Table 2.
Treatment-related adverse events (TRAEs) with incidence of ≥10% in SS at stage 2
| Safety population (n = 82) | ||
|---|---|---|
| Any grade | Grade 3 or more | |
| TRAEs | 82 (100.0%) | 63 (76.8%) |
| Hyperglycemia | 68 (82.9%) | 16 (19.5%) |
| Diarrhea | 46 (56.1%) | 11 (13.4%) |
| Neutropenia | 37 (45.1%) | 18 (22.0%) |
| Leukopenia | 31 (37.8%) | 9 (11.0%) |
| Weight loss | 30 (36.6%) | 2 (2.4%) |
| Thrombopenia | 30 (36.6%) | 7 (8.5%) |
| Lymphopenia | 26 (31.7%) | 7 (8.5%) |
| Anemia | 24 (29.3%) | 3 (3.7%) |
| Hypokalemia | 23 (28.1%) | 6 (7.3%) |
| Blood bilirubin increased | 18 (22.0%) | 0 |
| Decreased appetite | 16 (19.5%) | 3 (3.7%) |
| Glycosylated hemoglobin (A1c) elevated | 16 (19.5%) | 2 (2.4%) |
| Proteinuria | 15 (18.3%) | 0 |
| Alanine aminotransferase increased | 15 (18.3%) | 2 (2.4%) |
| Hypoalbuminemia | 14 (17.1%) | 0 |
| Glucosuria | 14 (17.1%) | 1 (1.2%) |
| Pneumonitis | 13 (15.9%) | 5 (6.1%) |
| Nausea | 13 (15.9%) | 0 |
| Vomiting | 12 (14.6%) | 1 (1.2%) |
| Fatigue | 12 (14.6%) | 3 (3.7%) |
| Infectious pneumonia | 12 (14.6%) | 6 (7.3%) |
| Increased C-reactive protein | 12 (14.6%) | 3 (3.7%) |
| Aspartate aminotransferase increased | 12 (14.6%) | 2 (2.4%) |
| Lipase increased | 12 (14.6%) | 4 (4.9%) |
| Positive urinary ketone body | 11 (13.4%) | 0 |
| Creatinine increased | 11 (13.4%) | 0 |
| Blood lactate dehydrogenase increased | 11 (13.4%) | 0 |
| CD4 lymphocytes decreased | 9 (11.0%) | 3 (3.7%) |
| Elevated conjugated bilirubin | 9 (11.0%) | 0 |
| Hyponatremia | 9 (11.0%) | 0 |
Data were presented as n (%)
TRAEs treatment-related adverse events