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 |
|---|---|---|---|---|---|---|---|---|
| Cohort H (PrEP) | Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis). High Risk Cohort Criteria (one or more of the following has to be met): 1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months. 2. STI diagnosis during the last 12 months. 3. Previous PEP use during the last 12 months (\* see exclusion criteria) 4. Has at least one HIV infected sexual partner for ≥4 weeks. emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued. | None | None | 2 | 297 | 195 | 297 | View |
| Cohort LM (PEP) | Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis. emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued. | None | None | 0 | 4 | 0 | 4 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | None | Investigations | None | View |
| Hypophosphataemia | None | Metabolism and nutrition disorders | None | View |
| Oropharyngeal gonococcal infection | None | Infections and infestations | None | View |
| Proctitis chlamydial | None | Infections and infestations | None | View |
| Proctitis gonococcal | None | Infections and infestations | None | View |
| Syphilis | None | Infections and infestations | None | View |
| Urethritis chlamydial | None | Infections and infestations | None | View |