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 |
|---|---|---|---|---|---|---|---|---|
| Alinity s HBsAg Follow-Up Specimen Collection | For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis. No donors required for follow-up collection for Alinity s HBsAg study. | 0 | None | 0 | 0 | 0 | 0 | View |
| Alinity s HTLV I/II Follow-Up Specimen Collection | For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis. 12 donors were eligible for follow-up collection for Alinity s HTLV I/II study. 8 out of 12 were able to provide follow-up specimen. | 0 | None | 0 | 8 | 0 | 8 | View |
| Alinity s Anti-HCV Follow-Up Specimen Collection | For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis. 20 donors were eligible for follow-up collection for Alinity s Anti-HCV study. 2 out of 20 were able to provide follow-up specimen. | 0 | None | 0 | 2 | 0 | 2 | View |
| Alinity s HIV Ag/Ab Combo Follow-Up Specimen Collection | For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis. 15 donors were eligible for follow-up collection for Alinity s HIV Ag/Ab Combo study. 4 out of 15 were able to provide follow-up specimen. | 0 | None | 0 | 4 | 0 | 4 | View |
| Alinity s Anti-HBc Follow-Up Specimen Collection | For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis. 16 donors were eligible for follow-up collection for Alinity s Anti-HBc study. 2 out of 16 were able to provide follow-up specimen. | 0 | None | 0 | 2 | 0 | 2 | View |
| Alinity s Chagas Follow-Up Specimen Collection | For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis. 14 donors were eligible for follow-up collection for Alinity s Chagas study. 1 out of 14 were able to provide follow-up specimen. | 0 | None | 0 | 1 | 0 | 1 | View |