Intravenous tranexamic acid × Improved 90-day functional status in spontaneous intracerebral hemorrhage

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	Partly verified	Full text not readStored summary read	N01 · Evidence conditionSelected 90-day functional question and original valuesRequired	The selected subclaim is ‘Improved 90-day functional status’, graded D with a note that the prespecified primary endpoint was null at P=.11. Subclaim score/status/axes are absent; the parent D34 is not used to fill a subclaim score. S01 S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Subclaim score/status/axes are absent; early imaging/death results are not transferred to functional improvement. Existing content review remains incomplete.	Distinguish the existing grade/note from the parent score/axes	Proposed follow-up research specifying the functional endpoint/timepoint; no new search, calculation or trial was performed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionSpontaneous intracerebral hemorrhage and populationRequired	The original scope is acute spontaneous intracerebral hemorrhage not caused by anticoagulation, trauma or structural lesions. Established benefits in trauma/postpartum hemorrhage or other causes are not transferred to the selected functional result. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Detailed eligibility, age/baseline severity, recruitment, exclusions and between-group balance remain unverified. Existing content review remains incomplete.	Actual scope of acuity/cause, eligibility and baseline risk	Proposed follow-up comparative research specifying the population/indication; no new search, calculation or trial was performed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionIntravenous 2 g within eight hours: research exposureRequired	Only the research exposure of intravenous tranexamic acid 2 g within eight hours of acute hemorrhage is preserved. No administration/selection procedure, timing-specific effect or instructions for other doses/routes are created. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Actual administration/onset times, product/batch, exposure/discontinuation and timing-specific analyses remain unverified. Existing content review remains incomplete.	Distinguish the original drug/route/timing from actual exposure	Proposed follow-up research distinguishing route/timing and population specifications; no new search, calculation or trial was performed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionIdentical packs and saline comparatorRequired	The original record states that Sharp Clinical Services prepared active drug/saline placebo in identical packs at trial expense. This is not changed to donated product support or confirmation of all contact/masking maintenance. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original preparation/product, payment, concurrent treatment/contact, masking maintenance and role materials remain unread. Existing content review remains incomplete.	Trial-drug/placebo preparation, support, sensory characteristics and contact specifications	Proposed research disclosing the actual comparator and preparation/support roles; no new search, calculation or trial was performed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionCentral allocation, minimization and concealmentRequired	The manuscript records real-time central allocation through a secure website, country stratification, minimization on prognostic factors and allocation concealment. This is not upgraded to current certification of procedures/allocation records. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original variables, sequence/implementation, exceptions, baseline balance and protocol remain unread. Existing content review remains incomplete.	Historical allocation procedures and scope of actual original-material access	Proposed follow-up trials disclosing allocation procedures; no new search, calculation or trial was performed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionMasking and 90-day collectionRequired	The original description of concealment from patients/assessors/clinical staff and masked collection of 90-day mRS is preserved. This does not declare current original-material reading, masking-maintenance or expectation-effect verification. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original roles, maintenance/unmasking, actual collection methods and assessor training/adjudication details remain unread. Existing content review remains incomplete.	Masking scope for participants, assessment, clinical care and mRS collection	Proposed research specifying masking of measurement/adjudication; no new search, calculation or trial was performed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionmRS 0–6, direction and distributionRequired	mRS ranges from 0, no symptoms, to 6, death, with lower scores better; the TICH-2 endpoint is distribution shift at 90 days. This is not changed to a mean score, specific threshold or survival-only result. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Category-specific distributions, adjudication/collection, model categories/direction and clinical importance remain unverified. Existing content review remains incomplete.	Scale definitions and distinction of distribution shift from means/thresholds	Proposed follow-up research specifying differences between distributions, thresholds and importance; no new search, calculation or trial was performed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence condition90 days and actual assessment windowRequired	The prespecified primary endpoint is modified Rankin functional status at 90 days. Seven-day death, 24-hour hematoma expansion and long-term functional/daily-life outcomes are not combined as the same timepoint/endpoint. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Assessment windows, individual follow-up, period-specific missingness and later function/survival remain unverified. Existing content review remains incomplete.	Distinguish the original timepoint from assessment/follow-up and other periods	Proposed follow-up research separating timepoints, function and survival outcomes; no new search, calculation or trial was performed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionTICH-2 adjusted OR, CI and PRequired	Adjusted OR 0.88 (95% CI 0.76–1.03), P=.11 is preserved. No new between-group difference, RR, mean score, CI or individual response proportion is calculated. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original model/covariates, proportional-odds/category handling, exact distributions and sensitivity analyses remain unread. Existing content review remains incomplete.	Distinguish the original shift estimand from new effects/proportions	Proposed follow-up research disclosing the original estimand/precision; no new search, calculation or trial was performed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionCI, meaningful benefits and the null resultRequired	The manuscript records that no minimum clinically important between-group difference was declared, so the CI cannot be said to exclude all meaningful benefits. A null result is not newly certified as exactly zero effect, equivalence or no effect in every population. S01 S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified importance/success/equivalence criteria and a sufficient range for the exact effect remain unverified. Existing content review remains incomplete.	Scope of nonsignificance versus importance/equivalence	Proposed research distinguishing effects/importance and question scope; no new search, calculation or trial was performed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence condition2,325 participants, countries/hospitals and denominatorsRequired	Twelve countries, 124 hospitals and 2,325 participants (1,161/1,164) are preserved. Countries/hospitals, groups, timepoints and events are not summed as new independent trials/participants. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Group-specific 90-day observation/analysis, hospital/country distributions and risk/effective denominators remain unverified. Existing content review remains incomplete.	Randomized population versus 90-day observation and multicenter/group units	Proposed follow-up research distinguishing recruitment, observation and analysis units; no new search, calculation or trial was performed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence condition90-day 2,307/2,325 and 99.2%Required	The original wording that 90-day mRS was available in 2,307/2,325 participants, 99.2%, is preserved. No new missing counts/proportions are calculated, and this is not changed to complete observation of every endpoint/timepoint. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Group-specific missingness/dropout reasons, categories/timepoints, handling/sensitivity and actual analysis denominators remain unverified. Existing content review remains incomplete.	Distinguish the original availability rate from missingness/analysis populations	Proposed research distinguishing availability/missingness from estimation populations; no new search, calculation or trial was performed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionITT and retaining allocated groupsRequired	The original description of ITT retaining participants in their minimization-allocated groups is preserved. Actual mRS measurements for everyone, absence of missing-data effects or model details are not stated as verified in this work. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original inclusion/exclusion, missing-data/model and PPS/sensitivity materials remain unread. Existing content review remains incomplete.	Historical analysis principles and current original-material access scope	Proposed research separately disclosing allocation, observation and actual-exposure analyses; no new search, calculation or trial was performed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionRegistration, prespecified primary endpoint and combined identifiersRequired	The original registration-identifier value in the evidence list is ISRCTN93732214 · EudraCT 2012-004108-37. Historical statements of agreement with the prespecified 90-day mRS and registration before recruitment are preserved; full registration/plan materials remain unread in this work. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Registration dates/changes, protocol/SAP and full analysis specifications remain unread. Existing content review remains incomplete.	Descriptions of prerecruitment registration/endpoint agreement versus full plans	Proposed research publicly linking prespecified plans with actual analyses; no new search, calculation or trial was performed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionEarly secondary hematoma/death outcomesRequired	Reduced 24-hour hematoma expansion and seven-day death are secondary signals. They are not promoted to successful 90-day functional recovery, a primary endpoint or independent confirmation. S01 S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Counts/denominators, CI/P, prespecified hierarchy/multiplicity and measurement/analysis specifications for each secondary outcome remain unverified. Existing content review remains incomplete.	Hierarchy of 24-hour imaging, seven-day death and 90-day primary function	Proposed research distinguishing primary function from early death/imaging outcomes; no new search, calculation or trial was performed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionDeath/dependence sensitivity analysisRequired	The original record states that the 90-day death-or-dependence sensitivity analysis was also statistically null. No specific mRS threshold, exact effect or CI is newly filled, and other functional outcomes are not treated as the same result. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Death/dependence definitions, threshold, denominators/estimates/CI and model remain unverified. Existing content review remains incomplete.	Distinguish distribution shift from other definitions/sensitivity analyses	Proposed research separately reporting the primary distribution and sensitivity/threshold results; no new search, calculation or trial was performed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionIPD meta-analysis: poor function and ORRequired	S02 originally records null 90-day poor function: 53.2% vs 53.6%, adjusted common OR 0.93 (95% CI 0.81–1.07). This does not replace TICH-2’s distribution OR 0.88 as the same original result or a newly pooled value. S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Poor-function threshold/definition, distribution/common-OR model, proportion denominators and time/exposure correspondence remain unverified. Existing content review remains incomplete.	Distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution	Proposed follow-up evidence synthesis distinguishing functional definitions/estimands; no new search, calculation or trial was performed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionNine trials/3,194 and IPD from five/2,860Required	The original meta-analysis counts are nine trials/3,194 participants, with IPD supplied by five trials/2,860 participants (90%). These are not added to TICH-2, and remaining counts/proportions or new effects are not calculated. S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Included-trial lists/cohort correspondence, missing IPD/variable-specific denominators, duplication/weighting and data acquisition remain unread. Existing content review remains incomplete.	Distinguish reported aggregates/individual data from unique participants/overlap	Proposed research separately disclosing inclusion, acquisition, overlap and denominators; no new search, calculation or trial was performed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionMeta-analysis early death and imagingRequired	The original meta-analysis record states significant reductions in seven-day death/hematoma expansion and an adjusted OR of 0.70 for seven-day death. These are not used as success for the selected 90-day functional question or as the same estimand. S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Definitions/denominators/CI/P, multiplicity/plans and trial-specific correspondence for each early outcome remain unverified. Existing content review remains incomplete.	Separate meta-analysis results for 90-day function versus seven-day death/hematoma	Proposed research separately synthesizing early and long-term endpoints; no new search, calculation or trial was performed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionMeta-analysis/authors, original R1 and independenceRequired	Because meta-analysis authors overlapped with TICH-2 investigators and 90-day mRS was not primary in component trials, the original verdict did not count independent replication and retained R1. The same trials, references, follow-up or synthesis reports are not used as new independent-trial/participant totals. S01 S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Included-trial/author/endpoint correspondence, unique clinical totals and independent replication are not newly established. Existing content review remains incomplete.	Synthesis reports versus unique trials, endpoint hierarchy and author relationships	Proposed follow-up independent comparative research with the same functional specifications; no new search, calculation or trial was performed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionMeta-analysis funding and registration: preserved recordsRequired	S02’s funding field preserves ‘All included trials were at low risk of bias’, and its registration-identifier value is ‘Not applicable’. These are not used as verification of actual funding/no registration or as current bias assessment of individual trials. S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original synthesis-report funding/COI, review registration/protocol and bias-domain/assessment materials remain unread. Existing content review remains incomplete.	Distinguish original fields from funding/registration verification	Proposed research disclosing synthesis plans, support and assessment scope; no new search, calculation or trial was performed.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionConcurrent treatment and timing/group analysesRequired	The original scope is a placebo comparison in acute spontaneous intracerebral hemorrhage within eight hours. Absence of effects from other treatments/lifestyle, actual exposure or timing/subgroups is not verified. S01	Information currently required is unverified in the preserved summary. Concurrent treatments/drugs, procedures, group-specific contact/timing, subgroups/interactions and analyses remain unverified. Existing content review remains incomplete.	Distinguish the study drug from concurrent acute treatment/exposure	Proposed research distinguishing concurrent treatment from study exposure; no new search, calculation or trial was performed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionNIHR/Swiss support and trial sponsorRequired	The original record states support from the NIHR HTA Programme and Swiss Heart Foundation, with Nottingham as trial sponsor. Public/foundation funding does not newly certify absence of all relationships/roles or independence. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original funding/sponsorship agreements, data/analysis/publication rights and author COI remain unread. Existing content review remains incomplete.	Support organizations and the University of Nottingham’s role	Proposed research separately disclosing support and research roles; no new search, calculation or trial was performed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionPreparation expense and pharmaceutical/analysis/writing supportRequired	The original record states that Sharp prepared identical packs at trial expense and no pharmaceutical donation, analysis, medical writing or publication funding was reported. Unreported items are not judged actually absent. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original agreements/provision, support-specific roles, author relationships and external analysis/writing materials remain unread. Existing content review remains incomplete.	Trial-expense preparation versus donated support/unreported items	Proposed research distinguishing support items from preparation/research roles; no new search, calculation or trial was performed.
25	Partly verified	Full text not readStored summary read	N25 · Harm-information gaps supplementing the efficacy tableSeizures, thrombosis and serious adverse eventsSupplementary	The original record states seizures in 77 (7%) vs 85 (7%), no increase in venous thromboembolism and fewer serious adverse events through 90 days. These are not used as success on primary function or absence of all harms. S01	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Definitions/collection, group denominators/frequencies, relatedness/severity, effects/CI and long-term harms for each adverse outcome remain unverified. Existing content review remains incomplete.	Distinguish separate safety endpoints/denominators from functional efficacy	Proposed research separating harms from functional efficacy; no new search, calculation or trial was performed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionOther indications/periods and generalizationRequired	The preserved summary states that benefits in trauma/postpartum hemorrhage concern separate indications. This is not extended to other causes/doses/routes, emergency treatment/procedural guidance or long-term functional effects. S01 S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Direct functional comparisons under other specifications and later persistence/long-term harms remain unverified. Existing content review remains incomplete.	Original spontaneous hemorrhage/route/timing versus separate effects	Proposed research distinguishing directness across indications/periods; no new search, calculation or trial was performed.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionOriginal axes, Korean/English text, dates and correctionsRequired	Parent D34, B/P/R1/I2/E0/B0/C0, three false markers, empty override reasons and subclaim grade D are preserved. The summary’s 2026 meta-analysis label, 2026-08-26 date, Korean/English manuscripts, empty corrections/deliberation and cross-validation are not inherited as a current latest search or review in this work. S01 S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score/status/axes are not filled from parent values; original dates/history are not changed. Existing content review remains incomplete.	Distinguish parent/subclaim values, verdict date/meta-analysis year and history	Proposed research distinguishing original values/history from the scope of update materials; no new search, calculation or trial was performed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionActual summary reading, links and gapsRequired	The complete preserved summary and references were used for production, and links are retained. External TICH-2/meta-analysis, registration, protocol/SAP and support/COI originals remain unread, with no access attempted or separate external-link testing. S01 S02	Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. External contents, included-trial correspondence and actual acquisition/accessibility remain unverified. Existing content review remains incomplete.	Preserved summary versus external trial/meta-analysis/registration/plan access	Proposed research updating records with actual acquisition, timing and scope distinguished; no new search, calculation or trial was performed.

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28 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: TICH-2 population with acute spontaneous intracerebral hemorrhage within eight hours of onset. Original exclusions such as anticoagulation, trauma and structural-lesion causes are preserved. Twelve countries, 124 hospitals, 2,325 randomized participants (1,161/1,164) and 90-day mRS observed in 2,307/2,325 (99.2%) are recorded as separate original denominators. Recruitment, group-specific missingness and missing-data assumptions remain unverified.
Ingredient, formulation and route: The original study exposure of intravenous tranexamic acid, 2 g total within eight hours of onset, is preserved. Results from other indications such as trauma/postpartum hemorrhage are not transferred to this functional question, and administration/treatment procedures are not created.
Dose: The original study conditions of 2 g within eight hours are distinguished from actual individual administration, timing and adherence. Original detailed administration/discontinuation and time/dose subgroup materials remain unverified; no new conversion or administration guidance is created.
Comparator: Active drug versus saline placebo in identical packaging. Historical original descriptions of central allocation, country stratification/minimization on prognostic factors, role-specific concealment/masking and ITT are preserved without inheriting them as original-procedure verification. Concurrent treatment, actual individual exposure and analysis details remain unverified.
Measured outcome: Selected question: improved 90-day functional status. TICH-2’s mRS 0–6, lower-is-better distribution-shift adjusted OR 0.88 (95% CI 0.76–1.03), P=.11 is preserved. Death/dependence sensitivity analysis, 24-hour hematoma expansion and seven-day death signals are separate results. The 2026 IPD meta-analysis reports 90-day poor function at 53.2% vs 53.6%, adjusted common OR 0.93 (0.81–1.07), a separate estimand with an unspecified threshold; it is not used as a recalculation of the same distribution shift.
Duration: TICH-2’s prespecified 90-day functional status is separated from early 24-hour/seven-day outcomes. Actual individual assessment windows, later function and long-term results remain unverified. The IPD meta-analysis’s 90-day outcome and early seven-day death adjusted OR 0.70 also remain within separate original-report scopes.
Questions outside this scope: Mixing TICH-2 mRS distribution shift with IPD meta-analysis poor-function thresholds/estimands/denominators, or creating new effects/CI; Promoting 24-hour hematoma expansion/seven-day death to 90-day functional efficacy; Changing death/dependence sensitivity or nonsignificance to certification of equivalence, zero effect or exclusion of all important benefits; Summing meta-analysis nine trials/3,194, IPD five trials/2,860 and TICH-2, reports, groups, timepoints or sibling sheets as new independent trials/participants; Inheriting original R1, author overlap or historical cross-validation as new independence certification; Changing bias-risk wording preserved in the meta-analysis funding field to funding verification, or changing the registration-identifier record’s Not applicable to verified absence of registration/plans; Transferring results to other indications/formulations, periods or populations; Inheriting parent score/axes or historical narratives as subclaim score, current review or original-text reading; New calculations, invented values, effects/CI, grades, independence certification or medication/antisepsis/surgery/treatment implementation guidance

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.

S01 · Sprigg N et al. 2018 TICH-2

PubMed

Material type: International multicenter double-blind randomized placebo-controlled phase 3 trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: Adjusted OR 0.88 (95% CI 0.76–1.03), P=0.11; graded D. In TICH-2’s 2,325 participants, adjusted OR for 90-day mRS distribution shift was 0.88 (95% CI 0.76–1.03), P=0.11, a null result. The individual-patient-data meta-analysis described as latest in the preserved manuscript also had a null 90-day poor-functional-outcome result: 53.2% vs 53.6%, adjusted common OR 0.93 (95% CI 0.81–1.07). The manuscript records the same conclusion across the randomized evidence available to it, beyond TICH-2 alone.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 TICH-2 reports randomization of 2,325 participants (1,161/1,164) with spontaneous intracerebral hemorrhage across 124 hospitals in 12 countries. Observed 90-day mRS in 2,307/2,325 (99.2%) and mRS distribution-shift OR 0.88 (95% CI 0.76–1.03)/P=.11 are preserved and distinguished from 24-hour hematoma expansion, seven-day death and death/dependence sensitivity analysis. Participants, groups, timepoints, early endpoints, the same references and sibling sheets are not summed as new independent trials/participants. Report/material counts are not unique clinical-trial/participant/independent-replication totals; no new summing or independence certification is performed. S02 is the preserved 2026 systematic-review/IPD-meta-analysis report. Nine trials/3,194 participants overall, IPD from five trials/2,860 participants (90%), and 90-day poor function at 53.2% vs 53.6%, adjusted common OR 0.93 (0.81–1.07), are recorded as separate synthesis results. Component-trial lists/IPD correspondence, detailed TICH-2 inclusion relationships and thresholds remain externally unread. The manuscript’s overall evidence relationships, TICH-2 author overlap and original R1 judgment are preserved as history; current independence is not certified. Early seven-day death OR 0.70 and hematoma results are not changed to primary functional results. This synthesis is not turned into a new independent RCT or nine new reports, or added to TICH-2 participants. Report/material counts are not unique clinical-trial/participant/independent-replication totals; no new summing or independence certification is performed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · 2026 individual-patient-data meta-analysis of tranexamic acid

PubMed

Material type: Systematic review and individual-patient-data meta-analysis of randomized trials in acute spontaneous intracerebral hemorrhage
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: At 90 days, 53.2% vs 53.6%, adjusted common OR 0.93 (95% CI 0.81–1.07); significant reductions in seven-day death and hematoma expansion (adjusted OR 0.70 for seven-day death). The original funding-field wording All included trials were at low risk of bias does not identify a funder, and the original registration-identifier record’s Not applicable does not verify absence of a synthesis plan/registration.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 TICH-2 reports randomization of 2,325 participants (1,161/1,164) with spontaneous intracerebral hemorrhage across 124 hospitals in 12 countries. Observed 90-day mRS in 2,307/2,325 (99.2%) and mRS distribution-shift OR 0.88 (95% CI 0.76–1.03)/P=.11 are preserved and distinguished from 24-hour hematoma expansion, seven-day death and death/dependence sensitivity analysis. Participants, groups, timepoints, early endpoints, the same references and sibling sheets are not summed as new independent trials/participants. Report/material counts are not unique clinical-trial/participant/independent-replication totals; no new summing or independence certification is performed. S02 is the preserved 2026 systematic-review/IPD-meta-analysis report. Nine trials/3,194 participants overall, IPD from five trials/2,860 participants (90%), and 90-day poor function at 53.2% vs 53.6%, adjusted common OR 0.93 (0.81–1.07), are recorded as separate synthesis results. Component-trial lists/IPD correspondence, detailed TICH-2 inclusion relationships and thresholds remain externally unread. The manuscript’s overall evidence relationships, TICH-2 author overlap and original R1 judgment are preserved as history; current independence is not certified. Early seven-day death OR 0.70 and hematoma results are not changed to primary functional results. This synthesis is not turned into a new independent RCT or nine new reports, or added to TICH-2 participants. Report/material counts are not unique clinical-trial/participant/independent-replication totals; no new summing or independence certification is performed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

S01 TICH-2 reports randomization of 2,325 participants (1,161/1,164) with spontaneous intracerebral hemorrhage across 124 hospitals in 12 countries. Observed 90-day mRS in 2,307/2,325 (99.2%) and mRS distribution-shift OR 0.88 (95% CI 0.76–1.03)/P=.11 are preserved and distinguished from 24-hour hematoma expansion, seven-day death and death/dependence sensitivity analysis. Participants, groups, timepoints, early endpoints, the same references and sibling sheets are not summed as new independent trials/participants. Report/material counts are not unique clinical-trial/participant/independent-replication totals; no new summing or independence certification is performed. S02 is the preserved 2026 systematic-review/IPD-meta-analysis report. Nine trials/3,194 participants overall, IPD from five trials/2,860 participants (90%), and 90-day poor function at 53.2% vs 53.6%, adjusted common OR 0.93 (0.81–1.07), are recorded as separate synthesis results. Component-trial lists/IPD correspondence, detailed TICH-2 inclusion relationships and thresholds remain externally unread. The manuscript’s overall evidence relationships, TICH-2 author overlap and original R1 judgment are preserved as history; current independence is not certified. Early seven-day death OR 0.70 and hematoma results are not changed to primary functional results. This synthesis is not turned into a new independent RCT or nine new reports, or added to TICH-2 participants. Report/material counts are not unique clinical-trial/participant/independent-replication totals; no new summing or independence certification is performed.

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 · Selected 90-day functional question and original values

Required materials and conditions: Distinguish the existing grade/note from the parent score/axes
Conditions for verification: Corresponding original materials and analysis scope for distinguish the existing grade/note from the parent score/axes should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish the existing grade/note from the parent score/axes and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

N02 · Spontaneous intracerebral hemorrhage and population

Required materials and conditions: Actual scope of acuity/cause, eligibility and baseline risk
Conditions for verification: Corresponding original materials and analysis scope for actual scope of acuity/cause, eligibility and baseline risk should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing actual scope of acuity/cause, eligibility and baseline risk and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP

N03 · Intravenous 2 g within eight hours: research exposure

Required materials and conditions: Distinguish the original drug/route/timing from actual exposure
Conditions for verification: Corresponding original materials and analysis scope for distinguish the original drug/route/timing from actual exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish the original drug/route/timing from actual exposure and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

N04 · Identical packs and saline comparator

Required materials and conditions: Trial-drug/placebo preparation, support, sensory characteristics and contact specifications
Conditions for verification: Corresponding original materials and analysis scope for trial-drug/placebo preparation, support, sensory characteristics and contact specifications should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing trial-drug/placebo preparation, support, sensory characteristics and contact specifications and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed; Chamgap’s own independence/attribution conditions. The official method sections used in this pilot do not warrant every detailed item; M08 Table 8.2.a, M03 §3.2.4; internal application

N05 · Central allocation, minimization and concealment

Required materials and conditions: Historical allocation procedures and scope of actual original-material access
Conditions for verification: Corresponding original materials and analysis scope for historical allocation procedures and scope of actual original-material access should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing historical allocation procedures and scope of actual original-material access and connecting materials needed for the selected question with current materials.
Referenced methods: M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications are internally designed

N06 · Masking and 90-day collection

Required materials and conditions: Masking scope for participants, assessment, clinical care and mRS collection
Conditions for verification: Corresponding original materials and analysis scope for masking scope for participants, assessment, clinical care and mRS collection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing masking scope for participants, assessment, clinical care and mRS collection and connecting materials needed for the selected question with current materials.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP

N07 · mRS 0–6, direction and distribution

Required materials and conditions: Scale definitions and distinction of distribution shift from means/thresholds
Conditions for verification: Corresponding original materials and analysis scope for scale definitions and distinction of distribution shift from means/thresholds should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing scale definitions and distinction of distribution shift from means/thresholds and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4; internal extension boundary

N08 · 90 days and actual assessment window

Required materials and conditions: Distinguish the original timepoint from assessment/follow-up and other periods
Conditions for verification: Corresponding original materials and analysis scope for distinguish the original timepoint from assessment/follow-up and other periods should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish the original timepoint from assessment/follow-up and other periods and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

N09 · TICH-2 adjusted OR, CI and P

Required materials and conditions: Distinguish the original shift estimand from new effects/proportions
Conditions for verification: Corresponding original materials and analysis scope for distinguish the original shift estimand from new effects/proportions should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish the original shift estimand from new effects/proportions and connecting materials needed for the selected question with current materials.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design

N10 · CI, meaningful benefits and the null result

Required materials and conditions: Scope of nonsignificance versus importance/equivalence
Conditions for verification: Corresponding original materials and analysis scope for scope of nonsignificance versus importance/equivalence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing scope of nonsignificance versus importance/equivalence and connecting materials needed for the selected question with current materials.
Referenced methods: M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries

N11 · 2,325 participants, countries/hospitals and denominators

Required materials and conditions: Randomized population versus 90-day observation and multicenter/group units
Conditions for verification: Corresponding original materials and analysis scope for randomized population versus 90-day observation and multicenter/group units should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing randomized population versus 90-day observation and multicenter/group units and connecting materials needed for the selected question with current materials.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application

N12 · 90-day 2,307/2,325 and 99.2%

Required materials and conditions: Distinguish the original availability rate from missingness/analysis populations
Conditions for verification: Corresponding original materials and analysis scope for distinguish the original availability rate from missingness/analysis populations should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish the original availability rate from missingness/analysis populations and connecting materials needed for the selected question with current materials.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N13 · ITT and retaining allocated groups

Required materials and conditions: Historical analysis principles and current original-material access scope
Conditions for verification: Corresponding original materials and analysis scope for historical analysis principles and current original-material access scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing historical analysis principles and current original-material access scope and connecting materials needed for the selected question with current materials.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications are internally designed

N14 · Registration, prespecified primary endpoint and combined identifiers

Required materials and conditions: Descriptions of prerecruitment registration/endpoint agreement versus full plans
Conditions for verification: Corresponding original materials and analysis scope for descriptions of prerecruitment registration/endpoint agreement versus full plans should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing descriptions of prerecruitment registration/endpoint agreement versus full plans and connecting materials needed for the selected question with current materials.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

N15 · Early secondary hematoma/death outcomes

Required materials and conditions: Hierarchy of 24-hour imaging, seven-day death and 90-day primary function
Conditions for verification: Corresponding original materials and analysis scope for hierarchy of 24-hour imaging, seven-day death and 90-day primary function should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing hierarchy of 24-hour imaging, seven-day death and 90-day primary function and connecting materials needed for the selected question with current materials.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M03 §3.2.4; internal extension boundary; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed

N16 · Death/dependence sensitivity analysis

Required materials and conditions: Distinguish distribution shift from other definitions/sensitivity analyses
Conditions for verification: Corresponding original materials and analysis scope for distinguish distribution shift from other definitions/sensitivity analyses should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish distribution shift from other definitions/sensitivity analyses and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application

N17 · IPD meta-analysis: poor function and OR

Required materials and conditions: Distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution
Conditions for verification: Corresponding original materials and analysis scope for distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application

N18 · Nine trials/3,194 and IPD from five/2,860

Required materials and conditions: Distinguish reported aggregates/individual data from unique participants/overlap
Conditions for verification: Corresponding original materials and analysis scope for distinguish reported aggregates/individual data from unique participants/overlap should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish reported aggregates/individual data from unique participants/overlap and connecting materials needed for the selected question with current materials.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are internally applied; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M08 §8.2.2, M15 §15.3.1; internal application

N19 · Meta-analysis early death and imaging

Required materials and conditions: Separate meta-analysis results for 90-day function versus seven-day death/hematoma
Conditions for verification: Corresponding original materials and analysis scope for separate meta-analysis results for 90-day function versus seven-day death/hematoma should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing separate meta-analysis results for 90-day function versus seven-day death/hematoma and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed

N20 · Meta-analysis/authors, original R1 and independence

Required materials and conditions: Synthesis reports versus unique trials, endpoint hierarchy and author relationships
Conditions for verification: Corresponding original materials and analysis scope for synthesis reports versus unique trials, endpoint hierarchy and author relationships should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing synthesis reports versus unique trials, endpoint hierarchy and author relationships and connecting materials needed for the selected question with current materials.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are internally applied; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

N21 · Meta-analysis funding and registration: preserved records

Required materials and conditions: Distinguish original fields from funding/registration verification
Conditions for verification: Corresponding original materials and analysis scope for distinguish original fields from funding/registration verification should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish original fields from funding/registration verification and connecting materials needed for the selected question with current materials.
Referenced methods: Chamgap’s own independence/attribution conditions. The official method sections used in this pilot do not warrant every detailed item; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application

N22 · Concurrent treatment and timing/group analyses

Required materials and conditions: Distinguish the study drug from concurrent acute treatment/exposure
Conditions for verification: Corresponding original materials and analysis scope for distinguish the study drug from concurrent acute treatment/exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish the study drug from concurrent acute treatment/exposure and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed

N23 · NIHR/Swiss support and trial sponsor

Required materials and conditions: Support organizations and the University of Nottingham’s role
Conditions for verification: Corresponding original materials and analysis scope for support organizations and the University of Nottingham’s role should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing support organizations and the University of Nottingham’s role and connecting materials needed for the selected question with current materials.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N24 · Preparation expense and pharmaceutical/analysis/writing support

Required materials and conditions: Trial-expense preparation versus donated support/unreported items
Conditions for verification: Corresponding original materials and analysis scope for trial-expense preparation versus donated support/unreported items should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing trial-expense preparation versus donated support/unreported items and connecting materials needed for the selected question with current materials.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

N25 · Seizures, thrombosis and serious adverse events

Required materials and conditions: Distinguish separate safety endpoints/denominators from functional efficacy
Conditions for verification: Corresponding original materials and analysis scope for distinguish separate safety endpoints/denominators from functional efficacy should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Supplement the selected subclaim’s safety-material gaps. Functional-status/infection efficacy results or parent safety wording do not establish safety or create harms rates or new usage instructions.
Why this condition is needed: Applicability item distinguishing distinguish separate safety endpoints/denominators from functional efficacy and connecting materials needed for the selected question with current materials.
Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application

N26 · Other indications/periods and generalization

Required materials and conditions: Original spontaneous hemorrhage/route/timing versus separate effects
Conditions for verification: Corresponding original materials and analysis scope for original spontaneous hemorrhage/route/timing versus separate effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing original spontaneous hemorrhage/route/timing versus separate effects and connecting materials needed for the selected question with current materials.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed; M03 §3.2.4; internal extension boundary

N27 · Original axes, Korean/English text, dates and corrections

Required materials and conditions: Distinguish parent/subclaim values, verdict date/meta-analysis year and history
Conditions for verification: Corresponding original materials and analysis scope for distinguish parent/subclaim values, verdict date/meta-analysis year and history should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing distinguish parent/subclaim values, verdict date/meta-analysis year and history and connecting materials needed for the selected question with current materials.
Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed

N28 · Actual summary reading, links and gaps

Required materials and conditions: Preserved summary versus external trial/meta-analysis/registration/plan access
Conditions for verification: Corresponding original materials and analysis scope for preserved summary versus external trial/meta-analysis/registration/plan access should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Applicability item distinguishing preserved summary versus external trial/meta-analysis/registration/plan access and connecting materials needed for the selected question with current materials.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

What the statuses mean

Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete: Existing content review remains incomplete.
Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable: Not used as a substitute for an evidence gap.
Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-13 · Public page/material version 1.0

Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

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

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N01 · Selected 90-day functional question and original values

Current findings: The selected subclaim is ‘Improved 90-day functional status’, graded D with a note that the prespecified primary endpoint was null at P=.11. Subclaim score/status/axes are absent; the parent D34 is not used to fill a subclaim score.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Subclaim score/status/axes are absent; early imaging/death results are not transferred to functional improvement. Existing content review remains incomplete.
Reason for missing information: Subclaim score/status/axes are absent; early imaging/death results are not transferred to functional improvement.
Required materials and conditions: Distinguish the existing grade/note from the parent score/axes
Materials to obtain first: Original selected/parent records and user correction comments
Further research: Proposed follow-up research specifying the functional endpoint/timepoint; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish the existing grade/note from the parent score/axes should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish the existing grade/note from the parent score/axes and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01 S02

N02 · Spontaneous intracerebral hemorrhage and population

Current findings: The original scope is acute spontaneous intracerebral hemorrhage not caused by anticoagulation, trauma or structural lesions. Established benefits in trauma/postpartum hemorrhage or other causes are not transferred to the selected functional result.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Detailed eligibility, age/baseline severity, recruitment, exclusions and between-group balance remain unverified. Existing content review remains incomplete.
Reason for missing information: Detailed eligibility, age/baseline severity, recruitment, exclusions and between-group balance remain unverified.
Required materials and conditions: Actual scope of acuity/cause, eligibility and baseline risk
Materials to obtain first: Eligibility/recruitment, baseline characteristics and definitions of cause
Further research: Proposed follow-up comparative research specifying the population/indication; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for actual scope of acuity/cause, eligibility and baseline risk should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing actual scope of acuity/cause, eligibility and baseline risk and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP

Related sources S01

N03 · Intravenous 2 g within eight hours: research exposure

Current findings: Only the research exposure of intravenous tranexamic acid 2 g within eight hours of acute hemorrhage is preserved. No administration/selection procedure, timing-specific effect or instructions for other doses/routes are created.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Actual administration/onset times, product/batch, exposure/discontinuation and timing-specific analyses remain unverified. Existing content review remains incomplete.
Reason for missing information: Actual administration/onset times, product/batch, exposure/discontinuation and timing-specific analyses remain unverified.
Required materials and conditions: Distinguish the original drug/route/timing from actual exposure
Materials to obtain first: Drug/product, onset/administration and actual-exposure materials
Further research: Proposed follow-up research distinguishing route/timing and population specifications; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish the original drug/route/timing from actual exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish the original drug/route/timing from actual exposure and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources S01

N04 · Identical packs and saline comparator

Current findings: The original record states that Sharp Clinical Services prepared active drug/saline placebo in identical packs at trial expense. This is not changed to donated product support or confirmation of all contact/masking maintenance.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original preparation/product, payment, concurrent treatment/contact, masking maintenance and role materials remain unread. Existing content review remains incomplete.
Reason for missing information: Original preparation/product, payment, concurrent treatment/contact, masking maintenance and role materials remain unread.
Required materials and conditions: Trial-drug/placebo preparation, support, sensory characteristics and contact specifications
Materials to obtain first: Preparation/product agreements, contact and masking materials
Further research: Proposed research disclosing the actual comparator and preparation/support roles; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for trial-drug/placebo preparation, support, sensory characteristics and contact specifications should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing trial-drug/placebo preparation, support, sensory characteristics and contact specifications and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed; Chamgap’s own independence/attribution conditions. The official method sections used in this pilot do not warrant every detailed item; M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources S01

N05 · Central allocation, minimization and concealment

Current findings: The manuscript records real-time central allocation through a secure website, country stratification, minimization on prognostic factors and allocation concealment. This is not upgraded to current certification of procedures/allocation records.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original variables, sequence/implementation, exceptions, baseline balance and protocol remain unread. Existing content review remains incomplete.
Reason for missing information: Original variables, sequence/implementation, exceptions, baseline balance and protocol remain unread.
Required materials and conditions: Historical allocation procedures and scope of actual original-material access
Materials to obtain first: Original allocation/minimization, baseline and protocol materials
Further research: Proposed follow-up trials disclosing allocation procedures; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for historical allocation procedures and scope of actual original-material access should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing historical allocation procedures and scope of actual original-material access and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications are internally designed

Related sources S01

N06 · Masking and 90-day collection

Current findings: The original description of concealment from patients/assessors/clinical staff and masked collection of 90-day mRS is preserved. This does not declare current original-material reading, masking-maintenance or expectation-effect verification.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original roles, maintenance/unmasking, actual collection methods and assessor training/adjudication details remain unread. Existing content review remains incomplete.
Reason for missing information: Original roles, maintenance/unmasking, actual collection methods and assessor training/adjudication details remain unread.
Required materials and conditions: Masking scope for participants, assessment, clinical care and mRS collection
Materials to obtain first: Original masking and mRS collection/adjudication materials
Further research: Proposed research specifying masking of measurement/adjudication; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for masking scope for participants, assessment, clinical care and mRS collection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing masking scope for participants, assessment, clinical care and mRS collection and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP

Related sources S01

N07 · mRS 0–6, direction and distribution

Current findings: mRS ranges from 0, no symptoms, to 6, death, with lower scores better; the TICH-2 endpoint is distribution shift at 90 days. This is not changed to a mean score, specific threshold or survival-only result.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Category-specific distributions, adjudication/collection, model categories/direction and clinical importance remain unverified. Existing content review remains incomplete.
Reason for missing information: Category-specific distributions, adjudication/collection, model categories/direction and clinical importance remain unverified.
Required materials and conditions: Scale definitions and distinction of distribution shift from means/thresholds
Materials to obtain first: mRS category distributions, collection/adjudication and model definitions
Further research: Proposed follow-up research specifying differences between distributions, thresholds and importance; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for scale definitions and distinction of distribution shift from means/thresholds should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing scale definitions and distinction of distribution shift from means/thresholds and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4; internal extension boundary

Related sources S01

N08 · 90 days and actual assessment window

Current findings: The prespecified primary endpoint is modified Rankin functional status at 90 days. Seven-day death, 24-hour hematoma expansion and long-term functional/daily-life outcomes are not combined as the same timepoint/endpoint.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Assessment windows, individual follow-up, period-specific missingness and later function/survival remain unverified. Existing content review remains incomplete.
Reason for missing information: Assessment windows, individual follow-up, period-specific missingness and later function/survival remain unverified.
Required materials and conditions: Distinguish the original timepoint from assessment/follow-up and other periods
Materials to obtain first: Assessment/follow-up and timepoint-specific functional/missingness materials
Further research: Proposed follow-up research separating timepoints, function and survival outcomes; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish the original timepoint from assessment/follow-up and other periods should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish the original timepoint from assessment/follow-up and other periods and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources S01

N09 · TICH-2 adjusted OR, CI and P

Current findings: Adjusted OR 0.88 (95% CI 0.76–1.03), P=.11 is preserved. No new between-group difference, RR, mean score, CI or individual response proportion is calculated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original model/covariates, proportional-odds/category handling, exact distributions and sensitivity analyses remain unread. Existing content review remains incomplete.
Reason for missing information: Original model/covariates, proportional-odds/category handling, exact distributions and sensitivity analyses remain unread.
Required materials and conditions: Distinguish the original shift estimand from new effects/proportions
Materials to obtain first: Distribution/adjusted-model, CI and original-result materials
Further research: Proposed follow-up research disclosing the original estimand/precision; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish the original shift estimand from new effects/proportions should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish the original shift estimand from new effects/proportions and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design

Related sources S01

N10 · CI, meaningful benefits and the null result

Current findings: The manuscript records that no minimum clinically important between-group difference was declared, so the CI cannot be said to exclude all meaningful benefits. A null result is not newly certified as exactly zero effect, equivalence or no effect in every population.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified importance/success/equivalence criteria and a sufficient range for the exact effect remain unverified. Existing content review remains incomplete.
Reason for missing information: Prespecified importance/success/equivalence criteria and a sufficient range for the exact effect remain unverified.
Required materials and conditions: Scope of nonsignificance versus importance/equivalence
Materials to obtain first: Prespecified criteria, estimand/CI and clinical-importance materials
Further research: Proposed research distinguishing effects/importance and question scope; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for scope of nonsignificance versus importance/equivalence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing scope of nonsignificance versus importance/equivalence and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries

Related sources S01 S02

N11 · 2,325 participants, countries/hospitals and denominators

Current findings: Twelve countries, 124 hospitals and 2,325 participants (1,161/1,164) are preserved. Countries/hospitals, groups, timepoints and events are not summed as new independent trials/participants.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Group-specific 90-day observation/analysis, hospital/country distributions and risk/effective denominators remain unverified. Existing content review remains incomplete.
Reason for missing information: Group-specific 90-day observation/analysis, hospital/country distributions and risk/effective denominators remain unverified.
Required materials and conditions: Randomized population versus 90-day observation and multicenter/group units
Materials to obtain first: Participant flow and group/timepoint-specific analysis/observation denominators
Further research: Proposed follow-up research distinguishing recruitment, observation and analysis units; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for randomized population versus 90-day observation and multicenter/group units should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing randomized population versus 90-day observation and multicenter/group units and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application

Related sources S01

N12 · 90-day 2,307/2,325 and 99.2%

Current findings: The original wording that 90-day mRS was available in 2,307/2,325 participants, 99.2%, is preserved. No new missing counts/proportions are calculated, and this is not changed to complete observation of every endpoint/timepoint.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Group-specific missingness/dropout reasons, categories/timepoints, handling/sensitivity and actual analysis denominators remain unverified. Existing content review remains incomplete.
Reason for missing information: Group-specific missingness/dropout reasons, categories/timepoints, handling/sensitivity and actual analysis denominators remain unverified.
Required materials and conditions: Distinguish the original availability rate from missingness/analysis populations
Materials to obtain first: mRS flow/missingness, group denominators and handling/sensitivity materials
Further research: Proposed research distinguishing availability/missingness from estimation populations; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish the original availability rate from missingness/analysis populations should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish the original availability rate from missingness/analysis populations and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01

N13 · ITT and retaining allocated groups

Current findings: The original description of ITT retaining participants in their minimization-allocated groups is preserved. Actual mRS measurements for everyone, absence of missing-data effects or model details are not stated as verified in this work.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original inclusion/exclusion, missing-data/model and PPS/sensitivity materials remain unread. Existing content review remains incomplete.
Reason for missing information: Original inclusion/exclusion, missing-data/model and PPS/sensitivity materials remain unread.
Required materials and conditions: Historical analysis principles and current original-material access scope
Materials to obtain first: Original ITT/inclusion, missing-data/model and sensitivity materials
Further research: Proposed research separately disclosing allocation, observation and actual-exposure analyses; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for historical analysis principles and current original-material access scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing historical analysis principles and current original-material access scope and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications are internally designed

Related sources S01

N14 · Registration, prespecified primary endpoint and combined identifiers

Current findings: The original registration-identifier value in the evidence list is ISRCTN93732214 · EudraCT 2012-004108-37. Historical statements of agreement with the prespecified 90-day mRS and registration before recruitment are preserved; full registration/plan materials remain unread in this work.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Registration dates/changes, protocol/SAP and full analysis specifications remain unread. Existing content review remains incomplete.
Reason for missing information: Registration dates/changes, protocol/SAP and full analysis specifications remain unread.
Required materials and conditions: Descriptions of prerecruitment registration/endpoint agreement versus full plans
Materials to obtain first: Both registrations, protocol and SAP
Further research: Proposed research publicly linking prespecified plans with actual analyses; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for descriptions of prerecruitment registration/endpoint agreement versus full plans should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing descriptions of prerecruitment registration/endpoint agreement versus full plans and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01

N15 · Early secondary hematoma/death outcomes

Current findings: Reduced 24-hour hematoma expansion and seven-day death are secondary signals. They are not promoted to successful 90-day functional recovery, a primary endpoint or independent confirmation.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Counts/denominators, CI/P, prespecified hierarchy/multiplicity and measurement/analysis specifications for each secondary outcome remain unverified. Existing content review remains incomplete.
Reason for missing information: Counts/denominators, CI/P, prespecified hierarchy/multiplicity and measurement/analysis specifications for each secondary outcome remain unverified.
Required materials and conditions: Hierarchy of 24-hour imaging, seven-day death and 90-day primary function
Materials to obtain first: Complete timepoint/endpoint-specific results, SAP and imaging/death definitions
Further research: Proposed research distinguishing primary function from early death/imaging outcomes; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for hierarchy of 24-hour imaging, seven-day death and 90-day primary function should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing hierarchy of 24-hour imaging, seven-day death and 90-day primary function and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M03 §3.2.4; internal extension boundary; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed

Related sources S01 S02

N16 · Death/dependence sensitivity analysis

Current findings: The original record states that the 90-day death-or-dependence sensitivity analysis was also statistically null. No specific mRS threshold, exact effect or CI is newly filled, and other functional outcomes are not treated as the same result.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Death/dependence definitions, threshold, denominators/estimates/CI and model remain unverified. Existing content review remains incomplete.
Reason for missing information: Death/dependence definitions, threshold, denominators/estimates/CI and model remain unverified.
Required materials and conditions: Distinguish distribution shift from other definitions/sensitivity analyses
Materials to obtain first: Sensitivity definitions/models and original results/CI
Further research: Proposed research separately reporting the primary distribution and sensitivity/threshold results; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish distribution shift from other definitions/sensitivity analyses should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish distribution shift from other definitions/sensitivity analyses and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application

Related sources S01

N17 · IPD meta-analysis: poor function and OR

Current findings: S02 originally records null 90-day poor function: 53.2% vs 53.6%, adjusted common OR 0.93 (95% CI 0.81–1.07). This does not replace TICH-2’s distribution OR 0.88 as the same original result or a newly pooled value.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Poor-function threshold/definition, distribution/common-OR model, proportion denominators and time/exposure correspondence remain unverified. Existing content review remains incomplete.
Reason for missing information: Poor-function threshold/definition, distribution/common-OR model, proportion denominators and time/exposure correspondence remain unverified.
Required materials and conditions: Distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution
Materials to obtain first: Meta-analysis/trial definitions and model/estimand/denominator materials
Further research: Proposed follow-up evidence synthesis distinguishing functional definitions/estimands; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application

Related sources S02

N18 · Nine trials/3,194 and IPD from five/2,860

Current findings: The original meta-analysis counts are nine trials/3,194 participants, with IPD supplied by five trials/2,860 participants (90%). These are not added to TICH-2, and remaining counts/proportions or new effects are not calculated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Included-trial lists/cohort correspondence, missing IPD/variable-specific denominators, duplication/weighting and data acquisition remain unread. Existing content review remains incomplete.
Reason for missing information: Included-trial lists/cohort correspondence, missing IPD/variable-specific denominators, duplication/weighting and data acquisition remain unread.
Required materials and conditions: Distinguish reported aggregates/individual data from unique participants/overlap
Materials to obtain first: Included trials/data acquisition, variable-specific denominators and pooling models
Further research: Proposed research separately disclosing inclusion, acquisition, overlap and denominators; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish reported aggregates/individual data from unique participants/overlap should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish reported aggregates/individual data from unique participants/overlap and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are internally applied; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M08 §8.2.2, M15 §15.3.1; internal application

Related sources S02

N19 · Meta-analysis early death and imaging

Current findings: The original meta-analysis record states significant reductions in seven-day death/hematoma expansion and an adjusted OR of 0.70 for seven-day death. These are not used as success for the selected 90-day functional question or as the same estimand.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Definitions/denominators/CI/P, multiplicity/plans and trial-specific correspondence for each early outcome remain unverified. Existing content review remains incomplete.
Reason for missing information: Definitions/denominators/CI/P, multiplicity/plans and trial-specific correspondence for each early outcome remain unverified.
Required materials and conditions: Separate meta-analysis results for 90-day function versus seven-day death/hematoma
Materials to obtain first: Original meta-analysis timepoint/endpoint-specific results and plans/CI
Further research: Proposed research separately synthesizing early and long-term endpoints; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for separate meta-analysis results for 90-day function versus seven-day death/hematoma should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing separate meta-analysis results for 90-day function versus seven-day death/hematoma and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed

Related sources S02

N20 · Meta-analysis/authors, original R1 and independence

Current findings: Because meta-analysis authors overlapped with TICH-2 investigators and 90-day mRS was not primary in component trials, the original verdict did not count independent replication and retained R1. The same trials, references, follow-up or synthesis reports are not used as new independent-trial/participant totals.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Included-trial/author/endpoint correspondence, unique clinical totals and independent replication are not newly established. Existing content review remains incomplete.
Reason for missing information: Included-trial/author/endpoint correspondence, unique clinical totals and independent replication are not newly established.
Required materials and conditions: Synthesis reports versus unique trials, endpoint hierarchy and author relationships
Materials to obtain first: Included-trial/report/author and endpoint/cohort relationships
Further research: Proposed follow-up independent comparative research with the same functional specifications; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for synthesis reports versus unique trials, endpoint hierarchy and author relationships should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing synthesis reports versus unique trials, endpoint hierarchy and author relationships and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are internally applied; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources S01 S02

N21 · Meta-analysis funding and registration: preserved records

Current findings: S02’s funding field preserves ‘All included trials were at low risk of bias’, and its registration-identifier value is ‘Not applicable’. These are not used as verification of actual funding/no registration or as current bias assessment of individual trials.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original synthesis-report funding/COI, review registration/protocol and bias-domain/assessment materials remain unread. Existing content review remains incomplete.
Reason for missing information: Original synthesis-report funding/COI, review registration/protocol and bias-domain/assessment materials remain unread.
Required materials and conditions: Distinguish original fields from funding/registration verification
Materials to obtain first: Meta-analysis funding/COI, registration/protocol and assessment materials
Further research: Proposed research disclosing synthesis plans, support and assessment scope; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish original fields from funding/registration verification should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish original fields from funding/registration verification and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap’s own independence/attribution conditions. The official method sections used in this pilot do not warrant every detailed item; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources S02

N22 · Concurrent treatment and timing/group analyses

Current findings: The original scope is a placebo comparison in acute spontaneous intracerebral hemorrhage within eight hours. Absence of effects from other treatments/lifestyle, actual exposure or timing/subgroups is not verified.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Information currently required is unverified in the preserved summary. Concurrent treatments/drugs, procedures, group-specific contact/timing, subgroups/interactions and analyses remain unverified. Existing content review remains incomplete.
Reason for missing information: Concurrent treatments/drugs, procedures, group-specific contact/timing, subgroups/interactions and analyses remain unverified.
Required materials and conditions: Distinguish the study drug from concurrent acute treatment/exposure
Materials to obtain first: Concurrent-exposure/treatment and period/subgroup-analysis materials
Further research: Proposed research distinguishing concurrent treatment from study exposure; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish the study drug from concurrent acute treatment/exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish the study drug from concurrent acute treatment/exposure and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed

Related sources S01

N23 · NIHR/Swiss support and trial sponsor

Current findings: The original record states support from the NIHR HTA Programme and Swiss Heart Foundation, with Nottingham as trial sponsor. Public/foundation funding does not newly certify absence of all relationships/roles or independence.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original funding/sponsorship agreements, data/analysis/publication rights and author COI remain unread. Existing content review remains incomplete.
Reason for missing information: Original funding/sponsorship agreements, data/analysis/publication rights and author COI remain unread.
Required materials and conditions: Support organizations and the University of Nottingham’s role
Materials to obtain first: Funding/sponsor, role and COI disclosures
Further research: Proposed research separately disclosing support and research roles; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for support organizations and the University of Nottingham’s role should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing support organizations and the University of Nottingham’s role and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N24 · Preparation expense and pharmaceutical/analysis/writing support

Current findings: The original record states that Sharp prepared identical packs at trial expense and no pharmaceutical donation, analysis, medical writing or publication funding was reported. Unreported items are not judged actually absent.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original agreements/provision, support-specific roles, author relationships and external analysis/writing materials remain unread. Existing content review remains incomplete.
Reason for missing information: Original agreements/provision, support-specific roles, author relationships and external analysis/writing materials remain unread.
Required materials and conditions: Trial-expense preparation versus donated support/unreported items
Materials to obtain first: Preparation/product and analysis/writing/publication-support disclosures
Further research: Proposed research distinguishing support items from preparation/research roles; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for trial-expense preparation versus donated support/unreported items should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing trial-expense preparation versus donated support/unreported items and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

Related sources S01

N25 · Seizures, thrombosis and serious adverse events

Current findings: The original record states seizures in 77 (7%) vs 85 (7%), no increase in venous thromboembolism and fewer serious adverse events through 90 days. These are not used as success on primary function or absence of all harms.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Definitions/collection, group denominators/frequencies, relatedness/severity, effects/CI and long-term harms for each adverse outcome remain unverified. Existing content review remains incomplete.
Reason for missing information: Definitions/collection, group denominators/frequencies, relatedness/severity, effects/CI and long-term harms for each adverse outcome remain unverified.
Required materials and conditions: Distinguish separate safety endpoints/denominators from functional efficacy
Materials to obtain first: Adverse-event/thrombosis/seizure and denominator/follow-up/CI materials
Further research: Proposed research separating harms from functional efficacy; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish separate safety endpoints/denominators from functional efficacy should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish separate safety endpoints/denominators from functional efficacy and connecting materials needed for the selected question with current materials.
Application exceptions: Supplement the selected subclaim’s safety-material gaps. Functional-status/infection efficacy results or parent safety wording do not establish safety or create harms rates or new usage instructions.
Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application

Related sources S01

N26 · Other indications/periods and generalization

Current findings: The preserved summary states that benefits in trauma/postpartum hemorrhage concern separate indications. This is not extended to other causes/doses/routes, emergency treatment/procedural guidance or long-term functional effects.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Direct functional comparisons under other specifications and later persistence/long-term harms remain unverified. Existing content review remains incomplete.
Reason for missing information: Direct functional comparisons under other specifications and later persistence/long-term harms remain unverified.
Required materials and conditions: Original spontaneous hemorrhage/route/timing versus separate effects
Materials to obtain first: Direct trials/follow-up by population, route and timing
Further research: Proposed research distinguishing directness across indications/periods; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for original spontaneous hemorrhage/route/timing versus separate effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing original spontaneous hemorrhage/route/timing versus separate effects and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed; M03 §3.2.4; internal extension boundary

Related sources S01 S02

N27 · Original axes, Korean/English text, dates and corrections

Current findings: Parent D34, B/P/R1/I2/E0/B0/C0, three false markers, empty override reasons and subclaim grade D are preserved. The summary’s 2026 meta-analysis label, 2026-08-26 date, Korean/English manuscripts, empty corrections/deliberation and cross-validation are not inherited as a current latest search or review in this work.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score/status/axes are not filled from parent values; original dates/history are not changed. Existing content review remains incomplete.
Reason for missing information: Absent subclaim score/status/axes are not filled from parent values; original dates/history are not changed.
Required materials and conditions: Distinguish parent/subclaim values, verdict date/meta-analysis year and history
Materials to obtain first: Corrections/versions and user correction comments
Further research: Proposed research distinguishing original values/history from the scope of update materials; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for distinguish parent/subclaim values, verdict date/meta-analysis year and history should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing distinguish parent/subclaim values, verdict date/meta-analysis year and history and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed

Related sources S01 S02

N28 · Actual summary reading, links and gaps

Current findings: The complete preserved summary and references were used for production, and links are retained. External TICH-2/meta-analysis, registration, protocol/SAP and support/COI originals remain unread, with no access attempted or separate external-link testing.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. External contents, included-trial correspondence and actual acquisition/accessibility remain unverified. Existing content review remains incomplete.
Reason for missing information: External contents, included-trial correspondence and actual acquisition/accessibility remain unverified.
Required materials and conditions: Preserved summary versus external trial/meta-analysis/registration/plan access
Materials to obtain first: External original papers, registration, protocol/SAP and support materials, or user comments
Further research: Proposed research updating records with actual acquisition, timing and scope distinguished; no new search, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original materials and analysis scope for preserved summary versus external trial/meta-analysis/registration/plan access should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed: Applicability item distinguishing preserved summary versus external trial/meta-analysis/registration/plan access and connecting materials needed for the selected question with current materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02