Table 3.

Dose management and outcomes of adverse events of special interest (safety analysis set)

	Infection		Bleeding		Arrhythmia
	All grades		All grades		All grades
AE of special interest, n (%)	49 (19.8)		25 (10.1)		5 (2.0)
	Grade 1/2	Grade ≥ 3	Grade 1/2	Grade ≥ 3	Grade 1/2	Grade ≥ 3
AE of special interest, n (%)	32 (12.9)	24 (9.7)	19 (7.7)	6 (2.4)	4 (1.6)	1 (0.4)
Ibrutinib dose management, n (%)
No dose change	13 (40.6)	5 (20.8)	6 (31.6)	0	1 (25.0)	0
Dose reduction	5 (15.6)	1 (4.2)	5 (26.3)	0	0	0
Temporary interruption	14 (43.8)	11 (45.8)	6 (31.6)	2 (33.3)	1 (25.0)	0
Discontinuation due to AE	0	7 (29.2)	2 (10.5)	4 (66.7)	2 (50.0)	1 (100.0)
Complete resolution of AEs, n (%)	30 (93.8)	18 (75.0)	17 (89.5)	3 (50.0)	2 (50.0)	1 (100.0)
Dose increased after reduction, n (%)	4 (80.0)	1 (100.0)	2 (40.0)	0	0	0
Restarted after temporary interruption, n (%)	14 (100.0)	8 (72.7)	6 (100.0)	2 (100.0)	1 (100.0)	0
Median (range) no. of AE episodes	1.0 (1.0–2.0)	1.0 (1.0–2.0)	1.0 (1.0–2.0)	1.0 (1.0–2.0)	1.0 (1.0–1.0)	1.0 (1.0–1.0)

AE adverse event, n number of patients, no. number