TABLE 6.

AEs (the Safety Population)

	Prophylaxis Arm (n = 54)	Observation Arm
		All Patients (n = 60)	Patients Receiving No Treatment (n = 46)	Patients Switched to Treatment (n = 14)
AE, n (%)	54 (100)	58 (96.7)	44 (95.7)	14 (100)
Treatment-related event, n (%)	52 (96.3)	13 (21.7)	Not applicable	13 (92.9)
SAE, n (%)	25 (46.3)	21 (35.0)	14 (30.4)	7 (50.0)
Death, n (%)	5	3	3	0
Most common events, n (%)*
Anemia	38 (70.4)	8 (13.3)	2 (4.3)	6 (42.9)
Fatigue	35 (64.8)	24 (40.0)	13 (28.3)	11 (78.6)
Headache	29 (53.7)	15 (25.0)	7 (15.2)	8 (57.1)
Neutropenia	24 (44.4)	7 (11.7)	2 (4.3)	5 (35.7)
Diarrhea	23 (42.6)	18 (30.0)	11 (23.9)	7 (50.0)
Nausea	23 (42.6)	13 (21.7)	6 (13.0)	7 (50.0)
Insomnia	18 (33.3)	6 (10.0)	2 (4.3)	4 (28.6)
Abdominal pain	16 (29.6)	11 (18.3)	7 (15.2)	4 (28.6)
Depression	14 (25.9)	11 (18.3)	4 (8.7)	7 (50.0)
Pain	14 (25.9)	3 (5.0)	2 (4.3)	1 (7.1)
Vomiting	13 (24.1)	6 (10.0)	3 (6.5)	3 (21.4)
Dizziness	13 (24.1)	6 (10.0)	2 (4.3)	4 (28.6)
Pyrexia	12 (22.2)	5 (8.3)	3 (6.5)	2 (14.3)
Arthralgia	10 (18.5)	9 (15.0)	6 (13.0)	3 (21.4)
Pruritus	10 (18.5)	8 (13.3)	6 (13.0)	2 (14.3)
Dyspnea	10 (18.5)	5 (8.3)	3 (6.5)	2 (14.3)
Back pain	9 (16.7)	10 (16.7)	9 (19.6)	1 (7.1)
Muscle spasms	9 (16.7)	4 (6.7)	2 (4.3)	2 (14.3)
Thrombocytopenia	9 (16.7)	1 (1.7)	0	1 (7.1)
Hypertension	8 (14.8)	7 (11.7)	6 (13.0)	1 (7.1)
Decreased appetite	8 (14.8)	4 (6.7)	1 (2.2)	3 (21.4)
Alopecia	8 (14.8)	3 (5.0)	3 (6.5)	0
Myalgia	7 (13.0)	4 (6.7)	0	4 (28.6)
Chills	7 (13.0)	3 (5.0)	1 (2.2)	2 (14.3)
Rash	6 (11.1)	6 (10.0)	5 (10.9)	1 (7.1)
Upper abdominal pain	6 (11.1)	3 (5.0)	2 (4.3)	1 (7.1)
Irritability	6 (11.1)	2 (3.3)	0	2 (14.3)
Influenza-like illness	6 (11.1)	0	0	0
Peripheral edema	4 (7.4)	12 (20.0)	10 (21.7)	2 (14.3)
Cough	4 (7.4)	7 (11.7)	4 (8.7)	3 (21.4)
Sinusitis	1 (1.9)	6 (10.0)	3 (6.5)	3 (21.4)

^*AEs reported in 10% or more of patients in either treatment arm.