{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Aphios purified liquid ginger-extract capsules as add-on therapy × Reduction of acute nausea severity in the first 24 hours after chemotherapy",
  "language": "en",
  "translation_date": "2026-10-25",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "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": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "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": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "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": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "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": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "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": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.",
    "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.",
    "Review incomplete": "Review of existing content remains incomplete.",
    "Met": "The selected condition for material, identity or preservation was verified; this does not establish efficacy success or independent clinical validation.",
    "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.",
    "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.",
    "Not applicable": "Used only with an application exception and reason based on the question scope.",
    "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.",
    "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which add-on treatment and nausea question in the first 24 hours are covered?",
      "needed": "The same Aphios liquid product, adults with prior chemotherapy nausea, common antiemetics, carrier placebo and the NAv definition",
      "role": "Required",
      "role_reason": "Needed to keep formulation, population and acute NAv separate from other ginger efficacy questions.",
      "application_exception": "Do not turn dose-specific efficacy, delayed nausea or vomiting into the current main question.",
      "criterion": "Linkage of the original claim and intervention/population descriptions to the selected main question's intervention, population, timing, endpoint and comparator",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The original question boundary and corresponding trial eligibility criteria. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "How are the two reports and review references related?",
      "needed": "Paper/registration identifiers, related reports, included trials in reviews and endpoint-specific links",
      "role": "Required",
      "role_reason": "Needed to avoid counting the 2012 dose groups, 2024 report and review recitations as independent replications.",
      "application_exception": "Do not establish unique trial or participant counts from registration strings or report counts alone.",
      "criterion": "Report, registration and inclusion tables establishing unique trial identity and overlap/inclusion relationships",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Related Ryan/Crichton reports and review inclusion-trial mapping. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What was actually read, and what remains unread?",
      "needed": "Actual access, acquisition and reading histories for the stored summary, external papers/abstracts, registration and protocols",
      "role": "Required",
      "role_reason": "Needed to separate the stored-summary reading badge from unread external full text.",
      "application_exception": "Do not label external material that was never accessed as inaccessible or read.",
      "criterion": "Distinction between actual local inputs read, dates, locations and hashes, and external material not accessed or read",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Reading records, safe original-source links and subsequent acquisition records. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "How specific was the 2012 population with prior chemotherapy nausea?",
      "needed": "Prior chemotherapy nausea, adult cancer patients, cancer types/chemotherapy, baseline nausea, eligibility/exclusions and baseline risk",
      "role": "Required",
      "role_reason": "Needed to avoid extrapolation to populations with other chemotherapy nausea risks or antiemetic regimens.",
      "application_exception": "Do not fill in actual characteristics of the 2024 study population from the intervention/population description of this question.",
      "criterion": "Eligibility/exclusions, cancer types, chemotherapy, baseline nausea and group composition",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2012 recruitment/baseline table and cancer-type, chemotherapy and nausea-risk specifications. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What formulation were the Aphios liquid extract and carrier?",
      "needed": "Purified liquid extract, olive-oil carrier, capsules, source/ingredient assays, manufacturing and batches",
      "role": "Required",
      "role_reason": "Needed to distinguish root-equivalent amounts from standardized active-ingredient amounts or powder.",
      "application_exception": "Product and manufacturer names alone do not certify ingredient assays or matching batches.",
      "criterion": "Material on actual manufacturing, root-equivalent definitions and active ingredients/batches",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Aphios manufacturing specifications, ingredient assays, root-equivalent definitions and carrier composition. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "What was added to 5-HT3 antagonists and corticosteroids?",
      "needed": "Common antiemetics, matched carrier placebo, arm-specific antiemetic/rescue treatment, adherence and changes",
      "role": "Required",
      "role_reason": "Needed to avoid attributing standard antiemetic effects or arm-specific concomitant-treatment differences to ginger.",
      "application_exception": "Do not convert an add-on study into antiemetic replacement or a comparison of ginger alone.",
      "criterion": "Arm-specific specifications of common treatment, carrier placebo, rescue treatment and actual adherence/changes",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: 5-HT3/corticosteroid treatment, placebo ingredients, rescue antiemetics and group-specific changes. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What were the denominator, NAv and interval for the 0.5 g/day root-equivalent arm?",
      "needed": "Allocation/analysis/completion, NAv estimate, CI, cycles/visits and placebo contrast for the 0.5 g/day arm",
      "role": "Required (dose-composition verification)",
      "role_reason": "Needed to retain an original dose stratum without copying the pooled estimate into it.",
      "application_exception": "Do not use the overall −0.350 and 744/576 as this arm's effect or denominator.",
      "criterion": "Denominators, NAv results, intervals and comparison definitions explicitly attributable to the 0.5 g arm",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Results, flow, analysis specifications and the comparator CI for the 0.5 g arm. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What were the denominator, NAv and interval for the 1 g/day root-equivalent arm?",
      "needed": "Allocation/analysis/completion, NAv estimate, CI, cycles/visits and placebo contrast for the 1 g/day arm",
      "role": "Required (dose-composition verification)",
      "role_reason": "Needed to distinguish the original middle dose stratum from the pooled result.",
      "application_exception": "Do not use the overall −0.350 and 744/576 as this arm's effect or denominator.",
      "criterion": "Denominators, NAv results, intervals and comparison definitions explicitly attributable to the 1 g arm",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Results, flow, analysis specifications and the comparator CI for the 1 g arm. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What were the denominator, NAv and interval for the 1.5 g/day root-equivalent arm?",
      "needed": "Allocation/analysis/completion, NAv estimate, CI, cycles/visits and placebo contrast for the 1.5 g/day arm",
      "role": "Required (dose-composition verification)",
      "role_reason": "Needed to distinguish the original higher dose stratum from the pooled result.",
      "application_exception": "Do not use the overall −0.350 and 744/576 as this arm's effect or denominator.",
      "criterion": "Denominators, NAv results, intervals and comparison definitions explicitly attributable to the 1.5 g arm",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Results, flow, analysis specifications and the comparator CI for the 1.5 g arm. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Does the material answer direct differences among the three doses or optimal dose?",
      "needed": "Prespecified between-dose contrasts, interaction, multiple comparisons, arm-specific estimates and CIs",
      "role": "Supplementary; required for dose-superiority claims",
      "role_reason": "Needed to avoid extending pooled significance into efficacy of every dose or dose superiority.",
      "application_exception": "Do not force proof of an optimal dose as a requirement for the main pooled-NAv question.",
      "criterion": "Evidence for direct contrasts among the three doses, test plans, interactions and intervals",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Original dose-specific contrast tables, multiplicity plans and dose-response analyses. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What was the pre-chemotherapy start and two-cycle schedule?",
      "needed": "Root equivalent of 250 mg per active capsule, 2 daily doses, starting 3 days before chemotherapy, 6 days per cycle, 2 cycles and actual intake",
      "role": "Required",
      "role_reason": "Needed to avoid attributing differences in efficacy across formulations to timing/duration differences alone.",
      "application_exception": "A prescribed schedule does not prove actual intake, adherence or effects in each of the two cycles.",
      "criterion": "Records linking prescribed schedules and actual intake with chemotherapy and measurement dates",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Cycle-specific intake, chemotherapy dates and actual adherence/intake-frequency records. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What scale and visits define NAv in the first 24 hours?",
      "needed": "Mean evening/night day-one scores on a 7-point scale, baseline, change definition, measurement window and score direction",
      "role": "Required",
      "role_reason": "Needed to distinguish mean nausea intensity from vomiting events or proportions with severe nausea.",
      "application_exception": "Do not infer score direction, averaging rules or baseline visits absent from the original record.",
      "criterion": "Specifications of NAv, baseline, measurement window and averaging/change formulas",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Diaries, scale description, visit schedule and NAv calculation definitions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Can allocation and baseline balance in the 2012 dose-ranging trial be verified?",
      "needed": "Randomized/multicenter design, parallel/crossover structure, sequence generation/concealment and arm-specific baseline balance",
      "role": "Required",
      "role_reason": "Needed to avoid judging allocation procedures as problem-free from a randomized label alone.",
      "application_exception": "Do not replace unverified design details with crossover/cluster not-applicable labels.",
      "criterion": "Methods material on actual allocation/concealment, trial structure and baseline characteristics",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Methods, allocation procedures and arm-specific baseline tables. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "How were double blinding and nausea measurement performed?",
      "needed": "Participant/staff/assessor blinding, carrier/flavor matching, diary collection and group-specific measurement missingness",
      "role": "Required",
      "role_reason": "Needed to separate subjective nausea measurement/blinding conditions from effect magnitude.",
      "application_exception": "A double-blind label does not verify every measurement procedure or successful blinding.",
      "criterion": "Specifications of blinded parties, placebo matching, diary collection and measurement limitations",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Blinding/diary-collection methods, measurement-data quality and group-specific missingness. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What do 744 allocated and 576 analyzed represent?",
      "needed": "Roles of overall allocation, analysis, completion and withdrawal counts, arm-specific flow and original count definitions",
      "role": "Required",
      "role_reason": "Needed to avoid turning overall counts into dose-arm, individual-visit or completer denominators.",
      "application_exception": "Do not newly calculate the difference between 744 and 576 as withdrawals with established reasons or a harm denominator.",
      "criterion": "Material establishing each number's analysis/completion role and arm-specific participant flow",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Overall/group-specific allocation, analysis and completion flow with exclusion reasons. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What were NAv denominators for each cycle and evening/night visit?",
      "needed": "Dose-by-cycle-by-evening/night measurement/analysis denominators and repeated-measures structure",
      "role": "Required",
      "role_reason": "Needed to avoid reusing the overall 576 for all cycle/visit denominators.",
      "application_exception": "Do not count two cycles in the same people as two independent trials or add them into unique-participant totals.",
      "criterion": "Specifications of actual time/cycle-specific outcomes, denominators and repeated-measures handling",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Cycle/visit-specific NAv analysis tables and arm-specific measurement-completion specifications. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "How were missingness and intake deviations handled in the 2012 analysis?",
      "needed": "ITT/PP/completer status, missingness causes/handling, adherence, assignment/adherence effects and sensitivity",
      "role": "Required",
      "role_reason": "Needed to avoid establishing ITT or an adherence effect from the count of 576 analyzed alone.",
      "application_exception": "Do not automatically apply the 2024 ITT label to the 2012 analysis population.",
      "criterion": "Material on the estimand, analysis population, missingness/deviation handling and sensitivity",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2012 SAP, analysis-population/missingness/adherence and sensitivity specifications. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Which comparison, adjustment and pooled estimate does −0.350 points represent?",
      "needed": "The pooled-all-dose adjusted NAv change contrast, placebo comparison, baseline, model/covariates and cycle combination",
      "role": "Required",
      "role_reason": "Needed to distinguish an adjusted pooled value from individual-arm values, within-arm changes and unadjusted effects.",
      "application_exception": "Do not reconstruct pooling weights or models not explained in the original record.",
      "criterion": "Specifications of the target comparison, change/adjustment definition, dose pooling and original results",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Original result tables, adjustment model and contrast/cycle/weight specifications. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Can the exact 95% CI and an important nausea difference be interpreted?",
      "needed": "The exact CI, variance, denominator and clinical important-difference evidence for −0.350",
      "role": "Required",
      "role_reason": "Needed to avoid establishing precision or clinical importance from P values/sample size alone.",
      "application_exception": "Do not back-calculate a CI from P=.013 or adopt arbitrary importance differences/minimum sample sizes.",
      "criterion": "The selected pooled estimate's exact CI and justified importance criteria",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Exact CI/SE/variance, NAv clinical-importance evidence and original analysis tables. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What is the conflict between the paper and current registration's primary endpoint (1st in the hierarchy)?",
      "needed": "The historically reported hierarchy conflict, registration versions/timing, protocol/SAP and paper endpoints",
      "role": "Required",
      "role_reason": "Needed to avoid turning a reported registration-hierarchy conflict into successful new source comparison or established selective reporting.",
      "application_exception": "The recorded selected endpoint does not prove a registered primary endpoint (1st in the hierarchy).",
      "criterion": "Comparison establishing actual paper/registration endpoint definitions, timing and reasons for changes",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Timestamped registration versions, protocol, SAP and the paper's results section. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "What do NCT00040742 and an unverified registration status mean?",
      "needed": "The bibliographic NCT string, original registration-status value and actual verification/access level",
      "role": "Required",
      "role_reason": "Needed to distinguish a bibliographic identifier from reading the original registration.",
      "application_exception": "Do not change unverified status into unregistered status or absence of an NCT string.",
      "criterion": "Specifications of the registration identifier, external verification history and paper/registration family relationships",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Original NCT00040742 registration and report-linkage evidence. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What related material is the Crichton 2024 report?",
      "needed": "PMID37699474, DOI, report title, related registration/reports and unique trial family",
      "role": "Required (retaining related results)",
      "role_reason": "Needed to avoid counting a newer report as independent replication of the same Aphios formulation.",
      "application_exception": "A different report identifier does not certify matching formulation, population or estimand.",
      "criterion": "Linkage of this report's bibliography, related registration, intervention/endpoint and trial family",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2024 report, registration, protocol and related-report family table. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Is the standardized formulation with 84 mg active compounds the same as Aphios?",
      "needed": "Standardized ginger root powder, the 84 mg active-compound reference, manufacturing, composition, dose and start time",
      "role": "Required (distinguishing directness)",
      "role_reason": "Needed to distinguish root-equivalent grams from active-ingredient milligrams and formulation differences.",
      "application_exception": "Do not convert 84 mg into 0.5/1/1.5 g root equivalents or claim direct formulation superiority.",
      "criterion": "Actual 2024 ingredients, active/root amounts, dose and start schedule compared with Aphios conditions",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2024 composition, dose, intake/start-date material and manufacturing specifications for both formulations. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Were the 2024 population and concomitant treatment the same as the original question?",
      "needed": "The 2024 eligibility, cancer types/chemotherapy, prior nausea, baseline risk and background antiemetic/rescue treatment",
      "role": "Required (applicability differences)",
      "role_reason": "Needed to avoid transferring the 2012 target population/intervention description into actual 2024 eligibility information.",
      "application_exception": "Absent 2024 population details do not establish that it was a different population.",
      "criterion": "Material comparing the actual 2024 population and arm-specific common treatment/changes with the original question",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2024 recruitment/baseline characteristics and chemotherapy, antiemetic and rescue-treatment specifications. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Which analysis do 103 participants and 52 versus 51 represent?",
      "needed": "Allocation/analysis/completion roles, arm mapping, acute-CINV/QoL/cycle-specific denominators and ITT handling",
      "role": "Required (verifying related analyses)",
      "role_reason": "Needed to avoid converting overall/group counts into denominators for a specific acute-NAv analysis.",
      "application_exception": "Do not infer ginger/placebo mapping for 52/51 or NAv analysis denominators.",
      "criterion": "Material establishing the roles of 103/52/51, outcome/time-specific analysis denominators and ITT handling",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2024 flow diagram, endpoint-specific denominators, arm mapping and ITT/missingness specifications. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "How are primary QoL (1st) and secondary acute CINV (2nd) distinguished?",
      "needed": "Nausea-related QoL as primary (1st), acute CINV as secondary (2nd), registration/analysis plans and definitions/timing",
      "role": "Required (endpoint attribution)",
      "role_reason": "Needed to avoid turning secondary acute CINV (2nd) into success/failure of the representative primary NAv endpoint (1st).",
      "application_exception": "The hierarchy in the retained report is not a current verification of original registration content.",
      "criterion": "Specifications of QoL/CINV definitions, hierarchy, plans and actual results",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2024 registration/protocol, endpoint table and CINV definitions/timing. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What comparison underlies the report of no acute-CINV effect?",
      "needed": "ITT, Bonferroni adjustment, acute-CINV estimate/CI, scale/denominators and differences from the original NAv question",
      "role": "Required (retaining contrary results)",
      "role_reason": "Needed to avoid deleting a recent null report or changing it into an effect of 0 for NAv with the same formulation.",
      "application_exception": "Retain no-effect wording as a report in the original record; do not extend it to proof of equivalence or noninferiority.",
      "criterion": "Adjusted acute-CINV effects/intervals, target comparison and differences from the NAv question",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Acute-CINV result tables, multiplicity/ITT specifications and exact CIs. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Where do positive delayed-nausea and quality-of-life findings belong?",
      "needed": "Delayed-nausea/QoL definitions, timing, denominators, effects/CIs and outcomes separate from acute NAv",
      "role": "Required (outcome boundaries)",
      "role_reason": "Needed to avoid transferring positive findings from other time windows/outcomes into NAv benefit within the first 24 hours.",
      "application_exception": "Retain positive findings for their own outcomes without erasing gaps in the current question.",
      "criterion": "Definitions/timing, effects and intervals attributable separately to delayed nausea and QoL",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2024 delayed-nausea/QoL result tables and analysis/visit-specific denominators. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "What are the bibliographies and included trials of reviews from 2019–2025?",
      "needed": "Each review's exact bibliography, search criteria, included trials, overlapping families and endpoint-contribution tables",
      "role": "Required (verifying synthesis context)",
      "role_reason": "Needed to avoid converting mentions of multiple years into unique review/trial counts or independent replications.",
      "application_exception": "Do not invent review identities outside the 2 original research/bibliographic entries or add their counts.",
      "criterion": "Exact bibliographies of the mentioned reviews, original included trials/endpoint contributions and overlap",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2019–2025 review bibliographies, inclusion tables, correction/search criteria and endpoint-specific material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Do severe acute-nausea or acute-vomiting signals answer NAv?",
      "needed": "Grade 3 nausea or vomiting, definitions/scales/timing, denominators, effects/CIs and differences from NAv",
      "role": "Required (limiting extensions)",
      "role_reason": "Needed to distinguish severity-subgroup and vomiting signals from effects on mean nausea intensity.",
      "application_exception": "Retain other-endpoint signals without substituting them for first 24 hours NAv success.",
      "criterion": "Material distinguishing review suboutcomes' endpoints, severity and measures from the original NAv definition",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Review subgroup-result tables, severity definitions and contributing trials/denominators. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "How far are NCI support and Aphios manufacturing verified?",
      "needed": "Support, product supply, manufacturing, employee authors/patents, declared COI and institutions/research teams",
      "role": "Required (independence claims)",
      "role_reason": "Needed to avoid inferring absent product support or author conflicts from NCI support alone.",
      "application_exception": "Do not inherit the original I2 or independent-support wording as current certification of independence.",
      "criterion": "Separate actual disclosures of funding, manufacturing, product supply, employment/patents and COI",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2012 funding/acknowledgments, affiliations/COI and Aphios product-supply specifications. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "How far are nongovernment support and author COI verified?",
      "needed": "Funding institutions, product supply, employment/patents, declared COI and original-trial funding/independence",
      "role": "Required (related independence)",
      "role_reason": "Needed to avoid changing nongovernment support into absence of conflicts or independent funding.",
      "application_exception": "Historical wording that COI was checked separately does not establish reading the original declarations in this preparation.",
      "criterion": "Actual 2024 support/supply, affiliations/patents and disclosed relationships",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The 2024 funding, product/author relationships and original COI text. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Were gastrointestinal discomfort and other harms actually collected as events?",
      "needed": "Arm-specific event definitions, collection methods, severity, discontinuation, follow-up missingness and reporting scope",
      "role": "Supplementary; required for safety questions",
      "role_reason": "Needed to avoid turning existing caution advice into event counts verified in a trial.",
      "application_exception": "Caution wording alone does not establish absence of harm reporting throughout every paper.",
      "criterion": "Actual specifications of harm events/collection, severity, missingness and discontinuation",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Each trial's adverse-event definitions, collection methods, group-specific tables and discontinuation records. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "What were the arm-specific harm-event counts and exposure denominators?",
      "needed": "People/events with harms, exposure/follow-up time, arm-specific denominators and actual comparisons",
      "role": "Supplementary; required for frequency/comparative-harm questions",
      "role_reason": "Needed to avoid reusing 744/576 or 103/52/51 as harm denominators.",
      "application_exception": "Do not convert unverified comparisons/denominators into 0 events or safety.",
      "criterion": "Specifications of arm-specific harm counts, exposure time, denominators and comparative estimates",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Adverse-event analysis populations, exposure time, arm mapping and event/discontinuation tables. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "Do anticoagulant/antiplatelet cautions describe observed interactions?",
      "needed": "Concomitant drugs, chemotherapy/antiemetics, interaction cases/denominators, alternative causes and original caution advice",
      "role": "Supplementary; required for interaction claims",
      "role_reason": "Needed to distinguish a possibility warning from an actual causal interaction.",
      "application_exception": "Do not use caution wording as a finding that bleeding or interactions actually occurred during coadministration.",
      "criterion": "Material on concurrent drugs/events, comparisons, alternative explanations and the original caution's basis",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Concomitant-drug specifications, actual interaction/event records and original safety evidence. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "Are intake, event onset, recovery and re-exposure linked?",
      "needed": "Actual event onset/recovery, withdrawal/re-exposure, exposure dates, latency and alternative causes",
      "role": "Supplementary; required for causal-harm claims",
      "role_reason": "Needed to avoid constructing harm timing or causality from pre-chemotherapy administration alone.",
      "application_exception": "Do not infer improvement after withdrawal or worsening on re-exposure without an event timeline.",
      "criterion": "Timeline material establishing events/exposure, withdrawal/recovery and alternative causes",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Actual adverse-event timing, withdrawal/re-exposure and clinical-course records. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "What harms and special populations are covered beyond two cycles?",
      "needed": "Long-term/rare events, other concomitant drugs/baseline risks, vulnerable populations and follow-up duration",
      "role": "Supplementary; required for scope extensions",
      "role_reason": "Needed to avoid extending limited cycles/populations into overall safety.",
      "application_exception": "Do not force all rare-harm studies as requirements of the first 24 hours NAv question.",
      "criterion": "Exposure, follow-up and event data directly attributable to long-term/rare harms or vulnerable populations",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Safety follow-up and exposure/event specifications by duration, concomitant treatment and population. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "Are reports of the same harm unique replications?",
      "needed": "Unique cases, report families, matching exposure/events, recitations and contrary records",
      "role": "Supplementary; required for repeated-signal questions",
      "role_reason": "Needed to avoid counting shared caution wording or recitations of the same case as independent harm repetition.",
      "application_exception": "The presence of 2 efficacy reports does not prove 2 occurrences of the same harm event.",
      "criterion": "Specifications establishing unique event/report families and recitation relationships",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Related original harm material, case-family tables and recitation/regulatory sources. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "What are the historical evidence dates and scope of the retained review?",
      "needed": "Original verdict date, correction date, actual review/reading scope, new searches and registration/retraction verification",
      "role": "Required",
      "role_reason": "Needed to avoid overstating this conversion as exhaustive review of current literature/publication status.",
      "application_exception": "Do not reuse 2026-09-08 or 2026-09-14 as full-text reading dates for this work.",
      "criterion": "Linkage of original dates, materials used and reading scope, no new search and the scope of statements about missing evidence",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The current original record/correction history and receipt of actual review scope. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "How are generic English and the historical correction of 2 items preserved?",
      "needed": "Specific Korean values, retained English wording, complete correction history, revised-text/field comparisons and current original identity",
      "role": "Required (original-text identity)",
      "role_reason": "Needed to avoid using a historical correction report as evidence of current specific English wording or clinical validation.",
      "application_exception": "Do not overwrite retained original English evidence or record new corrections merely because a reader translation is prepared.",
      "criterion": "Exact preservation of current Korean/English originals and the historical correction report at their respective locations",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Original correction specifications, revised originals and current original/field mapping. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N41",
      "question_type": "Evidence condition",
      "question": "Were C50, axes, empty values and historical verification wording preserved?",
      "needed": "Original grade/score/safety, axes, false/empty values, the additional detailed-claim list, existing URLs and historical cross-check wording",
      "role": "Required (preserving original text)",
      "role_reason": "Needed to avoid inheriting previous evaluations as newly met conditions or current independent certification.",
      "application_exception": "Do not fill EX/CX, false axes or empty review records with new values or favorable judgments.",
      "criterion": "Separation of original complete values, identity, Korean/English and historical verification wording from generation of new judgments/scores",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions are linked to the selected Aphios add-on and acute mean-nausea question. They do not establish preregistration, official assessment-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Original stored summary, current original selection and text-identity/history material. This records needed materials; no new research was executed."
    }
  ]
}