Incidence of TEAEs ≥30% patients in either arm by preferred term in safety population∗ in Part 2
| . | Ibrutinib plus RICE/RVICI (n = 35) . | RICE/RVICI (n = 15) . | ||||
|---|---|---|---|---|---|---|
| All Grades . | Grade 3-4 . | Grade 5 . | All Grades . | Grade 3-4 . | Grade 5 . | |
| Patients with TEAE, n (%) | 35 (100) | 31 (89) | 4 (11) | 15 (100) | 13 (87) | 2 (13) |
| Anemia | 29 (83) | 27 (77) | 0 | 14 (93) | 14 (93) | 0 |
| Febrile neutropenia | 24 (69) | 24 (69) | 0 | 7 (47) | 7 (47) | 0 |
| Combined thrombocytopenia and platelet count decreased | 31 (89) | 30 (86) | 0 | 14 (93) | 14 (93) | 0 |
| Vomiting | 25 (71) | 7 (20) | 0 | 4 (27) | 0 | 0 |
| Nausea | 21 (60) | 2 (6) | 0 | 2 (13) | 0 | 0 |
| Abdominal pain | 13 (37) | 0 | 0 | 2 (13) | 0 | 0 |
| Combined neutropenia and neutrophil count decreased | 26 (74) | 26 (74) | 0 | 14 (93) | 14 (93) | 0 |
| White blood cell count decreased | 8 (23) | 8 (23) | 0 | 6 (40) | 6 (40) | 0 |
| Alanine aminotransferase increased | 7 (20) | 5 (14) | 0 | 6 (40) | 4 (27) | 0 |
| Aspartate aminotransferase increased | 6 (17) | 3 (9) | 0 | 5 (33) | 2 (13) | 0 |
| Pyrexia | 14 (40) | 2 (6) | 0 | 6 (40) | 1 (7) | 0 |
| Hypokalemia | 12 (34) | 11 (31) | 0 | 7 (47) | 4 (27) | 0 |
| Hypomagnesemia | 6 (17) | 2 (6) | 0 | 5 (33) | 2 (13) | 0 |
| Headache | 16 (46) | 3 (9) | 0 | 3 (20) | 0 | 0 |
| Infections and infestations† | 19 (54) | 12 (34) | 2 (6) | 10 (67) | 6 (40) | 2 (13) |
| . | Ibrutinib plus RICE/RVICI (n = 35) . | RICE/RVICI (n = 15) . | ||||
|---|---|---|---|---|---|---|
| All Grades . | Grade 3-4 . | Grade 5 . | All Grades . | Grade 3-4 . | Grade 5 . | |
| Patients with TEAE, n (%) | 35 (100) | 31 (89) | 4 (11) | 15 (100) | 13 (87) | 2 (13) |
| Anemia | 29 (83) | 27 (77) | 0 | 14 (93) | 14 (93) | 0 |
| Febrile neutropenia | 24 (69) | 24 (69) | 0 | 7 (47) | 7 (47) | 0 |
| Combined thrombocytopenia and platelet count decreased | 31 (89) | 30 (86) | 0 | 14 (93) | 14 (93) | 0 |
| Vomiting | 25 (71) | 7 (20) | 0 | 4 (27) | 0 | 0 |
| Nausea | 21 (60) | 2 (6) | 0 | 2 (13) | 0 | 0 |
| Abdominal pain | 13 (37) | 0 | 0 | 2 (13) | 0 | 0 |
| Combined neutropenia and neutrophil count decreased | 26 (74) | 26 (74) | 0 | 14 (93) | 14 (93) | 0 |
| White blood cell count decreased | 8 (23) | 8 (23) | 0 | 6 (40) | 6 (40) | 0 |
| Alanine aminotransferase increased | 7 (20) | 5 (14) | 0 | 6 (40) | 4 (27) | 0 |
| Aspartate aminotransferase increased | 6 (17) | 3 (9) | 0 | 5 (33) | 2 (13) | 0 |
| Pyrexia | 14 (40) | 2 (6) | 0 | 6 (40) | 1 (7) | 0 |
| Hypokalemia | 12 (34) | 11 (31) | 0 | 7 (47) | 4 (27) | 0 |
| Hypomagnesemia | 6 (17) | 2 (6) | 0 | 5 (33) | 2 (13) | 0 |
| Headache | 16 (46) | 3 (9) | 0 | 3 (20) | 0 | 0 |
| Infections and infestations† | 19 (54) | 12 (34) | 2 (6) | 10 (67) | 6 (40) | 2 (13) |
Patients with multiple events for the same system organ class or preferred term are counted only once per row. If a patient had TEAEs more than once and with different toxicity grades, he or she was counted once in the highest toxicity grade. Patients who had events with missing toxicity grades were counted in the “all grades” column but not summarized separately. TEAEs were coded using MedDRA Version 23.1. Verbatim terms are displayed for any TEAEs not coded at the time of the database cutoff.
MedDRA, Medical Dictionary for Regulatory Activities; SOC, system, order, class.
Based on all patients who received at least 1 dose of study treatment.
SOC term.