Ginger extract 400 mg standardized to 5% active ingredient as add-on therapy × Improvement of 2-hour pain-relief response in acute migraine

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Evidence conditionWhat is this sheet's independent question?Required	The original claim concerns improved 2-hour pain-relief response in acute migraine, comparing ginger extract 400 mg added to common IV ketoprofen 100 mg. S1	Limited to identifying the question in the current retained summary. This is not verification of clinical efficacy or full-text review.	Emergency-department episodic migraine; a single oral ginger-extract add-on; common ketoprofen; 2-hour pain relief	Material needed: The current original wording and new comparison specification if the question boundary changes. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow are the original verdict, both languages and correction records retained?Required	C50, Caution and B/P/R1/I2/EX/B2/CX are retained as historical records. Some English evidence fields contain generic wording; the 1 correction and Korean/English cross-check statements are historical reports. S1 S2	The current original record was checked, but specific clinical values behind generic English wording and past independent verification were not newly certified.	Original C50, Caution, all axes, Korean/English text, the correction and the actual verification scope	Material needed: Historical source material establishing the specific English correspondence and correction scope. This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat product do 400 mg and 5% active ingredient describe?Required	The retained formulation is a 400 mg capsule with 5% active ingredient; the detailed gingerol/shogaol composition is unverified. S1	Nominal labeling cannot establish individual active-compound contents or product equivalence.	Rhizome-extract capsules, composition, trial product/batch and assay method	Material needed: Trial-product manufacturing, batch, quantitative-assay and composition documentation. This records needed materials; no new research was executed.
4	Met	Full text not readStored summary read	N04 · Evidence conditionWhat actually differs between the add-on groups?Required	This is oral add-on therapy; the comparator is common IV ketoprofen 100 mg plus cellulose placebo. S1	Confirms only the retained comparison specification. Add-on effect magnitude and details of concomitant-care management remain unverified in other items.	Common IV ketoprofen 100 mg; oral extract 400 mg versus cellulose placebo	Material needed: Administration procedures and concomitant-treatment tables for both groups. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWho was included in the trial?Required	The record describes 60 adults presenting to an emergency department with episodic migraine, 1–6 attacks per month. S1	Detailed diagnostic criteria, age distribution, eligibility/exclusions and baseline balance could not be established from the current summary.	Emergency care for adults with episodic migraine, 1–6 attacks per month; eligibility/exclusions and baseline characteristics	Material needed: Complete eligibility/exclusion criteria and baseline-characteristics table. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre pain-relief response and pain freedom distinguished?Required	The principal endpoint is 2-hour clinical pain-relief response; the original record explicitly distinguishes it from pain freedom. S1	The exact response definition, scale and event counts remain unverified within the retained scope.	Definition, scale and response threshold for 2-hour pain-relief clinical response	Material needed: Response-classification criteria, pain scale and result tables. This records needed materials; no new research was executed.
7	Met	Full text not readStored summary read	N07 · Evidence conditionWhat are the limits of the single dose and 2-hour observation?Required	Single administration and 2-hour follow-up are recorded, with separate P values at 1 hour, 1.5 hours and 2 hours. S1	Only the current time attribution is confirmed; long-term persistence is not addressed.	A single acute-attack dose of 400 mg; measurements at 1/1.5/2 hours	Material needed: Administration/measurement schedule and subsequent follow-up. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionHow well is the direct add-on report identified?Required	S1 corresponds to the direct placebo-add-on evidence summary[0] and the Martins 2019 bibliography entry. S1	Local linkage was checked, but external identity, registration family and total unique trials/participants remain unestablished.	Martins 2019, PMID29768938, DOI and evidence/bibliography correspondence	Material needed: Original paper, related reports and registration history. This records needed materials; no new research was executed.
9	Met	Full text not readStored summary read	N09 · Evidence conditionWhy is the sumatriptan comparison separate context?Required	S2 reports ginger powder versus sumatriptan, 100 people followed over 5 attacks and headache severity at two hours. Its comparison specification differs from S1. S2	Confirms only attribution of this related report. S2 product dose, group analyses and repeated-measure handling have not been verified.	Powder versus sumatriptan; 100 people; 5 attacks; headache severity at two hours	Material needed: Active-comparator full text and analyses at participant and attack levels. This records needed materials; no new research was executed.
10	Met	Full text not readStored summary read	N10 · Evidence conditionWhich material was actually read for this review?Required	The entire current summary, both languages, 2 evidence records and 2 bibliography entries were read. External abstract/full-text/registration access was 0; retained URLs are entry points. S1 S2	Confirms summary reading. Historical research-description wording is a past record, not full-text reading in this review.	Current retained summary and bibliography versus access history for external abstracts, full texts and registration	Material needed: Actual acquisition and reading records for original papers and registration/protocols. This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionHow does the registration-number clue relate to the structured registration status?Required	NCT02568644 appears in Korean/English research descriptions and bibliography, while S1's evidence-summary registration status is unverified. S1	Registration identity, the actual historical version and access/planning comparisons were not checked this time. Different record levels are not arbitrarily harmonized.	NCT02568644 in bibliography/both-language wording versus registration status marked unverified	Material needed: NCT02568644 initial registration, amendment history and paper correspondence. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionWhat do the evidence date and current review date mean?Required	The original verdict date is 2026-09-08 and the correction date is 2026-09-14; this review converts retained material. The original search cutoff and report-level access records are absent. S1 S2	The search cutoff and full scope of registration/publication/retraction checks were not newly verified.	Original verdict date, search cutoff, report-level access dates and correction date	Material needed: Historical search records and report-level access receipts. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhat is known about randomization and allocation concealment?Required	S1 is described as a randomized, double-blind, placebo-add-on trial. S1	Actual sequence-generation/concealment methods, design unit and baseline balance are absent from the summary. Nonreporting throughout the paper remains unverified.	Randomized, double-blind placebo add-on; sequence/concealment and baseline balance	Material needed: Methods section, allocation sequence/concealment and baseline table. This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionHow were blinding and subjective pain measurement conducted?Required	The double-blind design and cellulose placebo are retained, with pain relief as the selected endpoint. S1	Maintenance/success of blinding, assessors and measurement-classification details remain unverified.	Participant/assessor blinding, capsule matching and measurement procedures	Material needed: Original capsule-matching, assessor-procedure and response-scale descriptions. This records needed materials; no new research was executed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhich denominator does 60 represent?Required	S1's recorded sample size is 60 randomized; the population description also states 60 emergency-department adults. S1	Group allocation, measurement, analysis and completion counts remain unverified from the current material.	Overall 60 randomized versus group allocation, measurement, completion and analysis	Material needed: Group participant-flow table and denominator definitions. This records needed materials; no new research was executed.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionHow were withdrawals and missing data handled?Required	Only the overall 60 randomized are available; time-specific completion/missing counts are not linked. S1	The occurrence, reasons and handling of missing data and their effect on results cannot be judged from the retained scope.	Time-specific missing data, withdrawal reasons and analysis inclusion/handling	Material needed: Group/time-specific analysis denominators and missing-data handling. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhat are the magnitude and precision of the 2-hour effect?Required	The 2-hour P value is .04; the original summary explicitly identifies event counts, RR and 95% CI as unverified. S1	Exact effect magnitude, absolute response difference, interval and clinical-importance threshold are unverified. The historical statement that these were absent from the public abstract does not mean the abstract was reread this time.	Group response-event counts, RR/absolute difference, 95% CI and denominators	Material needed: 2-hour group event counts/denominators and reported effect estimates with CI. This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionHow are the P values at 1, 1.5 and 2 hours attributed?Required	The record states 1 hour P=.04, 1.5 hours P=.01 and 2 hours P=.04. S1	Planning material establishing the prospective hierarchy of multiple times, multiplicity handling and completeness of reporting has not been acquired.	1h P=.04, 1.5h P=.01, 2h P=.04 and the multiple-testing plan	Material needed: Time-specific plans, hypothesis hierarchy, multiplicity control and complete results. This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionHow far was the claim of a prespecified principal endpoint checked?Required	Korean/English reader answers describe pain relief as the prespecified principal endpoint. A registration-identifier clue exists, while the structured registration status is unverified. S1	Initial registration/plans/SAP were not read this time, so prospective hierarchy and reasons for amendments are not directly certified.	Designation of 2-hour pain relief, registration/protocol/SAP and amendment history	Material needed: Initial registration, protocol/SAP and amendment dates. This records needed materials; no new research was executed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionWere rescue medication, adherence and concomitant-treatment changes controlled?Required	Common IV ketoprofen 100 mg is specified, but rescue medication, adherence and concomitant-treatment changes are not linked in the summary. S1	Additional treatment, rescue use and their effects on outcome analysis remain unverified.	Common ketoprofen administration and additional concomitant/rescue medication, with administration timing	Material needed: Group concomitant treatment, rescue care, adherence, timing and analytic handling. This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionIs the analysis estimating assignment or adherence effects?Required	The original reader answer states that 2-hour clinical response was better than placebo add-on, but analysis population, adjustment and model are absent from the retained evidence table. S1	ITT/PP and the definition of assignment/adherence effects cannot be established from the current source material.	ITT/PP, analysis population, adjustment/model and time-specific between-group comparisons	Material needed: Analysis plan, analysis population, model and effect definition. This records needed materials; no new research was executed.
22	Met	Full text not readStored summary read	N22 · Evidence conditionDoes active-comparator nonsignificance prove equivalence?Required	S2 records improvement in both groups, states that between-group nonsignificance cannot establish equivalence and describes the design as not noninferiority. S2	Confirms only the retained result's interpretation boundary. External checks of exact between-group estimates, CI and trial design remain incomplete.	S2 noninferiority design/margin, between-group estimate, CI and repeated-attack handling	Material needed: Active-comparator protocol, noninferiority margin/CI and analysis method. This records needed materials; no new research was executed.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionIs 400 mg known to be the optimal dose?Supplementary; required for an optimal-dose extension	The retained direct question concerns only a single 400 mg dose; no optimal-dose comparison evidence is linked. S1	This does not claim all dose studies are absent. Optimal dose/dose response could not be established within the current input scope.	Direct dose comparisons for the same extract, composition and adherence	Material needed: Direct dose groups, batch composition and estimates/CI. This records needed materials; no new research was executed.
24	Met	Full text not readStored summary read	N24 · Evidence conditionDoes this answer recurrence, persistence or prevention questions?Supplementary; required for a persistence/prevention extension	The original scope note states that only 2-hour pain relief is judged; pain freedom, recurrence and prevention are separate. S1	Only the current extension boundary is confirmed. Evidence quantity and effects for each extension were not reviewed this time.	Pain/rescue medication after 2 hours, recurrence and prevention questions	Material needed: Subsequent follow-up, recurrence definitions and separate prevention material. This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionWhat independent replications match the same formulation and add-on comparison?Required	S1 direct add-on reporting is distinguished from S2 active-comparator context; the existing R1/I2 values are historical axes. S1 S2	The 2 retained reports alone do not establish total unique trials/participants or product-matched independent replication.	Unique report/trial families and matching product, common treatment, endpoint and time	Material needed: Original trial families, related reports, product matching and trial-specific results. This records needed materials; no new research was executed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionWhat is known about funding, product provision and author interests?Supplementary; required for an independence claim	S1 describes university research with product/funding details unverified; S2 has funding/product details unverified. S1 S2	Funding, manufacturer support, author employment/patents and declared COI were not checked in the original papers this time.	University research, funding, product support, author employment/patents and declared COI	Material needed: Original funding, product-provision and author/COI statements for both reports. This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionWhich adverse events were collected, and how?Required	Retained safety information concerns cautions about NSAID contraindications, gastrointestinal/renal/bleeding risks and interactions with other migraine medicines; no event table is retained. S1	Event names, collection/adjudication, severity and discontinuation could not be established from the current summary. Nonreporting throughout the original paper remains unverified.	Event definitions, collection methods, severity, discontinuation and group results	Material needed: S1 safety-result tables and event/collection definitions. This records needed materials; no new research was executed.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionWhat is the timeline of events and recovery after exposure?Required	Single administration and 2-hour efficacy follow-up are retained, but an event-onset/recovery timeline is not linked. S1	Harm onset/recovery, latency, discontinuation and re-exposure remain unverified.	Administration, event onset, recovery and discontinuation/re-exposure times	Material needed: Harm-onset/recovery and discontinuation/re-exposure records. This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionWhat is the actual comparison for harms?Required	The efficacy comparison is common ketoprofen plus ginger extract versus common ketoprofen plus placebo. The summary does not provide between-group safety results. S1	Comparative-harm estimates were not verified; this does not mean both groups were safe or the difference was 0.	Between-group safety estimates for extract versus placebo on common ketoprofen	Material needed: Group safety events, denominators and reported risk estimates/CI. This records needed materials; no new research was executed.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionAre denominators available for harm frequency?Required	Beyond the overall 60 randomized, safety-exposure/analysis denominators and event counts are not currently linked. S1	Incidence, risk ratios and overall event totals cannot be calculated or established.	Safety-exposed population, people with events/event counts, period and collection scope	Material needed: Safety-analysis population, group event counts and exposure time. This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionCan concomitant exposures and alternative causes be distinguished?Required	Common ketoprofen 100 mg and caution wording about interactions with other medicines are retained. S1	Actual individual concomitant use, baseline events, alternative causes and adjustment are unverified. Original caution wording is not evidence of causality for observed events.	IV ketoprofen, other migraine medicines, baseline/concomitant exposures and adjustment	Material needed: Concomitant medicines, baseline risk and event-specific alternative causes/adjustment. This records needed materials; no new research was executed.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionWhat is missing from harm reporting and follow-up?Required	The current summary contains caution wording, while safety collection/follow-up and event-disclosure scope remain unverified. S1	Collection methods, follow-up losses and detection differences in the original full text were not compared this time.	Systematic/spontaneous collection, detection, attrition and complete event disclosure	Material needed: Safety collection, follow-up/attrition and disclosure scope. This records needed materials; no new research was executed.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionCan independent repetitions of the same harm be counted?Supplementary; required for repeated-harm-signal claims	Korean/English safety guidance and product-fact cautions belong to the same original record; unique harm events are not established in the 2 efficacy reports. S1 S2	Unique harm-event counts and repetition of the same event cannot be established from the current input.	Unique event/trial families, exposure/event matching and repeated citation	Material needed: Original event data, families/related reports and exposure matching. This records needed materials; no new research was executed.
34	Unverified	Full text not readStored summary read	N34 · Evidence conditionWhat harms or vulnerable groups lie beyond the short follow-up?Supplementary; required for long-term/vulnerable-group safety extensions	Original cautions mention NSAID contraindications, gastrointestinal/renal/bleeding risks and interactions with other migraine medicines; direct efficacy concerns one dose and 2 hours. S1	Actual denominators/frequencies in vulnerable groups and long-term/rare events, and interaction estimates, remain unverified.	Long-term/rare events, baseline risk, interactions and exposure duration	Material needed: Vulnerable-group, long-term/rare-event and concomitant-treatment material. This records needed materials; no new research was executed.
35	Partly verified	Full text not readStored summary read	N35 · Evidence conditionWhat can this material say about safety?Required	The existing Caution label and cautions about medical care/concomitant ketoprofen are retained; no new safety conclusion is made. S1	Original cautions are retained information. Observed harms, incidence, causality or safety are not currently established.	Observed events, comparison, denominators, time, alternatives and original cautions	Material needed: Original material linking events, exposure, comparison, time and alternative explanations. This records needed materials; no new research was executed.

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35 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-06
Original evidence cut-off: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.
Population: 60 adults presenting to an emergency department with episodic migraine, 1–6 attacks per month
Ingredient, formulation and route: Zingiber officinale rhizome extract, 400 mg capsule, nominally 5% active ingredient, as oral add-on therapy; detailed gingerol/shogaol composition and batch unverified
Dose: A single 400 mg dose during an acute attack
Comparator: Ginger extract versus cellulose placebo added to the same IV ketoprofen 100 mg in both groups
Measured outcome: 2-hour pain-relief clinical response; distinct from complete pain freedom, with response criteria, group event counts, RR and 95% CI unverified
Duration: Single dose and 2-hour follow-up; results at 1 hour, 1.5 hours and 2 hours are separate observation times
Questions outside this scope: Pain relief is not extended to complete pain freedom at 2 hours, 24-hour persistence, reduced recurrence or migraine prevention under ID3009.; This is not converted to ginger monotherapy, intravenous ginger, ketoprofen replacement or triptan replacement.; The total 60 is not assumed to mean 30/30 per group or completion by everyone. The other comparison report’s 100 people and 5 attacks are not counted as 500 unique participants.; P values alone are not used to calculate events, effect magnitude, RR, CI or NNT, and nominal 5% is not used to calculate mg of individual active compounds.; A registration identifier clue, historical verdict or nonsignificance is not converted to verified prospective planning, new independent validation, equivalence or safety.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S1 · Martins LB et al. Cephalalgia. 2019;39:68-76. PMID: 29768938. DOI: 10.1177/0333102418776016. NCT02568644.

PubMed

Material type: Placebo-controlled report of ginger extract added to common ketoprofen
Materials actually read: Retained summary read; external abstract/full text, registration and plans unread
Findings recorded in the stored summary: 1 hour P=.04, 1.5 hours P=.01, 2 hours P=.04; event counts, RR and 95% CI unverified
Record level: The overall 60 randomized and time-specific P values are retained. Group allocation, analysis, completion and event denominators, effect magnitude, CI, ITT and multiplicity handling remain unverified.
Study overlap and independent replication: The retained S1 direct extract add-on report and S2 powder-versus-sumatriptan active-comparator report address different comparisons. Korean/English text, bibliography, three observation times and repeated attacks are not independent trials. Product-matched independent replication and total unique trials and participants remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Retained direct add-on summary and bibliography	Stored locally	Acquired	Stored existing review summary read	The current retained summary was read. An original clinical-paper file was not acquired. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.
PubMed original-report entry	Unverified	Access not attempted	Not read	Entry linked from the retained bibliographic URL/PMID; response, identity and abstract were not checked this time. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.
Publisher DOI entry; full text unverified	Unverified	Access not attempted	Not read	Entry constructed from the retained DOI. Actual full-text existence, public availability, acquisition and reading remain unverified. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.
NCT02568644 registration entry; history not cross-checked	Unverified	Access not attempted	Not read	The bibliographic NCT02568644 clue is retained. Structured registration status is unverified; initial registration, amendment history and correspondence with the paper were not cross-checked. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.
Protocol/analysis plan for the principal endpoint, multiple time points and ITT	Unverified	Access not attempted	Not read	Plan existence, public availability and location, prospective endpoint hierarchy, multiplicity, ITT and amendments remain unverified. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.
Trial-extract product, batch and quantitative-assay material	Unverified	Access not attempted	Not read	Material linking nominal 400 mg and 5% to actual composition and batch has not been acquired. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.

S2 · Maghbooli M et al. Phytother Res. 2014;28:412-415. PMID: 23657930. DOI: 10.1002/ptr.4996.

PubMed

Material type: Separate ginger-powder versus sumatriptan active-comparator context report
Materials actually read: Retained summary read; external abstract/full text and plans unread
Findings recorded in the stored summary: Both groups improved; between-group nonsignificance cannot be interpreted as equivalence.
Record level: A separate comparison of 100 people, 5 attacks followed and headache severity at two hours. Group analyses, repeated-measure handling, exact between-group estimates/CI and product dose are unverified.
Study overlap and independent replication: The retained S1 direct extract add-on report and S2 powder-versus-sumatriptan active-comparator report address different comparisons. Korean/English text, bibliography, three observation times and repeated attacks are not independent trials. Product-matched independent replication and total unique trials and participants remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Retained active-comparator context summary and bibliography	Stored locally	Acquired	Stored existing review summary read	The current retained summary was read. An original clinical-paper file was not acquired. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.
PubMed original-report entry	Unverified	Access not attempted	Not read	Entry linked from the retained bibliographic URL/PMID; response, identity and abstract were not checked this time. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.
Publisher DOI entry; full text unverified	Unverified	Access not attempted	Not read	Entry constructed from the retained DOI. Actual full-text existence, public availability, acquisition and reading remain unverified. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.
Active-comparator design and noninferiority/repeated-attack analysis material	Unverified	Access not attempted	Not read	Locations of prospective margin, CI, repeated-measure and group-analysis material for this separate comparison remain unverified. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates.

Report counts versus independent study counts

The retained S1 direct extract add-on report and S2 powder-versus-sumatriptan active-comparator report address different comparisons. Korean/English text, bibliography, three observation times and repeated attacks are not independent trials. Product-matched independent replication and total unique trials and participants remain unverified.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What is this sheet's independent question?

Required materials and conditions: Emergency-department episodic migraine; a single oral ginger-extract add-on; common ketoprofen; 2-hour pain relief
Conditions for verification: Connect the original Korean claim to formulation, population, comparison and time, and state exclusions.
Requirement and applicability: Required
Application exceptions: Do not merge the same ginger name or a different comparison into this question.
Why this condition is needed: Distinguish the add-on question from monotherapy, prevention and pain freedom.
Referenced methods: 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.

N02 · How are the original verdict, both languages and correction records retained?

Required materials and conditions: Original C50, Caution, all axes, Korean/English text, the correction and the actual verification scope
Conditions for verification: Retain the typed original and distinguish generic English text and historical cross-check wording from current certification.
Requirement and applicability: Required
Application exceptions: Do not arbitrarily retranslate or replace generic English fields and specific Korean content in the original correction record.
Why this condition is needed: Do not inherit historical verdicts or translation wording as current row statuses or independent clinical certification.
Referenced methods: 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.

N03 · What product do 400 mg and 5% active ingredient describe?

Required materials and conditions: Rhizome-extract capsules, composition, trial product/batch and assay method
Conditions for verification: Record the nominal formulation/dose alongside unverified actual composition and batch.
Requirement and applicability: Required
Application exceptions: Do not newly calculate gingerol/shogaol mg or batch equivalence from nominal 5%.
Why this condition is needed: Do not interchange ginger food, powder or essential oil with the trial extract.
Referenced methods: 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.

N04 · What actually differs between the add-on groups?

Required materials and conditions: Common IV ketoprofen 100 mg; oral extract 400 mg versus cellulose placebo
Conditions for verification: Distinguish common treatment from the add-on difference at the current source location.
Requirement and applicability: Required
Application exceptions: Do not attribute this to ginger monotherapy, ketoprofen replacement or triptan replacement.
Why this condition is needed: Separate the contribution of common treatment from the added-ingredient comparison.
Referenced methods: 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.

N05 · Who was included in the trial?

Required materials and conditions: Emergency care for adults with episodic migraine, 1–6 attacks per month; eligibility/exclusions and baseline characteristics
Conditions for verification: Distinguish the retained population from unverified diagnostic, baseline and eligibility information.
Requirement and applicability: Required
Application exceptions: Do not equate the overall 60 with the actual eligible or completing population.
Why this condition is needed: Do not extend this to general headache, chronic migraine or self-medication.
Referenced methods: 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.

N06 · Are pain-relief response and pain freedom distinguished?

Required materials and conditions: Definition, scale and response threshold for 2-hour pain-relief clinical response
Conditions for verification: Separate the retained response endpoint from other endpoints and retain uncertainty about its measurement definition.
Requirement and applicability: Required
Application exceptions: Pain intensity, pain freedom and recurrence are different endpoints.
Why this condition is needed: Do not turn a pain-relief signal into complete pain freedom.
Referenced methods: 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.

N07 · What are the limits of the single dose and 2-hour observation?

Required materials and conditions: A single acute-attack dose of 400 mg; measurements at 1/1.5/2 hours
Conditions for verification: Attribute administration and each reported time separately.
Requirement and applicability: Required
Application exceptions: Do not extend a single-dose 2-hour result to repeated dosing or prevention.
Why this condition is needed: Do not combine observations at different times into one sustained effect.
Referenced methods: 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.

N08 · How well is the direct add-on report identified?

Required materials and conditions: Martins 2019, PMID29768938, DOI and evidence/bibliography correspondence
Conditions for verification: Connect source locations for the same direct-report clues without inferring total unique participants.
Requirement and applicability: Required
Application exceptions: Identifiers alone do not complete registration or original-paper identity checks.
Why this condition is needed: Do not count summaries, bibliography and Korean/English recitation as independent replications.
Referenced methods: 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.

N09 · Why is the sumatriptan comparison separate context?

Required materials and conditions: Powder versus sumatriptan; 100 people; 5 attacks; headache severity at two hours
Conditions for verification: Separate S2 results and denominator/repeated-measure boundaries from S1.
Requirement and applicability: Required
Application exceptions: Do not multiply 100 people by 5 attacks to count 500 people; retain formulation and comparison differences.
Why this condition is needed: Do not count within-group improvement in an active comparison as replication of the same extract add-on effect.
Referenced methods: 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.

N10 · Which material was actually read for this review?

Required materials and conditions: Current retained summary and bibliography versus access history for external abstracts, full texts and registration
Conditions for verification: Link the retained summary actually read to its location and hash; leave external material unread.
Requirement and applicability: Required
Application exceptions: Do not label unattempted access as inaccessibility or nonreporting in the paper.
Why this condition is needed: Do not equate an available reading link with full-text reading.
Referenced methods: 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.

N11 · How does the registration-number clue relate to the structured registration status?

Required materials and conditions: NCT02568644 in bibliography/both-language wording versus registration status marked unverified
Conditions for verification: Retain both clues and state the scope of original-registration identity/version comparison.
Requirement and applicability: Required
Application exceptions: Do not delete either retained value or convert it to failed registration.
Why this condition is needed: Do not establish registration identity or prospective hierarchy from a bibliographic identifier.
Referenced methods: 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.

N12 · What do the evidence date and current review date mean?

Required materials and conditions: Original verdict date, search cutoff, report-level access dates and correction date
Conditions for verification: Distinguish the role of the evidence date from the current retained scope.
Requirement and applicability: Required
Application exceptions: An unperformed new search does not mean 0 studies.
Why this condition is needed: Do not reuse the original review date 2026-09-08 as a current search or external-access date.
Referenced methods: 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.

N13 · What is known about randomization and allocation concealment?

Required materials and conditions: Randomized, double-blind placebo add-on; sequence/concealment and baseline balance
Conditions for verification: Separate the retained design description from unverified procedures.
Requirement and applicability: Required
Application exceptions: Do not convert unverified parallel/cluster/crossover details to nonapplicability.
Why this condition is needed: An RCT label alone does not establish that allocation bias was resolved.
Referenced methods: 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.

N14 · How were blinding and subjective pain measurement conducted?

Required materials and conditions: Participant/assessor blinding, capsule matching and measurement procedures
Conditions for verification: State limitations according to the measurement procedure and actual verification scope.
Requirement and applicability: Required
Application exceptions: A subjective endpoint or blinding limitation alone is not an automatic failure.
Why this condition is needed: Distinguish the double-blind label from actual response assessment.
Referenced methods: 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.

N15 · Which denominator does 60 represent?

Required materials and conditions: Overall 60 randomized versus group allocation, measurement, completion and analysis
Conditions for verification: Distinguish the retained overall randomized count from other unavailable denominators.
Requirement and applicability: Required
Application exceptions: Do not equate the summary's 60 with actual analyzed or completing counts.
Why this condition is needed: Do not infer 30/30 per group or an outcome-analysis denominator from total N.
Referenced methods: 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.

N16 · How were withdrawals and missing data handled?

Required materials and conditions: Time-specific missing data, withdrawal reasons and analysis inclusion/handling
Conditions for verification: Distinguish reported randomization counts from unverified missingness and handling.
Requirement and applicability: Required
Application exceptions: Generic English sample-size wording is not an actual time-specific denominator.
Why this condition is needed: Do not convert missing denominators to 0 withdrawals or completion by everyone.
Referenced methods: 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.

N17 · What are the magnitude and precision of the 2-hour effect?

Required materials and conditions: Group response-event counts, RR/absolute difference, 95% CI and denominators
Conditions for verification: Show the reported P value separately from unverified estimates and intervals.
Requirement and applicability: Required
Application exceptions: Do not infer event counts/CI or fill gaps with new calculations.
Why this condition is needed: Do not read P=.04 as effect magnitude, an individual's response probability or sufficiency.
Referenced methods: 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.

N18 · How are the P values at 1, 1.5 and 2 hours attributed?

Required materials and conditions: 1h P=.04, 1.5h P=.01, 2h P=.04 and the multiple-testing plan
Conditions for verification: Link each time-specific value to the original record and retain unverified multiplicity control.
Requirement and applicability: Required
Application exceptions: Do not count the three values as independent trials or participants.
Why this condition is needed: Do not substitute the most favorable time-specific P value for the principal 2-hour effect.
Referenced methods: 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.

N19 · How far was the claim of a prespecified principal endpoint checked?

Required materials and conditions: Designation of 2-hour pain relief, registration/protocol/SAP and amendment history
Conditions for verification: Retain the historical wording while identifying unperformed comparisons with historical plans and amendments.
Requirement and applicability: Required
Application exceptions: Unacquired planning material does not establish nonregistration or selective reporting.
Why this condition is needed: Separate the manuscript's prespecification statement from original-plan comparison in this review.
Referenced methods: 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.

N20 · Were rescue medication, adherence and concomitant-treatment changes controlled?

Required materials and conditions: Common ketoprofen administration and additional concomitant/rescue medication, with administration timing
Conditions for verification: Record specified common treatment separately from unverified changes and handling.
Requirement and applicability: Required
Application exceptions: Specification of a common medicine does not establish identical concomitant care and adherence throughout.
Why this condition is needed: Do not attribute differences in other treatments to the ginger add-on contribution.
Referenced methods: 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.

N21 · Is the analysis estimating assignment or adherence effects?

Required materials and conditions: ITT/PP, analysis population, adjustment/model and time-specific between-group comparisons
Conditions for verification: Distinguish the add-on effect of interest from the unverified actual estimand.
Requirement and applicability: Required
Application exceptions: Do not equate unspecified within-group change with a between-group effect.
Why this condition is needed: Do not fill in ITT solely because allocation was randomized.
Referenced methods: 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.

N22 · Does active-comparator nonsignificance prove equivalence?

Required materials and conditions: S2 noninferiority design/margin, between-group estimate, CI and repeated-attack handling
Conditions for verification: Retain contrary/no-difference reporting and state the different comparison and its limitations.
Requirement and applicability: Required
Application exceptions: Do not make equivalence/noninferiority conclusions without a prospective margin and CI.
Why this condition is needed: Do not turn within-group improvement or between-group nonsignificance into triptan replacement efficacy.
Referenced methods: 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.

N23 · Is 400 mg known to be the optimal dose?

Required materials and conditions: Direct dose comparisons for the same extract, composition and adherence
Conditions for verification: Separate the current 400 mg dose from the gap for a distinct dose question.
Requirement and applicability: Supplementary; required for an optimal-dose extension
Application exceptions: Do not make dose-optimization research a completion requirement for this narrow add-on question.
Why this condition is needed: Do not extend one single dose to an optimal-dose claim.
Referenced methods: 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.

N24 · Does this answer recurrence, persistence or prevention questions?

Required materials and conditions: Pain/rescue medication after 2 hours, recurrence and prevention questions
Conditions for verification: Distinguish the original 2-hour result from later-outcome and prevention questions.
Requirement and applicability: Supplementary; required for a persistence/prevention extension
Application exceptions: Prevention ID3009 is not read/converted in this sheet or imposed as a requirement for the narrow question.
Why this condition is needed: Do not extend single-dose pain-relief results to long-term prevention or reduced recurrence.
Referenced methods: 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.

N25 · What independent replications match the same formulation and add-on comparison?

Required materials and conditions: Unique report/trial families and matching product, common treatment, endpoint and time
Conditions for verification: Distinguish currently linked reports from unestablished total independent families and unique participants.
Requirement and applicability: Required
Application exceptions: Do not add the current 2 reports as 2 trials of the same comparison or a total of 160 unique participants.
Why this condition is needed: Do not count S2's different comparison, Korean/English text or bibliography as independent confirmation.
Referenced methods: 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.

N26 · What is known about funding, product provision and author interests?

Required materials and conditions: University research, funding, product support, author employment/patents and declared COI
Conditions for verification: Link each report's specified support and each unverified aspect separately.
Requirement and applicability: Supplementary; required for an independence claim
Application exceptions: Generic English funding wording is not specific COI-verification material.
Why this condition is needed: Do not read a university label or historical I2 as independent funding or absence of bias.
Referenced methods: 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.

N27 · Which adverse events were collected, and how?

Required materials and conditions: Event definitions, collection methods, severity, discontinuation and group results
Conditions for verification: Show the verification scope for actual events separately from historical caution wording.
Requirement and applicability: Required
Application exceptions: Distinguish NSAID-related cautions from observed events in the ginger add-on comparison.
Why this condition is needed: Do not turn caution wording into adverse events observed in the trial.
Referenced methods: 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.

N28 · What is the timeline of events and recovery after exposure?

Required materials and conditions: Administration, event onset, recovery and discontinuation/re-exposure times
Conditions for verification: Separate known administration/follow-up from the unverified event timeline.
Requirement and applicability: Required
Application exceptions: Do not infer improvement after discontinuation or re-exposure information when unavailable.
Why this condition is needed: Do not turn single-dose 2-hour efficacy follow-up into sufficient harm observation.
Referenced methods: 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.

N29 · What is the actual comparison for harms?

Required materials and conditions: Between-group safety estimates for extract versus placebo on common ketoprofen
Conditions for verification: Show common/additional exposure and unverified comparative-harm material.
Requirement and applicability: Required
Application exceptions: Do not extrapolate background risk rates or convert this to a no-treatment comparison.
Why this condition is needed: An efficacy comparator does not establish a verified difference in harms.
Referenced methods: 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.

N30 · Are denominators available for harm frequency?

Required materials and conditions: Safety-exposed population, people with events/event counts, period and collection scope
Conditions for verification: Show frequencies only for original reported values linking exposure, events and time.
Requirement and applicability: Required
Application exceptions: Do not calculate incidence from P values, caution wording or original C50.
Why this condition is needed: Do not reuse the total 60 as a safety denominator or a denominator for 0 events.
Referenced methods: 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.

N31 · Can concomitant exposures and alternative causes be distinguished?

Required materials and conditions: IV ketoprofen, other migraine medicines, baseline/concomitant exposures and adjustment
Conditions for verification: Distinguish specified common medicine from unverified concomitant/baseline information and alternative explanations.
Requirement and applicability: Required
Application exceptions: Unavailable information about other causes does not mean other causes are absent.
Why this condition is needed: Do not attribute potential harm causally to ginger alone.
Referenced methods: 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.

N32 · What is missing from harm reporting and follow-up?

Required materials and conditions: Systematic/spontaneous collection, detection, attrition and complete event disclosure
Conditions for verification: Connect the summary actually read to unverified collection and missingness.
Requirement and applicability: Required
Application exceptions: Possible bias is not an established bias magnitude or proof that the trial is invalid.
Why this condition is needed: An unavailable event table does not mean events did not occur.
Referenced methods: 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.

N33 · Can independent repetitions of the same harm be counted?

Required materials and conditions: Unique event/trial families, exposure/event matching and repeated citation
Conditions for verification: Explain material types, family/exposure relationships and unestablished repetition counts.
Requirement and applicability: Supplementary; required for repeated-harm-signal claims
Application exceptions: Do not automatically link a different S2 formulation or administrative data as recurrence of the same event.
Why this condition is needed: Do not count the same caution wording and Korean/English recitation as independent events.
Referenced methods: 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.

N34 · What harms or vulnerable groups lie beyond the short follow-up?

Required materials and conditions: Long-term/rare events, baseline risk, interactions and exposure duration
Conditions for verification: Distinguish direct exposure scope from gaps in separate vulnerable-group/long-term questions.
Requirement and applicability: Supplementary; required for long-term/vulnerable-group safety extensions
Application exceptions: Do not require all rare-harm trials as completion conditions for the narrow efficacy sheet.
Why this condition is needed: Do not extend an emergency-department single-dose 2-hour result to overall safety.
Referenced methods: 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.

N35 · What can this material say about safety?

Required materials and conditions: Observed events, comparison, denominators, time, alternatives and original cautions
Conditions for verification: Distinguish retained cautions from unverified events, comparisons, denominators and causality.
Requirement and applicability: Required
Application exceptions: Do not run new efficacy/safety scoring or causal-assessment tools.
Why this condition is needed: Do not turn a Caution label into established harm causality, absence of harm or personal dosing advice.
Referenced methods: 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.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

What the statuses mean

Partly verified: Some retained information is available, while material needed for this criterion remains unverified.
Unverified: This criterion could not be established from the retained scope; this does not mean 0 studies, 0 effect or no harm.
Review incomplete: Source comparison or searching within the permitted scope was not performed.
Not reported: Limited to a specified read source or section that did not report the item.
Inaccessible: Used only where access was actually attempted and failed; not assigned to clinical material here.
Insufficient evidence for the conditions: Used only after reviewing relevant studies in the defined scope and finding evidence insufficient to answer the condition; not applied universally here.
Not applicable: A specific exception based on applicability conditions; not a substitute for unread material.
Conflicting data: Incompatible material was compared for the same question, time and analysis; different review estimates alone do not justify this status.
Met: Confirms the stated retained information and reading, attribution or interpretation boundary; not certification of clinical efficacy, full-text reading or reassessment.

Change history

2026-10-25 · Public page/material version 1.0

The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (2026-10-06) and original evidence cut-off (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What is this sheet's independent question?

Current findings: The original claim concerns improved 2-hour pain-relief response in acute migraine, comparing ginger extract 400 mg added to common IV ketoprofen 100 mg.
Verification status: Met
Materials actually 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.
Why unverified: Limited to identifying the question in the current retained summary. This is not verification of clinical efficacy or full-text review.
Reason for missing information: Limited to identifying the question in the current retained summary. This is not verification of clinical efficacy or full-text review.
Required materials and conditions: Emergency-department episodic migraine; a single oral ginger-extract add-on; common ketoprofen; 2-hour pain relief
Materials to obtain first: The current original wording and new comparison specification if the question boundary changes
Further research: Material needed: The current original wording and new comparison specification if the question boundary changes. This records needed materials; no new research was executed.
Remaining uncertainty: Limited to identifying the question in the current retained summary. This is not verification of clinical efficacy or full-text review.
Conditions for verification: Connect the original Korean claim to formulation, population, comparison and time, and state exclusions.
Why this condition is needed: Distinguish the add-on question from monotherapy, prevention and pain freedom.
Application exceptions: Do not merge the same ginger name or a different comparison into this question.
Referenced methods: 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.

Related sources S1

N02 · How are the original verdict, both languages and correction records retained?

Current findings: C50, Caution and B/P/R1/I2/EX/B2/CX are retained as historical records. Some English evidence fields contain generic wording; the 1 correction and Korean/English cross-check statements are historical reports.
Verification status: Partly verified
Materials actually 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.
Why unverified: The current original record was checked, but specific clinical values behind generic English wording and past independent verification were not newly certified.
Reason for missing information: The current original record was checked, but specific clinical values behind generic English wording and past independent verification were not newly certified.
Required materials and conditions: Original C50, Caution, all axes, Korean/English text, the correction and the actual verification scope
Materials to obtain first: Historical source material establishing the specific English correspondence and correction scope
Further research: Material needed: Historical source material establishing the specific English correspondence and correction scope. This records needed materials; no new research was executed.
Remaining uncertainty: The current original record was checked, but specific clinical values behind generic English wording and past independent verification were not newly certified.
Conditions for verification: Retain the typed original and distinguish generic English text and historical cross-check wording from current certification.
Why this condition is needed: Do not inherit historical verdicts or translation wording as current row statuses or independent clinical certification.
Application exceptions: Do not arbitrarily retranslate or replace generic English fields and specific Korean content in the original correction record.
Referenced methods: 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.

Related sources S1 S2

N03 · What product do 400 mg and 5% active ingredient describe?

Current findings: The retained formulation is a 400 mg capsule with 5% active ingredient; the detailed gingerol/shogaol composition is unverified.
Verification status: Partly verified
Materials actually 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.
Why unverified: Nominal labeling cannot establish individual active-compound contents or product equivalence.
Reason for missing information: Nominal labeling cannot establish individual active-compound contents or product equivalence.
Required materials and conditions: Rhizome-extract capsules, composition, trial product/batch and assay method
Materials to obtain first: Trial-product manufacturing, batch, quantitative-assay and composition documentation
Further research: Material needed: Trial-product manufacturing, batch, quantitative-assay and composition documentation. This records needed materials; no new research was executed.
Remaining uncertainty: Nominal labeling cannot establish individual active-compound contents or product equivalence.
Conditions for verification: Record the nominal formulation/dose alongside unverified actual composition and batch.
Why this condition is needed: Do not interchange ginger food, powder or essential oil with the trial extract.
Application exceptions: Do not newly calculate gingerol/shogaol mg or batch equivalence from nominal 5%.
Referenced methods: 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.

Related sources S1

N04 · What actually differs between the add-on groups?

Current findings: This is oral add-on therapy; the comparator is common IV ketoprofen 100 mg plus cellulose placebo.
Verification status: Met
Materials actually 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.
Why unverified: Confirms only the retained comparison specification. Add-on effect magnitude and details of concomitant-care management remain unverified in other items.
Reason for missing information: Confirms only the retained comparison specification. Add-on effect magnitude and details of concomitant-care management remain unverified in other items.
Required materials and conditions: Common IV ketoprofen 100 mg; oral extract 400 mg versus cellulose placebo
Materials to obtain first: Administration procedures and concomitant-treatment tables for both groups
Further research: Material needed: Administration procedures and concomitant-treatment tables for both groups. This records needed materials; no new research was executed.
Remaining uncertainty: Confirms only the retained comparison specification. Add-on effect magnitude and details of concomitant-care management remain unverified in other items.
Conditions for verification: Distinguish common treatment from the add-on difference at the current source location.
Why this condition is needed: Separate the contribution of common treatment from the added-ingredient comparison.
Application exceptions: Do not attribute this to ginger monotherapy, ketoprofen replacement or triptan replacement.
Referenced methods: 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.

Related sources S1

N05 · Who was included in the trial?

Current findings: The record describes 60 adults presenting to an emergency department with episodic migraine, 1–6 attacks per month.
Verification status: Partly verified
Materials actually 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.
Why unverified: Detailed diagnostic criteria, age distribution, eligibility/exclusions and baseline balance could not be established from the current summary.
Reason for missing information: Detailed diagnostic criteria, age distribution, eligibility/exclusions and baseline balance could not be established from the current summary.
Required materials and conditions: Emergency care for adults with episodic migraine, 1–6 attacks per month; eligibility/exclusions and baseline characteristics
Materials to obtain first: Complete eligibility/exclusion criteria and baseline-characteristics table
Further research: Material needed: Complete eligibility/exclusion criteria and baseline-characteristics table. This records needed materials; no new research was executed.
Remaining uncertainty: Detailed diagnostic criteria, age distribution, eligibility/exclusions and baseline balance could not be established from the current summary.
Conditions for verification: Distinguish the retained population from unverified diagnostic, baseline and eligibility information.
Why this condition is needed: Do not extend this to general headache, chronic migraine or self-medication.
Application exceptions: Do not equate the overall 60 with the actual eligible or completing population.
Referenced methods: 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.

Related sources S1

N06 · Are pain-relief response and pain freedom distinguished?

Current findings: The principal endpoint is 2-hour clinical pain-relief response; the original record explicitly distinguishes it from pain freedom.
Verification status: Partly verified
Materials actually 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.
Why unverified: The exact response definition, scale and event counts remain unverified within the retained scope.
Reason for missing information: The exact response definition, scale and event counts remain unverified within the retained scope.
Required materials and conditions: Definition, scale and response threshold for 2-hour pain-relief clinical response
Materials to obtain first: Response-classification criteria, pain scale and result tables
Further research: Material needed: Response-classification criteria, pain scale and result tables. This records needed materials; no new research was executed.
Remaining uncertainty: The exact response definition, scale and event counts remain unverified within the retained scope.
Conditions for verification: Separate the retained response endpoint from other endpoints and retain uncertainty about its measurement definition.
Why this condition is needed: Do not turn a pain-relief signal into complete pain freedom.
Application exceptions: Pain intensity, pain freedom and recurrence are different endpoints.
Referenced methods: 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.

Related sources S1

N07 · What are the limits of the single dose and 2-hour observation?

Current findings: Single administration and 2-hour follow-up are recorded, with separate P values at 1 hour, 1.5 hours and 2 hours.
Verification status: Met
Materials actually 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.
Why unverified: Only the current time attribution is confirmed; long-term persistence is not addressed.
Reason for missing information: Only the current time attribution is confirmed; long-term persistence is not addressed.
Required materials and conditions: A single acute-attack dose of 400 mg; measurements at 1/1.5/2 hours
Materials to obtain first: Administration/measurement schedule and subsequent follow-up
Further research: Material needed: Administration/measurement schedule and subsequent follow-up. This records needed materials; no new research was executed.
Remaining uncertainty: Only the current time attribution is confirmed; long-term persistence is not addressed.
Conditions for verification: Attribute administration and each reported time separately.
Why this condition is needed: Do not combine observations at different times into one sustained effect.
Application exceptions: Do not extend a single-dose 2-hour result to repeated dosing or prevention.
Referenced methods: 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.

Related sources S1

N08 · How well is the direct add-on report identified?

Current findings: S1 corresponds to the direct placebo-add-on evidence summary[0] and the Martins 2019 bibliography entry.
Verification status: Partly verified
Materials actually 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.
Why unverified: Local linkage was checked, but external identity, registration family and total unique trials/participants remain unestablished.
Reason for missing information: Local linkage was checked, but external identity, registration family and total unique trials/participants remain unestablished.
Required materials and conditions: Martins 2019, PMID29768938, DOI and evidence/bibliography correspondence
Materials to obtain first: Original paper, related reports and registration history
Further research: Material needed: Original paper, related reports and registration history. This records needed materials; no new research was executed.
Remaining uncertainty: Local linkage was checked, but external identity, registration family and total unique trials/participants remain unestablished.
Conditions for verification: Connect source locations for the same direct-report clues without inferring total unique participants.
Why this condition is needed: Do not count summaries, bibliography and Korean/English recitation as independent replications.
Application exceptions: Identifiers alone do not complete registration or original-paper identity checks.
Referenced methods: 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.

Related sources S1

N09 · Why is the sumatriptan comparison separate context?

Current findings: S2 reports ginger powder versus sumatriptan, 100 people followed over 5 attacks and headache severity at two hours. Its comparison specification differs from S1.
Verification status: Met
Materials actually 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.
Why unverified: Confirms only attribution of this related report. S2 product dose, group analyses and repeated-measure handling have not been verified.
Reason for missing information: Confirms only attribution of this related report. S2 product dose, group analyses and repeated-measure handling have not been verified.
Required materials and conditions: Powder versus sumatriptan; 100 people; 5 attacks; headache severity at two hours
Materials to obtain first: Active-comparator full text and analyses at participant and attack levels
Further research: Material needed: Active-comparator full text and analyses at participant and attack levels. This records needed materials; no new research was executed.
Remaining uncertainty: Confirms only attribution of this related report. S2 product dose, group analyses and repeated-measure handling have not been verified.
Conditions for verification: Separate S2 results and denominator/repeated-measure boundaries from S1.
Why this condition is needed: Do not count within-group improvement in an active comparison as replication of the same extract add-on effect.
Application exceptions: Do not multiply 100 people by 5 attacks to count 500 people; retain formulation and comparison differences.
Referenced methods: 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.

Related sources S2

N10 · Which material was actually read for this review?

Current findings: The entire current summary, both languages, 2 evidence records and 2 bibliography entries were read. External abstract/full-text/registration access was 0; retained URLs are entry points.
Verification status: Met
Materials actually 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.
Why unverified: Confirms summary reading. Historical research-description wording is a past record, not full-text reading in this review.
Reason for missing information: Confirms summary reading. Historical research-description wording is a past record, not full-text reading in this review.
Required materials and conditions: Current retained summary and bibliography versus access history for external abstracts, full texts and registration
Materials to obtain first: Actual acquisition and reading records for original papers and registration/protocols
Further research: Material needed: Actual acquisition and reading records for original papers and registration/protocols. This records needed materials; no new research was executed.
Remaining uncertainty: Confirms summary reading. Historical research-description wording is a past record, not full-text reading in this review.
Conditions for verification: Link the retained summary actually read to its location and hash; leave external material unread.
Why this condition is needed: Do not equate an available reading link with full-text reading.
Application exceptions: Do not label unattempted access as inaccessibility or nonreporting in the paper.
Referenced methods: 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.

Related sources S1 S2

N11 · How does the registration-number clue relate to the structured registration status?

Current findings: NCT02568644 appears in Korean/English research descriptions and bibliography, while S1's evidence-summary registration status is unverified.
Verification status: Partly verified
Materials actually 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.
Why unverified: Registration identity, the actual historical version and access/planning comparisons were not checked this time. Different record levels are not arbitrarily harmonized.
Reason for missing information: Registration identity, the actual historical version and access/planning comparisons were not checked this time. Different record levels are not arbitrarily harmonized.
Required materials and conditions: NCT02568644 in bibliography/both-language wording versus registration status marked unverified
Materials to obtain first: NCT02568644 initial registration, amendment history and paper correspondence
Further research: Material needed: NCT02568644 initial registration, amendment history and paper correspondence. This records needed materials; no new research was executed.
Remaining uncertainty: Registration identity, the actual historical version and access/planning comparisons were not checked this time. Different record levels are not arbitrarily harmonized.
Conditions for verification: Retain both clues and state the scope of original-registration identity/version comparison.
Why this condition is needed: Do not establish registration identity or prospective hierarchy from a bibliographic identifier.
Application exceptions: Do not delete either retained value or convert it to failed registration.
Referenced methods: 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.

Related sources S1

N12 · What do the evidence date and current review date mean?

Current findings: The original verdict date is 2026-09-08 and the correction date is 2026-09-14; this review converts retained material. The original search cutoff and report-level access records are absent.
Verification status: Partly verified
Materials actually 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.
Why unverified: The search cutoff and full scope of registration/publication/retraction checks were not newly verified.
Reason for missing information: The search cutoff and full scope of registration/publication/retraction checks were not newly verified.
Required materials and conditions: Original verdict date, search cutoff, report-level access dates and correction date
Materials to obtain first: Historical search records and report-level access receipts
Further research: Material needed: Historical search records and report-level access receipts. This records needed materials; no new research was executed.
Remaining uncertainty: The search cutoff and full scope of registration/publication/retraction checks were not newly verified.
Conditions for verification: Distinguish the role of the evidence date from the current retained scope.
Why this condition is needed: Do not reuse the original review date 2026-09-08 as a current search or external-access date.
Application exceptions: An unperformed new search does not mean 0 studies.
Referenced methods: 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.

Related sources S1 S2

N13 · What is known about randomization and allocation concealment?

Current findings: S1 is described as a randomized, double-blind, placebo-add-on trial.
Verification status: Partly verified
Materials actually 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.
Why unverified: Actual sequence-generation/concealment methods, design unit and baseline balance are absent from the summary. Nonreporting throughout the paper remains unverified.
Reason for missing information: Actual sequence-generation/concealment methods, design unit and baseline balance are absent from the summary. Nonreporting throughout the paper remains unverified.
Required materials and conditions: Randomized, double-blind placebo add-on; sequence/concealment and baseline balance
Materials to obtain first: Methods section, allocation sequence/concealment and baseline table
Further research: Material needed: Methods section, allocation sequence/concealment and baseline table. This records needed materials; no new research was executed.
Remaining uncertainty: Actual sequence-generation/concealment methods, design unit and baseline balance are absent from the summary. Nonreporting throughout the paper remains unverified.
Conditions for verification: Separate the retained design description from unverified procedures.
Why this condition is needed: An RCT label alone does not establish that allocation bias was resolved.
Application exceptions: Do not convert unverified parallel/cluster/crossover details to nonapplicability.
Referenced methods: 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.

Related sources S1

N14 · How were blinding and subjective pain measurement conducted?

Current findings: The double-blind design and cellulose placebo are retained, with pain relief as the selected endpoint.
Verification status: Partly verified
Materials actually 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.
Why unverified: Maintenance/success of blinding, assessors and measurement-classification details remain unverified.
Reason for missing information: Maintenance/success of blinding, assessors and measurement-classification details remain unverified.
Required materials and conditions: Participant/assessor blinding, capsule matching and measurement procedures
Materials to obtain first: Original capsule-matching, assessor-procedure and response-scale descriptions
Further research: Material needed: Original capsule-matching, assessor-procedure and response-scale descriptions. This records needed materials; no new research was executed.
Remaining uncertainty: Maintenance/success of blinding, assessors and measurement-classification details remain unverified.
Conditions for verification: State limitations according to the measurement procedure and actual verification scope.
Why this condition is needed: Distinguish the double-blind label from actual response assessment.
Application exceptions: A subjective endpoint or blinding limitation alone is not an automatic failure.
Referenced methods: 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.

Related sources S1

N15 · Which denominator does 60 represent?

Current findings: S1's recorded sample size is 60 randomized; the population description also states 60 emergency-department adults.
Verification status: Partly verified
Materials actually 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.
Why unverified: Group allocation, measurement, analysis and completion counts remain unverified from the current material.
Reason for missing information: Group allocation, measurement, analysis and completion counts remain unverified from the current material.
Required materials and conditions: Overall 60 randomized versus group allocation, measurement, completion and analysis
Materials to obtain first: Group participant-flow table and denominator definitions
Further research: Material needed: Group participant-flow table and denominator definitions. This records needed materials; no new research was executed.
Remaining uncertainty: Group allocation, measurement, analysis and completion counts remain unverified from the current material.
Conditions for verification: Distinguish the retained overall randomized count from other unavailable denominators.
Why this condition is needed: Do not infer 30/30 per group or an outcome-analysis denominator from total N.
Application exceptions: Do not equate the summary's 60 with actual analyzed or completing counts.
Referenced methods: 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.

Related sources S1

N16 · How were withdrawals and missing data handled?

Current findings: Only the overall 60 randomized are available; time-specific completion/missing counts are not linked.
Verification status: Unverified
Materials actually 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.
Why unverified: The occurrence, reasons and handling of missing data and their effect on results cannot be judged from the retained scope.
Reason for missing information: The occurrence, reasons and handling of missing data and their effect on results cannot be judged from the retained scope.
Required materials and conditions: Time-specific missing data, withdrawal reasons and analysis inclusion/handling
Materials to obtain first: Group/time-specific analysis denominators and missing-data handling
Further research: Material needed: Group/time-specific analysis denominators and missing-data handling. This records needed materials; no new research was executed.
Remaining uncertainty: The occurrence, reasons and handling of missing data and their effect on results cannot be judged from the retained scope.
Conditions for verification: Distinguish reported randomization counts from unverified missingness and handling.
Why this condition is needed: Do not convert missing denominators to 0 withdrawals or completion by everyone.
Application exceptions: Generic English sample-size wording is not an actual time-specific denominator.
Referenced methods: 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.

Related sources S1

N17 · What are the magnitude and precision of the 2-hour effect?

Current findings: The 2-hour P value is .04; the original summary explicitly identifies event counts, RR and 95% CI as unverified.
Verification status: Partly verified
Materials actually 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.
Why unverified: Exact effect magnitude, absolute response difference, interval and clinical-importance threshold are unverified. The historical statement that these were absent from the public abstract does not mean the abstract was reread this time.
Reason for missing information: Exact effect magnitude, absolute response difference, interval and clinical-importance threshold are unverified. The historical statement that these were absent from the public abstract does not mean the abstract was reread this time.
Required materials and conditions: Group response-event counts, RR/absolute difference, 95% CI and denominators
Materials to obtain first: 2-hour group event counts/denominators and reported effect estimates with CI
Further research: Material needed: 2-hour group event counts/denominators and reported effect estimates with CI. This records needed materials; no new research was executed.
Remaining uncertainty: Exact effect magnitude, absolute response difference, interval and clinical-importance threshold are unverified. The historical statement that these were absent from the public abstract does not mean the abstract was reread this time.
Conditions for verification: Show the reported P value separately from unverified estimates and intervals.
Why this condition is needed: Do not read P=.04 as effect magnitude, an individual's response probability or sufficiency.
Application exceptions: Do not infer event counts/CI or fill gaps with new calculations.
Referenced methods: 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.

Related sources S1

N18 · How are the P values at 1, 1.5 and 2 hours attributed?

Current findings: The record states 1 hour P=.04, 1.5 hours P=.01 and 2 hours P=.04.
Verification status: Partly verified
Materials actually 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.
Why unverified: Planning material establishing the prospective hierarchy of multiple times, multiplicity handling and completeness of reporting has not been acquired.
Reason for missing information: Planning material establishing the prospective hierarchy of multiple times, multiplicity handling and completeness of reporting has not been acquired.
Required materials and conditions: 1h P=.04, 1.5h P=.01, 2h P=.04 and the multiple-testing plan
Materials to obtain first: Time-specific plans, hypothesis hierarchy, multiplicity control and complete results
Further research: Material needed: Time-specific plans, hypothesis hierarchy, multiplicity control and complete results. This records needed materials; no new research was executed.
Remaining uncertainty: Planning material establishing the prospective hierarchy of multiple times, multiplicity handling and completeness of reporting has not been acquired.
Conditions for verification: Link each time-specific value to the original record and retain unverified multiplicity control.
Why this condition is needed: Do not substitute the most favorable time-specific P value for the principal 2-hour effect.
Application exceptions: Do not count the three values as independent trials or participants.
Referenced methods: 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.

Related sources S1

N19 · How far was the claim of a prespecified principal endpoint checked?

Current findings: Korean/English reader answers describe pain relief as the prespecified principal endpoint. A registration-identifier clue exists, while the structured registration status is unverified.
Verification status: Partly verified
Materials actually 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.
Why unverified: Initial registration/plans/SAP were not read this time, so prospective hierarchy and reasons for amendments are not directly certified.
Reason for missing information: Initial registration/plans/SAP were not read this time, so prospective hierarchy and reasons for amendments are not directly certified.
Required materials and conditions: Designation of 2-hour pain relief, registration/protocol/SAP and amendment history
Materials to obtain first: Initial registration, protocol/SAP and amendment dates
Further research: Material needed: Initial registration, protocol/SAP and amendment dates. This records needed materials; no new research was executed.
Remaining uncertainty: Initial registration/plans/SAP were not read this time, so prospective hierarchy and reasons for amendments are not directly certified.
Conditions for verification: Retain the historical wording while identifying unperformed comparisons with historical plans and amendments.
Why this condition is needed: Separate the manuscript's prespecification statement from original-plan comparison in this review.
Application exceptions: Unacquired planning material does not establish nonregistration or selective reporting.
Referenced methods: 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.

Related sources S1

N20 · Were rescue medication, adherence and concomitant-treatment changes controlled?

Current findings: Common IV ketoprofen 100 mg is specified, but rescue medication, adherence and concomitant-treatment changes are not linked in the summary.
Verification status: Partly verified
Materials actually 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.
Why unverified: Additional treatment, rescue use and their effects on outcome analysis remain unverified.
Reason for missing information: Additional treatment, rescue use and their effects on outcome analysis remain unverified.
Required materials and conditions: Common ketoprofen administration and additional concomitant/rescue medication, with administration timing
Materials to obtain first: Group concomitant treatment, rescue care, adherence, timing and analytic handling
Further research: Material needed: Group concomitant treatment, rescue care, adherence, timing and analytic handling. This records needed materials; no new research was executed.
Remaining uncertainty: Additional treatment, rescue use and their effects on outcome analysis remain unverified.
Conditions for verification: Record specified common treatment separately from unverified changes and handling.
Why this condition is needed: Do not attribute differences in other treatments to the ginger add-on contribution.
Application exceptions: Specification of a common medicine does not establish identical concomitant care and adherence throughout.
Referenced methods: 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.

Related sources S1

N21 · Is the analysis estimating assignment or adherence effects?

Current findings: The original reader answer states that 2-hour clinical response was better than placebo add-on, but analysis population, adjustment and model are absent from the retained evidence table.
Verification status: Unverified
Materials actually 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.
Why unverified: ITT/PP and the definition of assignment/adherence effects cannot be established from the current source material.
Reason for missing information: ITT/PP and the definition of assignment/adherence effects cannot be established from the current source material.
Required materials and conditions: ITT/PP, analysis population, adjustment/model and time-specific between-group comparisons
Materials to obtain first: Analysis plan, analysis population, model and effect definition
Further research: Material needed: Analysis plan, analysis population, model and effect definition. This records needed materials; no new research was executed.
Remaining uncertainty: ITT/PP and the definition of assignment/adherence effects cannot be established from the current source material.
Conditions for verification: Distinguish the add-on effect of interest from the unverified actual estimand.
Why this condition is needed: Do not fill in ITT solely because allocation was randomized.
Application exceptions: Do not equate unspecified within-group change with a between-group effect.
Referenced methods: 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.

Related sources S1

N22 · Does active-comparator nonsignificance prove equivalence?

Current findings: S2 records improvement in both groups, states that between-group nonsignificance cannot establish equivalence and describes the design as not noninferiority.
Verification status: Met
Materials actually 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.
Why unverified: Confirms only the retained result's interpretation boundary. External checks of exact between-group estimates, CI and trial design remain incomplete.
Reason for missing information: Confirms only the retained result's interpretation boundary. External checks of exact between-group estimates, CI and trial design remain incomplete.
Required materials and conditions: S2 noninferiority design/margin, between-group estimate, CI and repeated-attack handling
Materials to obtain first: Active-comparator protocol, noninferiority margin/CI and analysis method
Further research: Material needed: Active-comparator protocol, noninferiority margin/CI and analysis method. This records needed materials; no new research was executed.
Remaining uncertainty: Confirms only the retained result's interpretation boundary. External checks of exact between-group estimates, CI and trial design remain incomplete.
Conditions for verification: Retain contrary/no-difference reporting and state the different comparison and its limitations.
Why this condition is needed: Do not turn within-group improvement or between-group nonsignificance into triptan replacement efficacy.
Application exceptions: Do not make equivalence/noninferiority conclusions without a prospective margin and CI.
Referenced methods: 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.

Related sources S2

N23 · Is 400 mg known to be the optimal dose?

Current findings: The retained direct question concerns only a single 400 mg dose; no optimal-dose comparison evidence is linked.
Verification status: Unverified
Materials actually 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.
Why unverified: This does not claim all dose studies are absent. Optimal dose/dose response could not be established within the current input scope.
Reason for missing information: This does not claim all dose studies are absent. Optimal dose/dose response could not be established within the current input scope.
Required materials and conditions: Direct dose comparisons for the same extract, composition and adherence
Materials to obtain first: Direct dose groups, batch composition and estimates/CI
Further research: Material needed: Direct dose groups, batch composition and estimates/CI. This records needed materials; no new research was executed.
Remaining uncertainty: This does not claim all dose studies are absent. Optimal dose/dose response could not be established within the current input scope.
Conditions for verification: Separate the current 400 mg dose from the gap for a distinct dose question.
Why this condition is needed: Do not extend one single dose to an optimal-dose claim.
Application exceptions: Do not make dose-optimization research a completion requirement for this narrow add-on question.
Referenced methods: 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.

Related sources S1

N24 · Does this answer recurrence, persistence or prevention questions?

Current findings: The original scope note states that only 2-hour pain relief is judged; pain freedom, recurrence and prevention are separate.
Verification status: Met
Materials actually 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.
Why unverified: Only the current extension boundary is confirmed. Evidence quantity and effects for each extension were not reviewed this time.
Reason for missing information: Only the current extension boundary is confirmed. Evidence quantity and effects for each extension were not reviewed this time.
Required materials and conditions: Pain/rescue medication after 2 hours, recurrence and prevention questions
Materials to obtain first: Subsequent follow-up, recurrence definitions and separate prevention material
Further research: Material needed: Subsequent follow-up, recurrence definitions and separate prevention material. This records needed materials; no new research was executed.
Remaining uncertainty: Only the current extension boundary is confirmed. Evidence quantity and effects for each extension were not reviewed this time.
Conditions for verification: Distinguish the original 2-hour result from later-outcome and prevention questions.
Why this condition is needed: Do not extend single-dose pain-relief results to long-term prevention or reduced recurrence.
Application exceptions: Prevention ID3009 is not read/converted in this sheet or imposed as a requirement for the narrow question.
Referenced methods: 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.

Related sources S1

N25 · What independent replications match the same formulation and add-on comparison?

Current findings: S1 direct add-on reporting is distinguished from S2 active-comparator context; the existing R1/I2 values are historical axes.
Verification status: Unverified
Materials actually 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.
Why unverified: The 2 retained reports alone do not establish total unique trials/participants or product-matched independent replication.
Reason for missing information: The 2 retained reports alone do not establish total unique trials/participants or product-matched independent replication.
Required materials and conditions: Unique report/trial families and matching product, common treatment, endpoint and time
Materials to obtain first: Original trial families, related reports, product matching and trial-specific results
Further research: Material needed: Original trial families, related reports, product matching and trial-specific results. This records needed materials; no new research was executed.
Remaining uncertainty: The 2 retained reports alone do not establish total unique trials/participants or product-matched independent replication.
Conditions for verification: Distinguish currently linked reports from unestablished total independent families and unique participants.
Why this condition is needed: Do not count S2's different comparison, Korean/English text or bibliography as independent confirmation.
Application exceptions: Do not add the current 2 reports as 2 trials of the same comparison or a total of 160 unique participants.
Referenced methods: 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.

Related sources S1 S2

N26 · What is known about funding, product provision and author interests?

Current findings: S1 describes university research with product/funding details unverified; S2 has funding/product details unverified.
Verification status: Partly verified
Materials actually 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.
Why unverified: Funding, manufacturer support, author employment/patents and declared COI were not checked in the original papers this time.
Reason for missing information: Funding, manufacturer support, author employment/patents and declared COI were not checked in the original papers this time.
Required materials and conditions: University research, funding, product support, author employment/patents and declared COI
Materials to obtain first: Original funding, product-provision and author/COI statements for both reports
Further research: Material needed: Original funding, product-provision and author/COI statements for both reports. This records needed materials; no new research was executed.
Remaining uncertainty: Funding, manufacturer support, author employment/patents and declared COI were not checked in the original papers this time.
Conditions for verification: Link each report's specified support and each unverified aspect separately.
Why this condition is needed: Do not read a university label or historical I2 as independent funding or absence of bias.
Application exceptions: Generic English funding wording is not specific COI-verification material.
Referenced methods: 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.

Related sources S1 S2

N27 · Which adverse events were collected, and how?

Current findings: Retained safety information concerns cautions about NSAID contraindications, gastrointestinal/renal/bleeding risks and interactions with other migraine medicines; no event table is retained.
Verification status: Unverified
Materials actually 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.
Why unverified: Event names, collection/adjudication, severity and discontinuation could not be established from the current summary. Nonreporting throughout the original paper remains unverified.
Reason for missing information: Event names, collection/adjudication, severity and discontinuation could not be established from the current summary. Nonreporting throughout the original paper remains unverified.
Required materials and conditions: Event definitions, collection methods, severity, discontinuation and group results
Materials to obtain first: S1 safety-result tables and event/collection definitions
Further research: Material needed: S1 safety-result tables and event/collection definitions. This records needed materials; no new research was executed.
Remaining uncertainty: Event names, collection/adjudication, severity and discontinuation could not be established from the current summary. Nonreporting throughout the original paper remains unverified.
Conditions for verification: Show the verification scope for actual events separately from historical caution wording.
Why this condition is needed: Do not turn caution wording into adverse events observed in the trial.
Application exceptions: Distinguish NSAID-related cautions from observed events in the ginger add-on comparison.
Referenced methods: 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.

Related sources S1

N28 · What is the timeline of events and recovery after exposure?

Current findings: Single administration and 2-hour efficacy follow-up are retained, but an event-onset/recovery timeline is not linked.
Verification status: Unverified
Materials actually 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.
Why unverified: Harm onset/recovery, latency, discontinuation and re-exposure remain unverified.
Reason for missing information: Harm onset/recovery, latency, discontinuation and re-exposure remain unverified.
Required materials and conditions: Administration, event onset, recovery and discontinuation/re-exposure times
Materials to obtain first: Harm-onset/recovery and discontinuation/re-exposure records
Further research: Material needed: Harm-onset/recovery and discontinuation/re-exposure records. This records needed materials; no new research was executed.
Remaining uncertainty: Harm onset/recovery, latency, discontinuation and re-exposure remain unverified.
Conditions for verification: Separate known administration/follow-up from the unverified event timeline.
Why this condition is needed: Do not turn single-dose 2-hour efficacy follow-up into sufficient harm observation.
Application exceptions: Do not infer improvement after discontinuation or re-exposure information when unavailable.
Referenced methods: 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.

Related sources S1

N29 · What is the actual comparison for harms?

Current findings: The efficacy comparison is common ketoprofen plus ginger extract versus common ketoprofen plus placebo. The summary does not provide between-group safety results.
Verification status: Unverified
Materials actually 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.
Why unverified: Comparative-harm estimates were not verified; this does not mean both groups were safe or the difference was 0.
Reason for missing information: Comparative-harm estimates were not verified; this does not mean both groups were safe or the difference was 0.
Required materials and conditions: Between-group safety estimates for extract versus placebo on common ketoprofen
Materials to obtain first: Group safety events, denominators and reported risk estimates/CI
Further research: Material needed: Group safety events, denominators and reported risk estimates/CI. This records needed materials; no new research was executed.
Remaining uncertainty: Comparative-harm estimates were not verified; this does not mean both groups were safe or the difference was 0.
Conditions for verification: Show common/additional exposure and unverified comparative-harm material.
Why this condition is needed: An efficacy comparator does not establish a verified difference in harms.
Application exceptions: Do not extrapolate background risk rates or convert this to a no-treatment comparison.
Referenced methods: 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.

Related sources S1

N30 · Are denominators available for harm frequency?

Current findings: Beyond the overall 60 randomized, safety-exposure/analysis denominators and event counts are not currently linked.
Verification status: Unverified
Materials actually 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.
Why unverified: Incidence, risk ratios and overall event totals cannot be calculated or established.
Reason for missing information: Incidence, risk ratios and overall event totals cannot be calculated or established.
Required materials and conditions: Safety-exposed population, people with events/event counts, period and collection scope
Materials to obtain first: Safety-analysis population, group event counts and exposure time
Further research: Material needed: Safety-analysis population, group event counts and exposure time. This records needed materials; no new research was executed.
Remaining uncertainty: Incidence, risk ratios and overall event totals cannot be calculated or established.
Conditions for verification: Show frequencies only for original reported values linking exposure, events and time.
Why this condition is needed: Do not reuse the total 60 as a safety denominator or a denominator for 0 events.
Application exceptions: Do not calculate incidence from P values, caution wording or original C50.
Referenced methods: 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.

Related sources S1

N31 · Can concomitant exposures and alternative causes be distinguished?

Current findings: Common ketoprofen 100 mg and caution wording about interactions with other medicines are retained.
Verification status: Partly verified
Materials actually 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.
Why unverified: Actual individual concomitant use, baseline events, alternative causes and adjustment are unverified. Original caution wording is not evidence of causality for observed events.
Reason for missing information: Actual individual concomitant use, baseline events, alternative causes and adjustment are unverified. Original caution wording is not evidence of causality for observed events.
Required materials and conditions: IV ketoprofen, other migraine medicines, baseline/concomitant exposures and adjustment
Materials to obtain first: Concomitant medicines, baseline risk and event-specific alternative causes/adjustment
Further research: Material needed: Concomitant medicines, baseline risk and event-specific alternative causes/adjustment. This records needed materials; no new research was executed.
Remaining uncertainty: Actual individual concomitant use, baseline events, alternative causes and adjustment are unverified. Original caution wording is not evidence of causality for observed events.
Conditions for verification: Distinguish specified common medicine from unverified concomitant/baseline information and alternative explanations.
Why this condition is needed: Do not attribute potential harm causally to ginger alone.
Application exceptions: Unavailable information about other causes does not mean other causes are absent.
Referenced methods: 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.

Related sources S1

N32 · What is missing from harm reporting and follow-up?

Current findings: The current summary contains caution wording, while safety collection/follow-up and event-disclosure scope remain unverified.
Verification status: Unverified
Materials actually 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.
Why unverified: Collection methods, follow-up losses and detection differences in the original full text were not compared this time.
Reason for missing information: Collection methods, follow-up losses and detection differences in the original full text were not compared this time.
Required materials and conditions: Systematic/spontaneous collection, detection, attrition and complete event disclosure
Materials to obtain first: Safety collection, follow-up/attrition and disclosure scope
Further research: Material needed: Safety collection, follow-up/attrition and disclosure scope. This records needed materials; no new research was executed.
Remaining uncertainty: Collection methods, follow-up losses and detection differences in the original full text were not compared this time.
Conditions for verification: Connect the summary actually read to unverified collection and missingness.
Why this condition is needed: An unavailable event table does not mean events did not occur.
Application exceptions: Possible bias is not an established bias magnitude or proof that the trial is invalid.
Referenced methods: 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.

Related sources S1

N33 · Can independent repetitions of the same harm be counted?

Current findings: Korean/English safety guidance and product-fact cautions belong to the same original record; unique harm events are not established in the 2 efficacy reports.
Verification status: Unverified
Materials actually 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.
Why unverified: Unique harm-event counts and repetition of the same event cannot be established from the current input.
Reason for missing information: Unique harm-event counts and repetition of the same event cannot be established from the current input.
Required materials and conditions: Unique event/trial families, exposure/event matching and repeated citation
Materials to obtain first: Original event data, families/related reports and exposure matching
Further research: Material needed: Original event data, families/related reports and exposure matching. This records needed materials; no new research was executed.
Remaining uncertainty: Unique harm-event counts and repetition of the same event cannot be established from the current input.
Conditions for verification: Explain material types, family/exposure relationships and unestablished repetition counts.
Why this condition is needed: Do not count the same caution wording and Korean/English recitation as independent events.
Application exceptions: Do not automatically link a different S2 formulation or administrative data as recurrence of the same event.
Referenced methods: 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.

Related sources S1 S2

N34 · What harms or vulnerable groups lie beyond the short follow-up?

Current findings: Original cautions mention NSAID contraindications, gastrointestinal/renal/bleeding risks and interactions with other migraine medicines; direct efficacy concerns one dose and 2 hours.
Verification status: Unverified
Materials actually 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.
Why unverified: Actual denominators/frequencies in vulnerable groups and long-term/rare events, and interaction estimates, remain unverified.
Reason for missing information: Actual denominators/frequencies in vulnerable groups and long-term/rare events, and interaction estimates, remain unverified.
Required materials and conditions: Long-term/rare events, baseline risk, interactions and exposure duration
Materials to obtain first: Vulnerable-group, long-term/rare-event and concomitant-treatment material
Further research: Material needed: Vulnerable-group, long-term/rare-event and concomitant-treatment material. This records needed materials; no new research was executed.
Remaining uncertainty: Actual denominators/frequencies in vulnerable groups and long-term/rare events, and interaction estimates, remain unverified.
Conditions for verification: Distinguish direct exposure scope from gaps in separate vulnerable-group/long-term questions.
Why this condition is needed: Do not extend an emergency-department single-dose 2-hour result to overall safety.
Application exceptions: Do not require all rare-harm trials as completion conditions for the narrow efficacy sheet.
Referenced methods: 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.

Related sources S1

N35 · What can this material say about safety?

Current findings: The existing Caution label and cautions about medical care/concomitant ketoprofen are retained; no new safety conclusion is made.
Verification status: Partly verified
Materials actually 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.
Why unverified: Original cautions are retained information. Observed harms, incidence, causality or safety are not currently established.
Reason for missing information: Original cautions are retained information. Observed harms, incidence, causality or safety are not currently established.
Required materials and conditions: Observed events, comparison, denominators, time, alternatives and original cautions
Materials to obtain first: Original material linking events, exposure, comparison, time and alternative explanations
Further research: Material needed: Original material linking events, exposure, comparison, time and alternative explanations. This records needed materials; no new research was executed.
Remaining uncertainty: Original cautions are retained information. Observed harms, incidence, causality or safety are not currently established.
Conditions for verification: Distinguish retained cautions from unverified events, comparisons, denominators and causality.
Why this condition is needed: Do not turn a Caution label into established harm causality, absence of harm or personal dosing advice.
Application exceptions: Do not run new efficacy/safety scoring or causal-assessment tools.
Referenced methods: 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.

Related sources S1