Table 2 Patients with study drug-related AEs during the long-term study, overall and by system organ class and preferred term (including only preferred terms reported by one or more patient with Grade >2 events).

System organ class	Grade 3		Any grade
Preferred term	N	%	N	%
Patients with any treatment-related AE	5	10.0	32	64.0
Blood and lymphatic system disorders	1	2.0	12	24.0
Thrombocytopenia	1	2.0	7	14.0
Cardiac disorders	0^a	0	1	2.0
Eye disorders	0^a	0	1	2.0
Gastrointestinal disorders	1	2.0	16	32.0
Diarrhea	1	2.0	12	24.0
General disorders and administration site conditions	1	2.0	3	6.0
Asthenia	1	2.0	3	6.0
Infections and infestations	0^a	0	2	4.0
Investigations	1	2.0	9	18.0
Electrocardiogram QT prolonged	1	2.0	3	6.0
Metabolism and nutrition disorders	0^a	0	1	2.0
Nervous system disorders	0^a	0	4	8.0
Psychiatric disorders	0^a	0	2	4.0
Skin and subcutaneous tissue disorders	0^a	0	6	12.0
Vascular disorders	1	2.0	1	2.0
Hypertension	1	2.0	1	2.0

Grades are based on CTCAE Version 4.03, where Grade 1 are mild events, Grade 2 are moderate, Grade 3 are severe, Grade 4 are life-threatening, and Grade 5 events result in death. “Any grade” means any Grade 1, 2, 3, 4, or 5 events. There were no Grade 4 or 5 treatment-related events.
AE adverse event, CTCAE common terminology criteria for AEs.
^aThere were no Grade 3 events for these system organ classes.

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