Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Stratum 1 - Aviptadil + Remdesivir | Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir * Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593) | 0 | None | 0 | 0 | 0 | 0 | View |
| Stratum 1 - Aviptadil +Remdesivir Placebo | Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir * Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593) | 0 | None | 0 | 0 | 0 | 0 | View |
| Stratum 1 - Aviptadil Placebo + Remdesivir | Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir * Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593) | 0 | None | 0 | 0 | 0 | 0 | View |
| Stratum 1 - Aviptadil Placebo + Remdesivir Placebo | Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir * Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593) | 0 | None | 0 | 0 | 0 | 0 | View |
| Stratum 2 - Aviptadil | Eligible for Aviptadil and Remdesivir contraindicated * Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal * Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606) | 0 | None | 0 | 0 | 0 | 0 | View |
| Stratum 2 - Aviptadil Placebo | Eligible for Aviptadil and Remdesivir contraindicated * Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal * Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606) | 0 | None | 0 | 0 | 0 | 0 | View |
| Stratum 3 - Remdesivir | Eligible for Remdesivir and Aviptadil contraindicated * Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection * Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593) | 0 | None | 0 | 0 | 0 | 0 | View |
| Stratum 3 - Remdesivir Placebo | Eligible for Remdesivir and Aviptadil contraindicated * Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection * Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593) | 0 | None | 0 | 0 | 0 | 0 | View |
| Stratum 4 - Aviptadil | Eligible for Aviptadil and prior/current use of Remdesivir * Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606) | 0 | None | 0 | 0 | 0 | 0 | View |
| Stratum 4 - Aviptadil Placebo | Eligible for Aviptadil and prior/current use of Remdesivir * Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606) | 0 | None | 0 | 0 | 0 | 0 | View |