Table 2.
Most Common Treatment‐Related Adverse Events: Safety Analysis Set, N = 49
| Event | No. (%) | |
|---|---|---|
| All Grades | Grade 3 | |
| All events | 21 (42.9) | 5 (10.2) |
| Metabolism and nutrition disorders | ||
| Type 2 diabetes mellitus/diabetes mellitus | 3 (6.1) | 3 (6.1) |
| Hyperglycemia | 3 (6.1) | |
| Glucose tolerance impaired | 1 (2.0) | |
| Investigations | ||
| γ‐GTP increased | 4 (8.2) | 1 (2.0) |
| Lymphocyte count decreased | 1 (2.0) | 1 (2.0) |
| ALP increased | 1 (2.0) | |
| Abnormal ECG | ||
| QRS complex prolonged | 3 (6.1) | |
| PR prolongation | 1 (2.0) | |
| Atrioventricular block first degree | 1 (2.0) | |
| Supraventricular extrasystoles | 1 (2.0) | |
| General disorders | ||
| Fatigue | 2 (4.1) | |
| Asthenia | 1 (2.0) | |
| Face edema | 1 (2.0) | |
| Thirst | 1 (2.0) | |
| Other | ||
| Endocrine disorder | 1 (2.0) | |
| Vision blurred | 1 (2.0) | |
| Nasopharyngitis | 1 (2.0) | |
| Hyperhidrosis | 1 (2.0) | |
| Hypertension | 1 (2.0) | |
Abbreviations: ALP, alkaline phosphatase; ECG, electrocardiogram; γ‐GTP, gamma glutamyl transpeptidase.