TEAE summary
| Patients, n (%) . | Ibrutinib intolerant (cohort 1; n = 44) . | Acalabrutinib intolerant∗ (cohort 2; n = 27) . | Total (N = 71) . |
|---|---|---|---|
| Any | 43 (97.7) | 25 (92.6) | 68 (95.8) |
| Grade ≥3 | 28 (63.6) | 15 (55.6) | 43 (60.6) |
| Serious | 15 (34.1) | 8 (29.6) | 23 (32.4) |
| Leading to death | 2 (4.5)† | 0 | 2 (2.8)† |
| Leading to treatment discontinuation | 5 (11.4) | 3 (11.1) | 8 (11.3) |
| Leading to dose interruption | 28 (63.6) | 17 (63.0) | 45 (63.4) |
| Leading to dose reduction | 14 (31.8) | 6 (22.2) | 20 (28.2) |
| Occurring in ≥10% of total patients | |||
| Fatigue | 15 (34.1) | 8 (29.6) | 23 (32.4) |
| COVID-19 | 15 (34.1) | 5 (18.5) | 20 (28.2) |
| Contusion | 12 (27.3) | 5 (18.5) | 17 (23.9) |
| Diarrhea | 10 (22.7) | 7 (25.9) | 17 (23.9) |
| Arthralgia | 10 (22.7) | 5 (18.5) | 15 (21.1) |
| Cough | 9 (20.5) | 6 (22.2) | 15 (21.1) |
| Hypertension | 7 (15.9) | 7 (25.9) | 14 (19.7) |
| Constipation | 11 (25.0) | 1 (3.7) | 12 (16.9) |
| Upper respiratory tract infection | 9 (20.5) | 3 (11.1) | 12 (16.9) |
| Nausea | 9 (20.5) | 2 (7.4) | 11 (15.5) |
| Sinusitis | 9 (20.5) | 2 (7.4) | 11 (15.5) |
| Dizziness | 8 (18.2) | 2 (7.4) | 10 (14.1) |
| Headache | 9 (20.5) | 1 (3.7) | 10 (14.1) |
| Myalgia | 7 (15.9) | 3 (11.1) | 10 (14.1) |
| Insomnia | 8 (18.2) | 1 (3.7) | 9 (12.7) |
| Neutropenia | 7 (15.9) | 2 (7.4) | 9 (12.7) |
| Pneumonia | 8 (18.2) | 1 (3.7) | 9 (12.7) |
| Dyspnea | 6 (13.6) | 2 (7.4) | 8 (11.3) |
| Pain in extremity | 5 (11.4) | 3 (11.1) | 8 (11.3) |
| Rash | 6 (13.6) | 2 (7.4) | 8 (11.3) |
| Grade ≥3 occurring in ≥2% of total patients | |||
| Neutropenia | 7 (15.9) | 2 (7.4) | 9 (12.7) |
| Pneumonia | 4 (9.1) | 1 (3.7) | 5 (7.0) |
| COVID-19 | 3 (6.8) | 1 (3.7) | 4 (5.6) |
| Hypertension | 2 (4.5) | 2 (7.4) | 4 (5.6) |
| COVID-19 pneumonia | 1 (2.3) | 2 (7.4) | 3 (4.2) |
| Cellulitis | 1 (2.3) | 2 (7.4) | 3 (4.2) |
| Dyspnea | 3 (6.8) | 0 | 3 (4.2) |
| Neutrophil count decreased | 1 (2.3) | 2 (7.4) | 3 (4.2) |
| Atrial fibrillation | 2 (4.5) | 0 | 2 (2.8) |
| Diarrhea | 1 (2.3) | 1 (3.7) | 2 (2.8) |
| Peripheral sensory neuropathy | 1 (2.3) | 1 (3.7) | 2 (2.8) |
| Syncope | 2 (4.5) | 0 | 2 (2.8) |
| Patients, n (%) . | Ibrutinib intolerant (cohort 1; n = 44) . | Acalabrutinib intolerant∗ (cohort 2; n = 27) . | Total (N = 71) . |
|---|---|---|---|
| Any | 43 (97.7) | 25 (92.6) | 68 (95.8) |
| Grade ≥3 | 28 (63.6) | 15 (55.6) | 43 (60.6) |
| Serious | 15 (34.1) | 8 (29.6) | 23 (32.4) |
| Leading to death | 2 (4.5)† | 0 | 2 (2.8)† |
| Leading to treatment discontinuation | 5 (11.4) | 3 (11.1) | 8 (11.3) |
| Leading to dose interruption | 28 (63.6) | 17 (63.0) | 45 (63.4) |
| Leading to dose reduction | 14 (31.8) | 6 (22.2) | 20 (28.2) |
| Occurring in ≥10% of total patients | |||
| Fatigue | 15 (34.1) | 8 (29.6) | 23 (32.4) |
| COVID-19 | 15 (34.1) | 5 (18.5) | 20 (28.2) |
| Contusion | 12 (27.3) | 5 (18.5) | 17 (23.9) |
| Diarrhea | 10 (22.7) | 7 (25.9) | 17 (23.9) |
| Arthralgia | 10 (22.7) | 5 (18.5) | 15 (21.1) |
| Cough | 9 (20.5) | 6 (22.2) | 15 (21.1) |
| Hypertension | 7 (15.9) | 7 (25.9) | 14 (19.7) |
| Constipation | 11 (25.0) | 1 (3.7) | 12 (16.9) |
| Upper respiratory tract infection | 9 (20.5) | 3 (11.1) | 12 (16.9) |
| Nausea | 9 (20.5) | 2 (7.4) | 11 (15.5) |
| Sinusitis | 9 (20.5) | 2 (7.4) | 11 (15.5) |
| Dizziness | 8 (18.2) | 2 (7.4) | 10 (14.1) |
| Headache | 9 (20.5) | 1 (3.7) | 10 (14.1) |
| Myalgia | 7 (15.9) | 3 (11.1) | 10 (14.1) |
| Insomnia | 8 (18.2) | 1 (3.7) | 9 (12.7) |
| Neutropenia | 7 (15.9) | 2 (7.4) | 9 (12.7) |
| Pneumonia | 8 (18.2) | 1 (3.7) | 9 (12.7) |
| Dyspnea | 6 (13.6) | 2 (7.4) | 8 (11.3) |
| Pain in extremity | 5 (11.4) | 3 (11.1) | 8 (11.3) |
| Rash | 6 (13.6) | 2 (7.4) | 8 (11.3) |
| Grade ≥3 occurring in ≥2% of total patients | |||
| Neutropenia | 7 (15.9) | 2 (7.4) | 9 (12.7) |
| Pneumonia | 4 (9.1) | 1 (3.7) | 5 (7.0) |
| COVID-19 | 3 (6.8) | 1 (3.7) | 4 (5.6) |
| Hypertension | 2 (4.5) | 2 (7.4) | 4 (5.6) |
| COVID-19 pneumonia | 1 (2.3) | 2 (7.4) | 3 (4.2) |
| Cellulitis | 1 (2.3) | 2 (7.4) | 3 (4.2) |
| Dyspnea | 3 (6.8) | 0 | 3 (4.2) |
| Neutrophil count decreased | 1 (2.3) | 2 (7.4) | 3 (4.2) |
| Atrial fibrillation | 2 (4.5) | 0 | 2 (2.8) |
| Diarrhea | 1 (2.3) | 1 (3.7) | 2 (2.8) |
| Peripheral sensory neuropathy | 1 (2.3) | 1 (3.7) | 2 (2.8) |
| Syncope | 2 (4.5) | 0 | 2 (2.8) |