conditions
Separate records of imaging-response definitions, denominators, ratio, CI and hierarchy
Materials to obtain first
Response ratio and intervals are not copied into OS HR or CI. Responder counts, new proportion differences and P are not calculated.
Further research
Proposal: Obtain original response definitions, assessments, denominators and hierarchy materials separately.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Separate records of imaging-response definitions, denominators, ratio, CI and hierarchy
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N12 · Were the definitions and effects of progression-free and overall survival distinguished?

Current findings
The record gives median PFS of 7.1 versus 7.1 months, HR 0.97 (95% CI 0.75 to 1.26).
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. PFS values and intervals are not transferred into OS values. PFS testing P, assessment procedures and hierarchy details remain unread.
Reason for missing information
PFS values and intervals are not transferred into OS values. PFS testing P, assessment procedures and hierarchy details remain unread.
Required materials and conditions
PFS and OS events, times, denominators, effects and CI
Materials to obtain first
PFS values and intervals are not transferred into OS values. PFS testing P, assessment procedures and hierarchy details remain unread.
Further research
Proposal: Obtain original PFS definitions, models, denominators, plans and tests separately.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
PFS and OS events, times, denominators, effects and CI
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N13 · What was the scope of original allocation-concealment and blinding methods?

Current findings
The original summary records 2:1 allocation through a central interactive response system and use of double-blinding with matching placebo.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not newly certify each assessor or analyst role, code breaking or actual implementation details. Parent B0 is historical.
Reason for missing information
Do not newly certify each assessor or analyst role, code breaking or actual implementation details. Parent B0 is historical.
Required materials and conditions
Central allocation, concealment and participant, assessor or analyst procedures
Materials to obtain first
Do not newly certify each assessor or analyst role, code breaking or actual implementation details. Parent B0 is historical.
Further research
Proposal: Obtain original methods, allocation, blinding roles and unblinding procedures.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Central allocation, concealment and participant, assessor or analyst procedures
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N14 · Were gaps in ITT, missing-data, censoring and subsequent-treatment handling retained?

Current findings
492 ITT participants and 330 deaths are preserved.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Complete follow-up, group-specific censoring, crossover, subsequent anticancer treatment and missing-data sensitivity are not newly specified.
Reason for missing information
Complete follow-up, group-specific censoring, crossover, subsequent anticancer treatment and missing-data sensitivity are not newly specified.
Required materials and conditions
Original analysis-population, model, censoring, deviation, subsequent-treatment and sensitivity materials
Materials to obtain first
Complete follow-up, group-specific censoring, crossover, subsequent anticancer treatment and missing-data sensitivity are not newly specified.
Further research
Proposal: Obtain original SAP, analysis-population, follow-up, censoring, subsequent-treatment and sensitivity materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original analysis-population, model, censoring, deviation, subsequent-treatment and sensitivity materials
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N15 · Is there information on actual drug exposure, discontinuation and anticancer dose intensity?

Current findings
Add-on therapy, shared anticancer treatment and mandatory prophylaxis conditions are preserved in the summary.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Exposure duration, dose intensity, discontinuation, crossover and adherence effects remain unread. Exposure is not converted into treatment recommendations.
Reason for missing information
Exposure duration, dose intensity, discontinuation, crossover and adherence effects remain unread. Exposure is not converted into treatment recommendations.
Required materials and conditions
Actual exposure, adherence and discontinuation for the added drug, shared regimen and prophylactic drug
Materials to obtain first
Exposure duration, dose intensity, discontinuation, crossover and adherence effects remain unread. Exposure is not converted into treatment recommendations.
Further research
Proposal: Obtain original exposure, discontinuation, group-specific concomitant-treatment and prespecified effect-of-interest materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Actual exposure, adherence and discontinuation for the added drug, shared regimen and prophylactic drug
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N16 · Was survival not filled in from mechanisms, hyaluronan selection or imaging response?

Current findings
Selection for hyaluronan staining of at least 50% and improved imaging response appear in the preserved summary, but survival was null.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Mechanistic explanations, selected biomarkers and imaging changes do not replace OS benefit. No mechanistic numbers or additional subgroup effects are created.
Reason for missing information
Mechanistic explanations, selected biomarkers and imaging changes do not replace OS benefit. No mechanistic numbers or additional subgroup effects are created.
Required materials and conditions
Relationships between biomarker, mechanism, imaging and direct survival
Materials to obtain first
Mechanistic explanations, selected biomarkers and imaging changes do not replace OS benefit. No mechanistic numbers or additional subgroup effects are created.
Further research
Proposal: Link original mechanism and biomarker analysis plans separately to direct survival materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Relationships between biomarker, mechanism, imaging and direct survival
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N17 · Were gaps in prespecified subgroups, sensitivity and long-term survival retained?

Current findings
The selected high-expression population and overall ITT survival results are preserved as recorded.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not generate subgroup numbers, effects, P or long-term survival proportions absent from the original summary. Median survival is not converted into follow-up duration.
Reason for missing information
Do not generate subgroup numbers, effects, P or long-term survival proportions absent from the original summary. Median survival is not converted into follow-up duration.
Required materials and conditions
Original subgroup, interaction, follow-up, model, denominator and multiplicity materials
Materials to obtain first
Do not generate subgroup numbers, effects, P or long-term survival proportions absent from the original summary. Median survival is not converted into follow-up duration.
Further research
Proposal: Obtain original subgroup, interaction, long-term follow-up and sensitivity materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original subgroup, interaction, follow-up, model, denominator and multiplicity materials
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N18 · Were the same HALO report, two outcomes and sibling sheets not added as independent evidence?

Current findings
The two sheets share one HALO109-301 report and the 494/492-participant context. The parent wording that the originally confirmed efficacy evidence was one manufacturer development trial is retained.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not add sheets, endpoints or repeated participant displays as new independent trials or participants. Final independent and total-participant counts remain unrecorded.
Reason for missing information
Do not add sheets, endpoints or repeated participant displays as new independent trials or participants. Final independent and total-participant counts remain unrecorded.
Required materials and conditions
Links among original trial, report, shared population, endpoints and times
Materials to obtain first
Do not add sheets, endpoints or repeated participant displays as new independent trials or participants. Final independent and total-participant counts remain unrecorded.
Further research
Proposal: Link additional reports to the same registration and trial identifiers and their relationships.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Links among original trial, report, shared population, endpoints and times
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N19 · Were Halozyme funding, products, employee authors, management and writing roles separated?

Current findings
Halozyme sponsorship and support, protocol, study drug or placebo and data management; 2 company-employee authors; and Paragon medical writing paid by Halozyme are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Paragon writing is not converted into outsourced analysis. Data-analysis roles and employee-identity details remain unread.
Reason for missing information
Paragon writing is not converted into outsourced analysis. Data-analysis roles and employee-identity details remain unread.
Required materials and conditions
Separate records of cash support, drug or placebo supply, affiliations and external analysis or writing
Materials to obtain first
Paragon writing is not converted into outsourced analysis. Data-analysis roles and employee-identity details remain unread.
Further research
Proposal: Obtain original disclosures separately for funding, supply, affiliations, data management, analysis and writing roles.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Separate records of cash support, drug or placebo supply, affiliations and external analysis or writing
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N20 · Were original independence, R1 and I0 axes distinguished from new certification?

Current findings
Parent R1 and I0 and the original manufacturer-development-trial context are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. No new external efficacy trial, independent replication or investigator certification is created. Original axes are not copied into absent subclaim values.
Reason for missing information
No new external efficacy trial, independent replication or investigator certification is created. Original axes are not copied into absent subclaim values.
Required materials and conditions
Preservation of original verdict, support, investigators and report relationships
Materials to obtain first
No new external efficacy trial, independent replication or investigator certification is created. Original axes are not copied into absent subclaim values.
Further research
Proposal: If other materials are provided, separately link only study, funding, author and denominator relationships.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Preservation of original verdict, support, investigators and report relationships
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N21 · Were original grade 3 or worse fatigue, muscle-spasm and hyponatremia proportions retained?

Current findings
Fatigue of 16.0% versus 9.6%, muscle spasms of 6.5% versus 0.6% and hyponatremia of 8.0% versus 3.8% are original grade 3 or worse proportions.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not calculate new harm differences, RR, P, CI or event counts. Group-specific safety-analysis denominators, collection periods and relatedness details remain unread.
Reason for missing information
Do not calculate new harm differences, RR, P, CI or event counts. Group-specific safety-analysis denominators, collection periods and relatedness details remain unread.
Required materials and conditions
Original group-specific harm definitions, denominators, grades, relatedness and exposure tables
Materials to obtain first
Do not calculate new harm differences, RR, P, CI or event counts. Group-specific safety-analysis denominators, collection periods and relatedness details remain unread.
Further research
Proposal: Obtain original safety-population, group-specific event, denominator, grade and exposure tables.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original group-specific harm definitions, denominators, grades, relatedness and exposure tables
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N22 · Were descriptively more frequent harms and inferential-testing plans distinguished?

Current findings
The preserved summary records descriptively more frequent harms in the PEGPH20 group and states that the protocol did not plan inferential safety testing.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Descriptive differences are not promoted into statistically significant harm or confirmed causality, and absence of testing is not converted into absence of harm.
Reason for missing information
Descriptive differences are not promoted into statistically significant harm or confirmed causality, and absence of testing is not converted into absence of harm.
Required materials and conditions
Prespecified safety plans, tests, effects, intervals and relatedness
Materials to obtain first
Descriptive differences are not promoted into statistically significant harm or confirmed causality, and absence of testing is not converted into absence of harm.
Further research
Proposal: Obtain original safety plans, descriptive tables, relatedness and follow-up materials separately.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Prespecified safety plans, tests, effects, intervals and relatedness
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N23 · Were thrombosis risk, shared enoxaparin and safety-applicability boundaries separated?

Current findings
The original condition of mandatory prophylaxis in both groups because of thromboembolic risk is preserved.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. The same safety is not applied to conditions without prophylaxis, and no prophylactic-drug instructions are given to readers. Thrombosis event counts and CI are absent from the summary.
Reason for missing information
The same safety is not applied to conditions without prophylaxis, and no prophylactic-drug instructions are given to readers. Thrombosis event counts and CI are absent from the summary.
Required materials and conditions
Risk management, shared prophylaxis, actual exposure, events and denominators
Materials to obtain first
The same safety is not applied to conditions without prophylaxis, and no prophylactic-drug instructions are given to readers. Thrombosis event counts and CI are absent from the summary.
Further research
Proposal: Obtain original thrombosis-event, prophylactic-exposure, deviation and group-specific denominator materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Risk management, shared prophylaxis, actual exposure, events and denominators
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N24 · Do gaps remain in other, rare or long-term harms and discontinuation?

Current findings
The current preserved summary focuses on some grade 3 or worse harms and prophylaxis conditions.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. This summary does not newly establish all harms, discontinuations, long-term harms or safety.
Reason for missing information
This summary does not newly establish all harms, discontinuations, long-term harms or safety.
Required materials and conditions
Original serious-event, discontinuation, exposure, follow-up and direct-harm materials
Materials to obtain first
This summary does not newly establish all harms, discontinuations, long-term harms or safety.
Further research
Proposal: Obtain complete original safety tables, exposure, discontinuation, serious or rare-event and long-term materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original serious-event, discontinuation, exposure, follow-up and direct-harm materials
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N25 · Were effects or harms not generalized to other cancers, treatment lines or combinations?

Current findings
The trial concerns add-on therapy in untreated high-expression stage IV pancreatic ductal adenocarcinoma with specified shared regimen and prophylaxis conditions.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not certify efficacy or harms for other cancers, treatment lines or prophylaxis conditions or create treatment or drug-substitution instructions.
Reason for missing information
Do not certify efficacy or harms for other cancers, treatment lines or prophylaxis conditions or create treatment or drug-substitution instructions.
Required materials and conditions
Direct comparative and safety materials by population, exposure and combination
Materials to obtain first
Do not certify efficacy or harms for other cancers, treatment lines or prophylaxis conditions or create treatment or drug-substitution instructions.
Further research
Proposal: Link direct materials on new populations or combinations to separate questions if provided.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Direct comparative and safety materials by population, exposure and combination
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N26 · Were actual access to the preserved summary, external papers, registration and plans distinguished?

Current findings
The entire parent preserved summary was read for production, and the original PubMed URL and NCT02715804 are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. No new URL is created from registration identifiers. Abstracts, full texts, registration, protocol and SAP remain unread, and no separate external link tests were performed.
Reason for missing information
No new URL is created from registration identifiers. Abstracts, full texts, registration, protocol and SAP remain unread, and no separate external link tests were performed.
Required materials and conditions
Original source links, registration identifiers and material-specific reading states
Materials to obtain first
No new URL is created from registration identifiers. Abstracts, full texts, registration, protocol and SAP remain unread, and no separate external link tests were performed.
Further research
Proposal: Link materials acquired by the user to individual types and access states.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original source links, registration identifiers and material-specific reading states
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N27 · Were original dates, Korean and English drafts, false or missing values, empty values and verdict history preserved?

Current findings
The date 2026-08-26, empty correction and deliberation values, original Korean and English drafts, D34, false or missing axis values and empty values, and the true marker for failure of the primary endpoint with a positive secondary result are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Historical cross-checking is not used as current review completion. Absent subclaim scores are not filled with parent scores.
Reason for missing information
Historical cross-checking is not used as current review completion. Absent subclaim scores are not filled with parent scores.
Required materials and conditions
Separate records of the complete preserved summary, subclaim verdict, parent values, corrections and history
Materials to obtain first
Historical cross-checking is not used as current review completion. Absent subclaim scores are not filled with parent scores.
Further research
Proposal: Link new materials or decisions to separate change events while preserving original text.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Separate records of the complete preserved summary, subclaim verdict, parent values, corrections and history
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01

N28 · Were production completion, incomplete existing-content review and independence status distinguished?

Current findings
Original review-pending and production-eligibility markers and boundary-review requirements are preserved as history. Existing content review remains incomplete; activation and completion markers for model, content and boundary review are false.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. No new verdict, split or independence certification exists; new units are 0 and the final independent total is not recorded.
Reason for missing information
No new verdict, split or independence certification exists; new units are 0 and the final independent total is not recorded.
Required materials and conditions
Existing candidate history and current production or review states
Materials to obtain first
No new verdict, split or independence certification exists; new units are 0 and the final independent total is not recorded.
Further research
Proposal: Reflect only user-provided materials or decisions as separate events.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Existing candidate history and current production or review states
Why this condition is needed
Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries
Application exceptions
Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.
Referenced methods
Improved overall survival

Related sources R01