Table 2.
Adverse Events in the Safety Population
| AEs | Placebo + SOC (n = 24) |
Ibrutinib + SOC (n = 22) |
All Patients (N = 46) |
|---|---|---|---|
| Any AE | 12 (50) | 12 (55) | 24 (52) |
| Most common AEs (≥5% of all patients) | |||
| ALT increased | 3 (13) | 2 (9) | 5 (11) |
| Anemia | 2 (8) | 3 (14) | 5 (11) |
| Acute respiratory failure | 3 (13) | 1 (5) | 4 (9) |
| Hypertension | 1 (4)a | 3 (14)b | 4 (9) |
| AST increased | 2 (8) | 1 (5) | 3 (7) |
| Nausea | 1 (4) | 2 (9) | 3 (7) |
| Sepsis | 2 (8) | 1 (5) | 3 (7) |
| Grade ≥3 AE | 4 (17) | 3 (14) | 7 (15) |
| Serious AE | 3 (13) | 4 (18) | 7 (15) |
| Fatal AE | 1 (4)c | 1 (5)d | 2 (4) |
| AE leading to discontinuation | 4 (17) | 6 (27) | 10 (22) |
| AE leading to dose reduction | 0 | 0 | 0 |
Data are presented as No. (%).
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; SOC, standard of care.
Grade 2 hypertension in 1 patient.
Grade 1 hypertension in 3 patients.
Death due to coronavirus disease 2019 (COVID-19) pneumonia (unrelated to study treatment) on study day 43.
Death due to acute respiratory failure due to COVID-19 pneumonia (unrelated to study treatment) on study day 21.