Table 2

Summary of serious adverse events (≥2% of patients) regardless of attribution

Total (N = 111)
SAE*, n (%)Any gradeGrade 3-4Grade 5
Disease progression 11 (10%) 3 (3%) 8 (7%) 
Pneumonia 8 (7%) 7 (6%) 1 (1%) 
Atrial fibrillation 7 (6%) 6 (5%) 
Urinary tract infection 4 (4%) 3 (3%) 
Febrile neutropenia 3 (3%) 3 (3%) 
Abdominal pain 3 (3%) 3 (3%) 
Acute renal failure 3 (3%) 2 (2%) 1 (1%) 
Subdural hematoma 3 (3%) 2 (2%) 
Pyrexia 3 (3%) 1 (1%) 
Confusional state 3 (3%) 1 (1%) 
Total (N = 111)
SAE*, n (%)Any gradeGrade 3-4Grade 5
Disease progression 11 (10%) 3 (3%) 8 (7%) 
Pneumonia 8 (7%) 7 (6%) 1 (1%) 
Atrial fibrillation 7 (6%) 6 (5%) 
Urinary tract infection 4 (4%) 3 (3%) 
Febrile neutropenia 3 (3%) 3 (3%) 
Abdominal pain 3 (3%) 3 (3%) 
Acute renal failure 3 (3%) 2 (2%) 1 (1%) 
Subdural hematoma 3 (3%) 2 (2%) 
Pyrexia 3 (3%) 1 (1%) 
Confusional state 3 (3%) 1 (1%) 
*

SAEs were updated with an estimated median follow-up of 26.7 months.

Mantle cell lymphoma reported as a SAE by investigators.

One additional patient had a grade 3 atrial fibrillation that was not considered an SAE.

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