Summary of patients with adverse events* reported in the double-blind period and in the cumulative abatacept-treated population
| Double-blind treatment period | Cumulative abatacept-treated population† (n=178) | ||
| Abatacept (n=92) | Placebo (n=95) | ||
| Deaths | 0 (0) | 1 (1.1) | 1 (0.6) |
| Serious adverse events | 9 (9.8) | 3 (3.2) | 20 (11.2) |
| Cardiac disorders | 1 (1.1) | 1 (1.1) | 2 (1.1) |
| Gastrointestinal disorders | 1 (1.1) | 1 (1.1) | 1 (0.6) |
| Immune system disorders | 2 (2.2) | 0 | 2 (1.1) |
| Infections and infestations | 1 (1.1) | 1 (1.1) | 3 (1.7) |
| Musculoskeletal and connective tissue disorders | 2 (2.2) | 0 | 4 (2.2) |
| Hepatobiliary disorders | 1 (1.1) | 0 | 2 (1.1) |
| Neoplasms | 1 (1.1) | 0 | 3 (1.7) |
| General disorders | 0 | 0 | 2 (1.1) |
| Blood and lymphatic system disorders | 0 | 0 | 1 (0.6) |
| Product issues | 0 | 0 | 1 (0.6) |
| Respiratory, thoracic and mediastinal disorders | 0 | 0 | 1 (0.6) |
| Study drug-related serious adverse events | 3 (3.3) | 1 (1.1) | 6 (3.4) |
| Discontinuations due to serious adverse events | 2 (2.2) | 1 (1.1) | 4 (2.2) |
| Adverse events | 79 (85.9) | 68 (71.6) | 127 (71.3) |
| Study drug-related adverse events‡ | 42 (45.7) | 24 (25.3) | 67 (37.6) |
| Discontinuations due to adverse events | 3 (3.3) | 2 (2.1) | 5 (2.8) |
Data are n, %.
*Adverse events reported up to 56 days post-last abatacept dose. Serious adverse events include hospitalisations for elective surgical procedures. Study drug-related adverse event or serious adverse event is defined as an adverse event or serious adverse event with a related or missing relationship to study medication.
†The cumulative abatacept-treated population were followed from the first day of abatacept treatment in the study up to 56 days after the last abatacept treatment in the study.
‡Adverse events related to abatacept were not driven by any specific system organ class.