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 |
|---|---|---|---|---|---|---|---|---|
| Treated Patients Randomized to Receive Survey | A subset of patients (described above) will receive an automated SMS text message with a link to an online survey. This survey contains the script questions about pain management and opioid use. Observation: Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption. Text to online survey: Subset of surgical patients will receive an automated text message with a link to a secure online survey with questions that assess pain, functional status, and opioid consumption. | 0 | None | 0 | 63 | 0 | 63 | View |
| Treated Patients Randomized to Receive Text Script | A subset of patients (described above) will receive an automated questionnaire conducted via text message. Questions will be about pain management and opioid use. Observation: Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption. Bi-directional text script: Subset of surgical patients will receive an automated bi-directional text message script with questions that assess pain, functional status, and opioid consumption. | 0 | None | 0 | 64 | 0 | 64 | View |