Table 5.

Most common temporally associated and possibly related AEs (ITT)

	All AEs		Temporally associated AEs (72 hours)		At least possibly related AEs
	Number of patients (%)	AEs (rate per infusion)	Number of patients (%)	AEs (rate per infusion)	Number of patients (%)	AEs (rate per infusion)
Total number of patients or infusions	28	259	28	259	28	259
Headache	9 (32.1)	20 (0.077)	8 (28.6)	19 (0.073)	8 (28.6)	18 (0.069)
Pain in extremity	6 (21.4)	7 (0.027)	3 (10.7)	3 (0.012)	n/a	n/a
Hypertension	4 (14.3)	6 (0.023)	4 (14.3)	6 (0.023)	4 (14.3)	5 (0.019)
Asthenia	4 (14.3)	4 (0.015)	4 (14.3)	4 (0.015)	4 (14.3)	4 (0.015)
Leukopenia	4 (14.3)	4 (0.015)	0	0	2 (7.1)	2 (0.008)
Nausea	3 (10.7)	3 (0.012)	3 (10.7)	3 (0.012)	3 (10.7)	3 (0.012)
Arthralgia	2 (7.1)	3 (0.012)	1 (3.6)	1 (0.004)	n/a	n/a
Influenza-like illness	2 (7.1)	2 (0.008)	2 (7.1)	2 (0.008)	2 (7.1)	2 (0.008)
Hemolysis	2 (7.1)	2 (0.008)	2 (7.1)	2 (0.008)	2 (7.1)	2 (0.008)
Oropharyngeal pain	2 (7.1)	2 (0.008)	1 (3.6)	1 (0.004)	n/a	n/a
Contusion	2 (7.1)	2 (0.008)	0	0	n/a	n/a
Rash	2 (7.1)	2 (0.008)	0	0	2 (7.1)	2 (0.008)

Numbers of patients and rates per infusion are shown for most common (≥3.5%) adverse events (AEs) for all patients in the intention-to-treat (ITT) analysis. AEs that occurred during or within 72 h after infusion were considered temporally associated. Relatedness of the AEs to study medication was evaluated by the investigators.

n/a, data not available.