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 |
|---|---|---|---|---|---|---|---|---|
| Comparator for Package 1 | 4 facilities were assigned to the comparator group and did not receive any implementation strategies. | 0 | None | 0 | 836 | 0 | 836 | View |
| Comparator for Package 3 | 4 facilities were assigned to the comparator group and did not receive any implementation strategies. | 0 | None | 0 | 815 | 0 | 815 | View |
| Package 1 | Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders | 0 | None | 0 | 800 | 0 | 800 | View |
| Package 2 | Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders | 0 | None | 0 | 841 | 0 | 841 | View |
| Comparator for Package 2 | 4 facilities were assigned to the comparator group and did not receive any implementation strategies. | 0 | None | 0 | 841 | 0 | 841 | View |
| Package 3 | Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders | 0 | None | 0 | 839 | 0 | 839 | View |