Table 3.
Treatment-emergent safety outcomes in the open-label and follow-up periods
| TEAEs during open-label and follow-up periods, n (%) | Batoclimab 680 mg (N = 11) | Batoclimab 340 mg (N = 10) | Placebo (N = 9) | Total (N = 30) |
|---|---|---|---|---|
| Total | 10 (90.9) | 8 (80.0) | 8 (88.9) | 26 (86.7) |
| Infections and infestations | 3 (27.3) | 2 (20.0) | 4 (44.4) | 9 (30.0) |
| Upper respiratory infection | 2 (18.2) | 1 (10.0) | 2 (22.2) | 5 (16.7) |
| Urinary tract infection | 2 (18.2) | 1 (10.0) | 2 (22.2) | 5 (16.7) |
| Nervous system disorders | 3 (27.3) | 1 (10.0) | 0 | 4 (13.3) |
| Myasthenia gravis | 2 (18.2) | 0 | 0 | 2 (6.7) |
| Headache | 1 (9.1) | 0 | 0 | 1 (3.3) |
| Dizziness | 0 | 1 (10.0) | 0 | 1 (3.3) |
| Metabolism and nutrition disorders | 2 (18.2) | 5 (50.0) | 4 (44.4) | 11 (36.7) |
| Hyponatremia | 2 (18.2) | 4 (40.0) | 2 (22.2) | 8 (26.7) |
| Hypomagnesemia | 2 (18.2) | 1 (10.0) | 0 | 3 (10.0) |
| Hypercholesterolemia | 1 (9.1) | 3 (30.0) | 1 (11.1) | 5 (16.7) |
| Hypertriglyceridemia | 1 (9.1) | 1 (10.0) | 1 (11.1) | 3 (10.0) |
| Hypochloremia | 1 (9.1) | 0 | 0 | 1 (3.3) |
| Hyperuricemia | 0 | 2 (20.0) | 0 | 2 (6.7) |
| Hypokalemia | 0 | 0 | 1 (11.1) | 1 (3.3) |
| General disorders and administration site conditions | 2 (18.2) | 1 (10.0) | 1 (11.1) | 4 (13.3) |
| Edema peripheral | 2 (18.2) | 1 (10.0) | 0 | 3 (10.0) |
| Facial edema | 1 (9.1) | 0 | 0 | 1 (3.3) |
| Chest pain | 0 | 0 | 1 (11.1) | 1 (3.3) |
| Chest discomfort | 0 | 0 | 1 (11.1) | 1 (3.3) |
| Musculoskeletal and connective tissue disorders | 2 (18.2) | 1 (10.0) | 1 (11.1) | 4 (13.3) |
| Muscle twitching | 2 (18.2) | 1 (10.0) | 0 | 3 (10.0) |
| Limb discomfort | 0 | 0 | 1 (11.1) | 1 (3.3) |
| Pain in extremity | 0 | 0 | 1 (11.1) | 1 (3.3) |
| Musculoskeletal chest pain | 0 | 0 | 1 (11.1) | 1 (3.3) |
| Gastrointestinal disorders | 2 (18.2) | 0 | 1 (11.1) | 3 (10.0) |
| Diarrhea | 1 (9.1) | 0 | 1 (11.1) | 2 (6.7) |
| Tongue edema | 1 (9.1) | 0 | 0 | 1 (3.3) |
| Investigations | 1 (9.1) | 5 (50.0) | 1 (11.1) | 7 (23.3) |
| Blood in urine | 1 (9.1) | 1 (10.0) | 0 | 2 (6.7) |
| Blood chloride increased | 1 (9.1) | 0 | 0 | 1 (3.3) |
| Blood cholesterol increased | 1 (9.1) | 0 | 0 | 1 (3.3) |
| Blood glucose increased | 1 (9.1) | 0 | 1 (11.1) | 2 (6.7) |
| Blood sodium increased | 1 (9.1) | 0 | 0 | 1 (3.3) |
| Blood calcium decreased | 0 | 2 (20.0) | 0 | 2 (6.7) |
| Urine ketone body present | 0 | 1 (10.0) | 0 | 1 (3.3) |
| Blood chloride decreased | 0 | 1 (10.0) | 0 | 1 (3.3) |
| Blood creatinine increased | 0 | 1 (10.0) | 0 | 1 (3.3) |
| Blood magnesium decreased | 0 | 1 (10.0) | 0 | 1 (3.3) |
| Blood glucose abnormal | 0 | 0 | 1 (11.1) | 1 (3.3) |
| Eye disorders | 1 (9.1) | 1 (10.0) | 0 | 2 (6.7) |
| Paraesthesia eye | 1 (9.1) | 0 | 0 | 1 (3.3) |
| Eye pruritus | 1 (9.1) | 0 | 0 | 1 (3.3) |
| Visual fatigue | 0 | 1 (10.0) | 0 | 1 (3.3) |
| Skin and subcutaneous tissue disorders | 0 | 1 (10.0) | 0 | 1 (3.3) |
| Pruritus | 0 | 1 (10.0) | 0 | 1 (3.3) |
| Renal and urinary disorders | 0 | 0 | 1 (11.1) | 1 (3.3) |
| Urinary frequency | 0 | 0 | 1 (11.1) | 1 (3.3) |