Table 3.
HPs (SAD) | HPs (MAD) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Pooled placebo (n = 16) |
Pooled active (n = 24) |
ARO-ANG3 (35 mg) (n = 6) |
ARO-ANG3 (100 mg) (n = 6) |
ARO-ANG3 (200 mg) (n = 6) |
ARO-ANG3 (300 mg) (n = 6) |
Pooled Active (n = 12) | ARO-ANG3 (100 mg) (n = 4) |
ARO-ANG3 (200 mg) (n = 4) |
ARO-ANG3 (300 mg) (n = 4) |
|
Number of TEAEs | 34 | 65 | 12 | 13 | 23 | 17 | 44 | 17 | 6 | 21 |
Number of participants reporting at least one: | ||||||||||
TEAE | 14 (87.5%) | 22 (91.7%) | 5 (83.3%) | 6 (100%) | 6 (100%) | 5 (83.3%) | 10 (83.3%) | 4 (100%) | 2 (50.0%) | 4 (100%) |
Serious TEAE | 1 (6.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Severe TEAE | 1 (6.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Related TEAE | 2 (12.5%) | 4 (16.7%) | 0 | 1 (16.7%) | 2 (33.3%) | 1 (16.7%) | 2 (16.7%) | 0 | 0 | 2 (50.0%) |
Related serious TEAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Related severe TEAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
TEAEs leading to drug/study withdrawal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants reporting TEAEs by severity: | ||||||||||
Mild | 12 (75.0%) | 20 (83.3%) | 5 (83.3%) | 5 (83.3%) | 6 (100%) | 4 (66.7%) | 10 (83.3%) | 4 (100%) | 2 (50.0%) | 4 (100%) |
Moderate | 5 (31.3%) | 5 (20.8%) | 1 (16.7%) | 1 (16.7%) | 1 (16.7%) | 2 (33.3%) | 0 | 0 | 0 | 0 |
Severe | 1 (6.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants reporting TEAEs by relationship to study treatment: | ||||||||||
Not related | 14 (87.5%) | 22 (91.7%) | 5 (83.3%) | 6 (100%) | 6 (100%) | 5 (83.3%) | 10 (83.3%) | 4 (100%) | 2 (50.0%) | 4 (100%) |
Possibly | 2 (12.5%) | 3 (12.5%) | 0 | 1 (16.7%) | 1 (16.7%) | 1 (16.7%) | 1 (8.3%) | 0 | 0 | 1 (25.0%) |
Probably | 0 | 1 (4.2%) | 0 | 0 | 1 (16.7%) | 0 | 1 (8.3%) | 0 | 0 | 1 (25.0%) |
Notes: MedDRA version 21.1; related denotes possibly or probably.