Table 3.
Number (%) of subjects with adverse events during the 52-week treatment period
| Adverse events | Omalizumab (n = 68) n (%) | Placebo (n = 69) n (%) |
|---|---|---|
| Any adverse events | 68 (100) | 69 (100) |
| Suspected by investigator to be drug related | 16 (23.5) | 22 (31.9) |
| Severity | ||
| Mild | 28 (41.2) | 25 (36.2) |
| Moderate | 35 (51.5) | 40 (58.0) |
| Severe* | 5 (7.4) | 4 (5.8) |
| Serious adverse events† | 1 (1.5) | 2 (2.9) |
| System organ class affected (≥5% in either treatment group) | ||
| Infections and infestations | 66 (97.1) | 68 (98.6) |
| Respiratory, thoracic and mediastinal disorders | 48 (70.6) | 60 (87.0) |
| Nervous system disorders | 38 (55.9) | 50 (72.5) |
| Gastrointestinal disorders | 35 (51.5) | 39 (56.5) |
| Skin and subcutaneous tissue disorders | 30 (44.1) | 15 (21.7) |
| General disorders and administration site conditions | 21 (30.9) | 22 (31.9) |
| Reproductive system and breast disorders | 17 (25.0) | 17 (24.6) |
| Musculoskeletal and connective tissue disorders | 14 (20.6) | 20 (29.0) |
| Injury, poisoning and procedural complications | 14 (20.6) | 11 (15.9) |
| Eye disorders | 10 (14.7) | 17 (24.6) |
| Ear and labyrinth disorders | 5 (7.4) | 3 (4.3) |
| Blood and lymphatic system disorders | 3 (4.4) | 4 (5.8) |
| Metabolism and nutrition disorders | 3 (4.4) | 4 (5.8) |
| Vascular disorders | 1 (1.5) | 4 (5.8) |
*
Three omalizumab-treated subjects had a single severe adverse event (AE; elective abortion, headache, rhinitis) and 2 subjects had 2 severe AEs (chest pain/headache and anxiety/headache). One placebo recipient had 3 severe AEs (pregnancy, spontaneous abortion, giardiasis) and 3 subjects had a single severe AE (abdominal pain, hypotension, asthma).
†
Elective abortion (omalizumab-treated patient), spontaneous abortion (placebo) and severe asthma exacerbation (placebo).