Proportion of patients experiencing at least one adverse event (Safety Analysis Set)
| Placebo n=154 | Atacicept 75 mg n=157 | Atacicept 150 mg n=144 | |
|---|---|---|---|
| Adverse events, treatment and follow-up | 123 (79.9) | 131 (83.4) | 120 (83.3) |
| Adverse events, treatment only | 117 (76.0) | 130 (82.8) | 116 (80.6) |
| Adverse events leading to treatment discontinuation | 17 (11.0) | 14 (8.9) | 16 (11.1) |
| Serious adverse events, treatment and follow-up | 27 (17.5) | 30 (19.1) | 23 (16.0) |
| Serious adverse events, treatment only | 21 (13.6) | 23 (14.6) | 20 (13.9) |
| Serious adverse events leading to treatment discontinuation | 12 (7.8) | 4 (2.5) | 6 (4.2) |
| Infections, treatment and follow-up | 83 (53.9) | 97 (61.8) | 85 (59.0) |
| Infections, treatment only | 80 (51.9) | 93 (59.2) | 79 (54.9) |
| Upper respiratory tract infection | 20 (13.0) | 24 (15.3) | 22 (15.3) |
| Urinary tract infection | 15 (9.7) | 18 (11.5) | 20 (13.9) |
| Nasopharyngitis | 10 (6.5) | 20 (12.7) | 15 (10.4) |
| Bronchitis | 5 (3.2) | 9 (5.7) | 9 (6.3) |
| Sinusitis | 10 (6.5) | 6 (3.8) | 4 (2.8) |
| Influenza | 8 (5.2) | 3 (1.9) | 5 (3.5) |
| Serious infections, treatment and follow-up | 11 (7.1) | 13 (8.3) | 11 (7.6) |
| Pneumonia | 2 (1.3) | 5 (3.2) | 3 (2.1) |
| Upper respiratory tract infection | – | 2 (1.3) | 2 (1.4) |
| Urinary tract infection | 2 (1.3) | 1 (0.6) | – |
| Serious infections, treatment only | 7 (4.5) | 6 (3.8) | 10 (6.9) |
| Pneumonia | 1 (0.6) | 3 (1.9) | 3 (2.1) |
| Upper respiratory tract infection | – | 1 (0.6) | 2 (1.4) |
| Urinary tract infection | 1 (0.6) | 1 (0.6) | – |
| Deaths | 0 (0) | 0 (0) | 2 (1.4) |
All data are n (%).