Summary of safety and most common AEs (occurring in more than 10% of subjects in the combined avatrombopag treatment groups) during the randomized and extension studies
| AE . | Total number of subjects receiving avatrombopag (N = 64) . | ||
|---|---|---|---|
| Any AE* . | Severe AE† . | Serious AE . | |
| No. of subjects with ≥1 AE | 64 (100) | 26 (41) | 12 (19) |
| Fatigue | 24 (38) | 2 (3) | 0 |
| Headache | 21 (33) | 1 (2) | 0 |
| Epistaxis | 16 (25) | 1 (2) | 0 |
| Contusion | 13 (20) | 0 | 0 |
| Arthralgia | 9 (14) | 0 | 0 |
| Diarrhea | 9 (14) | 1 (2) | 1 (2) |
| Severe thrombocytopenia (platelets <10 × 109/L) | 9 (14) | 8 (13) | 5 (8) |
| Gingival bleeding | 8 (13) | 0 | 0 |
| Back pain | 7 (11) | 1 (2) | 1 (2) |
| Peripheral edema | 7 (11) | 1 (2) | 0 |
| Petechiae | 7 (11) | 0 | 0 |
| PC increased | 7 (11) | 7 (11) | 0 |
| Vomiting | 7 (11) | 2 (3) | 2 (3) |
| AE . | Total number of subjects receiving avatrombopag (N = 64) . | ||
|---|---|---|---|
| Any AE* . | Severe AE† . | Serious AE . | |
| No. of subjects with ≥1 AE | 64 (100) | 26 (41) | 12 (19) |
| Fatigue | 24 (38) | 2 (3) | 0 |
| Headache | 21 (33) | 1 (2) | 0 |
| Epistaxis | 16 (25) | 1 (2) | 0 |
| Contusion | 13 (20) | 0 | 0 |
| Arthralgia | 9 (14) | 0 | 0 |
| Diarrhea | 9 (14) | 1 (2) | 1 (2) |
| Severe thrombocytopenia (platelets <10 × 109/L) | 9 (14) | 8 (13) | 5 (8) |
| Gingival bleeding | 8 (13) | 0 | 0 |
| Back pain | 7 (11) | 1 (2) | 1 (2) |
| Peripheral edema | 7 (11) | 1 (2) | 0 |
| Petechiae | 7 (11) | 0 | 0 |
| PC increased | 7 (11) | 7 (11) | 0 |
| Vomiting | 7 (11) | 2 (3) | 2 (3) |