System organ class Preferred term | Patients (n = 49)a | |||||
---|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3b | Grade 4 | Grade 5 | Total | |
n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
Metabolism and nutrition disorders | ||||||
Hyperuricemia | 16 (32.7%) | 0 | 0 | 0 | 0 | 16 (32.7%) |
Hypertriglyceridemia | 9 (18.4%) | 0 | 2 (4.1%) | 0 | 0 | 11 (22.4%) |
Decreased appetite | 5 (10.2%) | 0 | 0 | 0 | 0 | 5 (10.2%) |
General disorders and administration site conditions | ||||||
Fatigue | 7 (14.3%) | 3 (6.1%) | 0 | 0 | 0 | 10 (20.4%) |
Skin and subcutaneous tissue disorders | ||||||
Alopecia | 9 (18.4%) | 0 | 0 | 0 | 0 | 9 (18.4%) |
Infections and infestations | ||||||
Urinary tract infection | 5 (10.2%) | 4 (8.2%) | 0 | 0 | 0 | 9 (18.4%) |
Musculoskeletal and connective tissue disorders | ||||||
Back pain | 5 (10.2%) | 0 | 0 | 0 | 0 | 5 (10.2%) |
Renal and urinary disorders | ||||||
Albuminuria | 6 (12.2%) | 1 (2.0%) | 0 | 0 | 0 | 7 (14.3%) |
Nervous system disorders | ||||||
Hypoesthesia | 6 (12.2%) | 0 | 0 | 0 | 0 | 6 (12.2%) |
Investigations | ||||||
Alanine aminotransferase increased* | 21 (42.9%) | 3 (6.1%) | 1 (2.0%) | 0 | 0 | 25 (51.0%) |
Aspartate aminotransferase increased** | 20 (40.8%) | 5(10.2%) | 0 | 0 | 0 | 25 (51.0%) |
Gamma glutamyl transferase increased*** | 13 (26.5%) | 3 (6.1%) | 2 (4.1%) | 0 | 0 | 18 (36.7%) |
White blood cell count decreased# | 8 (16.3%) | 9 (18.4%) | 2 (4.1%) | 0 | 0 | 19 (38.8%) |
Neutrophil count decreased | 7 (14.3%) | 6 (12.2%) | 2 (4.1%) | 0 | 0 | 15 (30.6%) |
Lymphocytopenia | 2 (4.1%) | 6 (12.2%) | 1 (2.0%) | 0 | 0 | 9 (18.4%) |
Beta 2 microglobulin urine increased | 8 (16.3%) | 0 | 0 | 0 | 0 | 8 (16.3%) |
Thrombocytopenia | 8 (16.3%) | 0 | 0 | 0 | 0 | 8 (16.3%) |
Weight loss | 6 (12.2%) | 1 (2.0%) | 0 | 0 | 0 | 7 (14.3%) |
Bilirubin increased## | 6 (12.2%) | 0 | 0 | 0 | 0 | 6 (12.2%) |
Blood alkaline phosphatase increased | 6 (12.2%) | 0 | 0 | 0 | 0 | 6 (12.2%) |
White blood cell urine positive | 5 (10.2%) | 0 | 0 | 0 | 0 | 5 (10.2%) |
Lactate dehydrogenase increased | 5 (10.2%) | 0 | 0 | 0 | 0 | 5 (10.2%) |
Anemia | 3 (6.1%) | 2 (4.1%) | 0 | 0 | 0 | 5 (10.2%) |