Adverse events† in AIR pivotal trial occurring in ≥3% of patients treated with VENTAVIS1 | |||||
---|---|---|---|---|---|
Adverse event | VENTAVIS (n=101) % |
Placebo (n=102) % |
Placebo Subtracted % |
||
Vasodilation (flushing) | 27 | 9 | 18 | ||
Cough increased | 39 | 26 | 13 | ||
Headache | 30 | 20 | 10 | ||
Trismus | 12 | 3 | 9 | ||
Insomnia | 8 | 2 | 6 | ||
Nausea | 13 | 8 | 5 | ||
Hypotension | 11 | 6 | 5 | ||
Vomiting | 7 | 2 | 5 | ||
Alk phos increased | 6 | 1 | 5 | ||
Flu syndrome | 14 | 10 | 4 | ||
Back pain | 7 | 3 | 4 | ||
Tongue pain | 4 | 0 | 4 | ||
Palpitations | 7 | 4 | 3 | ||
Syncope | 8 | 5 | 3 | ||
GGT increased | 6 | 3 | 3 | ||
Muscle cramps | 6 | 3 | 3 | ||
Hemoptysis | 5 | 2 | 3 | ||
Pneumonia | 4 | 1 | 3 |
†Adverse events reported by at least 4 VENTAVIS® (iloprost) Inhalation Solution patients and reported at least 3% more frequently for VENTAVIS patients than placebo patients in a 12-week study.