Table 4 Overview of TEAEs (reported in ≥2 participants in the overall study population)
SAD | MAD | ||||
|---|---|---|---|---|---|
Empasiprubart (IV) N = 40 n (%) | Placebo N = 14 n (%) | Empasiprubart (IV) N = 18 n (%) | Placebo N = 6 n (%) | TOTAL N = 78 n (%) | |
Related TEAEsa | 19 (47.5) | 8 (57.1) | 14 (77.8) | 5 (83.3) | 46 (59.0) |
Gastrointestinal disorders | 13 (32.5) | 3 (21.4) | 6 (33.3) | 2 (33.3) | 24 (30.8) |
Nausea | 4 (10.0) | 1 (7.1) | 0 | 0 | 5 (6.4) |
Diarrhea | 5 (12.5) | 0 | 2 (11.1) | 1 (16.7) | 8 (10.3) |
General disorders and administration site conditions | 15 (37.5) | 8 (57.1) | 13 (72.2) | 4 (66.7) | 40 (51.3) |
Fatigue | 3 (7.5) | 2 (14.3) | 4 (22.2) | 1 (16.7) | 10 (12.8) |
Feeling cold | 1 (2.5) | 0 | 1 (5.6) | 0 | 2 (2.6) |
Feeling hot | 0 | 1 (7.1) | 2 (11.1) | 0 | 3 (3.8) |
Infusion site irritation | 1 (2.5) | 1 (7.1) | 0 | 0 | 2 (3.7) |
Malaise | 1 (2.5) | 0 | 1 (5.6) | 0 | 2 (2.6) |
Infections and infestations | 3 (7.5) | 2 (14.3) | 8 (44.4) | 0 | 13 (16.7) |
COVID-19 | 0 | 1 (7.1) | 2 (11.1) | 0 | 3 (1.3) |
Folliculitis | 0 | 0 | 4 (22.2) | 0 | 4 (16.6) |
Nasopharyngitis | 2 (5.0) | 1 (7.1) | 4 (22.2) | 0 | 7 (9.0) |
Musculoskeletal and connective tissue disorders | 7 (17.5) | 1 (7.1) | 5 (27.8) | 2 (33.3) | 15 (19.2) |
Nervous system disorders | 8 (20.0) | 3 (21.4) | 7 (38.9) | 2 (33.3) | 20 (25.6) |
Headache | 6 (15.0) | 3 (21.4) | 6 (33.3) | 1 (16.7) | 16 (20.5) |
Tension headache | 0 | 1 (7.1) | 1 (5.6) | 1 (16.7) | 3 (3.8) |
Skin and subcutaneous tissue disorders | 7 (17.5) | 0 | 1 (5.6) | 1 (16.7) | 9 (11.5) |
Hyperhidrosis | 3 (7.5) | 0 | 0 | 0 | 3 (5.6) |
