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. 2023 Aug 25;29(9):2216–2223. doi: 10.1038/s41591-023-02494-2

Table 3.

Overall summary of TEAEs in HP cohorts receiving placebo or 35 mg, 100 mg, 200 mg or 300 mg of ARO-ANG3 (SADs) and cohorts receiving placebo or 100 mg, 200 mg or 300 mg of ARO-ANG3 (MADs)

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.