Table 2.
Treatment-emergent safety outcomes in the double-blinded periods
| TEAEs during double-blinded period, n (%) | Batoclimab 680 mg (N = 11) | Batoclimab 340 mg (N = 10) | Placebo (N = 9) |
|---|---|---|---|
| Total | 10 (90.9) | 10 (100) | 9 (100) |
| Metabolism and nutrition disorders | 7 (63.6) | 7 (70.0) | 5 (55.6) |
| Hypoalbuminemia | 4 (36.4) | 0 | 0 |
| Hypercholesterolemia | 3 (27.3) | 2 (20.0) | 2 (22.2) |
| Hyponatremia | 1 (9.1) | 5 (50.0) | 4 (44.4) |
| Hypomagnesemia | 1 (9.1) | 2 (20.0) | 3 (33.3) |
| Hypoproteinemia | 1 (9.1) | 1 (10.0) | 0 |
| Decreased appetite | 1 (9.1) | 0 | 0 |
| Hypertriglyceridemia | 1 (9.1) | 0 | 0 |
| Hyperuricemia | 0 | 2 (20.0) | 0 |
| Hypocalcemia | 0 | 1 (10.0) | 0 |
| Hypokalemia | 0 | 0 | 1 (11.1) |
| General disorders and administration site conditions | 5 (45.5) | 5 (50.0) | 1 (11.1) |
| Injection site hemorrhage | 3 (27.3) | 2 (20.0) | 1 (11.1) |
| Edema peripheral | 2 (18.2) | 2 (20.0) | 0 |
| Injection site pain | 1 (9.1) | 0 | 1 (11.1) |
| Injection site reactions | 0 | 1 (10.0) | 0 |
| Injection site pruritus | 0 | 1 (10.0) | 0 |
| Injection site nodule | 0 | 1 (10.0) | 0 |
| Facial edema | 0 | 1 (10.0) | 0 |
| Injection site erythema | 0 | 0 | 1 (11.1) |
| Infections and infestations | 3 (27.3) | 4 (40.0) | 6 (66.7) |
| Urinary tract infection | 2 (18.2) | 3 (30.0) | 2 (22.2) |
| Upper respiratory infection | 1 (9.1) | 1 (10.0) | 2 (22.2) |
| Herpes simplex | 1 (9.1) | 0 | 0 |
| Folliculitis | 1 (9.1) | 0 | 0 |
| Urethritis | 0 | 0 | 1 (11.1) |
| Blepharitis | 0 | 0 | 1 (11.1) |
| Gastrointestinal disorders | 3 (27.3) | 3 (30.0) | 3 (33.3) |
| Abdominal pain upper | 1 (9.1) | 1 (10.0) | 0 |
| Abdominal pain | 1 (9.1) | 1 (10.0) | 1 (11.1) |
| Nausea | 1 (9.1) | 0 | 0 |
| Toothache | 1 (9.1) | 0 | 1 (11.1) |
| Diarrhea | 1 (9.1) | 0 | 2 (22.2) |
| Gingival pain | 0 | 1 (10.0) | 0 |
| Lower abdominal pain | 0 | 0 | 1 (11.1) |
| Investigations | 2 (18.2) | 5 (50.0) | 3 (33.3) |
| Blood albumin decreased | 2 (18.2) | 2 (20.0) | 1 (11.1) |
| Blood cholesterol increased | 1 (9.1) | 1 (10.0) | 1 (11.1) |
| Blood in urine | 0 | 3 (30.0) | 1 (11.1) |
| Weight gain | 0 | 1 (10.0) | 0 |
| Urine ketone body present | 0 | 1 (10.0) | 0 |
| Blood calcium decreased | 0 | 1 (10.0) | 1 (11.1) |
| White blood cell urine positive | 0 | 0 | 1 (11.1) |
| Blood bicarbonate decreased | 0 | 0 | 1 (11.1) |
| Musculoskeletal and connective tissue disorders | 2 (18.2) | 0 | 0 |
| Muscle twitching | 2 (18.2) | 0 | 0 |
| Skin and subcutaneous tissue disorders | 1 (9.1) | 1 (10.0) | 0 |
| Pruritus | 1 (9.1) | 0 | 0 |
| Rash | 1 (9.1) | 0 | 0 |
| Night sweats | 0 | 1 (10.0) | 0 |
| Respiratory, thoracic, and mediastinal disorders | 1 (9.1) | 0 | 0 |
| Cough | 1 (9.1) | 0 | 0 |
| Psychiatric disorders | 1 (9.1) | 0 | 1 (11.1) |
| Trouble sleeping | 1 (9.1) | 0 | 0 |
| Anxious | 0 | 0 | 1 (11.1) |
| Hepatobiliary disorders | 1 (9.1) | 0 | 0 |
| Hepatic function abnormal | 1 (9.1) | 0 | 0 |
| Vascular disorders | 1 (9.1) | 0 | 0 |
| Flushing | 1 (9.1) | 0 | 0 |
| Nervous system disorders | 0 | 4 (40.0) | 1 (11.1) |
| Dizziness | 0 | 4 (40.0) | 0 |
| Headache | 0 | 0 | 1 (11.1) |
| Cardiac disorders | 0 | 1 (10.0) | 0 |
| Palpitations | 0 | 1 (10.0) | 0 |
| Eye disorders | 0 | 1 (10.0) | 0 |
| Blurred vision | 0 | 1 (10.0) | 0 |
| Renal and urinary disorders | 0 | 0 | 1 (11.1) |
| Urinary frequency | 0 | 0 | 1 (11.1) |