Table 8.
Treatment-emergent adverse events (safety set).
| System Organ Class/Preferred Term | Liztox® Group (n = 98) |
Botox® Group (n = 100) |
Total (n = 198) |
|---|---|---|---|
| Subjects with TEAEs, n (%) [event] | 11 (11.22) [29] | 13 (13.00) [17] | 24 (12.12) [46] |
| Infections and infestations | 3 (3.06) [5] | 6 (6.00) [6] | 9 (4.55) [11] |
| COVID-19 | 3 (3.06) [3] | 4 (4.00) [4] | 7 (3.54) [7] |
| Bacterial infection | 0 (0.00) [0] | 1 (1.00) [1] | 1 (0.51) [1] |
| Bronchitis | 1 (1.02) [1] | 0 (0.00) [0] | 1 (0.51) [1] |
| Otitis media | 0 (0.00) [0] | 1 (1.00) [1] | 1 (0.51) [1] |
| Pneumonia | 1 (1.02) [1] | 0 (0.00) [0] | 1 (0.51) [1] |
| Nervous system disorders | 2 (2.04) [2] | 4 (4.00) [4] | 6 (3.03) [6] |
| 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] |
| Dizziness | 1 (1.02) [1] | 0 (0.00) [0] | 1 (0.51) [1] |
| Headache | 0 (0.00) [0] | 1 (1.00) [1] | 1 (0.51) [1] |
| Paresthesia | 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] |
| General disorders and administration site conditions | 3 (3.06) [3] | 1 (1.00) [1] | 4 (2.02) [4] |
| Pyrexia | 1 (1.02) [1] | 1 (1.00) [1] | 2 (1.01) [2] |
| Asthenia | 1 (1.02) [1] | 0 (0.00) [0] | 1 (0.51) [1] |
| Peripheral oedema | 1 (1.02) [1] | 0 (0.00) [0] | 1 (0.51) [1] |
| Injury, poisoning, and procedural complications | 1 (1.02) [1] | 2 (2.00) [2] | 3 (1.52) [3] |
| Hand fracture | 1 (1.02) [1] | 1 (1.00) [1] | 2 (1.01) [2] |
| Tooth fracture | 0 (0.00) [0] | 1 (1.00) [1] | 1 (0.51) [1] |
| Investigations | 2 (2.04) [8] | 0 (0.00) [0] | 2 (1.01) [8] |
| Alanine aminotransferase increased | 2 (2.04) [4] | 0 (0.00) [0] | 2 (1.01) [4] |
| Aspartate aminotransferase increased | 2 (2.04) [4] | 0 (0.00) [0] | 2 (1.01) [4] |
| Gastrointestinal disorders | 2 (2.04) [5] | 0 (0.00) [0] | 2 (1.01) [5] |
| Constipation | 1 (1.02) [1] | 0 (0.00) [0] | 1 (0.51) [1] |
| Diarrhea | 1 (1.02) [1] | 0 (0.00) [0] | 1 (0.51) [1] |
| Dyspepsia | 1 (1.02) [1] | 0 (0.00) [0] | 1 (0.51) [1] |
| Hemorrhoids | 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] |
| Metabolism and nutrition disorders | 1 (1.02) [2] | 1 (1.00) [1] | 2 (1.01) [3] |
| Hypokalemia | 1 (1.02) [2] | 0 (0.00) [0] | 1 (0.51) [2] |
| Diabetes mellitus | 0 (0.00) [0] | 1 (1.00) [1] | 1 (0.51) [1] |
| Skin and subcutaneous tissue disorders | 1 (1.02) [1] | 1 (1.00) [1] | 2 (1.01) [2] |
| Dermatitis | 0 (0.00) [0] | 1 (1.00) [1] | 1 (0.51) [1] |
| Pruritus | 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] |
| Musculoskeletal and connective tissue disorders | 0 (0.00) [0] | 1 (1.00) [1] | 1 (0.51) [1] |
| Pain in extremity | 0 (0.00) [0] | 1 (1.00) [1] | 1 (0.51) [1] |
| Neoplasms: benign, malignant, and unspecified (including cysts and polyps) |
0 (0.00) [0] | 1 (1.00) [1] | 1 (0.51) [1] |
| Benign neoplasm of skin | 0 (0.00) [0] | 1 (1.00) [1] | 1 (0.51) [1] |
| Respiratory, thoracic, and mediastinal disorders | 1 (1.02) [1] | 0 (0.00) [0] | 1 (0.51) [1] |
| Oropharyngeal pain | 1 (1.02) [1] | 0 (0.00) [0] | 1 (0.51) [1] |
TEAEs = treatment-emergent adverse events, AEs = 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.