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 |
|---|---|---|---|---|---|---|---|---|
| Dyspepsia Review- Competing Interest Statement 1 | Honoraria \& Travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference. | None | None | 0 | 100 | 0 | 100 | View |
| Gout Review- Competing Interest Statement 2 | Advisory board \& consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member. | None | None | 0 | 90 | 0 | 90 | View |
| Dyspepsia Review- Competing Interest Statement 3 | Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals | None | None | 0 | 96 | 0 | 96 | View |
| Dyspepsia Review- Competing Interest Statement 4 | None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests. | None | None | 0 | 87 | 0 | 87 | View |
| Gout Review- Competing Interest Statement 1 | Honoraria \& travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference. | None | None | 0 | 99 | 0 | 99 | View |
| Dyspepsia Review- Competing Interest Statement 2 | Advisory board \& consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member. | None | None | 0 | 93 | 0 | 93 | View |
| Gout Review- Competing Interest Statement 3 | Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals.. | None | None | 0 | 93 | 0 | 93 | View |
| Gout Review- Competing Interest Statement 4 | None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests. | None | None | 0 | 91 | 0 | 91 | View |