Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes without ST-Segment Elevation
New England Journal of Medicine, 2001 · paper · Clinical trials
A randomized trial of 12,562 patients with acute coronary syndromes without ST-segment elevation, given clopidogrel or placebo on top of aspirin. Clopidogrel lowered cardiovascular death, heart attack or stroke (9.3% versus 11.4%) but increased major bleeding.
2 findings
Substance Abstract gives life-threatening bleeding as "(2.1 percent vs. 1.8 percent, P=0.13)", but the Safety text and Table 3 give "135 (2.2)" for the clopidogrel group; 135/6259 rounds to 2.2 percent.
- p. 1 Abstract, Results
bleeding (2.1 percent vs. 1.8 percent, P=0.13)
- p. 4 Results, Safety
in the clopidogrel group (2.2 percent) as compared
- p. 8 Table 3, Life-threatening row
135 (2.2)
- p. 1 Abstract, Results
(2.1 percent vs. 1.8 percent, P=0.13)
Judge's note: Read the abstract on the page 1 image (2.1 percent vs. 1.8 percent, P=0.13) and the Table 3 life-threatening row on the page 8 crop (135 (2.2), 112 (1.8), P 0.13). The Safety text on page 4 (text layer) also says 2.2 percent. Same comparator and P value, so it is the same analysis. 135/6259 = 2.157%, which rounds to 2.2. No other population or definition is stated, and there is no correction notice in the files.
Second check: another model agreed
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Reference or label "The design and rationale of the study have been reported previously.9" cites reference 9 (CAPRIE Steering Committee, Lancet 1996), whereas the CURE rationale and design paper is reference 10.
- p. 1 Methods, Study Design
design and rationale of the study have been reported previously.9
- p. 9 References 9 and 10
10. CURE Study Investigators. The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme: rationale, design
- p. 9 References 9 and 10
10. CURE Study Investigators. The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme: rationale, design and baseline characteristics
- p. 1 Study Design
The design and rationale of the study have been reported previously.
Judge's note: The page 1 image shows superscript 9 after 'reported previously'. In the reference list on the page 9 image, reference 9 is the CAPRIE trial report and reference 10 is 'CURE Study Investigators ... rationale, design and baseline characteristics'. Reference 9 is used appropriately in the Introduction, so the list is not shifted; this pointer should be 10.
Second check: another model agreed
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5 minor (typos and the like; most checked by the judge only)
Wording Table 1, Heparin or LMW heparin, clopidogrel group: "4522 (72.3)"; 4522/6259 is 72.2 percent.
- p. 3 Table 1, Heparin or LMW heparin, clopidogrel column
4522 (72.3)
Judge's note: The crop shows 4522 (72.3) under N=6259. 4522/6259 = 72.248%, which rounds to 72.2 and is not a rounding tie. Other rows in the same column match N=6259 (for example 2347 gives 37.5 and 3678 gives 58.8). It is a 0.1-point discrepancy in a baseline table. A slightly smaller denominator from missing data is possible but not stated.
Second check: another model agreed
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Wording Table 1, Lipid-lowering agent, clopidogrel group: "1599 (25.6)"; 1599/6259 is 25.5 percent.
- p. 3 Table 1, Lipid-lowering agent, clopidogrel column
1599 (25.6)
Judge's note: The crop shows 1599 (25.6). 1599/6259 = 25.547%, which rounds to 25.5 and is not a rounding tie. It is a 0.1-point discrepancy in a baseline table. An unstated smaller denominator or a count that is off by one could explain it.
Second check: another model agreed
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Typo Writing committee footnote prints "Keith K. Fox, M.D., F.R.C.P." while the Appendix lists the steering committee cochair as "K.A.A. Fox (cochair)".
- p. 1 Footnote, Manuscript Writing Committee
Keith K. Fox, M.D., F.R.C.P.
- p. 8 Appendix, Steering Committee
K.A.A. Fox (cochair)
Judge's note: The page 1 crop shows 'Keith K. Fox'; the page 8 image shows 'K.A.A. Fox (cochair)' in the Appendix. Only one Fox appears in the steering committee and the disclosure names a single Fox, so the initials are inconsistent within the paper. Which form is right is not stated in the files, though the Appendix form is the more specific one.
Second check: none (judge only)
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Typo The board is called an "independent data and safety monitoring board" in the Methods but headed "Data Safety and Monitoring Board" in the Appendix.
- p. 9 Appendix
Data Safety and Monitoring Board
- p. 2 Study Organization
independent data and safety monitoring board
Judge's note: The page 2 image shows 'data and safety monitoring board' twice in the Methods; the page 9 image shows the bold Appendix heading 'Data Safety and Monitoring Board'. The wording is inconsistent, but both forms are in common use and nothing substantive turns on it.
Second check: none (judge only)
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Typo Unbalanced parenthesis: "(11.4 percent); relative risk, 0.80; 95 percent confidence interval, 0.72 to 0.90; P<0.001) (Fig. 1 and 2 and Table 2)". The closing parenthesis after P<0.001 has no matching opening parenthesis.
- p. 3 Results, Primary Outcomes, first sentence (top of left column)
(11.4 percent); relative risk, 0.80; 95 percent confidence interval, 0.72 to 0.90; P<0.001) (Fig. 1 and 2 and Table 2)
Judge's note: On the page 3 image the sentence reads '...placebo group (11.4 percent); relative risk, 0.80; ... P<0.001) (Fig. 1 and 2 and Table 2)'. The parenthesis closes after '11.4 percent' and a second, unmatched one follows P<0.001. This is on the page and is not an extraction artefact.
Second check: none (judge only)