Table IV.
Incidence of Treatment‐Emergent Adverse Events (All Causes, Occurring in ≥2% of Combination‐Treated Patients During Weeks 0–8)
| Double‐Blind Treatment Group* | |||||
|---|---|---|---|---|---|
| Adverse Event (n [%]) | AML 5 mg+ ATV | AML 5 mg | ATV 10 mg | Placebo | Single‐Blind, Open‐Label** (n=775) |
| Respiratory infection | 15 (7.2) | 17 (8.5) | 12 (6.0) | 17 (7.1) | 107 (13.7) |
| Headache | 14 (6.8) | 14 (7.0) | 20 (10.0) | 24 (10.0) | 53 (6.8) |
| Peripheral edema | 11 (5.3) | 11 (5.5) | 1 (0.5) | 5 (2.1) | 133 (17.0) |
| Myalgia | 10 (4.8) | 5 (2.5) | 5 (2.5) | 5 (2.1) | 33 (4.2) |
| Accidental injury | 8 (3.9) | 3(1.5) | 5 (2.5) | 6 (2.5) | 52 (6.6) |
| Asthenia | 7 (3.4) | 6 (3.0) | 8 (4.0) | 11 (4.6) | 45 (5.8) |
| Sinusitis | 6 (2.9) | 2 (1.0) | 2 (1.0) | 2 (0.8) | 26 (3.3) |
| Pain | 5 (2.4) | 5 (2.5) | 4 (2.0) | 5 (2.1) | 36 (4.6) |
| Flatulence | 5 (2.4) | 3(1.5) | 6 (3.0) | 6 (2.5) | 9 (1.2) |
| Arthralgia | 4 (1.9) | 9 (4.5) | 3(1.5) | 8 (3.3) | 58 (7.4) |
| *Weeks 0–8; **Weeks 9–28 | |||||