Number of patients with one or more treatment-emergent serious adverse events for treated patients through the end of study by Medical Dictionary for Regulatory Activities system organ class
| Placebo | Carlumab | |||
| 1 mg·kg−1 | 5 mg·kg−1 | 15 mg·kg−1 | ||
| Treated patients | 28 | 33 | 32 | 32 |
| Mean duration of follow-up weeks | 61 | 61 | 59 | 59 |
| Patients with ≥1 adverse event | 28 | 32 | 32 | 32 |
| Patients with serious adverse events | 13 (46.4) | 5 (15.2) | 17 (53.1) | 7 (21.9) |
| System organ class/preferred term#,¶ | ||||
| Respiratory, thoracic and mediastinal disorders | 5 (17.9) | 2 (6.1) | 9 (28.1) | 5 (15.6) |
| Infections and infestations | 4 (14.3) | 1 (3.0) | 6 (18.8) | 1 (3.1) |
| Cardiac disorders | 2 (7.1) | 0 | 4 (12.5) | 1 (3.1) |
| General disorders and administration site conditions | 2 (7.1) | 1 (3.0) | 2 (6.3) | 1 (3.1) |
| Metabolism and nutrition disorders | 0 | 0 | 1 (3.1) | 1 (3.1) |
| Musculoskeletal and connective disorders | 1 (3.6) | 0 | 2 (6.3) | 0 |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 0 | 0 | 1 (3.1) | 1 (3.1) |
| Nervous system disorders | 2 (7.1) | 1 (3.0) | 1 (3.1) | 0 |
| Renal and urinary disorders | 1 (3.6) | 0 | 2 (6.3) | 0 |
| Ear and labyrinth disorders | 0 | 0 | 0 | 1 (3.1) |
| Gastrointestinal disorders | 2 (7.1) | 0 | 1 (3.1) | 0 |
| Investigations | 0 | 0 | 1 (3.1) | 0 |
| Surgical and medical procedures | 0 | 1 (3.0) | 0 | 0 |
| Injury, poisoning and procedural complications | 1 (3.6) | 0 | 0 | 0 |
| Skin and subcutaneous tissue disorders | 1 (3.6) | 0 | 0 | 0 |
Data are presented as n or n (%). #: percentages calculated with the number of patients in each group as denominator; ¶: incidence is based on the number of patients experiencing at least one adverse event, not the number of events.