Table 3.
Treatment-related AEs occurring in ≥2% of patients.
| Adverse Events, n (%) |
All Treated Patients N = 103 |
|
|---|---|---|
| Any Grade | Grade 3–5 | |
| Blood and lymphatic system disorders | ||
| Anemia | 11 (10.7) | 5 (4.9) |
| Endocrine disorders | ||
| Hypothyroidism | 24 (23.3) | 0 |
| Hyperthyroidism | 6 (5.8) | 0 |
| Autoimmune thyroiditis | 3 (2.9) | 0 |
| Gastrointestinal disorders | ||
| Nausea | 4 (3.9) | 0 |
| Diarrhea | 3 (2.9) | 0 |
| General disorders and administration site conditions | ||
| Fatigue | 15 (14.6) | 1 (1.0) |
| Asthenia | 6 (5.8) | 0 |
| Pyrexia | 4 (3.9) | 0 |
| Peripheral swelling | 3 (2.9) | 0 |
| Hepatobiliary disorders | ||
| Hepatic function abnormal | 4 (3.9) | 1 (1.0) |
| Laboratory investigations | ||
| Blood lactate dehydrogenase increased | 16 (15.5) | 0 |
| Alanine aminotransferase increased | 15 (14.6) | 0 |
| Blood bilirubin increased | 11 (10.7) | 0 |
| Aspartate aminotransferase increased | 10 (9.7) | 0 |
| Bilirubin conjugated increased | 7 (6.8) | 2 (1.9) |
| Blood creatine phosphokinase increased | 7 (6.8) | 0 |
| Blood cholesterol increased | 6 (5.8) | 0 |
| Blood bilirubin unconjugated increased | 5 (4.9) | 0 |
| Blood glucose increased | 5 (4.9) | 0 |
| Blood thyroid stimulating hormone increased | 5 (4.9) | 0 |
| Total bile acids increased | 5 (4.9) | 0 |
| Blood urea increased | 4 (3.9) | 0 |
| Blood uric acid increased | 4 (3.9) | 0 |
| Neutrophil count decreased | 10 (9.7) | 0 |
| Platelet count decreased | 3 (2.9) | 1 (1.0) |
| Transaminases increased | 4 (3.9) | 0 |
| Weight decreased | 3 (2.9) | 1 (1.0) |
| White blood cell count decreased | 12 (11.7) | 3 (2.9) |
| Metabolism and nutrition disorders | ||
| Hypertriglyceridemia | 21 (20.4) | 0 |
| Hyperglycemia | 11 (10.7) | 0 |
| Hyperuricemia | 9 (8.7) | 0 |
| Decreased appetite | 8 (7.8) | 1 (1.0) |
| Hypercholesterolemia | 5 (4.9) | 1 (1.0) |
| Musculoskeletal and connective tissue disorders | ||
| Myalgia | 4 (3.9) | 0 |
| Arthralgia | 3 (2.9) | 0 |
| Backpain | 3 (2.9) | 0 |
| Neoplasms benign, malignant, and unspecifieda | ||
| Tumor pain | 5 (4.9) | 0 |
| Nervous system disorders | 5 (4.9) | 0 |
| Renal and urinary disorders | ||
| Proteinuria | 4 (3.9) | 0 |
| Respiratory, thoracic and mediastinal disorders | 6 (5.8) | 0 |
| Skin and subcutaneous tissue disorders | ||
| Rash | 14 (13.6) | 0 |
| Pruritus | 11 (10.7) | 0 |
| Skin depigmentation | 4 (3.9) | 0 |
| Skin hypopigmentation | 4 (3.9) | 0 |
AE, adverse event.
aIncluding cysts and polyps.