{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3048-main", "verdict_number": "3048", "title": "Aphios purified liquid ginger-extract capsules as add-on therapy × Reduction of acute nausea severity in the first 24 hours after chemotherapy", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": "2026-10-06T09:33:39.802275+09:00", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific conditions/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, "claim_context": { "population": "Adults with prior chemotherapy nausea; the question retains 5-HT3 antagonists plus corticosteroids.", "intervention": "Oral add-on Aphios purified liquid ginger extract in olive-oil carrier capsules derived from Zingiber officinale Roscoe rhizome. Ingredient assays, batches and manufacturing details remain unverified.", "dose": "A 250 mg root equivalent per active capsule; 0.5, 1 and 1.5 g/day root equivalents, taken 2 times daily. Root-equivalent and active-ingredient amounts are not converted.", "comparator": "The same antiemetics plus carrier-matched placebo. Actual arm-specific concomitant/rescue treatment, adherence and changes remain unverified.", "endpoint": "Change in mean evening/night day-one NAv on a 7-point scale within the first 24 hours. The adjusted pooled change contrast is not converted into individual-dose effects, within-arm changes or other endpoints.", "duration": "For 6 days per chemotherapy cycle, starting 3 days before chemotherapy, over 2 cycles. Actual cycle/visit-specific exposure and denominators remain unverified.", "excluded_extensions": [ "Stopping/replacing standard antiemetics or effects of ginger alone", "Extending pooled results to individual-dose efficacy, optimal dose or dose superiority", "Equivalent conversion or direct superiority claims between the standardized 84 mg active-compound formulation and root-equivalent amounts", "Substituting delayed nausea, vomiting, grade 3 nausea or quality of life for mean NAv in the first 24 hours", "Establishing overall efficacy/safety for long-term exposure, rare events or vulnerable populations" ] }, "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original claim is reduced acute nausea severity in the first 24 hours after chemotherapy. Aphios purified liquid extract in olive-oil carrier capsules is added to existing 5-HT3 plus corticosteroid treatment and compared with carrier-matched placebo; the selected outcome is the mean evening/night day-one score on a 7-point NAv scale. The three doses remain within the same pooled comparison.", "condition_status": "Met", "status_reason": "The original question and its boundaries are directly linked; this verifies question identity, without proving efficacy or confirming each dose's effect.", "missingness": "The additional detailed-claim list is empty; independent dose-specific efficacy claims are absent from the current original wording.", "uncertainty": "Question identity and sufficient results are separate matters.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original question boundary and corresponding trial eligibility criteria" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 2 retained report summaries and 2 bibliographies describe the 2012 Ryan/URCC CCOP dose-ranging trial and the 2024 Crichton standardized-formulation trial. Reviews from 2019–2025 are mentioned in the narrative, but individual bibliographies and inclusion tables are absent.", "condition_status": "Partly verified", "status_reason": "Report links are retained, but external originals needed to establish overlap among unique trials, related reports and review inclusions are unavailable.", "missingness": "The 2 reports do not establish 2 unique studies or 2 independent replications.", "uncertainty": "Related registration, repeat reports of the same participants and overlap of included trials remain unverified.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Related Ryan/Crichton reports and review inclusion-trial mapping" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Actual reading in the retained preparation covered the complete stored summary for case 3048. The two papers were linked through PubMed bibliographies; external abstracts, full texts, registration and plans were neither accessed nor read. The 5 local method HTML files were checked only through whole-byte copying/hashes; their full contents were not reread.", "condition_status": "Met", "status_reason": "Stored-summary reading, unread external material, no access attempt and link presence are separated. This does not establish completed clinical validation of material content.", "missingness": "External full text, registration, protocols and original disclosures remain unread/unacquired; no failed access attempt occurred.", "uncertainty": "Historical verdict dates or verification wording do not prove the reading level in this preparation.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Reading records, safe original-source links and subsequent acquisition records" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original population is adults with prior chemotherapy nausea who continued common 5-HT3 antagonists plus corticosteroids. This stored summary lacks details on cancer types, chemotherapy, eligibility/exclusions and arm-specific baseline nausea risk.", "condition_status": "Partly verified", "status_reason": "The population definition is known, but tables establishing the scope of actual recruitment and baseline characteristics are unavailable.", "missingness": "Detailed recruitment/baseline information is unrecorded in the specified stored summary; this does not mean it was unreported throughout the paper.", "uncertainty": "Applicability of the same result to other cancer types, chemotherapy regimens and nausea-risk populations remains unverified.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2012 recruitment/baseline table and cancer-type, chemotherapy and nausea-risk specifications" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original intervention is Aphios purified liquid ginger extract in olive-oil carrier capsules, given orally as an add-on and derived from Zingiber officinale Roscoe rhizome. The retained report names Aphios manufacturing but lacks batch-specific active-ingredient, assay and purification specifications.", "condition_status": "Partly verified", "status_reason": "Formulation/source names are identified, but root-equivalent definitions and reproducibility of active ingredients/manufacturing batches cannot be established from the summary alone.", "missingness": "Root-equivalent definitions, gingerol/shogaol assays and manufacturing/batch test certificates remain unverified.", "uncertainty": "This does not establish equivalence or superiority to powder or the standardized 84 mg formulation.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Aphios manufacturing specifications, ingredient assays, root-equivalent definitions and carrier composition" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original question compares the same antiemetics plus carrier-matched placebo. Ginger is added to background 5-HT3 antagonists and corticosteroids in both arms. Actual arm-specific antiemetic types/doses, rescue treatment, adherence and changes remain unverified.", "condition_status": "Partly verified", "status_reason": "Common treatment, added ingredient and placebo are separated, but actual arm-specific concomitant treatment/deviations are unspecified.", "missingness": "Details of rescue antiemetics, actual adherence/changes and placebo ingredients are unrecorded.", "uncertainty": "Do not interpret an add-on as replacement of standard antiemetics or an effect of ginger alone.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "5-HT3/corticosteroid treatment, placebo ingredients, rescue antiemetics and group-specific changes" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original dose list includes 0.5 g/day root equivalents. This arm's allocation/analysis/completion, NAv effect, 95% CI, cycle/visit-specific denominators and placebo contrast are not established in the stored summary.", "condition_status": "Unverified", "status_reason": "Presence of a dose differs from verification of its arm-specific results/denominators. The pooled −0.350 points and 744/576 were not copied into this arm.", "missingness": "The 0.5 g arm's own denominators, effects, CIs and time-specific contrasts all remain unverified.", "uncertainty": "A positive pooled signal does not establish an effect for the 0.5 g arm or an optimal dose.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Results, flow, analysis specifications and the comparator CI for the 0.5 g arm" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original dose list includes 1 g/day root equivalents. This arm's allocation/analysis/completion, NAv effect, 95% CI, cycle/visit-specific denominators and placebo contrast are not established in the stored summary.", "condition_status": "Unverified", "status_reason": "The middle dose has no individual estimate; pooled results were not substituted for its results.", "missingness": "The 1 g arm's own denominators, effects, CIs and time-specific contrasts all remain unverified.", "uncertainty": "Significance in another dose or pooled comparison does not prove an individual effect in the 1 g arm.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Results, flow, analysis specifications and the comparator CI for the 1 g arm" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original dose list includes 1.5 g/day root equivalents. This arm's allocation/analysis/completion, NAv effect, 95% CI, cycle/visit-specific denominators and placebo contrast are not established in the stored summary.", "condition_status": "Unverified", "status_reason": "The higher dose has no individual estimate; pooled results were not substituted for its results.", "missingness": "The 1.5 g arm's own denominators, effects, CIs and time-specific contrasts all remain unverified.", "uncertainty": "A higher listed dose alone does not establish greater efficacy or dose superiority.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Results, flow, analysis specifications and the comparator CI for the 1.5 g arm" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 2012 report is a randomized multicenter dose-ranging trial; the three-dose list and overall pooled result are retained. Direct between-dose effect differences, CIs, interactions/prespecified contrasts and multiple-comparison specifications are absent.", "condition_status": "Unverified", "status_reason": "A dose-ranging title does not replace verification of direct superiority estimates or optimal-dose results.", "missingness": "Direct 0.5 versus 1 versus 1.5 g comparisons/interactions, intervals and plans remain unverified.", "uncertainty": "This supplementary gap does not justify splitting the main pooled question into three efficacy tables.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original dose-specific contrast tables, multiplicity plans and dose-response analyses" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The intervention description records 250 mg root equivalent per active capsule, 2 daily doses, starting 3 days before chemotherapy, 6 days in each cycle and two cycles. Actual cycle-specific intake, adherence and chemotherapy/measurement dates are not established in detail.", "condition_status": "Partly verified", "status_reason": "The original planned exposure schedule is identified, but concordance of actual intake and timing cannot be established from this input alone.", "missingness": "Medication diaries, actual exposure/visits and cycle-specific adherence remain unverified.", "uncertainty": "Do not extend the 6-day cycle schedule and 2 cycles into delayed/long-term persistence or independent replication in individual cycles.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Cycle-specific intake, chemotherapy dates and actual adherence/intake-frequency records" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The selected endpoint is change in mean evening/night day-one NAv on a 7-point scale; the original claim concerns acute nausea intensity within the first 24 hours. Baseline, averaging rules, score direction and diary definitions are not specified in detail in the retained summary.", "condition_status": "Partly verified", "status_reason": "Scale/time labels and the mean-change definition are present, but actual baseline, measurement and calculation specifications are absent.", "missingness": "NAv baseline visit, detailed time window, score direction and calculation rules remain unverified.", "uncertainty": "Mean 7-point NAv, proportions with severe acute nausea and vomiting events are different outcomes.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Diaries, scale description, visit schedule and NAv calculation definitions" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 2012 design is a randomized double-blind multicenter dose-ranging trial. Details of sequence generation/concealment, parallel/crossover/cluster structure and arm-specific baseline balance are absent from the summary.", "condition_status": "Partly verified", "status_reason": "The RCT title is retained without substituting it for verification of actual allocation, structure or baseline balance.", "missingness": "Allocation/concealment, detailed design and baseline tables remain unverified; they are not recast as not applicable.", "uncertainty": "This work does not newly judge allocation procedures as problematic or problem-free.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Methods, allocation procedures and arm-specific baseline tables" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 2012 report names double blinding; the original question uses carrier-matched placebo and subjective NAv measurement. Blinded parties/success, diary collection, flavor matching and group-specific measurement missingness remain unverified.", "condition_status": "Partly verified", "status_reason": "The double-blind label is separated from actual nausea measurement conditions, without claiming verification of all procedures.", "missingness": "Actual blinding/diary collection and group-specific measurement limitations remain unverified.", "uncertainty": "This input does not establish how far measurement differences explain the actual result.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Blinding/diary-collection methods, measurement-data quality and group-specific missingness" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 2012 counts are 744 randomized and 576 analyzed. Completion counts, group/cycle-specific denominator roles and exclusion/withdrawal reasons are not recorded in detail.", "condition_status": "Partly verified", "status_reason": "The allocation/analysis roles of the original numbers are retained, but 576 is not established as a completer, arm-specific, visit-specific or harm denominator.", "missingness": "Arm-specific allocation/completion/analysis, exclusion reasons and the actual analysis population remain unverified.", "uncertainty": "Do not newly calculate count differences as withdrawal causes or event counts.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Overall/group-specific allocation, analysis and completion flow with exclusion reasons" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original schedule has two chemotherapy cycles, with mean evening/night day-one NAv as the outcome. Actual measured/analyzed denominators by dose, cycle and visit and specifications for combining repeated measurements are absent from the stored summary.", "condition_status": "Unverified", "status_reason": "This outcome unit remains unverified because the overall 576 cannot be copied into each cycle and evening/night denominator.", "missingness": "Cycle/visit/dose-specific denominators and repeated-measures handling remain unverified.", "uncertainty": "Do not add two cycles in the same people as independent trials or unique participants.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Cycle/visit-specific NAv analysis tables and arm-specific measurement-completion specifications" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 2012 summary reports limited completion data and 576 analyzed participants. ITT/PP/completer definitions, missingness/adherence handling, rescue treatment and sensitivity analyses are not recorded in detail.", "condition_status": "Unverified", "status_reason": "The 2012 estimand and missingness handling are unavailable, so the 2024 ITT label was not inherited by the 2012 analysis.", "missingness": "The 2012 analysis population, missingness causes/imputation/sensitivity and intake-deviation handling remain unverified.", "uncertainty": "Limited completion data do not establish a new missingness-effect magnitude or validity judgment.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2012 SAP, analysis-population/missingness/adherence and sensitivity specifications" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 2012 result is the pooled-all-dose adjusted NAv change contrast of −0.350 points, P=.013, with exact 95% CI retained as unverified. Detailed comparison, adjustment, baseline and cycle-combination model specifications are absent.", "condition_status": "Partly verified", "status_reason": "The selected pooled result is explicit in the retained record, but complete specifications of the target comparison, adjustment variables and pooling are absent.", "missingness": "The model, covariates, dose/cycle pooling weights and baseline remain unverified.", "uncertainty": "Do not substitute individual-dose effects, within-arm change or an unadjusted difference, or calculate a new effect.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original result tables, adjustment model and contrast/cycle/weight specifications" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original record reports a pooled −0.350 points, P=.013, and explicitly leaves the exact 95% CI unverified. Variance and criteria for a clinically important NAv difference are absent from this input.", "condition_status": "Unverified", "status_reason": "P values and a large overall sample do not establish the CI or clinical importance; no back-calculation was performed.", "missingness": "The selected estimate's exact CI, variance and importance criteria remain unverified.", "uncertainty": "Do not newly grade an effect as present/absent or set arbitrary minimum sample sizes or important differences.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact CI/SE/variance, NAv clinical-importance evidence and original analysis tables" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original answer/grade explanation reports a conflict between the paper and current registration's primary endpoint (1st in the hierarchy). The actual endpoint wordings, registration versions/timing and protocol/SAP were not read in the retained preparation.", "condition_status": "Partly verified", "status_reason": "The historical report of a conflict is retained without labeling current independent original-source comparison as successful or selective reporting as established.", "missingness": "Comparison of actual paper/registration endpoint wording, timing and change reasons was not performed.", "uncertainty": "The recorded selected endpoint does not establish the representative NAv as the registered primary endpoint (1st in the hierarchy).", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Timestamped registration versions, protocol, SAP and the paper's results section" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original registration status is unverified, while the bibliography contains NCT00040742. Both original values are retained; the registration text remains unread, with no access attempt.", "condition_status": "Partly verified", "status_reason": "A bibliographic identifier string differs from actual registration verification; the original registration-status field was not automatically corrected.", "missingness": "Original registration, related trial family and versions were not verified; this does not mean unregistered.", "uncertainty": "Do not turn the difference between the fields into a new conclusion that the registration is absent or wrong.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original NCT00040742 registration and report-linkage evidence" }, { "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.", "current_reports": [ "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 2024 title and Crichton J Acad Nutr Diet bibliography, PMID37699474 and DOI10.1016/j.jand.2023.09.003 are retained. External reports, registration and related families were not read in this preparation.", "condition_status": "Partly verified", "status_reason": "A related report's identity is linked to the original bibliography, but material certifying independent replication of the same formulation/population/endpoint is unavailable.", "missingness": "Related registration/reports, unique trial family and participant relationships remain unverified.", "uncertainty": "Separate bibliographies are not labeled independent replication of the same Aphios formulation.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2024 report, registration, protocol and related-report family table" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 2024 report title describes standardized ginger root powder, and the retained research explanation mentions a standardized trial with 84 mg active compounds. The original crux retains differences in timing and active-compound amounts. These were not converted into equivalent Aphios root-equivalent grams.", "condition_status": "Partly verified", "status_reason": "Formulation differences and the 84 mg reference are identified, but detailed 2024 manufacturing, root amounts, dose and start schedule are unavailable.", "missingness": "The 2024 composition/root-equivalent amount, actual dose/start time and manufacturing batches remain unverified.", "uncertainty": "Do not convert 84 mg active compounds into 0.5/1/1.5 g root equivalents or direct formulation superiority.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2024 composition, dose, intake/start-date material and manufacturing specifications for both formulations" }, { "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.", "current_reports": [ "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Adults with prior chemotherapy nausea and 5-HT3 plus corticosteroids in the retained intervention/population description define the original question. The 2024 summary describes a multicenter ITT trial but lacks exact recruitment/baseline and background/rescue-treatment details.", "condition_status": "Unverified", "status_reason": "The original question's population/treatment cannot be automatically inserted as actual 2024 study information.", "missingness": "The 2024 eligibility, cancer types/chemotherapy, prior nausea/baseline risk and arm-specific concomitant/rescue treatment remain unverified.", "uncertainty": "Unverified information establishes neither identical nor different populations across the trials.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2024 recruitment/baseline characteristics and chemotherapy, antiemetic and rescue-treatment specifications" }, { "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.", "current_reports": [ "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 2024 counts are 103 participants, 52 versus 51, and the design is an ITT randomized multicenter trial. Detailed allocation/analysis/completion roles, arm mapping and acute-CINV/QoL/visit-specific denominators are absent.", "condition_status": "Partly verified", "status_reason": "Overall/arm counts and the ITT label are retained without establishing them as specific acute-NAv denominators or arm-specific event counts.", "missingness": "Arm mapping for 52/51, endpoint/time-specific denominators and missing-data handling remain unverified.", "uncertainty": "Do not recalculate separate effects, events or withdrawals from these counts or add them to 744/576.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2024 flow diagram, endpoint-specific denominators, arm mapping and ITT/missingness specifications" }, { "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.", "current_reports": [ "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 2024 endpoint hierarchy has nausea-related quality of life as primary (1st) and acute CINV as secondary (2nd). Actual registration/protocol, QoL/CINV scales, timing and multiplicity plans were not read in this preparation.", "condition_status": "Partly verified", "status_reason": "The retained primary/secondary hierarchy is maintained without claiming external registration verification or identity with the representative NAv primary endpoint (1st).", "missingness": "Actual QoL/CINV definitions, registration/plans, measurement windows and multiplicity comparisons remain unverified.", "uncertainty": "Do not substitute another endpoint's hierarchy for the current NAv registration hierarchy.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2024 registration/protocol, endpoint table and CINV definitions/timing" }, { "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.", "current_reports": [ "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original 2024 result reports no acute-CINV effect, and its retained explanation reports null acute CINV after ITT and Bonferroni adjustment. Exact estimates/CIs, scales and denominators are absent from this summary.", "condition_status": "Partly verified", "status_reason": "The contrary/null report is retained, but it concerns another standardized formulation and CINV definition; it is not used as proof of an Aphios NAv effect of 0 or equivalence.", "missingness": "Exact acute-CINV effects/intervals, definitions, denominators and multiplicity details remain unverified.", "uncertainty": "No effect is wording in the original record, not a new judgment of magnitude 0, equivalence or absence of all ginger effects.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Acute-CINV result tables, multiplicity/ITT specifications and exact CIs" }, { "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.", "current_reports": [ "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 2024 results report positive delayed-nausea and quality-of-life findings. The retained scope/advertising-interpretation explanation separates delayed nausea, vomiting and QoL from nausea results in the first 24 hours.", "condition_status": "Partly verified", "status_reason": "Positive findings at other times/for other outcomes are retained, but exact definitions, effects/CIs, duration and denominators are absent.", "missingness": "Individual delayed-nausea/QoL effects, definitions, timing, denominators and CIs remain unverified.", "uncertainty": "Do not use these positive reports to fill gaps in first 24 hours mean NAv or claim replacement of standard antiemetics.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2024 delayed-nausea/QoL result tables and analysis/visit-specific denominators" }, { "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.", "current_reports": [], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained research explanation reports comparisons of systematic reviews from 2019~2025. The current research/bibliography summaries contain only two individual-trial reports, without exact review bibliographies or inclusion/endpoint-contribution tables.", "condition_status": "Unverified", "status_reason": "No actual identifiers/inclusion specifications trace these synthesis references, so review counts, unique trials and overlap are not established.", "missingness": "Each review's identity, search scope, included trials, overlap/endpoint contributions and corrections remain unverified.", "uncertainty": "No search or unverified bibliography does not mean no reviews or 0 human studies.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2019–2025 review bibliographies, inclusion tables, correction/search criteria and endpoint-specific material" }, { "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.", "current_reports": [], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original counterview reports severe acute-nausea or acute-vomiting subgroup signals in recent reviews; the English counterview specifies grade 3 acute nausea/acute vomiting. The original record states that these scale/severity definitions differ from the representative mean NAv.", "condition_status": "Partly verified", "status_reason": "Other-endpoint signals are retained, but exact bibliographies, contributing trials/denominators and estimates/CIs are unavailable, so they cannot be combined as the same NAv effect.", "missingness": "Subgroup definitions, bibliographies, trial contributions/denominators and effects/CIs remain unverified.", "uncertainty": "Do not substitute acute vomiting or grade 3 nausea for reduced mean NAv.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Review subgroup-result tables, severity definitions and contributing trials/denominators" }, { "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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 2012 funding description states NCI support and Aphios manufacturing, and the original grade explanation cites independent NCI support as a strength. Details of product supply, employee authors, patents and actual COI declarations are not established in the stored summary.", "condition_status": "Partly verified", "status_reason": "Funding/manufacturing reports are retained without claiming that NCI support excludes all conflicts or completes current independence verification.", "missingness": "Original specifications of product supply, author employment/patents, declared COI and team independence remain unverified.", "uncertainty": "Historical I2 and independent-support wording do not establish new table independence or absence of bias.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2012 funding/acknowledgments, affiliations/COI and Aphios product-supply specifications" }, { "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.", "current_reports": [ "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 2024 funding description states nongovernment research support and separately checked author COI. This input lacks details of the supporting institutions, product supply, author employment/patents and declarations compared.", "condition_status": "Partly verified", "status_reason": "The historical separately-checked wording is retained as an original report, without upgrading it to current disclosure verification, absence of conflicts or independent funding.", "missingness": "Funding institutions, product/author/patent relationships and actual COI text remain unverified.", "uncertainty": "A nongovernment funding category alone does not establish result independence or absence of bias.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2024 funding, product/author relationships and original COI text" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original safety description provides caution about gastrointestinal discomfort and possible anticoagulant/antiplatelet interactions. The two report summaries lack actual group-specific specifications of harm-event definitions, collection/severity, discontinuation and missingness.", "condition_status": "Unverified", "status_reason": "Caution advice and actually observed harm events/systematic collection are different levels; event counts or completed collection are not claimed.", "missingness": "Actual harm collection, definitions, severity and discontinuation are unrecorded within the summary read; this does not mean they were unreported throughout the papers.", "uncertainty": "Do not change unverified harms into 0, no harm or established safety.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Each trial's adverse-event definitions, collection methods, group-specific tables and discontinuation records" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The trials provide efficacy/study counts of 744 allocated and 576 analyzed, and 103 participants with 52 versus 51. Actual harm events, exposure/follow-up time, harm denominators and arm-specific comparisons are absent from the retained material.", "condition_status": "Unverified", "status_reason": "Efficacy denominators were not reused as harm denominators, and event counts, incidence and relative risks were not calculated.", "missingness": "Harm-arm mapping, people/event counts, exposure time, denominators and comparative estimates remain unverified.", "uncertainty": "Study totals or 2 reports do not establish event frequencies or comparative risks.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event analysis populations, exposure time, arm mapping and event/discontinuation tables" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original safety advice says to discuss possible anticoagulant/antiplatelet interactions with the oncology team. Common chemotherapy/antiemetics, actual anticoagulant/antiplatelet exposure/events and alternative causes are not established in detail.", "condition_status": "Partly verified", "status_reason": "The retained caution is identified, but actual interaction cases, comparisons/denominators or causal proof are absent from this material.", "missingness": "Concomitant drugs/events, alternative causes and original interaction evidence remain unverified.", "uncertainty": "Do not change a possible-risk caution into observed bleeding/interactions or newly issue personal medication instructions.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant-drug specifications, actual interaction/event records and original safety evidence" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original schedule starts 3 days before chemotherapy and lasts 6 days per cycle for 2 cycles. This input lacks actual timelines of harm onset, recovery, withdrawal/re-exposure, latency or alternative causes.", "condition_status": "Unverified", "status_reason": "An efficacy dosing schedule alone cannot establish a harm timeline, causality or improvement after stopping.", "missingness": "Event onset/recovery, withdrawal/re-exposure and alternative-cause timelines remain unverified.", "uncertainty": "Do not claim use of a causality tool or an established signal when even temporal order is unverified.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual adverse-event timing, withdrawal/re-exposure and clinical-course records" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current question concerns nausea in the first 24 hours of two chemotherapy cycles. The original safety advice contains no long-term/rare-event or vulnerable-population-specific exposure/follow-up data.", "condition_status": "Unverified", "status_reason": "No direct material supports extending limited exposure/populations into overall safety; the supplementary gap is retained.", "missingness": "Long-term/rare harms and follow-up by special populations/concomitant drugs remain unverified.", "uncertainty": "This gap neither makes all long-term harm research mandatory for the current narrow NAv question nor establishes absence of effect.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety follow-up and exposure/event specifications by duration, concomitant treatment and population" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current material contains two efficacy reports and common safety caution wording, but no material linking the same unique harm case's reports, recitations and other independent events.", "condition_status": "Unverified", "status_reason": "The presence of 2 efficacy reports does not establish 2 independent repetitions of the same harm; unique harm-case counts were not established.", "missingness": "Unique events, related reports and recitation/independent-replication families remain unverified.", "uncertainty": "Do not label caution advice as newly certified regulatory warnings or proof of event repetition.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Related original harm material, case-family tables and recitation/regulatory sources" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original verdict date is 2026-09-08, and the correction history reports corrections to 2 English items on 2026-09-14. The retained review was a preservation conversion of the then-current original summary on 2026-10-06; no new clinical search or abstract/full-text, registration or retraction verification was performed.", "condition_status": "Met", "status_reason": "Original dates, correction date and local review are separated from searches/unread full text. This does not establish completed review of the latest literature.", "missingness": "New searches and publication/retraction/registration checks were not performed; this does not mean 0 studies.", "uncertainty": "Do not use historical dates as current full-text verification dates.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "The current original record/correction history and receipt of actual review scope" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original correction of 2026-09-14 reports replacing 2 generic English evidence-table items with specific translations. Generic descriptions remain in the English participant, funding, endpoint, result and weighting fields of the two current reports. Specific Korean values, literal English and the correction text were preserved separately.", "condition_status": "Met", "status_reason": "Exact preservation of the current Korean/English originals and historical correction report meets the frozen preservation criterion. This does not establish specific English translations or verification that the 2 corrected items were actually reflected; that comparison remains unverified.", "missingness": "The 2 corrected items were not compared with actual revised originals/manifests.", "uncertainty": "Do not silently replace generic English in retained originals or label historical corrections as verified.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original correction specifications, revised originals and current original/field mapping" }, { "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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Original C50/caution, EX/CX/R1/I2/B1 axes, false-valued fields, empty override/review records, the empty additional detailed-claim list, existing URLs and Korean/English historical independent cross-check wording are preserved unchanged in the complete original record. Grade/score were not automatically inherited as this table's condition states.", "condition_status": "Met", "status_reason": "Historical-value/identity preservation is separated from new judgments or independent certification; Met verifies the text-preservation condition.", "missingness": "Original empty values remain unchanged; they are not filled with evidence of new execution of the original calculations/independent verification.", "uncertainty": "Met preservation status does not establish sufficient NAv efficacy evidence or current independent clinical verification.", "review_date": "2026-10-06T09:33:39.802275+09:00", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original stored summary, current original selection and text-identity/history material" } ], "reports": [ { "report_id": "R01", "title": "Ryan et al. (2012): Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: a URCC CCOP study of 576 patients", "url": "https://pubmed.ncbi.nlm.nih.gov/21818642/", "report_type": "Report described in the stored summary as a randomized double-blind multicenter dose-ranging trial", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "Stored research/bibliographic summary read; external abstract, full text, registration and plans unread", "study_family": "Pooled-comparison report from the same dose-ranging trial; dose arms are not counted as separate trials", "independent_replication": "Independent replication and unique participant counts matching formulation, population, timing and NAv remain unverified.", "observed_result": "There were 744 randomized and 576 analyzed. The pooled-all-dose adjusted NAv change contrast is −0.350 points, P=.013, with exact 95% CI unverified. Effects, denominators and intervals for 0.5, 1 and 1.5 g separately remain unverified. The paper/registration conflict over the primary endpoint (1st) is a historical report, not a current original-text comparison.", "result_level": "Adjusted change contrast pooled across doses; distinguished from individual-dose effects", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Stored existing summary acquired", "access_status": "Local acquisition and reading", "acquired": true, "actually_read": "Stored summary read", "as_of": "2026-10-06T09:33:39.801837+09:00", "qualification": "The retained research/bibliographic summary was read. Ryan JL et al. Support Care Cancer. 2012;20:1479-1489. PMID: 21818642. PMCID: PMC3361530. DOI: 10.1007/s00520-011-1236-3. NCT00040742. Bibliographic NCT00040742 and PMC3361530 are identifiers; original registration status remains unverified. Identifier/link presence does not establish current reading of registration, abstract or full text. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, { "material_type": "External article abstract", "public_status": "Bibliographic link retained; abstract availability unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-06T09:33:39.801837+09:00", "qualification": "A PubMed bibliographic link is not an abstract-reading record. Current abstract availability was not newly verified. Bibliographic NCT00040742 and PMC3361530 are identifiers; original registration status remains unverified. Identifier/link presence does not establish current reading of registration, abstract or full text. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, { "material_type": "External article full text", "public_status": "Bibliography retained; full-text availability unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-06T09:33:39.801837+09:00", "qualification": "Bibliographic, DOI and any PMCID references do not establish full-text acquisition or reading. External full text remains unread. Bibliographic NCT00040742 and PMC3361530 are identifiers; original registration status remains unverified. Identifier/link presence does not establish current reading of registration, abstract or full text. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, { "material_type": "External trial registration", "public_status": "Bibliographic identifier retained; actual registration unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-06T09:33:39.801837+09:00", "qualification": "Bibliographic identity is distinguished from actual registration verification. Original registration, versions and timing remain unread. Bibliographic NCT00040742 and PMC3361530 are identifiers; original registration status remains unverified. Identifier/link presence does not establish current reading of registration, abstract or full text. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, { "material_type": "Protocol/statistical-analysis-plan material needed (existence unverified)", "public_status": "Material needed; existence/public availability unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-06T09:33:39.801837+09:00", "qualification": "Existence, public availability and prespecification of original protocols/analysis plans remain unverified; their contents are unread. Bibliographic NCT00040742 and PMC3361530 are identifiers; original registration status remains unverified. Identifier/link presence does not establish current reading of registration, abstract or full text. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, { "material_type": "Manufacturing/composition/conflict material needed (existence unverified)", "public_status": "Material needed; existence/public availability unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-06T09:33:39.801837+09:00", "qualification": "Detailed original manufacturing/composition/support/author-relationship or harm material is unacquired and unread. Needed-material slots are not counted as independent studies or harm cases. Bibliographic NCT00040742 and PMC3361530 are identifiers; original registration status remains unverified. Identifier/link presence does not establish current reading of registration, abstract or full text. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/21818642/" } ] }, { "report_id": "R02", "title": "Crichton et al. (2024): Effect of a Standardized Ginger Root Powder Regimen on Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial", "url": "https://pubmed.ncbi.nlm.nih.gov/37699474/", "report_type": "Report described in the stored summary as a randomized double-blind multicenter ITT trial", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "Stored research/bibliographic summary read; external abstract, full text, registration and plans unread", "study_family": "Related report of another standardized formulation; distinguished from direct replication of the same Aphios NAv question", "independent_replication": "A report of another standardized formulation/outcome is not certified as independent replication of the selected Aphios conditions.", "observed_result": "There were 103 participants, 52 versus 51; arm mapping and endpoint-specific denominators remain unverified. Nausea-related quality of life is primary (1st), acute CINV secondary (2nd). Null acute CINV after ITT/Bonferroni adjustment and positive delayed-nausea/quality-of-life findings are retained. This does not establish an exact effect or equivalence for the same Aphios NAv question.", "result_level": "Related results for another formulation, endpoint and time window; not an exact NAv effect for the selected product", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Stored existing summary acquired", "access_status": "Local acquisition and reading", "acquired": true, "actually_read": "Stored summary read", "as_of": "2026-10-06T09:33:39.802049+09:00", "qualification": "The retained research/bibliographic summary was read. Crichton M et al. J Acad Nutr Diet. 2024;124:313-330.e6. PMID: 37699474. DOI: 10.1016/j.jand.2023.09.003. Registration identity and acquisition of an original full-text copy remain unverified. Shared historical research wording is not inherited as current external reading of this report. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, { "material_type": "External article abstract", "public_status": "Bibliographic link retained; abstract availability unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-06T09:33:39.802049+09:00", "qualification": "A PubMed bibliographic link is not an abstract-reading record. Current abstract availability was not newly verified. Registration identity and acquisition of an original full-text copy remain unverified. Shared historical research wording is not inherited as current external reading of this report. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, { "material_type": "External article full text", "public_status": "Bibliography retained; full-text availability unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-06T09:33:39.802049+09:00", "qualification": "Bibliographic, DOI and any PMCID references do not establish full-text acquisition or reading. External full text remains unread. Registration identity and acquisition of an original full-text copy remain unverified. Shared historical research wording is not inherited as current external reading of this report. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, { "material_type": "External trial registration", "public_status": "Registration identifier, existence and public availability unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-06T09:33:39.802049+09:00", "qualification": "Bibliographic identity is distinguished from actual registration verification. Original registration, versions and timing remain unread. Registration identity and acquisition of an original full-text copy remain unverified. Shared historical research wording is not inherited as current external reading of this report. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, { "material_type": "Protocol/statistical-analysis-plan material needed (existence unverified)", "public_status": "Material needed; existence/public availability unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-06T09:33:39.802049+09:00", "qualification": "Existence, public availability and prespecification of original protocols/analysis plans remain unverified; their contents are unread. Registration identity and acquisition of an original full-text copy remain unverified. Shared historical research wording is not inherited as current external reading of this report. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." }, { "material_type": "Safety/conflict material needed (existence unverified)", "public_status": "Material needed; existence/public availability unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-06T09:33:39.802049+09:00", "qualification": "Detailed original manufacturing/composition/support/author-relationship or harm material is unacquired and unread. Needed-material slots are not counted as independent studies or harm cases. Registration identity and acquisition of an original full-text copy remain unverified. Shared historical research wording is not inherited as current external reading of this report. The stored-material review record dated 2026-10-06 concerns local-summary/condition-application review, not new reading of external documents. The date 2026-09-08 is the original verdict date and is not changed into current full-text reading or completion of a new search." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/37699474/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The 2012 dose-ranging report is distinguished from the 2024 report of another standardized formulation. The 744 allocated/576 analyzed and 103 participants/52 versus 51 are not added together; cycles in the same people are not counted as independent replications. Exact identities/inclusion relationships of reviews from 2019–2025 and unique trial/participant counts remain unverified." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 41 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }