TABLE 5.
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.
TEAEs were those that began after the study treatment start date up to 30 days after permanent discontinuation of study treatment.
Severity grades were defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1.