Table 2.
TRAEs occurring in ≥10% of patients and grade ≥3 TRAEs in more than one patient
| Preferred term | 30 mg (N = 17) n (%) | 50 mg (N = 20) n (%) | 70 mg (N = 13) n (%) | 100 mg (N = 6) n (%) | Total (N = 56) n (%) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| TRAE ≥10% | Grade ≥3 TRAE | TRAE ≥10% | Grade ≥3 TRAE | TRAE ≥10% | Grade ≥3 TRAE | TRAE ≥10% | Grade ≥3 TRAE | TRAE ≥10% | Grade ≥3 TRAE | |
| At least one event | 16 (94.1) | 6 (35.3) | 19 (95.0) | 12 (60.0) | 12 (92.3) | 10 (76.9) | 6 (100) | 5 (83.3) | 53 (94.6) | 33 (58.9) |
| Platelet count decreased* | 8 (47.1) | 2 (11.8) | 10 (50.0) | 4 (20.0) | 11 (84.6) | 5 (38.5) | 3 (50.0) | 1 (16.7) | 32 (57.1) | 12 (21.4) |
| Fatigue* | 7 (41.2) | – | 10 (50.0) | 4 (20.0) | 6 (46.2) | 1 (7.7) | 4 (66.7) | 1 (16.7) | 27 (48.2) | 6 (10.7) |
| Anemia | 5 (29.4) | 4 (23.5) | 5 (20.0) | 3 (15.0) | 5 (38.5) | 5 (38.5) | 4 (66.7) | 3 (50.0) | 19 (33.9) | 15 (26.8) |
| Hyperglycemia* | 2 (11.8) | – | 6 (30.0) | 2 (10.0) | 6 (46.2) | 1 (7.7) | 2 (33.3) | 1 (16.7) | 16 (28.6) | 4 (7.1) |
| AST increased | 3 (17.6) | – | 2 (10.0) | – | 6 (46.2) | – | 2 (33.3) | – | 13 (23.2) | – |
| Hypertriglyceridemia | 4 (23.5) | – | 5 (25.0) | – | 2 (15.4) | – | 2 (33.3) | – | 13 (23.2) | – |
| Diarrhea | 2 (11.8) | – | 3 (15.0) | – | 3 (23.1) | – | 4 (66.7) | – | 12 (21.4) | – |
| ALT increased | 1 (5.9) | – | 2 (10.0) | – | 6 (46.2) | – | 2 (33.3) | – | 11 (19.6) | – |
| Decreased appetite | 3 (17.6) | – | 4 (20.0) | – | 3 (23.1) | – | 1 (16.7) | – | 11 (19.6) | – |
| Dry eye | 5 (29.4) | – | 2 (10.0) | – | 2 (15.4) | – | 2 (33.3) | – | 11 (19.6) | – |
| Nausea | 2 (11.8) | – | 2 (10.0) | – | 2 (15.4) | – | 2 (33.3) | – | 8 (14.3) | – |
| Hypomagnesemia | 2 (11.8) | – | 2 (10.0) | – | 2 (15.4) | – | 1 (16.7) | – | 7 (12.5) | – |
| Hypophosphatemia | 3 (17.6) | – | 3 (15.0) | – | 0 | – | 1 (16.7) | – | 7 (12.5) | – |
| Vomiting | 2 (11.8) | – | 3 (15.0) | – | 1 (7.7) | – | 1 (16.7) | – | 7 (12.5) | – |
| GGT increased | 1 (5.9) | – | 0 | – | 3 (23.1) | – | 2 (33.3) | – | 6 (10.7) | – |
| Hypokalemia | 1 (5.9) | – | 2 (10.0) | – | 0 | – | 3 (50.0) | – | 6 (10.7) | – |
*The following combined terms are included in this presentation: platelet count decreased includes thrombocytopenia; fatigue includes malaise and asthenia; hyperglycemia includes diabetes
AST, aspartate aminotransferase; ALT, alanine aminotransferase; GGT, gamma-glutamyl transferase.