TABLE 2.
Summary of most frequently reported treatment-emergent adverse events regardless of relationship to study drug
| Capsule formulation | Tablet formulation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| System organ class preferred term | 6 mg N = 5 n (%) |
12 mg N = 3 n (%) |
24 mg N = 3 n (%) |
48 mg N = 7 n (%) |
80 mg N = 6 n (%) |
120 mg N = 4 n (%) |
170 mg N = 7 n (%) |
230 mg N = 9 n (%) |
300 mg N = 3 n (%) |
125 mg N = 7 n (%) |
225 mg N = 10 n (%) |
Overall N = 64 n (%) |
| Hematologic events | ||||||||||||
| Thrombocytopenia eventsa | 0 | 0 | 1 (33.3) | 1 (14.3) | 3 (50.0) | 2 (05.0) | 4 (57.1) | 6 (66.7) | 2 (66.7) | 4 (57.1) | 6 (60.0) | 29 (45.3) |
| Anemia | 1 (20.0) | 1 (33.3) | 0 | 2 (28.6) | 1 (16.7) | 2 (50.0) | 0 | 4 (44.4) | 1 (33.3) | 2 (28.6) | 2 (20.0) | 16 (25.0) |
| Lymphopenia | 0 | 0 | 0 | 1 (14.3) | 2 (33.3) | 1 (25.0) | 1 (14.3) | 4 (44.4) | 0 | 1 (14.3) | 3 (30.0) | 13 (20.3) |
| Nonhematologic events | ||||||||||||
| Gastrointestinal disorders | ||||||||||||
| Nausea | 1 (20.0) | 2 (66.7) | 1 (33.3) | 0 | 1 (16.7) | 0 | 0 | 3 (33.3) | 2 (66.7) | 4 (57.1) | 4 (40.0) | 18 (28.1) |
| Vomiting | 1 (20.0) | 1 (33.3) | 1 (33.3) | 1 (14.3) | 3 (50.0) | 1 (25.0) | 0 | 2 (22.2) | 0 | 0 | 3 (30.0) | 13 (20.3) |
| Diarrhea | 1 (20.0) | 0 | 0 | 0 | 0 | 1 (25.0) | 3 (42.9) | 2 (22.2) | 2 (66.7) | 1 (14.3) | 2 (20.0) | 12 (18.8) |
| Other nonhematologic events | ||||||||||||
| Fatigue | 2 (40.0) | 1 (33.3) | 1 (33.3) | 3 (42.9) | 2 (33.3) | 2 (50.0) | 1 (14.3) | 3 (33.3) | 0 | 3 (42.9) | 5 (50.0) | 23 (35.9) |
| Decreased appetite | 0 | 0 | 0 | 2 (28.6) | 3 (50.0) | 1 (25.0) | 1 (14.3) | 2 (22.2) | 0 | 3 (42.9) | 5 (50.0) | 17 (26.6) |
| Hyperglycemia | 1 (20.0) | 1 (33.3) | 0 | 0 | 0 | 1 (25.0) | 1 (14.3) | 2 (22.2) | 1 (33.3) | 1 (14.3) | 4 (40.0) | 12 (18.8) |
| Dysgeusia | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 3 (33.3) | 1 (33.3) | 1 (14.3) | 4 (40.0) | 10 (15.6) |
aInclude MedDRA PTs platelet count decreased and thrombocytopenia.