Table 3:
Adverse events (safety population)
| Double-blind phase |
Open-label extension |
|||
|---|---|---|---|---|
| Placebo (n=44) | Abatacept (n=44) | Placebo–abatacept (n=34) | Abatacept–abatacept (n=33) | |
| One or more adverse event | 40 (91%) | 35 (80%) | 23 (68%) | 25 (76%) |
| One or more infectious adverse event | 25 (57%) | 19 (43%) | 9 (26%) | 11 (33%) |
| Adverse events leading to withdrawal | 6 (14%) | 5 (11%) | 1 (3%) | 2 (6%) |
| One or more serious adverse event | 12 (27%) | 9 (20%) | 2 (6%) | 4 (12%) |
| Infections and infestations (serious adverse events) | 2/2 | 2/2 | 1/1 | 1/1 |
| Cellulitis | 0 | 1 | 0 | 1 |
| Mastoiditis | 0 | 1 | 0 | 0 |
| Paronychia | 1 | 0 | 0 | 0 |
| Pneumonia | 1 | 0 | 0 | 0 |
| Infected Bartholin’s cyst | 0 | 0 | 1 | 0 |
| Cardiac disorders (serious adverse events) | 6/3 | 2/2 | 1/1 | 0 |
| Atrial flutter with conduction defects | 1 | 0 | 0 | 0 |
| Cardiac arrest | 1 | 0 | 0 | 0 |
| Congestive heart failure | 1 | 0 | 0 | 0 |
| Myocardial infarction or acute coronary syndrome | 1 | 1 | 0 | 0 |
| Pulmonary arterial hypertension | 1 | 1 | 0 | 0 |
| Pericardial effusion | 0 | 1 | 0 | 0 |
| Worsening atrioventricular block | 1 | 0 | 0 | 0 |
| Ventricular fibrillation cardiac arrest | 0 | 0 | 1 | 0 |
| Gastrointestinal disorders (serious adverse events) | 6/6 | 3/2 | 0 | 2/2 |
| Anaemia | 1 | 0 | 0 | 0 |
| Cholecystitis | 1 | 0 | 0 | 0 |
| Dysphagia | 1 | 1 | 0 | 0 |
| Erosive oesophagitis | 1 | 0 | 0 | 0 |
| Gastric antral vascular ectasia | 1 | 0 | 0 | 1 |
| Gastric antral vascular ectasia with anaemia | 1 | 0 | 0 | 0 |
| Melaena | 0 | 1 | 0 | 0 |
| Pseudo-obstruction | 0 | 1 | 0 | 0 |
| Pancreatitis | 0 | 0 | 0 | 1 |
| Gynaecological events (serious adverse events) | 0 | 0 | 0 | 1/1 |
| Pregnancy | 0 | 0 | 0 | 1 |
| Malignant disorders (serious adverse events) | 1/1 | 1/1 | 0 | 0 |
| Basal-cell skin carcinoma | 1 | 0 | 0 | 0 |
| Squamous-cell skin carcinoma | 0 | 1 | 0 | 0 |
| Respiratory disorders (serious adverse events) | 0 | 1/1 | 0 | 0 |
| Respiratory failure | 0 | 1 | 0 | 0 |
| Renal disorders (serious adverse events) | 1/1 | 3/3 | 0 | 0 |
| Scleroderma renal crisis | 1 | 3 | 0 | 0 |
| Vascular disorders (serious adverse events) | 1/1 | 0 | 0 | 0 |
| Digital ischaemia | 1 | 0 | 0 | 0 |
| Mental disorders (serious adverse events) | 1/1 | 0 | 0 | 0 |
| Depression with suicidal ideation | 1 | 0 | 0 | 0 |
Data are either number of adverse events (%), number of serious adverse events by system organ class/number of patients with at least one serious adverse event in that class, or number of serious adverse events for preferred terms within a system organ class. Percentages of adverse events are reported separately for the 12-month double-blind phase and the 6-month open-label extension.