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Safety data from the pivotal phase 3 trials in IBD, i.e., ACCENT I, ACCENT II, SONIC, ACT 1, and ACT 2, were also separately pooled across the three CD, two UC, and all five pivotal phase 3 IBD studies.
To evaluate the occurrence of uncommon events, safety data from the seven studies in CD (with the majority of the data coming from the pivotal ACCENT I, ACCENT II, and SONIC studies) were pooled and are reported as 'CD studies'.
The five pivotal phase 3 trials, i.e., ACCENT I, ACCENT II, SONIC, ACT 1, and ACT 2, contributed approximately 89% (2,119/2,385) of all patients with data in the overall pooled analyses and were generally consistent in terms of study designs, in that they were all randomized, multicenter, double-blind trials that included a control group (Table 1).
Note that for four of the five pivotal phase 3 trials (ACCENT I, ACCENT II, ACT 1, and ACT 2), treatment with the immunomodulators AZA, 6-MP, and MTX or with corticosteroids was allowed during study participation, but such use was not a randomized study treatment.
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