Table 2.

Number of Patients with Infusion-Related Events According to Study Group.^*

Event	Rituximab (N = 57)	Control (N = 30)	P Value†
	number (percent)
Patients receiving first infusion	56 (98)	30 (100)
Patients with one or more events	52 (93)	7 (23)	<0.001
Fever	12 (21)	1 (3)	0.02
Cough	3 (5)	0	0.27
Shortness of breath	4 (7)‡	1 (3)	0.43
Hypotension	13 (23)	1 (3)	0.01
Hypertension	6 (11)	0	0.07
Tachycardia	12 (21)	0	0.004
Rash	21 (38)‡	0	<0.001
Pruritus	18 (32)	0	<0.001
Vomiting	10 (18)	0	0.01
Nausea	18 (32)	1 (3)	0.001
Other	22 (39)	3 (10)	0.003
Patients receiving more than one infusion	51 (89)	29 (97)
Patients with one or more events during second, third, or fourth infusion	14 (27)	8 (28)	0.61
Fever	1 (2)	1 (3)	0.88
Cough	0	1 (3)	1.00
Shortness of breath	0	0	NA
Hypotension	7 (14)	5 (17)	0.78
Hypertension	0	0	NA
Tachycardia	1 (2)	0	0.64
Rash	1 (2)	0	0.64
Pruritus	1 (2)	0	0.64
Vomiting	0	0	NA
Nausea	0	0	NA
Other	4 (8)	4 (14)	0.89

^*Rituximab or placebo was administered at a rate of 50 mg per hour. If infusion-related events did not occur, the infusion rate could be increased in increments of 50 mg per hour every 30 minutes to a maximum of 400 mg per hour. If an infusion rate of 400 mg per hour was tolerated, subsequent infusions started at a rate of 100 mg per hour and were increased by 100 mg per hour every 30 minutes until a rate of 400 mg per hour was reached. For mild infusion reactions, the rate of infusion was slowed or temporarily interrupted and was resumed at half the previous rate on alleviation of symptoms. For moderate or severe infusion reactions, the infusion was not restarted and subsequent infusions were not administered. One patient could have multiple events. NA denotes not applicable.

^†P values are one-sided and were calculated with the use of Fisher’s exact test.

^‡One patient had a grade 3 infusion reaction consisting of shortness of breath and rash.