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) |
| . | 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.