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 | All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics. | 29 | None | 0 | 102 | 0 | 102 | View |
| Intervention Group | The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis. | 73 | None | 0 | 186 | 0 | 186 | View |