Table 4.

Adverse Events, According to Treatment Group.^*

Event	Platelet Dose†
	Low Dose (N = 417)	P Value, Low vs. Medium Dose	Medium Dose (N = 423)	P Value, Medium vs. High Dose	High Dose (N = 432)	P Value, High vs. Low Dose
Serious adverse event — no. of patients (%)
Anaphylaxis	0		0	0.50	2 (<1)	0.50
Bleeding	5 (1)	0.50	3 (1)	0.73	5 (1)	1.00
Cardiac event	3 (1)	0.68	2 (<1)	0.45	5 (1)	0.73
Central nervous system event	4 (1)	0.21	1 (<1)	1.00	1 (<1)	0.21
Deep-vein thrombosis	3 (1)	0.12	0		0	0.12
Graft-versus-host disease	0		0	0.25	3 (1)	0.25
Infection	10 (2)	0.11	4 (1)	0.12	11 (3)	1.00
Pulmonary event	12 (3)	0.84	14 (3)	0.69	12 (3)	1.00
Renal failure	3 (1)	0.12	0	0.25	3 (1)	1.00
Veno-occlusive disease of liver	6 (1)	0.77	5 (1)	0.28	2 (<1)	0.17
Other	5 (1)	0.75	4 (1)	0.72	3 (1)	0.50
Any	35 (8)	0.29	27 (6)	0.30	36 (8)	1.00
Event occurring during or ≤ 4 hr after a trans-   fusion — no. of patients (%)‡
Allergic reaction or hypersensitivity	37 (9)	0.42	45 (11)	0.29	57 (13)	0.05
Sinus bradycardia	4 (1)	0.75	6 (1)	1.00	7 (2)	0.55
Sinus tachycardia	44 (11)	0.73	41 (10)	0.64	37 (9)	0.35
Hypertension	39 (9)	0.54	34 (8)	0.20	46 (11)	0.57
Hypotension	33 (8)	0.28	25 (6)	0.78	28 (6)	0.43
Dyspnea	18 (4)	0.74	21 (5)	0.88	23 (5)	0.53
Hypoxia	14 (3)	0.85	16 (4)	1.00	17 (4)	0.72
Wheezing	7 (2)	0.11	2 (<1)	0.004	14 (3)	0.19
Cough	3 (1)	1.00	4 (1)	0.38	8 (2)	0.22
Hemolysis	2 (<1)	0.62	1 (<1)	1.00	2 (<1)	1.00
Rigors or chills	37 (9)	0.56	43 (10)	0.51	50 (12)	0.21
Fever	149 (36)	0.17	132 (31)	0.51	144 (33)	0.47
Infection	5 (1)	1.00	5 (1)	0.77	7 (2)	0.77
Any event listed	193 (46)	0.33	181 (43)	0.19	205 (47)	0.78

^*Patients could have had more than one event.

^†Platelet doses were as follows: low dose, 1.1×10¹¹ platelets per square meter of body-surface area; medium dose, 2.2×10¹¹ platelets per square meter; and high dose, 4.4×10¹¹ platelets per square meter.

^‡For events occurring during or within 4 hours after a transfusion, data were missing for one patient in each of the three treatment groups.