Table 4. Incidence of adverse events... | American Society of Hematology

Table 4.

Incidence of adverse events with probable or definite relationship to study medication

Category	GM-CSF + Epoetin Alfa^4-150 N (%)	GM-CSF + Placebo^4-151 N (%)
Skin reaction at injection site	15 (33)	12 (57)
Hepatomegaly	3 (8)	3 (16)
Splenomegaly	2 (5)	4 (21)
Erythema/pruritis/rash/urticaria	3 (6)	4 (19)
Myalgia	3 (6.7)	3 (14.3)
Thrombocytopenia	5 (11.1)	0 (0)
Chills	1 (2)	1 (4)
Headache	1 (2)	1 (4)
Asthenia/fatigue	2 (4)	0 (0)
Pain in extremities	1 (2)	0 (0)
Pyrexia	1 (2)	0 (0)
Allergic	1 (2)	0 (0)
Stroke	1 (2)	0 (0)
Pericarditis	1 (2)	0 (0)

Category	GM-CSF + Epoetin Alfa^4-150 N (%)	GM-CSF + Placebo^4-151 N (%)
Skin reaction at injection site	15 (33)	12 (57)
Hepatomegaly	3 (8)	3 (16)
Splenomegaly	2 (5)	4 (21)
Erythema/pruritis/rash/urticaria	3 (6)	4 (19)
Myalgia	3 (6.7)	3 (14.3)
Thrombocytopenia	5 (11.1)	0 (0)
Chills	1 (2)	1 (4)
Headache	1 (2)	1 (4)
Asthenia/fatigue	2 (4)	0 (0)
Pain in extremities	1 (2)	0 (0)
Pyrexia	1 (2)	0 (0)
Allergic	1 (2)	0 (0)
Stroke	1 (2)	0 (0)
Pericarditis	1 (2)	0 (0)

FAB, French-American-British; RA, refractory anemia; RAEB, refractory anemia with excess blasts; RARS, refractory anemia with ringed sideroblasts; RAEB-t, refractory anemia with excess blasts in transformation.

F4-150

N = 45.

F4-151

N = 21.

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