Table 4.

Adverse Events Irrespective of Relationship to Study Treatment With ≥ 10% Incidence in the Everolimus Plus BSC Treatment Arm in the Safety Population

Adverse Event	Everolimus Plus BSC (n = 437)				Placebo Plus BSC (n = 215)
	Any Grade		Grade 3/4		Any Grade		Grade 3/4
	No. of Patients	%	No. of Patients	%	No. of Patients	%	No. of Patients	%
Decreased appetite	208	48	48	11	78	36	12	6
Stomatitis	174	40	20	5	23	11	0	0
Fatigue	150	34	34	8	65	30	11	5
Nausea	132	30	16	4	69	32	8	4
Diarrhea	115	26	15	3	33	15	2	1
Anemia	114	26	70	16	42	20	27	13
Abdominal pain	107	24	21	5	57	27	13	6
Vomiting	107	24	13	3	62	29	9	4
Constipation	91	21	3	< 1	42	20	3	1
Rash	87	20	1	< 1	19	9	0	0
Weight decreased	86	20	11	3	19	9	0	0
Pyrexia	81	19	3	< 1	24	11	2	1
Thrombocytopenia	80	18	22	5	5	2	3	1
Asthenia	70	16	20	5	22	10	9	4
Dyspnea	61	14	18	4	23	11	9	4
Upper abdominal pain	53	12	6	1	27	13	2	1
Peripheral edema	53	12	1	< 1	23	11	2	1
Hypokalemia	52	12	26	6	9	4	2	1
Insomnia	51	12	2	< 1	22	10	0	0
Cough	50	11	1	< 1	17	8	0	0
Back pain	48	11	10	2	16	7	2	1
Neutropenia	47	11	17	4	6	3	1	< 1
Pruritus	47	11	0	0	9	4	0	0

NOTE. All data are sorted by descending frequency in the everolimus plus BSC treatment group.

Abbreviation: BSC, best supportive care.