Table 3.

Adverse events that occurred in 10% or more of patients

	All grades	Grade 1	Grade 2	Grade 3	Grade 4
Diarrhoea	21 (68%)	14 (45%)	3 (10%)	4 (13%)	0
Nausea	15 (48%)	12 (39%)	3 (10%)	0	0
Fatigue	10 (32%)	5 (16%)	4 (13%)	1 (3%)	0
Hypertension	9 (29%)	2 (6%)	5 (16%)	2 (6%)	0
Peripheral oedema	9 (29%)	8 (26%)	1 (3%)	0	0
Dizziness	8 (26%)	7 (23%)	0	1 (3%)	0
Dyspepsia	8 (26%)	7 (23%)	1 (3%)	0	0
Upper respiratory tract infection	8 (26%)	2 (6%)	6 (19%)	0	0
Arthralgia	7 (23%)	5 (16%)	2 (6%)	0	0
Constipation	7 (23%)	7 (23%)	0	0	0
Urinary tract infection	7 (23%)	0	6 (19%)	1 (3%)	0
Vomiting	7 (23%)	4 (13%)	3 (10%)	0	0
Abdominal pain	6 (19%)	6 (19%)	0	0	0
Gastro-oesophageal reflux disease	6 (19%)	4 (13%)	2 (6%)	0	0
Headache	6 (19%)	3 (10%)	2 (6%)	1 (3%)	0
Anaemia	5 (16%)	2 (6%)	3 (10%)	0	0
Anxiety	5 (16%)	5 (16%)	0	0	0
Contusion	5 (16%)	5 (16%)	0	0	0
Epistaxis	5 (16%)	5 (16%)	0	0	0
Insomnia	5 (16%)	4 (13%)	1 (3%)	0	0
Petechiae	5 (16%)	5 (16%)	0	0	0
Stomatitis	5 (16%)	4 (13%)	1 (3%)	0	0
Aphthous stomatitis	4 (13%)	4 (13%)	0	0	0
Back pain	4 (13%)	1 (3%)	2 (6%)	1 (3%)	0
Cellulitis	4 (13%)	2 (6%)	2 (6%)	0	0
Dry eye	4 (13%)	4 (13%)	0	0	0
Erythema	4 (13%)	4 (13%)	0	0	0
Muscle spasms	4 (13%)	3 (10%)	1 (3%)	0	0
Peripheral sensory neuropathy	4 (13%)	4 (13%)	0	0	0
Pruritus	4 (13%)	4 (13%)	0	0	0
Rash pruritic	4 (13%)	4 (13%)	0	0	0
Sinusitis	4 (13%)	2 (6%)	2 (6%)	0	0
Thrombocytopenia	4 (13%)	1 (3%)	2 (6%)	0	1 (3%)

Data are n (%). Adverse events reported from first dose up to 30 days of last dose of ibrutinib, not including the extension study.