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Data on 1,042 patients with potential GI events were reviewed for end-points adjudication; the adjudication committee confirmed 89 patients with CSULGIEs.
Of the 354 patients with narratives, the adjudication committee confirmed 89 patients with CSULGIEs (Table 3).
Of the 688 patients who had a decrease in hemoglobin ≥ 2 g/dl, the adjudication committee confirmed 577 patients as having significant bleeds of GI-related or potential GI cause.
The adjudication committee confirmed a CSULGIE or symptomatic ulcer in 103 of 354 patients with narratives (47 (0.2%) patients in celecoxib, 44 (0.3%) in nsNSAID, and 12 (0.2%) in placebo groups) (Table 3).
A three-cardiologist blinded adjudication committee confirmed that 32 cardiovascular disease events occurred in placebo subjects but 15 in acarbose-treated trial participants, with favorable trends for angina and revascularization and significant reduction of myocardial infarction after a 2-year lag period, suggesting a biologically relevant mechanism.
The main difference between the primary study and the follow-up study is that the primary study used medical record abstraction and adjudication to confirm claims-identified cases of acute pancreatitis.
Six participants had events of osteonecrosis of the jaw confirmed by adjudication.
There were three events of acute pancreatitis confirmed by adjudication (sitagliptin: two; placebo [during the sitagliptin period]: one).
During the 4 years of the CORE trial, there were 61 cases of breast cancer (30 in the placebo group and 31 in the raloxifene group) that were confirmed by adjudication (Martino et al 2004; Lippman et al 2006).
For the 7705 MORE participants, the total number of reported breast cancers confirmed by adjudication from randomization in MORE to the end of their participation in either MORE or CORE was 121 (56 cancers in the raloxifene group and 65 cancers in the placebo group).
Recruitment has now ended and 780 patients have been kept for final analysis, the remaining being secondary excluded mainly because sepsis was not confirmed by the adjudication committee.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com