Pooled safety data for KALYDECO (Trials 1, 2, and 3)1
The proportion of patients who prematurely discontinued study drug due to adverse reactions was 2% for patients treated with KALYDECO and 5% for patients treated with placebo.
Serious adverse reactions that occurred more frequently in patients treated with KALYDECO included abdominal pain, increased hepatic enzymes, and hypoglycemia.
The most common adverse reactions in patients treated with KALYDECO (ivacaftor) in Trials 1, 2, and 3 (N=221) were headache (17%), upper respiratory tract infection (16%), nasal congestion (16%), nausea (10%), rash (10%), rhinitis (6%), dizziness (5%), arthralgia (5%), and bacteria in sputum (5%).
Trials 1 and 21
Most Common Adverse Reactions (≥8%) in Patients With a G551D Mutation Treated With KALYDECO and Greater Than Placebo in Clinical Trials 1 and 2
Trials 4, 5, and 6 safety data1
The safety profiles for patients with a G1244E, G1349D, G178R, G551S, G970R, S1251N, S1255P, S549N, or S549R mutation enrolled in Trial 4, for patients with an R117H mutation enrolled in Trial 5, and for patients ages 2 to less than 6 years enrolled in Trial 6 were similar to that observed in Trials 1 and 2.