Table 2.
AEs in 15 patients treated with PV
| All-cause AEs (≥25%), % |
Treatment-related AEs, % |
|||
|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| AE | ||||
| Neutropenia∗ | 7 (46.7) | 7 (46.7) | 7 (46.7) | 7 (46.7) |
| Nausea | 9 (60.0) | 0 (0.0) | 7 (46.7) | 0 (0.0) |
| Fatigue | 8 (53.3) | 0 (0.0) | 5 (33.3) | 0 (0.0) |
| Diarrhea | 7 (46.7) | 2 (13.3) | 4 (26.7) | 2 (13.3) |
| Hypophosphatemia | 5 (33.3) | 0 (0.0) | 2 (13.3) | 0 (0.0) |
| Constipation | 4 (26.7) | 0 (0.0) | 3 (20.0) | 0 (0.0) |
| Cough | 4 (26.7) | 0 (0.0) | 1 (6.7) | 0 (0.0) |
| Platelet count decreased | 4 (26.7) | 1 (6.7) | 4 (26.7) | 1 (6.7) |
| Vomiting | 4 (26.7) | 0 (0.0) | 2 (13.3) | 0 (0.0) |
| AEs of interest† | ||||
| Infections‡ | 12 (80.0) | 4 (26.7) | 7 (46.7) | 3 (20.0) |
| Arthralgia | 4 (26.7) | 0 (0.0) | 2 (13.3) | 0 (0.0) |
| Bruising§ | 3 (20.0) | 0 (0.0) | 3 (20.0) | 0 (0.0) |
| Hypertension | 3 (20.0) | 1 (6.7) | 2 (13.3) | 0 (0.0) |
| Rash|| | 1 (6.7) | 0 (0.0) | 1 (6.7) | 0 (0.0) |
| Hemorrhage¶ | 1 (6.7) | 0 (0.0) | 1 (6.7) | 0 (0.0) |
| Atrial fibrillation/flutter# | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
∗
Aggregate of neutropenia and neutrophil count decrease.
†
AEs of interest are those that were previously associated with covalent BTK inhibitors regardless of occurrence rate.
‡
Aggregate of all preferred terms indicating infection and including COVID-19. Infection-related grade 3 to 4 (no grade 5) AEs included COVID-19 pneumonia, pneumonia, oral candidiasis, sepsis, soft tissue infection, and abscess.
§
Aggregate of contusion, petechiae, ecchymosis, and increased tendency to bruise.
‖
Aggregate of all preferred terms including rash.
¶
Aggregate of all preferred terms including hemorrhage or hematoma.
#
Aggregate of atrial fibrillation and atrial flutter.