Summary of safety among all patients who received at least 1 dose of study treatment
| Event, n (%) . | Ibrutinib + CIT (n = 201) . | Placebo + CIT (n = 199) . |
|---|---|---|
| TEAE | 199 (99.0) | 197 (99.0) |
| COVID-19 related | 12 (6.0) | 3 (1.5) |
| Treatment related | 187 (93.0) | 160 (80.4) |
| TEAE leading to death | 13 (6.5) | 13 (6.5) |
| Grade ≥3 TEAE | 172 (85.6) | 150 (75.4) |
| Serious TEAE | 112 (55.7) | 74 (37.2) |
| COVID-19 related | 3 (1.5) | 0 |
| Treatment related | 70 (34.8) | 36 (18.1) |
| TEAE leading to dose reduction of Ibr or Pbo | 41 (20.4) | 21 (10.6) |
| TEAE leading to discontinuation of Ibr or Pbo | 62 (30.8) | 37 (18.6) |
| Event, n (%) . | Ibrutinib + CIT (n = 201) . | Placebo + CIT (n = 199) . |
|---|---|---|
| TEAE | 199 (99.0) | 197 (99.0) |
| COVID-19 related | 12 (6.0) | 3 (1.5) |
| Treatment related | 187 (93.0) | 160 (80.4) |
| TEAE leading to death | 13 (6.5) | 13 (6.5) |
| Grade ≥3 TEAE | 172 (85.6) | 150 (75.4) |
| Serious TEAE | 112 (55.7) | 74 (37.2) |
| COVID-19 related | 3 (1.5) | 0 |
| Treatment related | 70 (34.8) | 36 (18.1) |
| TEAE leading to dose reduction of Ibr or Pbo | 41 (20.4) | 21 (10.6) |
| TEAE leading to discontinuation of Ibr or Pbo | 62 (30.8) | 37 (18.6) |
Intestine obstruction, failure to thrive, and respiratory failure in 1 patient each.
Ibr, ibrutinib; Pbo, placebo.