Table 3.
Treatment-emergent adverse events.
| Adverse events | Safety set (n = 108) | Main efficacy analysis population (n = 68) |
|---|---|---|
| Any TEAEs | 105 (97.2) | 67 (98.5) |
| Grade ≥3 | 53 (49.1) | 28 (41.2) |
| Grade 5 | 15 (13.9) | 5 (7.4) |
| TEAEs leading to treatment discontinuation | 4 (3.7) | 2 (2.9) |
| Serious TEAEs | 32 (29.6) | 16 (23.5) |
| irAEs | 52 (48.1) | 39 (57.4) |
| Any ADRs | 86 (79.6) | 58 (85.3) |
| Grade ≥3 | 27 (25.0) | 18 (26.5) |
| Grade 5 | 3 (2.8) | 2 (2.9) |
| ADRs leading to treatment discontinuation | 3 (2.8) | 2 (2.9) |
| Serious ADRs | 16 (14.8) | 10 (14.7) |
| TEAEs of grade ≥3 in ≥5% of patients in the SS | ||
| Anaemia | 9 (8.3) | 4 (5.9) |
| Disease progression | 7 (6.5) | 2 (2.9) |
| Gamma-glutamyltransferase increased | 6 (5.6) | 3 (4.4) |
| Intestinal obstruction | 6 (5.6) | 5 (7.4) |
| irAEs in ≥3% patients in the SS | ||
| Hypothyroidism | 18 (16.7) | 13 (19.1) |
| Hyperthyroidism | 9 (8.3) | 7 (10.3) |
| Pneumonitis | 5 (4.6) | 1 (1.5) |
| Thyroid-stimulating hormone increased | 4 (3.7) | 2 (2.9) |
| Abnormal liver function | 4 (3.7) | 4 (5.9) |
ADR adverse drug reaction, irAE immune-related adverse event, MSI-H microsatellite instability-high, SS safety set, TEAE treatment-emergent adverse event.