Table 2.
Incidence of SAEs and AEs during the 25‐week atacicept/placebo treatment period (safety population)a
| Type of event, system | Rituximab then atacicept | Rituximab then placebo | Overall | |||
|---|---|---|---|---|---|---|
| organ class preferred term | Patients | Events | Patients | Events | Patients | Events |
| SAEs | ||||||
| All | 1/18 (5.6) | 2/2 (100.0) | 2/9 (22.2) | 2/2 (100.0) | 3/27 (11.1) | 4/4 (100.0) |
| Nervous system disorders Transient ischemic attack | 1/18 (5.6) | 1/2 (50.0) | 1/9 (11.1) | 1/2 (50.0) | 2/27 (7.4) | 2/4 (50.0) |
| Ruptured cerebral aneurysm | 1/9 (11.1) | 1/2 (50.0) | 1/27 (3.7) | 1/4 (25.0) | ||
| Immune system disorders, drug hypersensitivity | 1/18 (5.6) | 1/2 (50.0) | 0 | 0 | 1/27 (3.7) | 1/4 (25.0) |
| AEs | ||||||
| All | 17/18 (94.4) | 241/241 (100.0) | 9/9 (100.0) | 54/54 (100.0) | 26/27 (96.3) | 295/295 (100.0) |
| General disorders and administration site conditions | 13/18 (72.2) | 156/241 (64.7) | 4/9 (44.4) | 20/54 (37.0) | 17/27 (63.0) | 176/295 (59.7) |
| Infections and infestations | 8/18 (44.4) | 11/241 (4.6) | 6/9 (66.7) | 10/54 (18.5) | 14/27 (51.9) | 21/295 (7.1) |
| Musculoskeletal and connective tissue disorders | 6/18 (33.3) | 6/241 (2.5) | 5/9 (55.6) | 5/54 (9.3) | 11/27 (40.7) | 11/295 (3.7) |
| Skin and subcutaneous tissue disorders | 8/18 (44.4) | 16/241 (6.6) | 2/9 (22.2) | 2/54 (3.7) | 10/27 (37.0) | 18/295 (6.1) |
| Gastrointestinal disorders | 5/18 (27.8) | 10/241 (4.1) | 3/9 (33.3) | 3/54 (5.6) | 8/27 (29.6) | 13/295 (4.4) |
| Nervous system disorders | 3/18 (16.7) | 8/241 (3.3) | 4/9 (44.4) | 8/54 (14.8) | 7/27 (25.9) | 16/295 (5.4) |
| Respiratory, thoracic, and mediastinal disorders | 3/18 (16.7) | 22/241 (9.1) | 3/9 (33.3) | 3/54 (5.6) | 6/27 (22.2) | 25/295 (8.5) |
| Immune system disorders | 4/18 (22.2) | 4/241 (1.7) | 0 | 0 | 4/27 (14.8) | 4/295 (1.4) |
| Eye disorders | 3/18 (16.7) | 3/241 (1.2) | 0 | 0 | 3/27 (11.1) | 3/295 (1.0) |
| Injury, poisoning, and procedural complications | 2/18 (11.1) | 3/241 (1.2) | 0 | 0 | 2/27 (7.4) | 3/295 (1.0) |
| Vascular disorders | 1/18 (5.6) | 1/241 (0.4) | 1 (11.1) | 1 (1.9) | 2 (7.4) | 2/295 (0.7) |
| Cardiac disorders | 1/18 (5.6) | 1/241 (0.4) | 1 (3.7) | 1/295 (0.3) | ||
| Investigationsb | 0 | 0 | 1 (11.1) | 1 (1.9) | 1 (3.7) | 1/295 (0.3) |
| Reproductive system and breast disorders | 0 | 0 | 1 (11.1) | 1 (1.9) | 1 (3.7) | 1/295 (0.3) |
a
Serious adverse events (SAEs) and AEs were evaluated in the safety population (comprising patients who were randomized and received at least one study treatment dose and for whom safety data were available; n = 27). The atacicept period ranged from the date of the first atacicept/placebo dose to the date of the last atacicept/placebo dose plus 7 days. AEs were coded using MedDRA version 13.0. Values are the number/total number (percentage) of patients or events.
b
Defined as laboratory abnormalities.