Table 3. AEs in the NOHARM study... | American Society of Hematology

Table 3.

AEs in the NOHARM study population

	Hydroxyurea (N = 104)		Placebo (N = 103)		P
	Events	Participants	Events	Participants	P
SAEs	6	6	6	6
Bacteremia/sepsis	2	2	2	2	1.0*
Acute chest syndrome/pneumonia	1	1	2	2	.62*
Vaso-occlusive crisis	0	0	1	1	.50*
Acute splenic sequestration	2	2	0	0	.50*
Anemia	0	0	1	1	.50*
Sudden death	1	1	0	0	1.0*
SCA-related events (composite)
Vaso-occlusive pain crisis, dactylitis, acute chest syndrome, splenic sequestration, or blood transfusion		47		71	.001
Clinical AEs	232	76	308	88
Vaso-occlusive pain crisis/dactylitis	58	38	106	59	.004
Acute chest syndrome/pneumonia	24	21	32	24	.71
Clinical sepsis	8	6	16	13	.14
Acute splenic sequestration	0	0	0	0	—
Upper respiratory tract infection	107	54	108	62	.29
Gastrointestinal related	15	13	15	12	1.0
Malaria	5	3	7	7	.21*
Other infections	8	7	14	14	.16
Others (eg, injury)	7	7	10	9	.78
Clinical interventions	34	14	53	32
Transfusion	14	12	18	17	.41
Hospitalization	20	12	35	28	.007
Laboratory AEs	57	31	78	46
Anemia	40	25	65	42	.015
Reticulocytopenia	3	3	6	5	.50*
Neutropenia	2	2	0	0	.50*
Thrombocytopenia	12	11	4	4	.11
Elevated AST/ALT	0	0	2	1	.50*
Elevated bilirubin	0	0	1	1	.50*
Dose-limiting toxicities	21	15	17	13
Anemia	6	4	8	8	.36
Reticulocytopenia	1	1	5	5	.12*
Neutropenia	2	2	0	0	.50*
Thrombocytopenia	12	11	4	4	.11

	Hydroxyurea (N = 104)		Placebo (N = 103)		P
	Events	Participants	Events	Participants	P
SAEs	6	6	6	6
Bacteremia/sepsis	2	2	2	2	1.0*
Acute chest syndrome/pneumonia	1	1	2	2	.62*
Vaso-occlusive crisis	0	0	1	1	.50*
Acute splenic sequestration	2	2	0	0	.50*
Anemia	0	0	1	1	.50*
Sudden death	1	1	0	0	1.0*
SCA-related events (composite)
Vaso-occlusive pain crisis, dactylitis, acute chest syndrome, splenic sequestration, or blood transfusion		47		71	.001
Clinical AEs	232	76	308	88
Vaso-occlusive pain crisis/dactylitis	58	38	106	59	.004
Acute chest syndrome/pneumonia	24	21	32	24	.71
Clinical sepsis	8	6	16	13	.14
Acute splenic sequestration	0	0	0	0	—
Upper respiratory tract infection	107	54	108	62	.29
Gastrointestinal related	15	13	15	12	1.0
Malaria	5	3	7	7	.21*
Other infections	8	7	14	14	.16
Others (eg, injury)	7	7	10	9	.78
Clinical interventions	34	14	53	32
Transfusion	14	12	18	17	.41
Hospitalization	20	12	35	28	.007
Laboratory AEs	57	31	78	46
Anemia	40	25	65	42	.015
Reticulocytopenia	3	3	6	5	.50*
Neutropenia	2	2	0	0	.50*
Thrombocytopenia	12	11	4	4	.11
Elevated AST/ALT	0	0	2	1	.50*
Elevated bilirubin	0	0	1	1	.50*
Dose-limiting toxicities	21	15	17	13
Anemia	6	4	8	8	.36
Reticulocytopenia	1	1	5	5	.12*
Neutropenia	2	2	0	0	.50*
Thrombocytopenia	12	11	4	4	.11

All serious adverse events (SAEs), AEs, and laboratory AEs were compared between treatment arms. Proportions of affected participants were compared by χ² tests with Yates correction. Full definitions of AEs are provided in Table 1.

Fisher's exact test instead of χ² test, because of the low expected frequency.

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