TABLE 3.
Summary of AE
| Preferred term | OMA 300 (N = 167) | OMA 150 (N = 167) | Placebo (N = 83) |
|---|---|---|---|
| Any AE | 119 (71.3) | 108 (64.7) | 53 (63.9) |
| Treatment‐related AE | 30 (18.0) | 29 (17.4) | 7 (8.4) |
| Severe AE | 5 (3.0) | 3 (1.8) | 2 (2.4) |
| SAE | 5 (3.0) | 5 (3.0) | 3 (3.6) |
| Treatment related | 0 | 1 (0.6) | 0 |
| Deaths | 0 | 0 | 0 |
| AE leading to discontinuation of study drug | 7 (4.2) | 1 (0.6) | 1 (1.2) |
| Treatment related | 3 (1.8) | 1 (0.6) | 0 |
| Most commonly reported AE (≥3% incidences in any group) | |||
| Upper respiratory tract infection | 37 (22.2) | 25 (15.0) | 12 (14.5) |
| Cough | 11 (6.6) | 3 (1.8) | 2 (2.4) |
| Influenza | 7 (4.2) | 7 (4.2) | 1 (1.2) |
| Nasopharyngitis | 7 (4.2) | 8 (4.8) | 7 (8.4) |
| Arthralgia | 6 (3.6) | 4 (2.4) | 0 |
| Blood uric acid increased | 5 (3.0) | 5 (3.0) | 4 (4.8) |
| Eczema | 5 (3.0) | 4 (2.4) | 1 (1.2) |
| Hypertension | 5 (3.0) | 3 (1.8) | 0 |
| Pyrexia | 5 (3.0) | 4 (2.4) | 1 (1.2) |
| Oropharyngeal pain | 4 (2.4) | 1 (0.6) | 3 (3.6) |
| Dermatitis | 2 (1.2) | 1 (0.6) | 3 (3.6) |
| Alanine aminotransferase increased | 1 (0.6) | 6 (3.6) | 1 (1.2) |
| Blood creatine phosphokinase increased | 1 (0.6) | 5 (3.0) | 0 |
| Pharyngitis | 1 (0.6) | 4 (2.4) | 3 (3.6) |
| Hepatic function abnormal | 0 | 2 (1.2) | 3 (3.6) |
Note: Preferred terms are sorted by descending frequency in the OMA 300 group. A patient with multiple occurrences of an AE under one treatment is counted only once in that AE category for that treatment. MedDRA Version 22.1 has been used for reporting.
Abbreviations: AE, adverse event; OMA, omalizumab; SAE, serious adverse event.