TABLE 2.
Most common treatment‐emergent adverse events experienced by volunteers in the intravenous and subcutaneous cohorts (safety analysis set).
| Preferred term | Garadacimab |
Placebo a n (%) |
|||||
|---|---|---|---|---|---|---|---|
|
0.1 mg/kg (n = 4) n |
0.3 mg/kg (n = 4) n |
1 mg/kg (n = 4) n |
3 mg/kg (n = 4) n |
10 mg/kg (n = 4) n |
All doses a n (%) |
||
| Intravenous | |||||||
| Headache | 0 | 2 | 1 | 0 | 3 | 6 (30.0) | 3 (30.0) |
| Dermatitis contact | 1 | 1 | 0 | 0 | 1 | 3 (15.0) | 1 (10.0) |
| Upper respiratory tract infection | 2 | 0 | 0 | 1 | 0 | 3 (15.0) | 3 (30.0) |
| Cough | 0 | 0 | 0 | 1 | 1 | 2 (10.0) | 0 |
| Hepatic enzyme increased | 2 | 0 | 0 | 0 | 0 | 2 (10.0) | 0 |
| Infusion‐site bruising | 0 | 0 | 0 | 1 | 1 | 2 (10.0) | 0 |
| Dry lip | 0 | 0 | 0 | 1 | 1 | 2 (10.0) | 0 |
| Medical device‐site dermatitis | 0 | 0 | 0 | 0 | 2 | 2 (10.0) | 1 (10.0) |
| Medical device‐site reaction | 1 | 0 | 0 | 1 | 0 | 2 (10.0) | 0 |
| Rhinitis | 0 | 0 | 1 | 0 | 1 | 2 (10.0) | 0 |
| Toothache | 0 | 0 | 0 | 1 | 1 | 2 (10.0) | 0 |
| Vessel puncture‐site bruise | 0 | 0 | 0 | 2 | 0 | 2 (10.0) | 0 |
| Subcutaneous | |||||||
| Injection‐site erythema | – | – | 3 | 4 | 2 | 9 (75.0) | 2 (33.3) |
| Injection‐site pain | – | – | 2 | 1 | 0 | 3 (25.0) | 0 |
| Injection‐site pruritus | – | – | 1 | 0 | 2 | 3 (25.0) | 1 (16.7) |
| Fatigue | – | – | 2 | 0 | 0 | 2 (16.7) | 1 (16.7) |
| Vessel puncture‐site bruise | – | – | 0 | 0 | 2 | 2 (16.7) | 1 (16.7) |
Treatment‐emergent adverse events reported in greater than or equal to 2 volunteers in the combined garadacimab intravenous and subcutaneous cohorts.
a
The “all doses” data refers to 20 volunteers in the intravenous cohort and 12 in the subcutaneous cohort. Similarly, the placebo data consists of 10 volunteers in the intravenous cohort and six in the subcutaneous cohort.