Patients with adverse events (AE) in most frequently affected body systems (≥5% in either group)
| 24‐week double-blind extension (all extension patients) | 52‐week overall safety (all randomized patients) | |||
| Omalizumab | Placebo | Omalizumab | Placebo | |
| Total patients studied | 254 (100) | 229 (100) | 274 (100) | 272 (100) |
| Total patients with an AE | 161 (63.4) | 151 (65.9) | 229 (83.6) | 232 (85.3) |
| Body system affected | ||||
| Respiratory | 84 (33.1) | 97 (42.4) | 160 (58.4) | 173 (63.6) |
| Infections and infestations | 49 (19.3) | 53 (23.1) | 124 (45.3) | 132 (48.5) |
| Nervous | 40 (15.7) | 40 (17.5) | 99 (36.1) | 90 (33.1) |
| Musculoskeletal | 40 (15.7) | 27 (11.8) | 86 (31.4) | 78 (28.7) |
| Body as a whole | 35 (13.8) | 36 (15.7) | 78 (28.5) | 81 (29.8) |
| Digestive | 33 (13.0) | 22 (9.6) | 88 (32.1) | 69 (25.4) |
| Skin and appendages | 22 (8.7) | 17 (7.4) | 46 (16.8) | 44 (16.2) |
| Special senses | 12 (4.7) | 13 (5.7) | 35 (12.8) | 26 (9.6) |
| Urogenital and reproductive | 16 (6.3) | 19 (8.3) | 36 (13.1) | 33 (12.1) |
| Cardiovascular | 2 (0.8) | 3 (1.3) | 13 (4.7) | 17 (6.3) |
Data are presented as n (%)