| 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.