{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2940-s1", "verdict_number": "2940", "title": "ESA anemia correction × improved survival during head-and-neck cancer radiotherapy: evidence checklist", "view_version": "1.0", "view_created_date": "2026-10-11", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Review of the existing content is incomplete. External abstracts, full texts, registration records, protocols and SAPs have not been read, and access has not been attempted.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Head-and-neck cancer radiotherapy populations and anemia/hemoglobin conditions of each original trial; not extended to other indications or diseases", "intervention": "ESA anemia correction during head-and-neck cancer radiotherapy; historical trial exposure to trial-specific darbepoetin/epoetin formulations", "dose": null, "comparator": "Original control, placebo or comparison management in DAHANCA10, ENHANCE and RTOG99-03; the review's pooled comparison is separate", "endpoint": "Improved survival in the selected existing question; disease-specific death, overall death and OS retain their original names, directions, periods and denominators", "duration": "Original trial-specific survival analysis timepoints and follow-up; the DAHANCA10 five-year locoregional-failure timepoint is not assigned to all survival HRs", "excluded_extensions": [ "Promoting the parent tumor-control primary endpoint to the selected survival primary endpoint, or transferring anemia correction into survival benefit", "Renaming death HR, survival RR or OS Peto OR, taking reciprocals, or producing new effects, CIs or absolute risks", "Assigning DAHANCA10's five-year locoregional-failure timepoint to all survival HRs", "Calculating new exclusions, incidence or survival/safety denominators from planned600, randomized522 and evaluable513 (254/259)", "Adding ENHANCE351/180/171, RTOG148 and the review's5RCT1397 into independent-trial or total-participant counts", "Counting initial/long-term RTOG reports, arms, endpoints or timepoints as new independent trials, or inventing the exact OS period", "Treating RTOG nonsignificance as zero effect, equivalence or certified exclusion of an important survival benefit", "Transferring preterm-infant2925 B72, CKD or other-indication outcomes into direct head-and-neck cancer survival effects", "Changing absence of other SAE, cardiovascular or radiation-toxicity signals into overall safety or absence of cancer-survival harm", "Presenting the account's FDA warning as reading/accessing the latest label or as new guidance", "Changing original registration-system-era absence/not-applicable wording into an actual registration identifier or current verification of registration absence", "Inheriting parent scores/axes, historical cross-checks or support/independence accounts as subclaim values, current content review or independence certification", "New numerical calculations, hypothetical values, new grades/evidence or patient drug choice, substitution, use, treatment or dosing guidance" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does the selected question concern improved survival or the parent tumor-control question?", "needed": "Preserve the survival subclaim, grade and note separately from the parent tumor-control claim, score and axes", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Preserve the survival subclaim, grade and note separately from the parent tumor-control claim, score and axes.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Preserve the survival subclaim, grade and note separately from the parent tumor-control claim, score and axes. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying questions; Detailed separation rules are a custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Track survival and tumor-control materials separately; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected question is 'Improved survival', with original grade F and a note that disease-specific and overall death both significantly favored harm. The parent asks about improved locoregional tumor control and has F12, Warning and original assessment axes. The selected record has no score, status or axes.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. The subclaim originally has no score, status or axes, and no new survival verdict was made. Existing content review remains incomplete.", "missingness": "The subclaim originally has no score, status or axes, and no new survival verdict was made.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "New subclaim materials or user correction comments" }, { "item_id": "N02", "question_type": "Efficacy comparison and presentation of stored material", "question": "What events and directions do the survival measures represent?", "needed": "Exact names and directions of death, survival, event-free survival and tumor control", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Exact names and directions of death, survival, event-free survival and tumor control.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Exact names and directions of death, survival, event-free survival and tumor control. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 §8.2.2, M15 §15.3.1; Custom application; M03 §3.2.4; Custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link endpoint-specific event coding and comparison directions; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S04" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account describes harm for DAHANCA10 disease-specific death, HR1.43 (95% CI1.08~1.90), and overall death, HR1.30 (1.02~1.64). EFS HR1.36 (1.09~1.69) and locoregional failure HR1.53 (1.16~2.02) are different outcomes. ENHANCE 'survival RR1.39' and the review's OS Peto OR0.73 retain their separate original names and directions.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Exact death/survival event coding and some estimator and analysis definitions cannot be fully verified from the summary. Existing content review remains incomplete.", "missingness": "Exact death/survival event coding and some estimator and analysis definitions cannot be fully verified from the summary.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome definitions, original analysis tables and SAP" }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "What population, study exposure and comparator did DAHANCA10 use?", "needed": "Actual cancer/anemia and radiotherapy population and the two arms' historical study conditions", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Actual cancer/anemia and radiotherapy population and the two arms' historical study conditions.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Actual cancer/anemia and radiotherapy population and the two arms' historical study conditions. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population conditions are a custom design; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptation are a custom design; M08 §8.1–8.2.3; Custom application; M03 §3.2.3, M08 §8.2.2–8.2.3; Custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link survival materials by population and comparison conditions; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The summary describes DAHANCA10 as a multicenter open-label randomized phase 3 comparison of weekly darbepoetin during head-and-neck cancer radiotherapy with hemoglobin <14.0g/dL. This is historical trial exposure, not an instruction on drug choice, substitution or use.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Details of cancer site/stage, baseline anemia, concurrent treatment, exact control management and exposure stopping conditions remain unverified. Existing content review remains incomplete.", "missingness": "Details of cancer site/stage, baseline anemia, concurrent treatment, exact control management and exposure stopping conditions remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/exclusion criteria, baseline tables and both arms' concurrent-treatment/exposure records" }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do DAHANCA10 planned, randomized and evaluable denominators differ?", "needed": "Roles of planned600, randomized522, evaluable513 and254/259", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Roles of planned600, randomized522, evaluable513 and254/259.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Roles of planned600, randomized522, evaluable513 and254/259. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M08 §8.2.2, M15 §15.3.1; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Separate analysis populations and exclusion reasons by denominator; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original denominators were planned600, stopping after522 randomized, and513 evaluable (254/259). The513 is not automatically assigned to every survival or safety analysis, and no missing-person counts or proportions are newly calculated.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Reasons for exclusion between randomized and evaluable groups, survival-specific ITT/follow-up denominators and arm-specific missingness remain unverified. Existing content review remains incomplete.", "missingness": "Reasons for exclusion between randomized and evaluable groups, survival-specific ITT/follow-up denominators and arm-specific missingness remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flowchart, survival analysis populations and exclusion/follow-up records" }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "What plan and criteria governed interim stopping?", "needed": "Prespecified interim analysis, inferiority stopping threshold and follow-up plan", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Prespecified interim analysis, inferiority stopping threshold and follow-up plan.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Prespecified interim analysis, inferiority stopping threshold and follow-up plan. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptation is a custom design; M15 §15.3.1–15.3.3; Custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Document the relationship between interim analysis and final survival outcomes; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original DAHANCA10 account reports stopping at522 after a planned interim analysis found inferiority in the experimental arm. Planned600, actual522 and evaluable513 have different roles; no new effect correction for early stopping is made.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Interim timing/threshold, alpha spending, committee decisions and survival follow-up after stopping remain unverified. Existing content review remains incomplete.", "missingness": "Interim timing/threshold, alpha spending, committee decisions and survival follow-up after stopping remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Interim analysis plan, committee/stopping records and final analysis plan" }, { "item_id": "N06", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is the hierarchy of the primary tumor-failure endpoint and selected survival outcomes?", "needed": "Primary endpoint, secondary survival outcomes, prespecified analysis hierarchy and multiplicity", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Primary endpoint, secondary survival outcomes, prespecified analysis hierarchy and multiplicity.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Primary endpoint, secondary survival outcomes, prespecified analysis hierarchy and multiplicity. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 Table 8.2.a, M04 §4.6.3; Custom application; M03 §3.2.4; Custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link endpoint hierarchy and prespecified multiple-comparison plans; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "DAHANCA10's primary endpoint was time to locoregional failure. Five-year cumulative locoregional failure47% versus34% and HR1.53 (1.16~2.02) retain their original scope. They are not relabeled as a survival primary endpoint or five-year overall-death incidence.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified hierarchy, multiplicity and individual analysis timepoints for EFS, disease-specific death and overall death remain unverified. Existing content review remains incomplete.", "missingness": "Prespecified hierarchy, multiplicity and individual analysis timepoints for EFS, disease-specific death and overall death remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol, SAP and endpoint-specific results tables" }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "What analysis produced the DAHANCA10 disease-specific death result?", "needed": "Cause-of-death definition, denominator, time, HR/CI and handling of competing events", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Cause-of-death definition, denominator, time, HR/CI and handling of competing events.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Cause-of-death definition, denominator, time, HR/CI and handling of competing events. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptation is a custom design; M08 §8.2.2, M15 §15.3.1; Custom application; M15 §15.3.1–15.3.3; Custom application; M19 §19.1.2–19.2.4; Detailed discrimination is a custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link endpoint definitions and competing-event/survival-analysis materials; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Disease-specific death HR1.43 (95% CI1.08~1.90) retains its original name and harm direction. It is not converted into an overall-death HR, survival proportion or absolute death rate.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Cause adjudication, competing-death handling, original event counts, denominators, follow-up time, original P value and model details remain unverified. Existing content review remains incomplete.", "missingness": "Cause adjudication, competing-death handling, original event counts, denominators, follow-up time, original P value and model details remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Disease-specific death results, cause adjudication/follow-up and analysis plan" }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "What analysis produced the DAHANCA10 overall-death result?", "needed": "Overall-death HR/CI, events/people, follow-up duration and analysis population", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Overall-death HR/CI, events/people, follow-up duration and analysis population.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Overall-death HR/CI, events/people, follow-up duration and analysis population. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptation is a custom design; M08 §8.2.2, M15 §15.3.1; Custom application; M15 §15.3.1–15.3.3; Custom application; M19 §19.2 design-specific harm questions; Details of temporal relationships are a custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Document overall-death follow-up and analysis in the randomized population; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Overall death HR1.30 (95% CI1.02~1.64) is recorded as in the preserved material. It is a separate endpoint from disease-specific death HR1.43 and is not reversed into support for improved survival.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Overall-death event counts, denominators, exact follow-up duration, censoring/missingness, model/covariates and original P value remain unverified. Existing content review remains incomplete.", "missingness": "Overall-death event counts, denominators, exact follow-up duration, censoring/missingness, model/covariates and original P value remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Overall-death results, follow-up/censoring materials and SAP" }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can EFS be substituted for survival or cancer-specific death?", "needed": "Link event-free survival event composition, hierarchy and analysis separately", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Link event-free survival event composition, hierarchy and analysis separately.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Link event-free survival event composition, hierarchy and analysis separately. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 Table 8.2.a, M04 §4.6.3; Custom application; M03 §3.2.4; Custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Document the composite endpoint and its components separately; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "DAHANCA10 EFS HR1.36 (1.09~1.69) is a separate event-free survival outcome in the original account. It is not merged with locoregional failure, disease-specific death or overall death, and no component events are invented.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Exact composite EFS components, first-event rule, denominator and timepoint remain unverified in the summary. Existing content review remains incomplete.", "missingness": "Exact composite EFS components, first-event rule, denominator and timepoint remain unverified in the summary.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "EFS definition, results table and prespecified plan" }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "May the five-year tumor-failure timepoint be assigned to every survival outcome?", "needed": "Actual endpoint-specific follow-up and distinction between absolute and time-to-event outcomes", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Actual endpoint-specific follow-up and distinction between absolute and time-to-event outcomes.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Actual endpoint-specific follow-up and distinction between absolute and time-to-event outcomes. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are a custom design; M19 §19.1.2–19.2.4; Custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Separate time scopes by endpoint in follow-up materials; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "DAHANCA10's five-year timepoint belongs to cumulative locoregional failure47%/34%. It is not assigned arbitrarily to the disease-specific death, overall-death or EFS HRs.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Survival-HR-specific median follow-up, end time, censoring and period-specific risk remain unverified. Existing content review remains incomplete.", "missingness": "Survival-HR-specific median follow-up, end time, censoring and period-specific risk remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up periods/timepoints, survival curves and censoring tables for each survival endpoint" }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "How might an open-label study and outcome assessment affect individual endpoints?", "needed": "Record allocation, open-label status, tumor assessment and death ascertainment separately", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Record allocation, open-label status, tumor assessment and death ascertainment separately.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Record allocation, open-label status, tumor assessment and death ascertainment separately. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; Custom application; M08 Table 8.2.a, M03 §3.2.4; Custom application; M19 §19.1.2–19.2.4; Detailed discrimination is a custom design; M19 §19.1.2–19.2.4, M04 §4.6.3; Custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link endpoint-specific measurement and missingness materials; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account describes DAHANCA10 as an open-label randomized study without uniform central blinded imaging assessment. Tumor-control assessment and overall-death ascertainment are not assumed to share the same measurement error.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Allocation concealment, cause-of-death adjudication, death follow-up/missingness and blinding of survival ascertainment remain unverified. Existing content review remains incomplete.", "missingness": "Allocation concealment, cause-of-death adjudication, death follow-up/missingness and blinding of survival ascertainment remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation procedures, endpoint assessment/follow-up instructions and original materials" }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "How were concurrent treatment and deviations reflected in survival estimates?", "needed": "Radiotherapy, concomitant treatment, crossover/adherence, ITT/PP and covariates", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Radiotherapy, concomitant treatment, crossover/adherence, ITT/PP and covariates.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Radiotherapy, concomitant treatment, crossover/adherence, ITT/PP and covariates. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Document concurrent treatment and comparison estimators; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account compares ESA anemia correction during radiotherapy and retains DAHANCA10's open-label randomized design. Details of study exposure, actual transfusion, additional ESA, radiotherapy/chemotherapy and deviations are not filled in.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Arm-specific actual exposure, concurrent treatment, crossover/adherence, adjustment variables and survival ITT/PP analysis specifications remain unverified. Existing content review remains incomplete.", "missingness": "Arm-specific actual exposure, concurrent treatment, crossover/adherence, adjustment variables and survival ITT/PP analysis specifications remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Both arms' actual treatment/deviations, crossover records and SAP" }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does successful hemoglobin correction imply improved survival?", "needed": "Distinguish anemia/hemoglobin surrogates from clinical survival events", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Distinguish anemia/hemoglobin surrogates from clinical survival events.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Distinguish anemia/hemoglobin surrogates from clinical survival events. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4; Custom extension boundary; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptation are a custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Document surrogate measures and clinical events separately; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The parent advertising and interpretation text distinguishes anemia correction from survival/tumor control during cancer treatment. Hemoglobin correction itself is not transferred into survival benefit, and the selected record's death-harm note is preserved.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Trial-specific hemoglobin changes, reduced-transfusion values and prespecified mediation analyses relating these to survival remain unverified in this summary. Existing content review remains incomplete.", "missingness": "Trial-specific hemoglobin changes, reduced-transfusion values and prespecified mediation analyses relating these to survival remain unverified in this summary.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific hemoglobin/transfusion results and prespecified survival-related analyses" }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do the ENHANCE comparison and denominators differ from DAHANCA10?", "needed": "Scope of epoetin beta, blinded placebo comparison,351/180/171 and ITT", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Scope of epoetin beta, blinded placebo comparison,351/180/171 and ITT.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Scope of epoetin beta, blinded placebo comparison,351/180/171 and ITT. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population conditions are a custom design; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptation are a custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptation is a custom design; M08 §8.1–8.2.3; Custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; Custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Separate population, formulation and comparison differences; the record includes no new search, calculation or trial.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "ENHANCE reports a multicenter randomized double-blind placebo comparison with351 participants, epoetin beta180/placebo171, and ITT. These are not treated as the same arms, formulation or522/513 denominators as DAHANCA10 darbepoetin.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Baseline conditions, exact dose/duration, survival-specific observation/censoring, concurrent treatment and analysis details remain unverified. Existing content review remains incomplete.", "missingness": "Baseline conditions, exact dose/duration, survival-specific observation/censoring, concurrent treatment and analysis details remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "ENHANCE protocol, participant flow and survival analysis tables" }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "What does ENHANCE survival RR1.39 mean?", "needed": "Original 'survival RR' coding, direction and CI, separate from the tumor primary endpoint", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Original 'survival RR' coding, direction and CI, separate from the tumor primary endpoint.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Original 'survival RR' coding, direction and CI, separate from the tumor primary endpoint. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 §8.2.2, M15 §15.3.1; Custom application; M15 §15.3.1–15.3.3; Custom application; M08 Table 8.2.a, M04 §4.6.3; Custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Document the original estimator name and comparison direction; the record includes no new search, calculation or trial.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "ENHANCE reports a harm direction for survival RR1.39 (95% CI1.05~1.84). Its original primary locoregional progression-free survival adjusted RR1.62 (1.22~2.14), P=.0008, is separate. Survival RR is not renamed HR, death HR or absolute death rate, and no reciprocal is calculated.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Exact survival-RR event/control coding, time, model, denominator/events and original P value remain unverified. Existing content review remains incomplete.", "missingness": "Exact survival-RR event/control coding, time, model, denominator/events and original P value remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "ENHANCE original results, endpoint/model definitions and SAP" }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do the initial and long-term RTOG99-03 reports concern the same trial?", "needed": "Relationship of original trial/follow-up reports,148 participants, bibliography and timepoints", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Relationship of original trial/follow-up reports,148 participants, bibliography and timepoints.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Relationship of original trial/follow-up reports,148 participants, bibliography and timepoints. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; Cohort/outcome linkage is a custom application; M04 §4.5–4.6 principles for collecting/selecting materials; Separating access from reading and hyperlink specifications is a custom design; M04 §4.6.1–4.6.2, M15 §15.3.1; Custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Document time-specific reports from the same cohort; the record includes no new search, calculation or trial.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The initial and long-term RTOG99-03 reports are linked to the same148-participant randomized trial. The original citation contains PMID17716826 and25670542, with the URL pointing to the25670542 long-term report. The reports are not added as separate independent trials or new participants.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Exact participant flow, endpoint-specific follow-up and links between original bibliography and materials remain unread externally. Existing content review remains incomplete.", "missingness": "Exact participant flow, endpoint-specific follow-up and links between original bibliography and materials remain unread externally.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Initial/long-term reports, trial registration and participant/outcome linkage tables" }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the periods and effects for RTOG survival and tumor failure?", "needed": "OS, three-/five-year locoregional failure, original P values and limits of nonsignificance", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: OS, three-/five-year locoregional failure, original P values and limits of nonsignificance.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: OS, three-/five-year locoregional failure, original P values and limits of nonsignificance. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptation is a custom design; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is a custom design; M15 §15.3.1–15.3.3; Custom application; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are a custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link time-specific tumor/survival outcomes and precision materials; the record includes no new search, calculation or trial.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "RTOG99-03 reports three-year locoregional failure44% versus36%, P=.56, and five-year46.2% versus39.4%, P=.42. OS36.9% versus38.2%, P=.54, is a separate survival outcome. No exact OS period is invented, and nonsignificance is not treated as zero effect, equivalence or certified exclusion of an important survival benefit.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Exact OS timepoint, CI, events/denominators, censoring, power and estimation model remain unverified in the summary. Existing content review remains incomplete.", "missingness": "Exact OS timepoint, CI, events/denominators, censoring, power and estimation model remain unverified in the summary.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "RTOG long-term survival tables, follow-up materials and prespecified plans" }, { "item_id": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the direction and analysis denominators of the Cochrane survival OR?", "needed": "Names/coding of5RCT1397 participants, OS Peto OR and other pooled endpoints", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Names/coding of5RCT1397 participants, OS Peto OR and other pooled endpoints.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Names/coding of5RCT1397 participants, OS Peto OR and other pooled endpoints. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Document pooled-endpoint comparison directions and included denominators; the record includes no new search, calculation or trial.", "current_reports": [ "S04" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The2009 Cochrane review preserves OS Peto OR0.73 (95% CI0.58~0.91) and locoregional progression-free survival OR0.63 (0.49~0.80), in the context of5RCTs and1,397 participants. The original account describes radiotherapy+EPO as worse than radiotherapy alone and OR<1 as favoring radiotherapy alone. No reciprocal, new HR or absolute effect is produced.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Endpoint-specific event coding, actual included denominators, models/weights, original P values and trial mapping remain unverified. Existing content review remains incomplete.", "missingness": "Endpoint-specific event coding, actual included denominators, models/weights, original P values and trial mapping remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review results, forest plots, included trials/denominators and analysis definitions" }, { "item_id": "N19", "question_type": "Efficacy comparison and presentation of stored material", "question": "How much do the review and individual reports overlap?", "needed": "Cross-links between review-included trials/follow-up reports and the three individual trials", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Cross-links between review-included trials/follow-up reports and the three individual trials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Cross-links between review-included trials/follow-up reports and the three individual trials. Preserved statements are linked here; existing content review remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Describe shared/overlapping relationships between synthesis and direct reports; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "DAHANCA10, ENHANCE, RTOG99-03 and the Cochrane5-trial1,397-participant review are distinguished at report, trial-family and synthesis levels. The review inclusion list and time-specific overlap remain unverified. The three reports are not added to the5 trials, and1397,522,351 and148 are not summed.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Included-trial lists, follow-up mappings, endpoint-specific overlap/exclusions and unique clinical totals remain unverified. Existing content review remains incomplete.", "missingness": "Included-trial lists, follow-up mappings, endpoint-specific overlap/exclusions and unique clinical totals remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review inclusion/exclusion tables and report↔trial↔population linkage tables" }, { "item_id": "N20", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do formulation, population and duration differences relate to the selected scope?", "needed": "Differences in ESA/arms/periods, denominators and analyses, with independence unverified", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Differences in ESA/arms/periods, denominators and analyses, with independence unverified.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Differences in ESA/arms/periods, denominators and analyses, with independence unverified. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2, M15 §15.3.1; Custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; Cohort/outcome linkage is a custom application; CHAMGAP's own independence and attribution conditions. Official method sections in this pilot do not validate all details of this item", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link replication/heterogeneity materials while separating different conditions; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "DAHANCA10 open-label darbepoetin comparison, ENHANCE placebo-controlled epoetin beta, RTOG99-03 epoetin alfa conditions and the review's mixture are preserved separately. Original RX/I1 and historical investigator-independence statements are not inherited as current independent-replication certification.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Unique replication counts under the same selected conditions, formulation equivalence, arm-specific effect modification and review heterogeneity details remain unverified. Existing content review remains incomplete.", "missingness": "Unique replication counts under the same selected conditions, formulation equivalence, arm-specific effect modification and review heterogeneity details remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific characteristics/endpoints, report families and heterogeneity materials" }, { "item_id": "N21", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "How do cancer-survival harm and other safety outcomes differ?", "needed": "Separate definitions and analysis scopes for death/cancer outcomes, SAE, cardiovascular events and radiation toxicity", "role": "Supplementary", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Separate definitions and analysis scopes for death/cancer outcomes, SAE, cardiovascular events and radiation toxicity.", "application_exception": "Supplement gaps in safety/death materials for the selected survival question. Tumor control, hemoglobin correction or other adverse-event statements do not determine overall safety, harm incidence, drug choice/substitution or treatment guidance.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Separate definitions and analysis scopes for death/cancer outcomes, SAE, cardiovascular events and radiation toxicity. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Separate cancer outcomes and other safety events; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Cancer-survival/tumor-control harm is central in the original account. The statement that DAHANCA10 found no excess serious adverse events, cardiovascular events or acute/late radiation toxicity is separate. Absence of other safety signals is not rewritten as overall safety or absence of cancer harm.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Definitions, ascertainment, events/denominators, exposure/follow-up, missingness and precision for individual safety outcomes remain unverified. Existing content review remains incomplete.", "missingness": "Definitions, ascertainment, events/denominators, exposure/follow-up, missingness and precision for individual safety outcomes remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific safety results, collection instructions and exposure/follow-up" }, { "item_id": "N22", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are death causes, missingness, vulnerable groups and long-term scope verified?", "needed": "Death ascertainment, cause, competing events, follow-up loss and vulnerable-group specifications", "role": "Supplementary", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Death ascertainment, cause, competing events, follow-up loss and vulnerable-group specifications.", "application_exception": "Supplement gaps in safety/death materials for the selected survival question. Tumor control, hemoglobin correction or other adverse-event statements do not determine overall safety, harm incidence, drug choice/substitution or treatment guidance.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Death ascertainment, cause, competing events, follow-up loss and vulnerable-group specifications. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; Detailed discrimination is a custom design; M19 §19.2 design-specific harm questions; Details of temporal relationships are a custom design; M19 §19.1.2–19.2.4, M04 §4.6.3; Custom application; M19 §19.1.2–19.2.4; Custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Separate time- and vulnerable-group-specific evidence gaps in follow-up materials; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected question preserves disease-specific and overall death separately and uses the original overall-death HR/CI. Long-term survival, vulnerable groups and cancer-site/stage results are not filled with values absent from the preserved materials.", "condition_status": "Unverified", "status_reason": "Currently required information remains unverified in the preserved summary. Cause adjudication, competing events, arm-specific follow-up loss, periods beyond follow-up and prespecified subgroups remain unverified. Existing content review remains incomplete.", "missingness": "Cause adjudication, competing events, arm-specific follow-up loss, periods beyond follow-up and prespecified subgroups remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Survival follow-up/cause-of-death materials and subgroup/long-term plans" }, { "item_id": "N23", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is the scope of DAHANCA10 support and investigator roles?", "needed": "Distinguish cash, free products, quality-control costs, study/manuscript roles and COI", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Distinguish cash, free products, quality-control costs, study/manuscript roles and COI.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Distinguish cash, free products, quality-control costs, study/manuscript roles and COI. Preserved statements are linked here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Separate types of support and study/manuscript roles; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account describes Danish Cancer Society and Amgen support, free Aranesp from Amgen and Amgen bearing most GCP/quality-control costs. Its investigator-driven statement, no Amgen role in design/conduct/collection/analysis, and an opportunity for manuscript comments without comments provided are preserved as history.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Support agreements, actual decision-making, employee authors, author-specific COI, other publication costs and original disclosures remain unread externally. Existing content review remains incomplete.", "missingness": "Support agreements, actual decision-making, employee authors, author-specific COI, other publication costs and original disclosures remain unread externally.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Support/product/quality-control agreements, original author/COI and contribution disclosures" }, { "item_id": "N24", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do ENHANCE, RTOG and review support have the same meaning?", "needed": "Funding, products, employees and COI for each company/public/review source", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Funding, products, employees and COI for each company/public/review source.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Funding, products, employees and COI for each company/public/review source. Preserved statements are linked here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link direct-trial and review support separately; the record includes no new search, calculation or trial.", "current_reports": [ "S02", "S03", "S04" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "ENHANCE F.Hoffmann-LaRoche and RTOG NCI/OrthoBiotech support are preserved separately. Mixed public/company support statements for the Cochrane review and included trials are not transferred into verification of the review's own funding or COI.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Free products, employee authors, actual roles and COI for each report, and the review's own funding/COI remain unverified. Existing content review remains incomplete.", "missingness": "Free products, employee authors, actual roles and COI for each report, and the review's own funding/COI remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific original funding/product support, authors, contributions and COI materials, and review disclosures" }, { "item_id": "N25", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do registration wording, actual registration identity and plans differ?", "needed": "Preserve original registration wording/identifiers separately from unread status", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Preserve original registration wording/identifiers separately from unread status.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Preserve original registration wording/identifiers separately from unread status. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link registration/plan histories by report; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S03", "S04" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The DAHANCA10/ENHANCE statement 'predates registration systems, so none exists' is historical wording with actual identifiers unrecorded. RTOG's NCT00004917 retains only the original identifier. The review's 'not applicable' is not treated as certified absence of clinical registration.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Actual registration text, change history, prespecified endpoints/follow-up, protocol and SAP are unread, with no access attempt. Existing content review remains incomplete.", "missingness": "Actual registration text, change history, prespecified endpoints/follow-up, protocol and SAP are unread, with no access attempt.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration or plan copies, or user-supplied materials" }, { "item_id": "N26", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Does the FDA warning account reflect actual reading of the original label?", "needed": "Separate the account's warning history from external FDA label/date/scope", "role": "Supplementary", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Separate the account's warning history from external FDA label/date/scope.", "application_exception": "Supplement gaps in safety/death materials for the selected survival question. Tumor control, hemoglobin correction or other adverse-event statements do not determine overall safety, harm incidence, drug choice/substitution or treatment guidance.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Separate the account's warning history from external FDA label/date/scope. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; Custom application; M04 §4.5–4.6 principles for collecting/selecting materials; Separating access from reading and hyperlink specifications is a custom design; M04 §4.5, §4.6.3; Limitations of the current material conversion follow the review scope and custom design; CHAMGAP's own interpretation boundary. M19 principles are referenced; no official causality tool was run", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link the original warning account to version-specific sources; the record includes no new search, calculation or trial.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The parent account contains an FDA warning that ESAs may shorten survival or increase tumor progression/recurrence in head-and-neck and other cancers. The FDA label remains unread in this work; no separate URL was provided in the preserved summary, so no address is invented.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Label version, actual warning text, indications/exceptions and update date remain unverified. Existing content review remains incomplete.", "missingness": "Label version, actual warning text, indications/exceptions and update date remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original FDA label/warning version or user-provided materials" }, { "item_id": "N27", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does the reduced-transfusion account for another indication answer cancer survival?", "needed": "Distinguish the preterm-infant2925 citation from the selected head-and-neck cancer survival question", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Distinguish the preterm-infant2925 citation from the selected head-and-neck cancer survival question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Distinguish the preterm-infant2925 citation from the selected head-and-neck cancer survival question. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying questions; Detailed separation rules are a custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; Cohort/outcome linkage is a custom application; M03 §3.2.4; Custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Separate source relationships for different indications; the record includes no new search, calculation or trial.", "current_reports": [ "S05" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The contextual2925 citation refers to a B72 account of reduced red-cell transfusions in very-low-birth-weight preterm infants. That indication and transfusion endpoint differ from cancer survival here. The citation is not turned into a direct survival trial, new RCT or opposite survival effect.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. That account's original text/trial and any direct link to these materials remain unread in this work. It is not substitute evidence for the selected survival question. Existing content review remains incomplete.", "missingness": "That account's original text/trial and any direct link to these materials remain unread in this work. It is not substitute evidence for the selected survival question.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Record indication/endpoint relationships if materials for the referenced account are provided" }, { "item_id": "N28", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can these findings be extended to CKD, other cancers or anemia conditions?", "needed": "Boundary between original head-and-neck cancer radiotherapy scope and other indications", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Boundary between original head-and-neck cancer radiotherapy scope and other indications.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Boundary between original head-and-neck cancer radiotherapy scope and other indications. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are Chamgap's own design; M03 §3.2.1; detailed population conditions are Chamgap's own design; M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap's own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Separate condition-specific questions and direct-material scope in follow-up materials; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S03", "S05" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "This sheet concerns survival with ESA anemia correction during head-and-neck cancer radiotherapy. Other anemia indications and preterm-infant transfusion context in the account are not transferred into head-and-neck cancer survival outcomes or extended into new effect/contraindication verdicts for every ESA indication.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Direct survival materials for other indications, anemia severity, target hemoglobin and treatment combinations are outside this production scope and remain unverified. Existing content review remains incomplete.", "missingness": "Direct survival materials for other indications, anemia severity, target hemoglobin and treatment combinations are outside this production scope and remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Link separate indication-specific direct materials if provided" }, { "item_id": "N29", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are preserved summaries and actual external reading displayed?", "needed": "Access status of summaries, external originals, registration, protocol, SAP and COI", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Access status of summaries, external originals, registration, protocol, SAP and COI.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Access status of summaries, external originals, registration, protocol, SAP and COI. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Record actual acquisition/reading levels and versions by material; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S03", "S04", "S05" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The full preserved summary's Korean/English text, evidence, citations and subclaims were read for production and preserved. Each preserved JSON summary is shown as 'summary read'; external papers, registration, plans and support materials are 'unread'. Bibliography, URLs, registration numbers and historical review statements do not prove external reading in this work.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. External abstracts, full texts, registration, plans and COI are unread with no access attempt; source-link operation was not tested. Existing content review remains incomplete.", "missingness": "External abstracts, full texts, registration, plans and COI are unread with no access attempt; source-link operation was not tested.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-provided original materials/reading records" }, { "item_id": "N30", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are original Korean/English text, reference date, empty values and correction history retained?", "needed": "Preserve original languages,2026-08-26, empty correction/deliberation values, false and unrecorded values", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Preserve original languages,2026-08-26, empty correction/deliberation values, false and unrecorded values.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Preserve original languages,2026-08-26, empty correction/deliberation values, false and unrecorded values. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Link sources/dates of the original version and new production content; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S03", "S04", "S05" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The parent Korean/English text, axes, F12, Warning,2026-08-26, empty corrections array and empty deliberation string are preserved in the full summary copy. The selected record retains F, note and English wording; absent score/status/axes are not filled from the parent. Absent facet values are not filled with new content.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. No external update, detailed translation content review or additional correction was performed in this original record. Existing content review remains incomplete.", "missingness": "No external update, detailed translation content review or additional correction was performed in this original record.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original correction materials or user correction comments" }, { "item_id": "N31", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are condition application, table production and completed content review separate events?", "needed": "Distinguish conditions saved first, freezing, separate application and existing content-review status", "role": "Required", "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Distinguish conditions saved first, freezing, separate application and existing content-review status.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Distinguish conditions saved first, freezing, separate application and existing content-review status. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal: Record production versions and user correction comments as history; the record includes no new search, calculation or trial.", "current_reports": [ "S01", "S02", "S03", "S04", "S05" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Conditions were saved before recording the frozen production event and a separate application time to create the table. The original model/content/boundary review-pending flags are false, completion is also false, and existing content review remains incomplete. Table production and material-slot counts do not certify clinical review or unique trial/independent participant counts.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information was recorded; detailed original materials remain unread and existing content review is incomplete. Existing full content review remains incomplete; QA, screen and link tests were not performed in the original production event. Existing content review remains incomplete.", "missingness": "Existing full content review remains incomplete; QA, screen and link tests were not performed in the original production event.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Comments on existing content review and additional preserved materials" } ], "reports": [ { "report_id": "S01", "title": "Overgaard J et al. 2018 DAHANCA 10", "url": "https://pubmed.ncbi.nlm.nih.gov/29523409/", "report_type": "Multicenter open-label randomized phase 3 trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2940-DAHANCA10", "independent_replication": null, "observed_result": "Disease-specific death HR1.43 (95% CI1.08~1.90) and overall death HR1.30 (1.02~1.64) retain their original harm direction. EFS HR1.36 (1.09~1.69) and five-year locoregional failure47% versus34%, HR1.53 (1.16~2.02), are different endpoints. Five years is not assigned to every survival HR, and death rates, differences or CIs are not newly calculated.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "External FDA label", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29523409/" } ] }, { "report_id": "S02", "title": "Henke M et al. 2003 ENHANCE", "url": "https://pubmed.ncbi.nlm.nih.gov/14575968/", "report_type": "Multicenter randomized double-blind placebo-controlled trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2940-ENHANCE", "independent_replication": null, "observed_result": "Adjusted RR1.62 (95% CI1.22~2.14), P=.0008; survival RR1.39 (1.05~1.84). Survival RR retains its original name; it is not changed into HR, death HR or absolute survival, and no reciprocal, new effect or denominator is calculated.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/14575968/" } ] }, { "report_id": "S03", "title": "Machtay M et al. RTOG 99-03 and long-term follow-up", "url": "https://pubmed.ncbi.nlm.nih.gov/25670542/", "report_type": "Reports of the same multicenter randomized phase 3 trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2940-RTOG99-03", "independent_replication": null, "observed_result": "Three-year failure44% versus36%, P=.56; five-year46.2% versus39.4%, P=.42; OS36.9% versus38.2%, P=.54. Locoregional-failure timepoints and OS are separate. Absent original OS timepoint, CI or denominator values are not filled, and no new significance, difference or sum is produced.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "External initial paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/25670542/" } ] }, { "report_id": "S04", "title": "Bohlius J et al. 2009 systematic review", "url": "https://pubmed.ncbi.nlm.nih.gov/19588382/", "report_type": "Systematic review and meta-analysis of5 randomized trials", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "SYN2940-COCHRANE-2009", "independent_replication": null, "observed_result": "OS Peto OR0.73 (95% CI0.58~0.91), locoregional PFS OR0.63 (0.49~0.80): radiotherapy+EPO is worse. Peto OR/OR names and the original comparison direction are preserved. No reciprocal, HR, absolute risk or new pooled value is produced; the review's own funding/COI remain unverified.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/19588382/" } ] }, { "report_id": "S05", "title": "Verdict2925 on reduced red-cell transfusions in very-low-birth-weight preterm infants has grade B,72 points.", "url": "https://chamgap.com/verdicts/general/darbepoetin-reduced-red-cell-transfusions-very-low-birth-weight-preterm-infants/", "report_type": "Citation-only report; no row in the original review summary's evidence list", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "REF2940-VERDICT2925", "independent_replication": null, "observed_result": "Even for the same drug, reduced transfusions in preterm infants concern a different indication and endpoint. They are not transferred into a direct effect for the selected survival question or a new independent-trial count.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External manuscript", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "Official source", "url": "https://chamgap.com/verdicts/general/darbepoetin-reduced-red-cell-transfusions-very-low-birth-weight-preterm-infants/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 DAHANCA10/Overgaard2018 is an open-label randomized phase3 report with planned600, randomized522 and evaluable513 (254/259). Primary locoregional failure, EFS, disease-specific death and overall death are separate. The same report, arms, people, endpoints or sibling sheets are not counted as new independent trials or participants. Report/material slots are not unique clinical trial, participant or independent-replication totals; clinical totals remain unrecorded. S02 ENHANCE/Henke2003 is a double-blind ITT trial report with351 participants, epoetin beta180/placebo171. It is separate from DAHANCA's darbepoetin formulation and denominators. Survival RR retains its original name/direction, and historical registration-era absence wording is not changed into new verification of registration absence. Report/material slots are not unique clinical trial, participant or independent-replication totals; clinical totals remain unrecorded. S03 RTOG99-03 links initial/long-term reports of the same148-participant epoetin alfa randomized trial in one existing citation. PMID17716826 and25670542 are preserved, and the URL points to long-term report25670542. Two reports, three-/five-year/OS outcomes and arms are not added as new independent trials or participants. Report/material slots are not unique clinical trial, participant or independent-replication totals; clinical totals remain unrecorded. S04 Cochrane/Bohlius2009 is a5RCT1,397-participant review. Inclusion/overlap with individual DAHANCA/ENHANCE/RTOG reports remains unverified; the review is not a new independent RCT. Review, individual-trial and sibling-sheet participants/trials are not summed. Report/material slots are not unique clinical trial, participant or independent-replication totals; clinical totals remain unrecorded. S05 refers to account2925 through an existing cross-citation absent from the evidence list, with another indication/endpoint: preterm-infant reduced transfusions, B72. That account/trial was not read in this production scope. It is not made into a direct head-and-neck cancer survival trial, independent replication or opposite effect. Report/material slots are not unique clinical trial, participant or independent-replication totals; clinical totals remain unrecorded." }, "history": [ { "date": "2026-10-11", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "A public view and materials were prepared from the existing31 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-11" }