Table 1 Treatment-emergent adverse events (AEs) in ≥20% of patients in either treatment arm
Safety population | Ibrutinib (N = 139) | Temsirolimus (N = 139) | ||
|---|---|---|---|---|
AE (%) | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
Hematological | ||||
Thrombocytopenia | 18.0 | 9.4 | 56.1 | 43.2 |
Anemia | 19.4 | 8.6 | 43.9 | 20.1 |
Neutropenia | 15.8 | 12.9 | 26.6 | 17.3 |
Non-hematological | ||||
Diarrhea | 33.1 | 3.6 | 30.9 | 4.3 |
Fatigue | 23.7 | 5.0 | 28.8 | 7.2 |
Cough | 23.0 | 0.7 | 22.3 | 0.0 |
Upper respiratory tract infection | 20.1 | 2.2 | 11.5 | 0.7 |
Pyrexia | 18.7 | 0.7 | 20.9 | 2.2 |
Nausea | 14.4 | 0.0 | 21.6 | 0.0 |
Peripheral edema | 13.7 | 0.0 | 23.7 | 2.2 |
Epistaxis | 9.4 | 0.7 | 23.7 | 1.4 |
Stomatitis | 2.9 | 0.0 | 20.9 | 3.6 |
