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 |
|---|---|---|---|---|---|---|---|---|
| Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | None | None | 0 | 25 | 4 | 25 | View |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | None | None | 0 | 25 | 6 | 25 | View |
| Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF | None | None | 0 | 24 | 1 | 24 | View |