Table 9.

Adverse drug reactions and serious adverse events (safety set analysis).

System Organ Class/Preferred Term	Liztox® Group (n = 98)	Botox® Group (n = 100)	Total (n = 198)
Subjects with ADRs, n (%) [event]	2 (2.04) [2]	1 (1.00) [1]	3 (1.52) [3]
General disorders and administration site conditions	1 (1.02) [1]	0 (0.00) [0]	1 (0.51) [1]
Asthenia	1 (1.02) [1]	0 (0.00) [0]	1 (0.51) [1]
Nervous system disorders	0 (0.00) [0]	1 (1.00) [1]	1 (0.51) [1]
Headache	0 (0.00) [0]	1 (1.00) [1]	1 (0.51) [1]
Skin and subcutaneous tissue disorders	1 (1.02) [1]	0 (0.00) [0]	1 (0.51) [1]
Pruritus	1 (1.02) [1]	0 (0.00) [0]	1 (0.51) [1]
Subjects with SAEs, n (%) [event]	2 (2.04) [3]	2 (2.00) [2]	4 (2.02) [5]
Nervous system disorders	1 (1.02) [1]	2 (2.00) [2]	3 (1.52) [3]
Cerebral infarction	0 (0.00) [0]	1 (1.00) [1]	1 (0.51) [1]
Cerebrovascular accident	0 (0.00) [0]	1 (1.00) [1]	1 (0.51) [1]
Transient ischemic attack	1 (1.02) [1]	0 (0.00) [0]	1 (0.51) [1]
Blood and lymphatic system disorders	1 (1.02) [1]	0 (0.00) [0]	1 (0.51) [1]
Febrile neutropenia	1 (1.02) [1]	0 (0.00) [0]	1 (0.51) [1]
Gastrointestinal disorders	1 (1.02) [1]	0 (0.00) [0]	1 (0.51) [1]
Vomiting	1 (1.02) [1]	0 (0.00) [0]	1 (0.51) [1]

ADRs = adverse drug reactions, SAEs = serious adverse events. Adverse events were coded using MedDRA Version 25.1. Adverse events are displayed as number of subjects, percentage of subjects, and number of events. Percentages are based on the number of subjects in the treatment group.