Table 3 Overview of adverse events in the open-label treatment phase
Preferred term | GMB/GMB (N = 243) n (%) | PBO/GMB (N = 241) n (%) | Total (N = 484) n (%) |
|---|---|---|---|
Deaths | 0 | 0 | 0 |
Patients with ≥ 1 SAEs | 3 (1.2) | 9 (3.7) | 12 (2.5) |
Patients discontinuing due to an AE | 2 (0.8) | 1 (0.4) | 3 (0.6) |
Patients with ≥ 1 TEAE | 94 (38.7) | 83 (34.4) | 177 (36.6) |
Patients with ≥ 1 TEAE relating to treatment | 33 (13.6) | 23 (9.5) | 56 (11.6) |
TEAEsa | |||
Injection site reaction | 12 (4.9) | 4 (1.7) | 16 (3.3) |
Injection site pruritis | 8 (3.3) | 4 (1.7) | 12 (2.5) |
Upper respiratory tract infection | 7 (2.9) | 6 (2.5) | 13 (2.7) |
Nasopharyngitis | 6 (2.5) | 2 (0.8) | 8 (1.7) |
Injection site erythema | 4 (1.6) | 5 (2.1) | 9 (1.9) |
Protein urine present | 4 (1.6) | 3 (1.2) | 7 (1.4) |
Pyrexia | 4 (1.6) | 3 (1.2) | 7 (1.4) |
Abdominal pain upper | 4 (1.6) | 1 (0.4) | 5 (1.0) |
Weight increased | 4 (1.6) | 1 (0.4) | 5 (1.0) |
Anemia | 4 (1.6) | 0 | 4 (0.8) |
Abdominal discomfort | 1 (0.4) | 4 (1.7) | 5 (1.0) |
Injection site discomfort | 1 (0.4) | 4 (1.7) | 5 (1.0) |
Injection site pain | 0 | 6 (2.5) | 6 (1.2) |