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 |
|---|---|---|---|---|---|---|---|---|
| Intervention- ACT Therapy | Participants randomized to this group will receive three ACT sessions over 1 month ACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation. | 3 | None | 5 | 67 | 2 | 67 | View |
| Standard of Care | Participants in the control group will receive standard care as normally provided to patients by civil society organizations. | 1 | None | 1 | 33 | 0 | 33 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization due to HIV progression | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Hospitalization due to pulmonary tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Death due to stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Death due to cerebral edema | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Death due to cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |