AEs in 10 patients treated with PVR
. | All-cause AEs (≥25%), % . | Treatment-related AEs, % . | ||
---|---|---|---|---|
Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
AE | ||||
Neutropenia∗ | 7 (70.0) | 6 (60.0) | 7 (70.0) | 6 (60.0) |
Diarrhea | 6 (60.0) | 0 (0.0) | 6 (60.0) | 0 (0.0) |
Fatigue | 5 (50.0) | 1 (10.0) | 2 (20.0) | 0 (0.0) |
Nausea | 4 (40.0) | 0 (0.0) | 4 (40.0) | 0 (0.0) |
Constipation | 4 (40.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) |
Infusion-related reaction | 4 (40.0) | 2 (20.0) | 4 (40.0) | 2 (20.0) |
Anemia | 3 (30.0) | 1 (10.0) | 2 (20.0) | 1 (10.0) |
Back pain | 3 (30.0) | 1 (10.0) | 1 (10.0) | 0 (0.0) |
Chills | 3 (30.0) | 0 (0.0) | 3 (30.0) | 0 (0.0) |
Dyspnea | 3 (30.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Cough | 3 (30.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Dry mouth | 3 (30.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) |
AEs of interest† | ||||
Infections‡ | 9 (90.0) | 4 (40.0) | 2 (20.0) | 1 (10.0) |
Bruising§ | 2 (20.0) | 0 (0.0) | 2 (20.0) | 0 (0.0) |
Rash|| | 3 (30.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) |
Arthralgia | 4 (40.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) |
Hemorrhage¶ | 2 (20.0) | 1 (10.0) | 1 (10.0) | 1 (10.0) |
Hypertension | 1 (10.0) | 1 (10.0) | 0 (0.0) | 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 (70.0) | 6 (60.0) | 7 (70.0) | 6 (60.0) |
Diarrhea | 6 (60.0) | 0 (0.0) | 6 (60.0) | 0 (0.0) |
Fatigue | 5 (50.0) | 1 (10.0) | 2 (20.0) | 0 (0.0) |
Nausea | 4 (40.0) | 0 (0.0) | 4 (40.0) | 0 (0.0) |
Constipation | 4 (40.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) |
Infusion-related reaction | 4 (40.0) | 2 (20.0) | 4 (40.0) | 2 (20.0) |
Anemia | 3 (30.0) | 1 (10.0) | 2 (20.0) | 1 (10.0) |
Back pain | 3 (30.0) | 1 (10.0) | 1 (10.0) | 0 (0.0) |
Chills | 3 (30.0) | 0 (0.0) | 3 (30.0) | 0 (0.0) |
Dyspnea | 3 (30.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Cough | 3 (30.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Dry mouth | 3 (30.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) |
AEs of interest† | ||||
Infections‡ | 9 (90.0) | 4 (40.0) | 2 (20.0) | 1 (10.0) |
Bruising§ | 2 (20.0) | 0 (0.0) | 2 (20.0) | 0 (0.0) |
Rash|| | 3 (30.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) |
Arthralgia | 4 (40.0) | 0 (0.0) | 1 (10.0) | 0 (0.0) |
Hemorrhage¶ | 2 (20.0) | 1 (10.0) | 1 (10.0) | 1 (10.0) |
Hypertension | 1 (10.0) | 1 (10.0) | 0 (0.0) | 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 3-4 (no grade 5) AEs included COVID-19, COVID-19 pneumonia, urinary tract infection, cellulitis, and cystitis.
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.