Table 3.

Treatment-emergent adverse events under forced upward titration conditions in Pump-Assisted Volume Cohort (safety analysis set)^a

Pump-Assisted Volume Cohort	25 mL (N = 15; Inf = 60)		40 mL (N = 12; Inf = 48)		50 mL (N = 11; Inf = 44)
	n (%)	E (Rate)	n (%)	E (Rate)	n (%)	E (Rate)
Any TEAE	4 (26.7)	11 (0.183)	4 (33.3)	9 (0.188)	1 (9.1)	1 (0.023)
Treatment related	3 (20.0)	9 (0.150)	1 (8.3)	3 (0.063)	0	0
Intensity of TEAEs
Mild	3 (20.0)	10 (0.167)	2 (16.7)	6 (0.125)	0	0
Moderate	1 (6.7)	1 (0.017)	2 (16.7)	3 (0.063)	1 (9.1)	1 (0.023)
Severe	0	0	0	0	0	0
Serious TEAEs	0	0	0	0	0	0
Deaths	0	0	0	0	0	0
Study discontinuation due to TEAE	1 (6.7)	1 (0.017)	0	0	0	0
Treatment related	1 (6.7)	1 (0.017)	0	0	0	0
Study drug withdrawal due to TEAE	1 (6.7)	2 (0.033)	0	0	0	0
Treatment related	1 (6.7)	2 (0.033)	0	0	0	0
Local TEAEs	3 (20.0)	9 (0.150)	1 (8.3)	3 (0.063)	0	0
Treatment related	3 (20.0)	9 (0.150)	1 (8.3)	3 (0.063)	0	0
Most common (> 1 event at any infusion volume) TEAEs by preferred term
Injection site swelling	1 (6.7)	4 (0.067)	0	0	0	0
Injection site erythema	1 (6.7)	1 (0.017)	1 (8.3)	2 (0.042)	0	0
Injection site pain	1 (6.7)	2 (0.033)	0	0	0	0
Most common (> 1 event at any infusion volume) treatment-related TEAEs by preferred term
Injection site swelling	1 (6.7)	4 (0.067)	0	0	0	0
Injection site erythema	1 (6.7)	1 (0.017)	1 (8.3)	2 (0.042)	0	0
Injection site pain	1 (6.7)	2 (0.033)	0	0	0	0

Rate = number of events/total number of infusions prior to patient’s start date of non-response

^aExcludes TEAEs occurring after non-response

E number of events, Inf infusions, n number of patients, TEAE treatment-emergent adverse event