Table 3 Summary of adverse events (Safety Population)
Description | DRL_RI (N = 70) n (%) (e) | RP/RMP (N = 70) n (%) (e) | Total (N = 140) n (%) (e) |
|---|---|---|---|
All Adverse event | 25 (35.7) (37) | 27 (38.6) (54) | 52 (37.1) (91) |
TEAEs | 24 (34.3) (35) | 27 (38.6) (54) | 51 (36.4) (89) |
Study drug-related TEAEs | 3 (4.3) (3) | 4 (5.7) (7) | 7 (5.0) (10) |
TEAEs leading to treatment discontinuation | 1 (1.4) (1)a | 1 (1.4) (1) | 2 (1.4) (2) |
TEAEs leading to death | 1 (1.4) (1) | 0 | 1 (0.7) (1) |
Study drug-related TEAEs leading to death | 0 | 0 | 0 |
TEAEs of Grade 3 or higher | 4 (5.7) (5) | 2 (2.9) (5) | 6 (4.3) (10) |
Treatment-emergent SAE | 4 (5.7) (4) | 2 (2.9) (5) | 6 (4.3) (9) |
Treatment-emergent study drug-related SAE | 0 | 1 (1.4) (1) | 1 (0.7) (1) |
Treatment-emergent SAE leading to treatment discontinuation | 0 | 0 | 0 |
Hypersensitivity reactions | 0 | 1 (1.4) (1) | 1 (0.7) (1) |
TEAEs leading to treatment discontinuation | 0 | 1 (1.4) (1) | 1 (0.7) (1) |
Infusion-related reactions | 2 (2.9) (2) | 0 | 2 (1.4) (2) |
Anaphylactic reactions | 0 | 0 | 0 |
TEAEs occurring in > 3% of patients | |||
Infections and infestations | 6 (8.6) (7) | 13 (18.6) (19) | 19 (13.6) (26) |
COVID-19 | 1 (1.4) (1) | 3 (4.3) (3) | 4 (2.9) (4) |
Nasopharyngitis | 0 | 3 (4.3) (3) | 3 (2.1) (3) |
Gastrointestinal disorders | 3 (4.3) (3) | 6 (8.6) (9) | 9 (6.4) (12) |
Diarrhoea | 2 (2.9) (2) | 5 (7.1) (6) | 7 (5.0) (8) |
Nervous system disorders | 1 (1.4) (1) | 6 (8.6) (8) | 7 (5.0) (9) |
Headache | 0 | 5 (7.1) (5) | 5 (3.6) (5) |