There was no difference between pirfenidone and placebo in the percentage of patients that experienced a serious adverse event (SAE). An SAE was reported in 35% and 33% of pirfenidone and placebo groups, respectively, in CAPACITY 2 and in 31% and 30%, respectively, in CAPACITY 1. In both studies, the incidence of Grade 3 or Grade 4 laboratory abnormalities was similar between patients treated with pirfenidone or placebo.
The pattern of adverse events was in general comparable to that observed in previous clinical studies of pirfenidone. The most common adverse events occurring more than 1.5 times in the pirfenidone 2403 mg group as compared to placebo in either study were nausea (35% vs. 18% in CAPACITY 2 and 38% vs. 16% in CAPACITY 1), rash (31% vs. 10% and 34% vs. 13%), fatigue (28% vs. 21% and 33% vs. 20%), diarrhea (25% vs. 17% and 33% vs. 21%), dyspepsia (17% vs. 9% and 21% vs. 6%), and dizziness (19% vs. 10% and 18% vs. 10%). Rash was generally mild to moderate in both studies; only 2 patients (1 in each CAPACITY study) receiving pirfenidone 2403 mg experienced a severe rash, and only 4 patients in each study discontinued study treatment due to a rash or photosensitivity. There was no difference in the incidence of skin cancer between patients treated with pirfenidone or placebo.
Low-dose Treatment Group
A low-dose group at 1197 mg per day was included in CAPACITY 2 to explore dose-response relationships in a descriptive fashion. In general, on efficacy o
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