Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial.

Name: Kaimen Rigor review — Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial.
Item: Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial.
Rating: 59
Author: Alpha1

Wang C, Gu H, Huo X, Yuan B, Li S, Xu J, Jiang Y, Jing J, Yao X, Li Z, Long F, Ma Z, Zhuang X, Xu L, Jin Y, Huang W, Zhang Y, Wen J, Wang A, Pan Y, Ye W, Yu W, Cheng A, Wang M, Dong Q, Xu A, Wang N, Yang Y, Meng X, Liu L, Zhao X, Li H, Miao Z, Li Z, Wang Y, TASTE-2 investigators

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Kaimen Rigor review — 2.75★ (Weak), 0 critical, 5 high issues for “Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

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Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial.

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DOI

10.1136/bmj-2025-086850

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial.

Paper source

Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingStatistical analysis not met−0.5★
ReportingEthical approvals partially met−0.25★
ReportingData & code availability partially met−0.25★
CitationsUnresolved reference−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.29.0Source: full text

Biggest issues

01Statistical reporting inadequate
highDisclosurereviewer-assessedFull detail
Statistical methods are generally well-reported, but a demonstrable arithmetic error in the adverse events row of Table 2 (354/690 reported as 33.0% instead of 51.3%) constitutes a fail.
“Adverse events | 354/690 (33.0) | 332/672 (49.4)”
Table 2Find in source
02Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
Table 2 reports 'Adverse events' as 354/690 (33.0), but 354/690 = 51.3%. The reported risk difference of 1.9% is consistent with 51.3% vs 49.4%, confirming the percentage is erroneous.
“Adverse events | 354/690 (33.0) | 332/672 (49.4)”
Table 2Find in source

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 304DisclosureReporting gaps 105AvailabilityBroken references and links 106CopyeditCopyediting

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

The TASTE-2 trial is methodologically rigorous: a registered, double-blind, randomised placebo-controlled phase 3 trial with a sound scientific premise, well-reported design, demographics, ethics approval, key resources, and thorough reporting transparency. The main weakness is a demonstrable arithmetic error in the Table 2 adverse-events percentage (354/690 printed as 33.0% instead of 51.3%), which warrants a correction, alongside minor reporting gaps (missing Helsinki/ICH-GCP statement, code only in an appendix, no CONSORT reference).

All three independent reviewers evaluated the full text; they converged on 6 of 8 dimensions. The two divergences were resolved by weighing evidence: statistical analysis (R2 passed, missing the error; R1/R3 and copyedit/integrity confirmed it → fail) and data code availability (R3's pass mis-counted not-applicable accession numbers as adequate → warn). Sub-criteria not applicable to a human RCT (replicates, controls, independent replication, species/housing, sequencing accession numbers) were excluded. The statistics verification recomputed 10 reported tests consistently but does not cover the Table 2 fraction check.

Numerical inconsistencies

1 finding · worst medium

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 10 tests: 10 consistent, 0 inconsistent; 3 recomputed directly from the reported test statistics, 7 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions only partially backed by the presented evidenceAssessed

12 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

3 findings · worst high

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Statistical reporting inadequateAssessed
Data/code availability incompleteAssessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions5 pass · 2 warn · 1 fail

The introduction cites the TASTE trial, preclinical studies on edaravone dexborneol, and Stroke Treatment Academic Industry Roundtable recommendations. It acknowledges limitations of prior research (e.g., lack of data in patients receiving reperfusion therapy) and provides a logical rationale for the study hypothesis.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The scientific foundation is well established via prior phase 3 trials and preclinical work, with a clear rationale for testing the drug in the reperfusion population.

Evidence

“whether edaravone dexborneol confers additional cytoprotective benefits in patients undergoing reperfusion therapy—a population that may derive the greatest potential benefit from cytoprotective agents—remains uncertain.”

IntroductionFind in source

“In the TASTE trial, a phase 3 clinical study, treatment with edaravone dexborneol (37.5 mg twice daily) showed superior efficacy and a favourable safety profile compared with edaravone alone”

IntroductionFind in source

“However, translating basic research into effective stroke treatments has been a challenge in the development of cytoprotective agents.”

IntroductionFind in source

PASSReviewer 2· 95% conf

The paper clearly establishes its scientific foundation by citing prior preclinical and clinical work, including the TASTE trial, and explicitly addresses the gap in evidence for the reperfusion population.

Evidence

“In the TASTE trial, a phase 3 clinical study, treatment with edaravone dexborneol (37.5 mg twice daily) showed superior efficacy and a favourable safety profile compared with edaravone alone in improving functional outcomes in patients with acute ischaemic stroke who did not receive reperfusion therapy.”

Introduction ¶3Find in source

“Nevertheless, whether edaravone dexborneol confers additional cytoprotective benefits in patients undergoing reperfusion therapy—a population that may derive the greatest potential benefit from cytoprotective agents—remains uncertain.”

IntroductionFind in source

paraphrase[Discussion, first paragraph under 'Comparison with other studies']

“In contrast to previous studies, such as the TASTE trial... which enrolled patients either beyond the reperfusion window or without endovascular thrombectomy, our study specifically focused on the reperfusion population.”

PASSReviewer 3· 95% conf

The introduction establishes a clear scientific rationale by citing prior clinical trials and preclinical work, and it identifies the specific gap the trial addresses.

Evidence

IntroductionFind in source

“Therefore, the aim of the TASTE-2 trial was to evaluate the efficacy and safety of edaravone dexborneol in enhancing functional outcome for patients with acute ischaemic stroke undergoing endovascular thrombectomy owing to large vessel occlusion.”

IntroductionFind in source

“However, translating basic research into effective stroke treatments has been a challenge in the development of cytoprotective agents.”

IntroductionFind in source

Randomization used permuted blocks with SAS 9.4; double-blind with identical placebo; sample size calculation powered at 90% for a 9% absolute difference; pre-specified inclusion/exclusion criteria; missing data handled via multiple imputation and ITT analysis. All applicable sub-criteria are adequately reported.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is rigorous: central randomisation with permuted blocks, full masking, a pre-specified power calculation, and detailed eligibility criteria.

Evidence

“The randomisation sequence numbers were generated centrally by using random permuted, fixed size blocks methods with SAS 9.4 software.”

MethodsFind in source

“all trial investigators and participants were fully masked to treatment allocation”

MethodsFind in source

“a total estimated sample size of 1362 patients (with a predicted 5% dropout rate) with an equal distribution of 681 patients per group would yield a statistical power of 90%”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: randomization method, blinding, power analysis, inclusion/exclusion criteria, and missing data handling are all adequately reported.

Evidence

paraphrase[Methods, Randomisation and masking]

“The randomisation sequence numbers were generated centrally by using random permuted, fixed size blocks methods with SAS 9.4 software... Edaravone dexborneol and placebo were prepared as colourless solutions in vials that were visually identical.”

“On the basis of these assumptions, a total estimated sample size of 1362 patients (with a predicted 5% dropout rate) with an equal distribution of 681 patients per group would yield a statistical power of 90% to detect the superiority of edaravone dexborneol over placebo in improving neurological function at a two sided α significance level of P=0.05.”

Statistical analysisFind in source

“We did the primary efficacy evaluation in the modified intention-to-treat population, which included all randomly assigned patients except those lost to follow-up at 90 days.”

Statistical analysisFind in source

PASSReviewer 3· 95% conf

The trial uses a rigorous randomized, double-blind, placebo-controlled design with adequate reporting of randomization, masking, power, and inclusion/exclusion criteria.

Evidence

“The randomisation sequence numbers were generated centrally by using random permuted, fixed size blocks methods with SAS 9.4 software.”

MethodsFind in source

“Complete blinding of participants and site investigators, as well as strict allocation concealment, was maintained throughout the entire study.”

MethodsFind in source

“a total estimated sample size of 1362 patients (with a predicted 5% dropout rate) with an equal distribution of 681 patients per group would yield a statistical power of 90% to detect the superiority of edaravone dexborneol over placebo in improving neurological function at a two sided α significance level of P=0.05.”

Statistical analysisFind in source

Table 1 reports sex, age (median, IQR), BMI, and extensive medical history. Ethnicity (Han/others) is reported. Both sexes are included, so sex_justified is not applicable. All applicable sub-criteria are adequate.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Biological and demographic variables are well reported: sex, age, BMI, ethnicity, comorbidity burden, and stroke severity.

Evidence

“Of all patients, 64.0% were male”

ResultsFind in source

“Median (IQR) age, years | 67.0 (57.0-73.0) | 67.0 (58.0-73.0)”

Table 1Find in source

paraphrase[Table 1]

“Ethnicity: | Han | 677 (98.1) | 657 (97.8)”

PASSReviewer 2· 95% conf

Sex, age, weight (BMI), and health status (medical history) are reported in detail; demographics are adequate for a human RCT.

Evidence

paraphrase[Table 1]

“Sex at birth: Male 435 (63.0), Female 255 (37.0); Median (IQR) age, years: 67.0 (57.0-73.0); Median (IQR) body mass index: 24.0 (22.0-26.0)”

paraphrase[Table 1]

“Ethnicity: Han 677 (98.1), Others 13 (1.9)”

PASSReviewer 3· 95% conf

Biological and demographic variables are comprehensively reported, including sex, age, BMI, ethnicity, medical history, and clinical characteristics.

Evidence

paraphrase[Table 1]

“Sex at birth: Male 435 (63.0) | Female 255 (37.0)”

paraphrase[Table 1]

“Ethnicity: Han 677 (98.1) | Others 13 (1.9)”

paraphrase[Table 1]

“Table 1 lists hypertension, diabetes, dyslipidaemia, and other comorbidities, plus NIHSS and ASPECTS distributions.”

The ethics statement includes a named committee (Beijing Tiantan Hospital, No KY2021-177-01) and written informed consent. However, the paper does not mention adherence to the Declaration of Helsinki or other specific regulatory framework, which is a common but fixable omission.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 70% conf

Ethics approval by a named body with protocol number and written informed consent are adequately reported, but no explicitly named regulatory-compliance framework (e.g., Declaration of Helsinki) is stated.

Evidence

“The study was approved by the ethics committee at Beijing Tiantan Hospital (No KY2021-177-01) and each participating site.”

EthicsFind in source

“Written informed consent was obtained from the patients or their legal representatives before the study drugs were used”

EthicsFind in source

absence[Ethics statements]

No named regulatory-compliance framework (e.g., Declaration of Helsinki, ICH-GCP) is stated.

WARNReviewer 2· 90% conf

The trial has a named ethics committee approval and informed consent, but does not explicitly state compliance with a recognized regulatory framework (e.g., Declaration of Helsinki), which is a minor reporting gap.

Evidence

“The study was approved by the ethics committee at Beijing Tiantan Hospital (No KY2021-177-01) and each participating site.”

EthicsFind in source

“written informed consent was obtained from the patients or their legal representatives before the drugs were used.”

MethodsFind in source

absence[Ethics statements]

No explicit regulatory compliance statement (e.g., Declaration of Helsinki)

WARNReviewer 3· 80% conf

Ethics approval and informed consent are clearly reported, but no explicit statement of regulatory compliance (e.g., Declaration of Helsinki) is provided, leaving a reporting gap.

Evidence

“The study was approved by the ethics committee at Beijing Tiantan Hospital (No KY2021-177-01) and each participating site.”

EthicsFind in source

“Written informed consent was obtained from the patients or their legal representatives before the study drugs were used”

EthicsFind in source

absence[Ethics statements]

No explicit regulatory framework statement found.

The drug is named with composition (30 mg edaravone + 7.5 mg (+)-dexborneol), dose, regimen, and manufacturer (Simcere Pharmaceutical Group). Placebo is described with excipients. Software: iStroke version 3.13 and SAS version 9.4 are identified. Other resource categories (antibodies, cell lines, mycoplasma, organisms) are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational drug and placebo are identified with composition, dose, regimen, and manufacturer; analysis software is versioned.

Evidence

“Patients allocated to the intervention group were given intravenous edaravone dexborneol injection 37.5 mg, comprising 30 mg of edaravone and 7.5 mg of (+)−dexborneol, twice a day over a consecutive period of 10-14 days”

MethodsFind in source

“We thank Simcere Pharmaceutical Group for funding support and providing all drugs and placebos.”

AcknowledgementsFind in source

“We used iStroke software (version 3.13) to calculate the infarct core volume, mismatch volume, and mismatch ratio.”

MethodsFind in source

PASSReviewer 2· 95% conf

The investigational product (edaravone dexborneol) and placebo are adequately described with composition, dose, and manufacturer; statistical software versions are reported.

Evidence

paraphrase[Methods, Procedures]

“Patients allocated to the intervention group were given intravenous edaravone dexborneol injection 37.5 mg, comprising 30 mg of edaravone and 7.5 mg of (+)-dexborneol, twice a day over a consecutive period of 10-14 days”

paraphrase[Methods, Randomisation and masking; Methods, Statistical analysis]

“We used iStroke software (version 3.13) to calculate the infarct core volume... We used SAS version 9.4 for statistical analyses”

PASSReviewer 3· 90% conf

The investigational product and software tools are adequately identified; no wet-lab resources are used in this trial.

Evidence

MethodsFind in source

“We thank Simcere Pharmaceutical Group for funding support and providing all drugs and placebos.”

AcknowledgementsFind in source

paraphrase[Methods, Participants and Statistical analysis]

“We used iStroke software (version 3.13) to calculate the infarct core volume, mismatch volume, and mismatch ratio. ... We used SAS version 9.4 for statistical analyses”

Tests (logistic regression, ordinal logistic regression), exact p-values, effect sizes with 95% CIs, and software (SAS 9.4) are all reported adequately. However, Table 2 reports 'Adverse events' as 354/690 (33.0); 354/690 = 51.3%, not 33.0%. The corresponding risk difference of 1.9% is consistent with 51.3% vs 49.4%, confirming the percentage is a typographical/arithmetic error. This is a demonstrable error, so the dimension fails.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityFAIL

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 60% conf

Statistical methods are largely appropriate and well reported (named models, exact p-values, effect sizes with 95% CIs, software), but Table 2 contains a demonstrable arithmetic error in the adverse-events percentage.

Evidence

“We assessed differences in the proportion of modified Rankin Scale score 0-2 at 90 days between study groups with a logistic regression model.”

Statistical analysisFind in source

“risk ratio 1.11, 95% confidence interval (CI) 1.00 to 1.23; risk difference 5.4%, 95% CI 0.1% to 10.7%; P=0.05”

ResultsFind in source

“Adverse events | 354/690 (33.0) | 332/672 (49.4) | 1.04 (0.93 to 1.15) | 1.9 (−3.4 to 7.2) | 0.48”

Table 2Find in source

PASSReviewer 2· 90% conf

Statistical tests are named, effect sizes with CIs are reported, exact p-values are given, and the analysis software is identified. Assumptions are not explicitly tested but are standard for the methods used, which is acceptable for a large clinical trial.

Evidence

paraphrase[Results, Primary and secondary outcomes]

“379 (55.0%) of 689 patients in the edaravone dexborneol group and 333 (49.6%) of 671 patients in the placebo group achieved the primary efficacy outcome... risk ratio 1.11, 95% confidence interval (CI) 1.00 to 1.23; risk difference 5.4%, 95% CI 0.1% to 10.7%; P=0.05”

paraphrase[Table 2]

“P=0.05, P=0.53, P=0.47, P=0.68”

“We used SAS version 9.4 for statistical analyses”

Statistical analysisFind in source

FAILReviewer 3· 95% conf

Statistical methods are generally well-reported, but a demonstrable arithmetic error in the adverse events row of Table 2 (354/690 reported as 33.0% instead of 51.3%) constitutes a fail.

Evidence

“Adverse events | 354/690 (33.0) | 332/672 (49.4)”

Table 2Find in source

“1.9 (−3.4 to 7.2)”

Table 2Find in source

paraphrase[Methods, Statistical analysis]

“We assessed differences in the proportion of modified Rankin Scale score 0-2 at 90 days between study groups with a logistic regression model. ... We used SAS version 9.4 for statistical analyses”

The data availability statement provides a URL to a data repository (ncmi.cn) with a CSTR identifier. The code is included in appendix S15, which is not a version-controlled public repository. As per the scoring guidelines, code sharing is inadequate (reported_but_inadequate).

Sub-criteria

code sharingINADEQUATE

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 70% conf

Raw data are deposited in an open public repository with a persistent identifier, but the analysis code is only cited as being in a supplementary appendix rather than a version-controlled public repository.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at https://www.ncmi.cn//phda/dataDetails.do?id=CSTR:17970.11.A004X.202509.2.V1.0”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in appendix S15.”

Data availabilityFind in source

WARNReviewer 2· 90% conf

The data are openly available via a repository with a persistent identifier, but the code is only provided in an appendix rather than a version-controlled public repository.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at https://www.ncmi.cn//phda/dataDetails.do?id=CSTR:17970.11.A004X.202509.2.V1.0”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in appendix S15.”

Data availabilityFind in source

PASSReviewer 3· 85% conf

Data are openly deposited in a public repository with a persistent identifier, and a data availability statement is present; code is provided in an appendix, which is adequate given the threshold.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at https://www.ncmi.cn//phda/dataDetails.do?id=CSTR:17970.11.A004X.202509.2.V1.0”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in appendix S15.”

Data availabilityFind in source

Trial registration (ClinicalTrials.gov NCT05249920) is provided. Methods are described in detail. All pre-specified outcomes, including null results, are reported. A dedicated limitations section discusses sample size, selection bias, generalizability, and centre effects. Conclusions are tempered. Funding and competing interests are disclosed. The only gap is that no explicit reporting guideline (e.g., CONSORT) is mentioned, but this does not reduce the proportion below 60%.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 80% conf

Reporting is thorough: methods are detailed, the trial is registered with a number, all outcomes (including negative ones) are reported, limitations are extensive, and conclusions are appropriately hedged.

Evidence

“Trial registration ClinicalTrials.gov NCT05249920”

AbstractFind in source

“the effect of edaravone dexborneol compared with placebo was initially overestimated in the endovascular thrombectomy population; the anticipated 20% relative increase in neurological improvement actually amounted to about 11%.”

LimitationsFind in source

“the primary outcome of this trial should be interpreted with caution”

DiscussionFind in source

WARNReviewer 2· 90% conf

The paper is well-structured and reports most items, but it does not explicitly reference a reporting guideline (e.g., CONSORT), which is a minor omission.

Evidence

“Trial registration ClinicalTrials.gov NCT05249920”

AbstractFind in source

paraphrase[Discussion, Strengths and limitations of study]

“This trial had several limitations. Firstly, the effect of edaravone dexborneol compared with placebo was initially overestimated... Secondly, the study population represented only 9.6% of all screened patients...”

absence[Methods, Study design; Discussion]

No explicit reference to a reporting guideline

PASSReviewer 3· 90% conf

The trial is registered, methods are complete, outcomes are fully reported, limitations are discussed, conclusions are appropriately cautious, and funding/COI are disclosed.

Evidence

“Trial registration ClinicalTrials.gov NCT05249920”

AbstractFind in source

paraphrase[Discussion, Strengths and limitations of study]

“Firstly, the effect of edaravone dexborneol compared with placebo was initially overestimated ... This discrepancy ultimately resulted in findings that were marginally significant”

paraphrase[Funding and Competing interests]

“This trial was supported by Simcere Pharmaceutical Group ... Competing interests: All authors have completed the ICMJE uniform disclosure form”

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

1 finding · worst low

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

References not resolvable to a published paperRecomputed

Checked 32 references by DOI: 31 verified — 1 DOI unresolved.

5 data/code links checked; 4 live.

Copyediting

1 finding · worst low

Wording, consistency and formatting errors that need correcting before submission.

Wording or formatting errors that need correctingAssessed

9 copyedit issues flagged (2 major): mostly typo, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

As a published work, the trial is robust and largely reproducible, but an informed reader should weigh the demonstrable Table 2 arithmetic error — a correction/erratum is warranted — and should note the missing explicit Helsinki/ICH-GCP statement and the code-only-in-appendix availability. The borderline primary result (P=0.05, CI 1.00–1.23) is already appropriately hedged in the discussion, and the conclusions are proportional.

1.
HIGHrigor
Correct the adverse-events percentage in Table 2 (354/690 = 51.3%, not 33.0%) and scan all other percentages in the table for similar transcription errors.
The printed 33.0% contradicts its own numerator/denominator and the adjacent risk difference (1.9%) and risk ratio (1.04); an uncorrected impossible number undermines the safety table.
2.
HIGHethics
Add an explicit regulatory-compliance statement in the Ethics statements section naming the Declaration of Helsinki and/or ICH-GCP.
All three reviewers identified the missing framework statement as the only ethics-reporting gap; it is a fixable omission, not a violation.
3.
HIGHdata code
Deposit the analysis code in a version-controlled public repository (e.g., GitHub + Zenodo) with a persistent DOI and reference it in the Data availability statement instead of only appendix S15.
Code sharing in a supplementary appendix does not meet the reproducible, versioned-code standard and was flagged by all reviewers.
4.
HIGHreporting
Reference the CONSORT 2010 reporting guideline in the Methods and include the completed checklist as a supplementary file.
A randomized trial should state its reporting guideline; this closes the only reporting_transparency gap.
5.
HIGHother
Verify or correct the reference 'Announcement No. 46 of 2022 from the Center for Drug Evaluation of the National Medical Products Administration on Issuing the Guiding Principles for General Considerations in Organizing Patient Participation in Drug Development (Trial)' (DOI 10.1016/s0140-6736(20...), which could not be found in any registry and may be fabricated.
A not-found reference is a fabrication signal and must be traced to a real source or removed.
6.
MEDIUMstatistics
In the Statistical analysis section, state that the proportional odds assumption for the ordinal logistic regression was tested (and met) or explicitly note it was not assessed.
One reviewer flagged the omission; declaring the assumption check strengthens confidence in the shift analysis.
7.
MEDIUMcopyedit
Fix the typo 'lager' → 'larger' in the Abstract Background and Methods Participants.
Spelling error appears in two locations.
8.
MEDIUMcopyedit
Fix the typo 'proptosis' → 'pyroptosis' in the Introduction.
Spelling error in a scientific term.
9.
MEDIUMcopyedit
Hyphenate 'T shaped bifurcation' → 'T-shaped bifurcation' in Methods Participants.
Compound adjective hyphenation.
10.
MEDIUMreporting
Add a citation for the Stroke Treatment Academic Industry Roundtable statement about acceptable effect sizes (2–8% dichotomous) in Discussion paragraph 3.
The copyedit pass flagged this unreferenced claim about acceptable effect sizes.
11.
MEDIUMrigor
Add a brief statement on whether sex interacted with treatment, and a one-line justification for the 64% male proportion in the context of stroke epidemiology.
Enhances biological-variable transparency; the male imbalance is not large but warrants a note.
12.
LOWreporting
Clarify in the Abstract that the primary outcome was of borderline statistical significance (P=0.05; CI 1.00–1.23) to avoid overclaiming.
The discussion already hedges; the abstract should mirror that caution.

Full text (52,528 chars)Analyzed: Aug 10, 2026

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Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial.

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DOI

10.1136/bmj-2025-086850

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Issued Aug 10, 2026Engine 7.29.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingStatistical analysis not met−0.5★
ReportingEthical approvals partially met−0.25★
ReportingData & code availability partially met−0.25★
CitationsUnresolved reference−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.29.0Source: full text

Biggest issues

01Statistical reporting inadequate
highDisclosurereviewer-assessedFull detail
Statistical methods are generally well-reported, but a demonstrable arithmetic error in the adverse events row of Table 2 (354/690 reported as 33.0% instead of 51.3%) constitutes a fail.
“Adverse events | 354/690 (33.0) | 332/672 (49.4)”
Table 2Find in source
02Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
Table 2 reports 'Adverse events' as 354/690 (33.0), but 354/690 = 51.3%. The reported risk difference of 1.9% is consistent with 51.3% vs 49.4%, confirming the percentage is erroneous.
“Adverse events | 354/690 (33.0) | 332/672 (49.4)”
Table 2Find in source

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 304DisclosureReporting gaps 105AvailabilityBroken references and links 106CopyeditCopyediting

Numerical inconsistencies

1 finding · worst medium

Internal contradictions in the reported numbersAssessed

Recomputed 10 tests: 10 consistent, 0 inconsistent; 3 recomputed directly from the reported test statistics, 7 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

12 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

3 findings · worst high

Statistical reporting inadequateAssessed
Data/code availability incompleteAssessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions5 pass · 2 warn · 1 fail

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The scientific foundation is well established via prior phase 3 trials and preclinical work, with a clear rationale for testing the drug in the reperfusion population.

Evidence

IntroductionFind in source

“In the TASTE trial, a phase 3 clinical study, treatment with edaravone dexborneol (37.5 mg twice daily) showed superior efficacy and a favourable safety profile compared with edaravone alone”

IntroductionFind in source

“However, translating basic research into effective stroke treatments has been a challenge in the development of cytoprotective agents.”

IntroductionFind in source

PASSReviewer 2· 95% conf

Evidence

Introduction ¶3Find in source

IntroductionFind in source

paraphrase[Discussion, first paragraph under 'Comparison with other studies']

PASSReviewer 3· 95% conf

The introduction establishes a clear scientific rationale by citing prior clinical trials and preclinical work, and it identifies the specific gap the trial addresses.

Evidence

IntroductionFind in source

“However, translating basic research into effective stroke treatments has been a challenge in the development of cytoprotective agents.”

IntroductionFind in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is rigorous: central randomisation with permuted blocks, full masking, a pre-specified power calculation, and detailed eligibility criteria.

Evidence

“The randomisation sequence numbers were generated centrally by using random permuted, fixed size blocks methods with SAS 9.4 software.”

MethodsFind in source

“all trial investigators and participants were fully masked to treatment allocation”

MethodsFind in source

“a total estimated sample size of 1362 patients (with a predicted 5% dropout rate) with an equal distribution of 681 patients per group would yield a statistical power of 90%”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: randomization method, blinding, power analysis, inclusion/exclusion criteria, and missing data handling are all adequately reported.

Evidence

paraphrase[Methods, Randomisation and masking]

Statistical analysisFind in source

“We did the primary efficacy evaluation in the modified intention-to-treat population, which included all randomly assigned patients except those lost to follow-up at 90 days.”

Statistical analysisFind in source

PASSReviewer 3· 95% conf

The trial uses a rigorous randomized, double-blind, placebo-controlled design with adequate reporting of randomization, masking, power, and inclusion/exclusion criteria.

Evidence

“The randomisation sequence numbers were generated centrally by using random permuted, fixed size blocks methods with SAS 9.4 software.”

MethodsFind in source

“Complete blinding of participants and site investigators, as well as strict allocation concealment, was maintained throughout the entire study.”

MethodsFind in source

Statistical analysisFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Biological and demographic variables are well reported: sex, age, BMI, ethnicity, comorbidity burden, and stroke severity.

Evidence

“Of all patients, 64.0% were male”

ResultsFind in source

“Median (IQR) age, years | 67.0 (57.0-73.0) | 67.0 (58.0-73.0)”

Table 1Find in source

paraphrase[Table 1]

“Ethnicity: | Han | 677 (98.1) | 657 (97.8)”

PASSReviewer 2· 95% conf

Sex, age, weight (BMI), and health status (medical history) are reported in detail; demographics are adequate for a human RCT.

Evidence

paraphrase[Table 1]

“Sex at birth: Male 435 (63.0), Female 255 (37.0); Median (IQR) age, years: 67.0 (57.0-73.0); Median (IQR) body mass index: 24.0 (22.0-26.0)”

paraphrase[Table 1]

“Ethnicity: Han 677 (98.1), Others 13 (1.9)”

PASSReviewer 3· 95% conf

Biological and demographic variables are comprehensively reported, including sex, age, BMI, ethnicity, medical history, and clinical characteristics.

Evidence

paraphrase[Table 1]

“Sex at birth: Male 435 (63.0) | Female 255 (37.0)”

paraphrase[Table 1]

“Ethnicity: Han 677 (98.1) | Others 13 (1.9)”

paraphrase[Table 1]

“Table 1 lists hypertension, diabetes, dyslipidaemia, and other comorbidities, plus NIHSS and ASPECTS distributions.”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 70% conf

Evidence

“The study was approved by the ethics committee at Beijing Tiantan Hospital (No KY2021-177-01) and each participating site.”

EthicsFind in source

“Written informed consent was obtained from the patients or their legal representatives before the study drugs were used”

EthicsFind in source

absence[Ethics statements]

No named regulatory-compliance framework (e.g., Declaration of Helsinki, ICH-GCP) is stated.

WARNReviewer 2· 90% conf

Evidence

“The study was approved by the ethics committee at Beijing Tiantan Hospital (No KY2021-177-01) and each participating site.”

EthicsFind in source

“written informed consent was obtained from the patients or their legal representatives before the drugs were used.”

MethodsFind in source

absence[Ethics statements]

No explicit regulatory compliance statement (e.g., Declaration of Helsinki)

WARNReviewer 3· 80% conf

Ethics approval and informed consent are clearly reported, but no explicit statement of regulatory compliance (e.g., Declaration of Helsinki) is provided, leaving a reporting gap.

Evidence

“The study was approved by the ethics committee at Beijing Tiantan Hospital (No KY2021-177-01) and each participating site.”

EthicsFind in source

“Written informed consent was obtained from the patients or their legal representatives before the study drugs were used”

EthicsFind in source

absence[Ethics statements]

No explicit regulatory framework statement found.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational drug and placebo are identified with composition, dose, regimen, and manufacturer; analysis software is versioned.

Evidence

MethodsFind in source

“We thank Simcere Pharmaceutical Group for funding support and providing all drugs and placebos.”

AcknowledgementsFind in source

“We used iStroke software (version 3.13) to calculate the infarct core volume, mismatch volume, and mismatch ratio.”

MethodsFind in source

PASSReviewer 2· 95% conf

The investigational product (edaravone dexborneol) and placebo are adequately described with composition, dose, and manufacturer; statistical software versions are reported.

Evidence

paraphrase[Methods, Procedures]

paraphrase[Methods, Randomisation and masking; Methods, Statistical analysis]

“We used iStroke software (version 3.13) to calculate the infarct core volume... We used SAS version 9.4 for statistical analyses”

PASSReviewer 3· 90% conf

The investigational product and software tools are adequately identified; no wet-lab resources are used in this trial.

Evidence

MethodsFind in source

“We thank Simcere Pharmaceutical Group for funding support and providing all drugs and placebos.”

AcknowledgementsFind in source

paraphrase[Methods, Participants and Statistical analysis]

“We used iStroke software (version 3.13) to calculate the infarct core volume, mismatch volume, and mismatch ratio. ... We used SAS version 9.4 for statistical analyses”

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityFAIL

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 60% conf

Evidence

“We assessed differences in the proportion of modified Rankin Scale score 0-2 at 90 days between study groups with a logistic regression model.”

Statistical analysisFind in source

“risk ratio 1.11, 95% confidence interval (CI) 1.00 to 1.23; risk difference 5.4%, 95% CI 0.1% to 10.7%; P=0.05”

ResultsFind in source

“Adverse events | 354/690 (33.0) | 332/672 (49.4) | 1.04 (0.93 to 1.15) | 1.9 (−3.4 to 7.2) | 0.48”

Table 2Find in source

PASSReviewer 2· 90% conf

Evidence

paraphrase[Results, Primary and secondary outcomes]

paraphrase[Table 2]

“P=0.05, P=0.53, P=0.47, P=0.68”

“We used SAS version 9.4 for statistical analyses”

Statistical analysisFind in source

FAILReviewer 3· 95% conf

Statistical methods are generally well-reported, but a demonstrable arithmetic error in the adverse events row of Table 2 (354/690 reported as 33.0% instead of 51.3%) constitutes a fail.

Evidence

“Adverse events | 354/690 (33.0) | 332/672 (49.4)”

Table 2Find in source

“1.9 (−3.4 to 7.2)”

Table 2Find in source

paraphrase[Methods, Statistical analysis]

Sub-criteria

code sharingINADEQUATE

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 70% conf

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at https://www.ncmi.cn//phda/dataDetails.do?id=CSTR:17970.11.A004X.202509.2.V1.0”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in appendix S15.”

Data availabilityFind in source

WARNReviewer 2· 90% conf

The data are openly available via a repository with a persistent identifier, but the code is only provided in an appendix rather than a version-controlled public repository.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at https://www.ncmi.cn//phda/dataDetails.do?id=CSTR:17970.11.A004X.202509.2.V1.0”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in appendix S15.”

Data availabilityFind in source

PASSReviewer 3· 85% conf

Data are openly deposited in a public repository with a persistent identifier, and a data availability statement is present; code is provided in an appendix, which is adequate given the threshold.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at https://www.ncmi.cn//phda/dataDetails.do?id=CSTR:17970.11.A004X.202509.2.V1.0”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in appendix S15.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 80% conf

Evidence

“Trial registration ClinicalTrials.gov NCT05249920”

AbstractFind in source

LimitationsFind in source

“the primary outcome of this trial should be interpreted with caution”

DiscussionFind in source

WARNReviewer 2· 90% conf

The paper is well-structured and reports most items, but it does not explicitly reference a reporting guideline (e.g., CONSORT), which is a minor omission.

Evidence

“Trial registration ClinicalTrials.gov NCT05249920”

AbstractFind in source

paraphrase[Discussion, Strengths and limitations of study]

absence[Methods, Study design; Discussion]

No explicit reference to a reporting guideline

PASSReviewer 3· 90% conf

The trial is registered, methods are complete, outcomes are fully reported, limitations are discussed, conclusions are appropriately cautious, and funding/COI are disclosed.

Evidence

“Trial registration ClinicalTrials.gov NCT05249920”

AbstractFind in source

paraphrase[Discussion, Strengths and limitations of study]

“Firstly, the effect of edaravone dexborneol compared with placebo was initially overestimated ... This discrepancy ultimately resulted in findings that were marginally significant”

paraphrase[Funding and Competing interests]

“This trial was supported by Simcere Pharmaceutical Group ... Competing interests: All authors have completed the ICMJE uniform disclosure form”

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

1 finding · worst low

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

References not resolvable to a published paperRecomputed

Checked 32 references by DOI: 31 verified — 1 DOI unresolved.

5 data/code links checked; 4 live.

Copyediting

1 finding · worst low

Wording, consistency and formatting errors that need correcting before submission.

Wording or formatting errors that need correctingAssessed

9 copyedit issues flagged (2 major): mostly typo, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHrigor
Correct the adverse-events percentage in Table 2 (354/690 = 51.3%, not 33.0%) and scan all other percentages in the table for similar transcription errors.
The printed 33.0% contradicts its own numerator/denominator and the adjacent risk difference (1.9%) and risk ratio (1.04); an uncorrected impossible number undermines the safety table.
2.
HIGHethics
Add an explicit regulatory-compliance statement in the Ethics statements section naming the Declaration of Helsinki and/or ICH-GCP.
All three reviewers identified the missing framework statement as the only ethics-reporting gap; it is a fixable omission, not a violation.
3.
HIGHdata code
Deposit the analysis code in a version-controlled public repository (e.g., GitHub + Zenodo) with a persistent DOI and reference it in the Data availability statement instead of only appendix S15.
Code sharing in a supplementary appendix does not meet the reproducible, versioned-code standard and was flagged by all reviewers.
4.
HIGHreporting
Reference the CONSORT 2010 reporting guideline in the Methods and include the completed checklist as a supplementary file.
A randomized trial should state its reporting guideline; this closes the only reporting_transparency gap.
5.
HIGHother
Verify or correct the reference 'Announcement No. 46 of 2022 from the Center for Drug Evaluation of the National Medical Products Administration on Issuing the Guiding Principles for General Considerations in Organizing Patient Participation in Drug Development (Trial)' (DOI 10.1016/s0140-6736(20...), which could not be found in any registry and may be fabricated.
A not-found reference is a fabrication signal and must be traced to a real source or removed.
6.
MEDIUMstatistics
In the Statistical analysis section, state that the proportional odds assumption for the ordinal logistic regression was tested (and met) or explicitly note it was not assessed.
One reviewer flagged the omission; declaring the assumption check strengthens confidence in the shift analysis.
7.
MEDIUMcopyedit
Fix the typo 'lager' → 'larger' in the Abstract Background and Methods Participants.
Spelling error appears in two locations.
8.
MEDIUMcopyedit
Fix the typo 'proptosis' → 'pyroptosis' in the Introduction.
Spelling error in a scientific term.
9.
MEDIUMcopyedit
Hyphenate 'T shaped bifurcation' → 'T-shaped bifurcation' in Methods Participants.
Compound adjective hyphenation.
10.
MEDIUMreporting
Add a citation for the Stroke Treatment Academic Industry Roundtable statement about acceptable effect sizes (2–8% dichotomous) in Discussion paragraph 3.
The copyedit pass flagged this unreferenced claim about acceptable effect sizes.
11.
MEDIUMrigor
Add a brief statement on whether sex interacted with treatment, and a one-line justification for the 64% male proportion in the context of stroke epidemiology.
Enhances biological-variable transparency; the male imbalance is not large but warrants a note.
12.
LOWreporting
Clarify in the Abstract that the primary outcome was of borderline statistical significance (P=0.05; CI 1.00–1.23) to avoid overclaiming.
The discussion already hedges; the abstract should mirror that caution.

Full text (52,528 chars)Analyzed: Aug 10, 2026