Skip to main content
. 2023 Sep 25;16(11):2276–2288. doi: 10.1111/cts.13627

TABLE 5.

Overall summary of AEs.

n (%) Cohort 1 2 mg RDV SAD (n = 8) Cohort 2 5 mg RDV SAD (n = 8) Cohort 3 5 mg RDV MAD (n = 8) Cohort 4 10 mg RDV SAD (n = 8) Cohort 5 10 mg RDV MAD (n = 8) Cohort 6 10.4 mg RDV MAD inhalation formulation (n = 8) Cohort 7 10 mg RDV SAD mouthpiece (n = 10) Placebo (n = 14) Total (N = 72)
TEAE a 1 (12.5) 1 (12.5) 4 (50.0) 3 (37.5) 4 (50.0) 5 (62.5) 5 (50.0) 8 (57.1) 31 (43.1)
TEAE grade ≥2 b 0 0 1 (12.5) 1 (12.5) 0 2 (25.0) 0 0 4 (5.6)
TEAE related to study treatment 0 1 (12.5) 2 (25.0) 3 (37.5) 3 (37.5) 4 (50.0) 2 (20.0) 7 (50.0) 22 (30.6)
TEAE related to study procedure 1 (12.5) 1 (12.5) 3 (37.5) 3 (37.5) 4 (50.0) 3 (37.5) 4 (40.0) 8 (57.1) 27 (37.5)
TE SAE 0 0 0 0 0 0 0 0 0
TEAE leading to study treatment discontinuation 0 0 0 0 0 0 0 0 0
TEAE leading to study discontinuation 0 0 0 0 0 0 0 0 0

Abbreviations: AE, adverse event; MAD, multiple ascending dose; RDV, remdesivir; SAD, single ascending dose; SAE, serious adverse event; TE, treatment‐emergent; TEAE, treatment‐emergent adverse event.

a

TEAEs were those that began after the study treatment start date up to 30 days after permanent discontinuation of study treatment.

b

Severity grades were defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1.