Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
New England Journal of Medicine, 2015 · paper · Clinical trials
A phase 3 trial of 945 previously untreated metastatic melanoma patients comparing nivolumab, nivolumab plus ipilimumab, and ipilimumab alone. Progression-free survival was longest with the combination (11.5 months) and also longer with nivolumab than with ipilimumab, with more serious side effects from the combination.
2 findings
Reference or label Reference 18 prints "J Clin Oncol 2014;52:15Suppl: LBA9003. abstract.", but by the paper's own reference 7 (2015;33) the 2014 volume would be 32.
- p. 12 Reference 18
J Clin Oncol 2014;52:15Suppl:
- p. 12 Reference 18
J Clin Oncol 2014;52:15Suppl
- p. 12 Reference 18
J Clin Oncol 2014;52:15Suppl
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that J Clin Oncol volume 32 is the 2014 volume. The page 12 image shows '2014;52:15Suppl:'. Within the files, reference 7 gives 'J Clin Oncol 2015;33:1191-', which fits 2014 being volume 32, so 52 looks like a typo.
Second check: another model agreed
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Wording The text says "The most common adverse events in the nivolumab-plus-ipilimumab group were diarrhea (in 44.1% of patients), fatigue (in 35.1%), and pruritus (in 33.2%)", but Table 3 lists rash at 126 (40.3) in that group, ahead of fatigue and pruritus.
- p. 8 Results, Adverse Events, first paragraph
diarrhea (in 44.1% of patients), fatigue (in 35.1%), and pruritus (in 33.2%)
- p. 10 Table 3, Rash row, nivolumab-plus-ipilimumab Any column
126 (40.3)
Judge's note: Page 8 text (crop) cites Table 3. Page 10, Table 3, treatment-related events in the combination group (N=313): diarrhea 138 (44.1), fatigue 110 (35.1), pruritus 104 (33.2), rash 126 (40.3). The text's percentages match the treatment-related rows exactly, so it is the same data set. Rash is the second most common event and is missing from the list. Nothing in the text limits the list to a subset of events.
Second check: another model agreed
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1 minor (typos and the like; most checked by the judge only)
Typo Misspelling in the affiliations: "Assitance Publique–Hôpitaux de Marseille" should read "Assistance".
- p. 11 Appendix, affiliations
Assitance Publique–Hôpitaux
- p. 11 Appendix, affiliations
Assitance Publique–Hôpitaux de Marseille
Judge's note: Page 11 crop: 'Assitance Publique–Hôpitaux' is printed in the page image, so this is not an extraction artefact. It is a plain misspelling of the French word 'Assistance'.
Second check: none (judge only)