AEs in the 3 groups of patients from randomization + 3 years (month 51)
| CTCAE grade . | Grade 2 . | Grade 3 . | Grade 4 . | Fatalities∗ . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Non-rdm Ibr (n = 116) . | Arm A Ibr (n = 24) . | Arm B Obs (n = 48) . | Non-rdm Ibr (n = 116) . | Arm A Ibr (n = 24) . | Arm B Obs (n = 48) . | Non-rdm Ibr (n = 116) . | Arm A Ibr (n = 24) . | Non-rdm Ibr (n = 116) . | Arm A Ibr (n = 24) . | Arm B Obs (n = 48) . | |
| Any | 27 (23%) | 9 (38%) | 10 (21%) | 58 (50%) | 8 (33%) | 18 (38%) | 10 (9%) | 3 (13%) | 9 (8%) | 1 (4%) | 4 (8%) |
| Infections | 24 (21%) | 9 (38%) | 11 (23%) | 32 (28%) | 4 (17%) | 3 (6%) | 6 (5%) | 1 (4%) | 2 (2%) | 1 (4%) | 1 (2%) |
| TLS | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Atrial fibrillation | 4 (3%) | 1 (4%) | 0 | 2 (2%) | 1 (4%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 2 (2%) | 0 | 3 (6%) | 2 (2%) | 0 | 2 (4%) | 2 (2%) | 0 | 0 | 0 | 0 |
| Arthralgia | 8 (7%) | 1 (4%) | 1 (2%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Diarrhea | 8 (7%) | 2 (8%) | 2 (4%) | 2 (2%) | 0 | 2 (4%) | 0 | 0 | 0 | 0 | 0 |
| Bleeding | 13 (11%) | 1 (4%) | 0 | 1 (1%) | 1 (4%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignancies | 6 (5%) | 0 | 3 (6%) | 8 (7%) | 2 (8%) | 3 (6%) | 0 | 1 (4%) | 6 (5%) | 0 | 2 (4%) |
| Hypertension | 5 (4%) | 3 (13%) | 0 | 4 (3%) | 1 (4%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Nail changes | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Headache | 1 (1%) | 0 | 2 (4%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AE other | 38 (33%) | 8 (33%) | 8 (17%) | 24 (21%) | 3 (13%) | 12 (25%) | 3 (3%) | 1 (4%) | 1 (1%) | 0 | 1 (2%) |
| CTCAE grade . | Grade 2 . | Grade 3 . | Grade 4 . | Fatalities∗ . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Non-rdm Ibr (n = 116) . | Arm A Ibr (n = 24) . | Arm B Obs (n = 48) . | Non-rdm Ibr (n = 116) . | Arm A Ibr (n = 24) . | Arm B Obs (n = 48) . | Non-rdm Ibr (n = 116) . | Arm A Ibr (n = 24) . | Non-rdm Ibr (n = 116) . | Arm A Ibr (n = 24) . | Arm B Obs (n = 48) . | |
| Any | 27 (23%) | 9 (38%) | 10 (21%) | 58 (50%) | 8 (33%) | 18 (38%) | 10 (9%) | 3 (13%) | 9 (8%) | 1 (4%) | 4 (8%) |
| Infections | 24 (21%) | 9 (38%) | 11 (23%) | 32 (28%) | 4 (17%) | 3 (6%) | 6 (5%) | 1 (4%) | 2 (2%) | 1 (4%) | 1 (2%) |
| TLS | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Atrial fibrillation | 4 (3%) | 1 (4%) | 0 | 2 (2%) | 1 (4%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 2 (2%) | 0 | 3 (6%) | 2 (2%) | 0 | 2 (4%) | 2 (2%) | 0 | 0 | 0 | 0 |
| Arthralgia | 8 (7%) | 1 (4%) | 1 (2%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Diarrhea | 8 (7%) | 2 (8%) | 2 (4%) | 2 (2%) | 0 | 2 (4%) | 0 | 0 | 0 | 0 | 0 |
| Bleeding | 13 (11%) | 1 (4%) | 0 | 1 (1%) | 1 (4%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignancies | 6 (5%) | 0 | 3 (6%) | 8 (7%) | 2 (8%) | 3 (6%) | 0 | 1 (4%) | 6 (5%) | 0 | 2 (4%) |
| Hypertension | 5 (4%) | 3 (13%) | 0 | 4 (3%) | 1 (4%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Nail changes | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Headache | 1 (1%) | 0 | 2 (4%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AE other | 38 (33%) | 8 (33%) | 8 (17%) | 24 (21%) | 3 (13%) | 12 (25%) | 3 (3%) | 1 (4%) | 1 (1%) | 0 | 1 (2%) |
Summary of AEs after cycle 15. Data are presented as n (%) unless otherwise indicated.
Fatalities in non-rdm arm: CLL (n = 3, included under malignancies in table), other malignancies (n = 3), infections (n = 2, 1 COVID-19), unknown (n = 1); fatalities in obs arm B: infection (COVID-19), Richter's transformation, myelodysplastic syndrome, and other malignancies (n = 1 each); fatality in ibr arm A: infection (n = 1, COVID-19).
CTCAE, common terminology criteria for AEs; ibr, arm A, ibrutinib maintenance; non-rdm, nonrandomized; obs, arm B, treatment cessation; TLS, tumor lysis syndrome.
Fatalities are included whether considered an AE or not.