Table 4. TRAEs in SAS.
AEsAny grade | All patients, n (%) | ||
---|---|---|---|
Hypothyroidism | 7 (20.6) | 7 (20.6) | 0 (0.0) |
Arrhythmia | 5 (14.7) | 4 (11.8) | 1 (2.9) |
Atrial premature beats | 2 (5.9) | 2 (5.9) | 0 (0.0) |
Atrioventricular block | 2 (5.9) | 2 (5.9) | 0 (0.0) |
Atrial fibrillation | 1 (2.9) | 0 (0.0) | 1 (2.9) |
Immune-related pneumonitis | 3 (8.8) | 1 (2.9) | 2 (5.9) |
Abnormal hepatic function | 2 (5.9) | 2 (5.9) | 0 (0.0) |
Blood creatinine increased | 2 (5.9) | 2 (5.9) | 0 (0.0) |
Proteinuria | 3 (8.8) | 3 (8.8) | 0 (0.0) |
Fatigue | 2 (5.9) | 2 (5.9) | 0 (0.0) |
Hyperglycemia | 2 (5.9) | 2 (5.9) | 0 (0.0) |
Creatine kinase | 2 (5.9) | 2 (5.9) | 0 (0.0) |
Hypertension | 2 (5.9) | 2 (5.9) | 0 (0.0) |
Rash | 1 (2.9) | 1 (2.9) | 0 (0.0) |
Left ventricular ejection fraction decreased | 1 (2.9) | 1 (2.9) | 0 (0.0) |
Catheter-related infection | 1 (2.9) | 0 (0.0) | 1 (2.9) |
Any AE | 18 (52.9) | 14 (41.1) | 4 (11.8) |
TRAE, treatment-related adverse event; SAS, safety analysis set; AE, adverse event.