Table 3.
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.