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 |
|---|---|---|---|---|---|---|---|---|
| Control Group | Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols | 154 | None | 0 | 0 | 0 | 0 | View |
| Intervention | Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy Process re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment. Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff | 145 | None | 0 | 0 | 0 | 0 | View |