{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2939-s0",
  "verdict_number": "2939",
  "title": "PEGPH20 add-on therapy × improved overall survival — evidence sheet for hyaluronan-high metastatic pancreatic ductal adenocarcinoma",
  "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": "The complete existing review summary was read for production, linking existing URLs and identifiers. External abstracts, full texts, registration, protocols and SAP were not newly read or checked.",
    "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": "Previously untreated stage IV pancreatic ductal adenocarcinoma with stromal hyaluronan staining of at least 50%; detailed eligibility remains unread",
    "intervention": "Historical research conditions for PEGPH20 add-on therapy; distinguished from shared nab-paclitaxel, gemcitabine and mandatory enoxaparin prophylaxis",
    "dose": "Research-drug or prophylaxis doses, schedules and actual-exposure details remain unread; no treatment or medication instructions are created",
    "comparator": "Original comparison with matching placebo and the same shared anticancer treatment and mandatory prophylaxis",
    "endpoint": "Selected primary overall survival; ORR, PFS and harms preserved separately",
    "duration": "Original median OS of 11.2/11.5 months and PFS of 7.1/7.1 months are outcome values and are not used as intervention or follow-up duration; data-cutoff and actual-exposure or follow-up details remain unread",
    "excluded_extensions": [
      "Transferring ORR into OS, PFS or clinical-function benefit",
      "Certifying exploratory lower-order results as confirmatory success under fixed-sequence testing",
      "Certifying effects or harms in other cancers, treatment lines, combinations or prophylaxis conditions",
      "Adding different endpoints, sibling sheets or the same people as independent evidence",
      "Drug selection, use, prophylaxis, substitution or treatment recommendations"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy",
      "question": "Were the original overall-survival subclaim verdict and parent context preserved separately?",
      "needed": "Separate records of the original claim, grade, note and parent values",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of the original claim, grade, note and parent values",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link additional materials separately to the selected survival question and parent context.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The selected original claim is improved overall survival, subclaim grade D, with a null-result note of HR 1.00 and P=.97. Parent D, 34 points and Caution are preserved as separate context.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Subclaim score, status and axes are absent and are not filled with parent values. This is not a new grade assessment.",
      "missingness": "Subclaim score, status and axes are absent and are not filled with parent values. This is not a new grade assessment.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Subclaim score, status and axes are absent and are not filled with parent values. This is not a new grade assessment."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "Who were the hyaluronan-high, untreated stage IV pancreatic ductal adenocarcinoma participants?",
      "needed": "Original tumor, expression, treatment-history, stage, eligibility and denominator materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original tumor, expression, treatment-history, stage, eligibility and denominator materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original eligibility, baseline characteristics, biomarker-assessment methods and denominators.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The trial recruited previously untreated stage IV pancreatic ductal adenocarcinoma patients with stromal hyaluronan staining of at least 50%.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not automatically apply results to other expression levels, stages, treatment lines or cancers. Detailed eligibility and baseline conditions remain unread.",
      "missingness": "Do not automatically apply results to other expression levels, stages, treatment lines or cancers. Detailed eligibility and baseline conditions remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not automatically apply results to other expression levels, stages, treatment lines or cancers. Detailed eligibility and baseline conditions remain unread."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "Were PEGPH20 add-on therapy and shared anticancer treatment distinguished?",
      "needed": "Records of study drug, placebo, shared regimen, actual exposure and concomitant-treatment management",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Records of study drug, placebo, shared regimen, actual exposure and concomitant-treatment management",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link original intervention, placebo, shared regimen, actual exposure and discontinuation materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The intervention was PEGPH20 add-on therapy; both groups received nab-paclitaxel plus gemcitabine.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. The added drug's effect is not converted into the overall effect of shared anticancer treatment. Dose, schedule and actual-exposure details remain unread, and no treatment instructions are created.",
      "missingness": "The added drug's effect is not converted into the overall effect of shared anticancer treatment. Dose, schedule and actual-exposure details remain unread, and no treatment instructions are created.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The added drug's effect is not converted into the overall effect of shared anticancer treatment. Dose, schedule and actual-exposure details remain unread, and no treatment instructions are created."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "What were the shared research conditions for matching placebo and thrombosis prophylaxis?",
      "needed": "Original placebo, shared prophylaxis, co-exposure and adherence materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original placebo, shared prophylaxis, co-exposure and adherence materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original protocol materials on shared management, actual exposure, deviations and concomitant treatments.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Matching placebo was used, and both groups had mandatory enoxaparin prophylaxis because of thromboembolic risk.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Research conditions are not converted into prophylaxis or medication instructions for readers. The same results are not certified for other prophylaxis or exposure conditions.",
      "missingness": "Research conditions are not converted into prophylaxis or medication instructions for readers. The same results are not certified for other prophylaxis or exposure conditions.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Research conditions are not converted into prophylaxis or medication instructions for readers. The same results are not certified for other prophylaxis or exposure conditions."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Were 494 randomized participants, 492 ITT participants and 2:1 allocation distinguished?",
      "needed": "Group-specific allocation, ITT, exclusions and outcome-specific analysis denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Group-specific allocation, ITT, exclusions and outcome-specific analysis denominators",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original participant flow, group allocation, ITT exclusions and outcome-specific denominators.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The record states that 492 of 494 participants randomized 2:1 were included in the ITT analysis.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not calculate group sizes from 2:1 or fill every endpoint and safety denominator with 492. Exclusion reasons and group-specific analysis sizes remain unread.",
      "missingness": "Do not calculate group sizes from 2:1 or fill every endpoint and safety denominator with 492. Exclusion reasons and group-specific analysis sizes remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not calculate group sizes from 2:1 or fill every endpoint and safety denominator with 492. Exclusion reasons and group-specific analysis sizes remain unread."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "What were the overall-survival definitions for start time, death ascertainment, follow-up and censoring?",
      "needed": "Original survival-time, start-point, death, censoring, follow-up and denominator materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original survival-time, start-point, death, censoring, follow-up and denominator materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original survival definitions, death ascertainment, censoring, follow-up and group-specific event tables.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original primary endpoint was overall survival; 330 of 492 ITT participants died.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not create death-ascertainment methods, data cutoffs, censoring, group-specific deaths or follow-up details. Do not duplicate 330 as each group's event count.",
      "missingness": "Do not create death-ascertainment methods, data cutoffs, censoring, group-specific deaths or follow-up details. Do not duplicate 330 as each group's event count.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not create death-ascertainment methods, data cutoffs, censoring, group-specific deaths or follow-up details. Do not duplicate 330 as each group's event count."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Were median overall survival and HR, CI and P preserved as original values?",
      "needed": "Group-specific medians, between-group HR, CI, tests, models and denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Group-specific medians, between-group HR, CI, tests, models and denominators",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original survival curves, median CI, models, group-specific denominators and tests.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Median overall survival was 11.2 versus 11.5 months, HR 1.00 (95% CI 0.80 to 1.27), P=.97.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not calculate median differences, survival proportions, new HR, NNT or restricted means. Median CI and model details remain unread.",
      "missingness": "Do not calculate median differences, survival proportions, new HR, NNT or restricted means. Median CI and model details remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not calculate median differences, survival proportions, new HR, NNT or restricted means. Median CI and model details remain unread."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Were the null HR 1.00 result and remaining possible benefit distinguished?",
      "needed": "Original CI, prespecified success or importance thresholds and effect interpretation",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original CI, prespecified success or importance thresholds and effect interpretation",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original planned clinical-importance criteria, testing assumptions and effect CI.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The parent records D34 for null overall survival while stating that the CI retained possible benefit.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. A point estimate of 1.00 is not converted into certification of zero effect, equivalence or exclusion of meaningful benefit. Clinical-importance and success-HR threshold details remain unread.",
      "missingness": "A point estimate of 1.00 is not converted into certification of zero effect, equivalence or exclusion of meaningful benefit. Clinical-importance and success-HR threshold details remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "A point estimate of 1.00 is not converted into certification of zero effect, equivalence or exclusion of meaningful benefit. Clinical-importance and success-HR threshold details remain unread."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Were the prespecified 2019 amendment and sole primary overall-survival endpoint preserved?",
      "needed": "Records of original registration, protocol, SAP, dates and decisions before and after amendment",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Records of original registration, protocol, SAP, dates and decisions before and after amendment",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original registration history, protocol, SAP and amendment events separately.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The preserved summary records overall survival as the sole primary endpoint after a prespecified 2019 amendment and states agreement with NCT02715804.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not infer earlier endpoints, amendment dates or data-access circumstances. Registration and plans were not compared in this production.",
      "missingness": "Do not infer earlier endpoints, amendment dates or data-access circumstances. Registration and plans were not compared in this production.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not infer earlier endpoints, amendment dates or data-access circumstances. Registration and plans were not compared in this production."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "What was the response-rate hierarchy in fixed-sequence testing?",
      "needed": "Original plans for OS, lower-order endpoints, testing sequence and multiplicity",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original plans for OS, lower-order endpoints, testing sequence and multiplicity",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original SAP materials on fixed sequence, outcome lists, changes and endpoint-specific tests.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Overall survival had to be significant first before lower-order endpoints could be tested confirmatorily. The record states that response was interpreted as exploratory after survival failed.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Positive response does not replace primary survival success, and the testing hierarchy is not newly changed.",
      "missingness": "Positive response does not replace primary survival success, and the testing hierarchy is not newly changed.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Positive response does not replace primary survival success, and the testing hierarchy is not newly changed."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Were objective response of 47% versus 36% and survival separated?",
      "needed": "Separate records of imaging-response definitions, denominators, ratio, CI and hierarchy",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of imaging-response definitions, denominators, ratio, CI and hierarchy",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original response definitions, assessments, denominators and hierarchy materials separately.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Original response was 47% versus 36%, ratio 1.29 (95% CI 1.03 to 1.63). Its exploratory lower-order status is preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Response ratio and intervals are not copied into OS HR or CI. Responder counts, new proportion differences and P are not calculated.",
      "missingness": "Response ratio and intervals are not copied into OS HR or CI. Responder counts, new proportion differences and P are not calculated.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Response ratio and intervals are not copied into OS HR or CI. Responder counts, new proportion differences and P are not calculated."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Were the definitions and effects of progression-free and overall survival distinguished?",
      "needed": "PFS and OS events, times, denominators, effects and CI",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "PFS and OS events, times, denominators, effects and CI",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original PFS definitions, models, denominators, plans and tests separately.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The record gives median PFS of 7.1 versus 7.1 months, HR 0.97 (95% CI 0.75 to 1.26).",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. PFS values and intervals are not transferred into OS values. PFS testing P, assessment procedures and hierarchy details remain unread.",
      "missingness": "PFS values and intervals are not transferred into OS values. PFS testing P, assessment procedures and hierarchy details remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "PFS values and intervals are not transferred into OS values. PFS testing P, assessment procedures and hierarchy details remain unread."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "What was the scope of original allocation-concealment and blinding methods?",
      "needed": "Central allocation, concealment and participant, assessor or analyst procedures",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Central allocation, concealment and participant, assessor or analyst procedures",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original methods, allocation, blinding roles and unblinding procedures.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original summary records 2:1 allocation through a central interactive response system and use of double-blinding with matching placebo.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not newly certify each assessor or analyst role, code breaking or actual implementation details. Parent B0 is historical.",
      "missingness": "Do not newly certify each assessor or analyst role, code breaking or actual implementation details. Parent B0 is historical.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not newly certify each assessor or analyst role, code breaking or actual implementation details. Parent B0 is historical."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Were gaps in ITT, missing-data, censoring and subsequent-treatment handling retained?",
      "needed": "Original analysis-population, model, censoring, deviation, subsequent-treatment and sensitivity materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original analysis-population, model, censoring, deviation, subsequent-treatment and sensitivity materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original SAP, analysis-population, follow-up, censoring, subsequent-treatment and sensitivity materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "492 ITT participants and 330 deaths are preserved.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Complete follow-up, group-specific censoring, crossover, subsequent anticancer treatment and missing-data sensitivity are not newly specified.",
      "missingness": "Complete follow-up, group-specific censoring, crossover, subsequent anticancer treatment and missing-data sensitivity are not newly specified.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Complete follow-up, group-specific censoring, crossover, subsequent anticancer treatment and missing-data sensitivity are not newly specified."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Is there information on actual drug exposure, discontinuation and anticancer dose intensity?",
      "needed": "Actual exposure, adherence and discontinuation for the added drug, shared regimen and prophylactic drug",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Actual exposure, adherence and discontinuation for the added drug, shared regimen and prophylactic drug",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original exposure, discontinuation, group-specific concomitant-treatment and prespecified effect-of-interest materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Add-on therapy, shared anticancer treatment and mandatory prophylaxis conditions are preserved in the summary.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Exposure duration, dose intensity, discontinuation, crossover and adherence effects remain unread. Exposure is not converted into treatment recommendations.",
      "missingness": "Exposure duration, dose intensity, discontinuation, crossover and adherence effects remain unread. Exposure is not converted into treatment recommendations.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Exposure duration, dose intensity, discontinuation, crossover and adherence effects remain unread. Exposure is not converted into treatment recommendations."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "Was survival not filled in from mechanisms, hyaluronan selection or imaging response?",
      "needed": "Relationships between biomarker, mechanism, imaging and direct survival",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Relationships between biomarker, mechanism, imaging and direct survival",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link original mechanism and biomarker analysis plans separately to direct survival materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Selection for hyaluronan staining of at least 50% and improved imaging response appear in the preserved summary, but survival was null.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Mechanistic explanations, selected biomarkers and imaging changes do not replace OS benefit. No mechanistic numbers or additional subgroup effects are created.",
      "missingness": "Mechanistic explanations, selected biomarkers and imaging changes do not replace OS benefit. No mechanistic numbers or additional subgroup effects are created.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Mechanistic explanations, selected biomarkers and imaging changes do not replace OS benefit. No mechanistic numbers or additional subgroup effects are created."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "Were gaps in prespecified subgroups, sensitivity and long-term survival retained?",
      "needed": "Original subgroup, interaction, follow-up, model, denominator and multiplicity materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original subgroup, interaction, follow-up, model, denominator and multiplicity materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original subgroup, interaction, long-term follow-up and sensitivity materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The selected high-expression population and overall ITT survival results are preserved as recorded.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not generate subgroup numbers, effects, P or long-term survival proportions absent from the original summary. Median survival is not converted into follow-up duration.",
      "missingness": "Do not generate subgroup numbers, effects, P or long-term survival proportions absent from the original summary. Median survival is not converted into follow-up duration.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not generate subgroup numbers, effects, P or long-term survival proportions absent from the original summary. Median survival is not converted into follow-up duration."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Were the same HALO report, two outcomes and sibling sheets not added as independent evidence?",
      "needed": "Links among original trial, report, shared population, endpoints and times",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Links among original trial, report, shared population, endpoints and times",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link additional reports to the same registration and trial identifiers and their relationships.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The two sheets share one HALO109-301 report and the 494/492-participant context. The parent wording that the originally confirmed efficacy evidence was one manufacturer development trial is retained.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not add sheets, endpoints or repeated participant displays as new independent trials or participants. Final independent and total-participant counts remain unrecorded.",
      "missingness": "Do not add sheets, endpoints or repeated participant displays as new independent trials or participants. Final independent and total-participant counts remain unrecorded.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not add sheets, endpoints or repeated participant displays as new independent trials or participants. Final independent and total-participant counts remain unrecorded."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy",
      "question": "Were Halozyme funding, products, employee authors, management and writing roles separated?",
      "needed": "Separate records of cash support, drug or placebo supply, affiliations and external analysis or writing",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of cash support, drug or placebo supply, affiliations and external analysis or writing",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original disclosures separately for funding, supply, affiliations, data management, analysis and writing roles.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Halozyme sponsorship and support, protocol, study drug or placebo and data management; 2 company-employee authors; and Paragon medical writing paid by Halozyme are preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Paragon writing is not converted into outsourced analysis. Data-analysis roles and employee-identity details remain unread.",
      "missingness": "Paragon writing is not converted into outsourced analysis. Data-analysis roles and employee-identity details remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Paragon writing is not converted into outsourced analysis. Data-analysis roles and employee-identity details remain unread."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Were original independence, R1 and I0 axes distinguished from new certification?",
      "needed": "Preservation of original verdict, support, investigators and report relationships",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Preservation of original verdict, support, investigators and report relationships",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: If other materials are provided, separately link only study, funding, author and denominator relationships.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Parent R1 and I0 and the original manufacturer-development-trial context are preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. No new external efficacy trial, independent replication or investigator certification is created. Original axes are not copied into absent subclaim values.",
      "missingness": "No new external efficacy trial, independent replication or investigator certification is created. Original axes are not copied into absent subclaim values.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "No new external efficacy trial, independent replication or investigator certification is created. Original axes are not copied into absent subclaim values."
    },
    {
      "item_id": "N21",
      "question_type": "Supplementary harm evidence",
      "question": "Were original grade 3 or worse fatigue, muscle-spasm and hyponatremia proportions retained?",
      "needed": "Original group-specific harm definitions, denominators, grades, relatedness and exposure tables",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original group-specific harm definitions, denominators, grades, relatedness and exposure tables",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original safety-population, group-specific event, denominator, grade and exposure tables.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Fatigue of 16.0% versus 9.6%, muscle spasms of 6.5% versus 0.6% and hyponatremia of 8.0% versus 3.8% are original grade 3 or worse proportions.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not calculate new harm differences, RR, P, CI or event counts. Group-specific safety-analysis denominators, collection periods and relatedness details remain unread.",
      "missingness": "Do not calculate new harm differences, RR, P, CI or event counts. Group-specific safety-analysis denominators, collection periods and relatedness details remain unread.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not calculate new harm differences, RR, P, CI or event counts. Group-specific safety-analysis denominators, collection periods and relatedness details remain unread."
    },
    {
      "item_id": "N22",
      "question_type": "Supplementary harm evidence",
      "question": "Were descriptively more frequent harms and inferential-testing plans distinguished?",
      "needed": "Prespecified safety plans, tests, effects, intervals and relatedness",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Prespecified safety plans, tests, effects, intervals and relatedness",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original safety plans, descriptive tables, relatedness and follow-up materials separately.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The preserved summary records descriptively more frequent harms in the PEGPH20 group and states that the protocol did not plan inferential safety testing.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Descriptive differences are not promoted into statistically significant harm or confirmed causality, and absence of testing is not converted into absence of harm.",
      "missingness": "Descriptive differences are not promoted into statistically significant harm or confirmed causality, and absence of testing is not converted into absence of harm.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Descriptive differences are not promoted into statistically significant harm or confirmed causality, and absence of testing is not converted into absence of harm."
    },
    {
      "item_id": "N23",
      "question_type": "Supplementary harm evidence",
      "question": "Were thrombosis risk, shared enoxaparin and safety-applicability boundaries separated?",
      "needed": "Risk management, shared prophylaxis, actual exposure, events and denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Risk management, shared prophylaxis, actual exposure, events and denominators",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original thrombosis-event, prophylactic-exposure, deviation and group-specific denominator materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The original condition of mandatory prophylaxis in both groups because of thromboembolic risk is preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. The same safety is not applied to conditions without prophylaxis, and no prophylactic-drug instructions are given to readers. Thrombosis event counts and CI are absent from the summary.",
      "missingness": "The same safety is not applied to conditions without prophylaxis, and no prophylactic-drug instructions are given to readers. Thrombosis event counts and CI are absent from the summary.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "The same safety is not applied to conditions without prophylaxis, and no prophylactic-drug instructions are given to readers. Thrombosis event counts and CI are absent from the summary."
    },
    {
      "item_id": "N24",
      "question_type": "Supplementary harm evidence",
      "question": "Do gaps remain in other, rare or long-term harms and discontinuation?",
      "needed": "Original serious-event, discontinuation, exposure, follow-up and direct-harm materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original serious-event, discontinuation, exposure, follow-up and direct-harm materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain complete original safety tables, exposure, discontinuation, serious or rare-event and long-term materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The current preserved summary focuses on some grade 3 or worse harms and prophylaxis conditions.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. This summary does not newly establish all harms, discontinuations, long-term harms or safety.",
      "missingness": "This summary does not newly establish all harms, discontinuations, long-term harms or safety.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "This summary does not newly establish all harms, discontinuations, long-term harms or safety."
    },
    {
      "item_id": "N25",
      "question_type": "Supplementary harm evidence",
      "question": "Were effects or harms not generalized to other cancers, treatment lines or combinations?",
      "needed": "Direct comparative and safety materials by population, exposure and combination",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Direct comparative and safety materials by population, exposure and combination",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link direct materials on new populations or combinations to separate questions if provided.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The trial concerns add-on therapy in untreated high-expression stage IV pancreatic ductal adenocarcinoma with specified shared regimen and prophylaxis conditions.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Do not certify efficacy or harms for other cancers, treatment lines or prophylaxis conditions or create treatment or drug-substitution instructions.",
      "missingness": "Do not certify efficacy or harms for other cancers, treatment lines or prophylaxis conditions or create treatment or drug-substitution instructions.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not certify efficacy or harms for other cancers, treatment lines or prophylaxis conditions or create treatment or drug-substitution instructions."
    },
    {
      "item_id": "N26",
      "question_type": "Comparative efficacy",
      "question": "Were actual access to the preserved summary, external papers, registration and plans distinguished?",
      "needed": "Original source links, registration identifiers and material-specific reading states",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original source links, registration identifiers and material-specific reading states",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link materials acquired by the user to individual types and access states.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The entire parent preserved summary was read for production, and the original PubMed URL and NCT02715804 are preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. No new URL is created from registration identifiers. Abstracts, full texts, registration, protocol and SAP remain unread, and no separate external link tests were performed.",
      "missingness": "No new URL is created from registration identifiers. Abstracts, full texts, registration, protocol and SAP remain unread, and no separate external link tests were performed.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "No new URL is created from registration identifiers. Abstracts, full texts, registration, protocol and SAP remain unread, and no separate external link tests were performed."
    },
    {
      "item_id": "N27",
      "question_type": "Comparative efficacy",
      "question": "Were original dates, Korean and English drafts, false or missing values, empty values and verdict history preserved?",
      "needed": "Separate records of the complete preserved summary, subclaim verdict, parent values, corrections and history",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of the complete preserved summary, subclaim verdict, parent values, corrections and history",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link new materials or decisions to separate change events while preserving original text.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "The date 2026-08-26, empty correction and deliberation values, original Korean and English drafts, D34, false or missing axis values and empty values, and the true marker for failure of the primary endpoint with a positive secondary result are preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. Historical cross-checking is not used as current review completion. Absent subclaim scores are not filled with parent scores.",
      "missingness": "Historical cross-checking is not used as current review completion. Absent subclaim scores are not filled with parent scores.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Historical cross-checking is not used as current review completion. Absent subclaim scores are not filled with parent scores."
    },
    {
      "item_id": "N28",
      "question_type": "Comparative efficacy",
      "question": "Were production completion, incomplete existing-content review and independence status distinguished?",
      "needed": "Existing candidate history and current production or review states",
      "role": "Supplementary",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Existing candidate history and current production or review states",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Reflect only user-provided materials or decisions as separate events.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved summary",
      "acquired_read": "Summary read; external materials not read",
      "observation": "Original review-pending and production-eligibility markers and boundary-review requirements are preserved as history. Existing content review remains incomplete; activation and completion markers for model, content and boundary review are false.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials remain unread and existing content review remains incomplete. No new verdict, split or independence certification exists; new units are 0 and the final independent total is not recorded.",
      "missingness": "No new verdict, split or independence certification exists; new units are 0 and the final independent total is not recorded.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "No new verdict, split or independence certification exists; new units are 0 and the final independent total is not recorded."
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Van Cutsem E, Tempero MA, Sigal D, et al. Randomized Phase III Trial of Pegvorhyaluronidase Alfa With Nab-Paclitaxel Plus Gemcitabine for Patients With Hyaluronan-High Metastatic Pancreatic Adenocarcinoma. J Clin Oncol. 2020;38:3185-3194. PMID: 32706635.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/32706635/",
      "report_type": "HALO109-301 randomized phase 3 trial report",
      "existence": "Materials preserved in original citation and evidence lists",
      "acquired_read": "Summary read; external materials not read",
      "study_family": "F01",
      "independent_replication": false,
      "observed_result": "Median OS 11.2 versus 11.5 months; HR 1.00 (95% CI 0.80 to 1.27), P=.97; 330 deaths",
      "result_level": "Preserved-summary results; ORR is linked from the body, and original evidence-list OS values are not changed into ORR",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "local_summary",
          "public_status": "Original source link preserved",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Preserved parent verdict summary"
        },
        {
          "material_type": "abstract",
          "public_status": "Original source link preserved",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; a URL does not mean acquisition, reading or completed review"
        },
        {
          "material_type": "fulltext",
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          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; a URL does not mean acquisition, reading or completed review"
        },
        {
          "material_type": "registration",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External material unread; a URL does not mean acquisition, reading or completed review"
        },
        {
          "material_type": "protocol_sap",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
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          "as_of": "2026-08-26",
          "qualification": "External material unread; a URL does not mean acquisition, reading or completed review"
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/32706635/"
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      ]
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      "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
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      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
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      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
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      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
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      "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
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      "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
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    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "HALO109-301 shares the same report, original trial, cohort and two subclaim outcomes; OS, ORR and PFS are not counted as separate new trials. A study-family identifier links relationships and does not certify unique trial counts; reports, endpoints, sibling sheets and the same participants are not newly added as independent evidence."
  },
  "history": [
    {
      "date": "2026-10-11",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-11"
}