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 |
|---|---|---|---|---|---|---|---|---|
| Comparison Practices Utilization Cohort | Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania Intervention: No intervention/Usual care | 0 | None | 0 | 0 | 0 | 0 | View |
| Pilot Practices Quality Measures Cohort | Patients with a new diagnosis of cancer in the past two years Intervention: Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance. | 0 | None | 0 | 0 | 0 | 0 | View |
| Pilot Practices Patient Survey Cohort | Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania Intervention: Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance. | 0 | None | 0 | 0 | 0 | 0 | View |
| Comparison Practices Patient Survey Cohort | Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania Intervention: No intervention/Usual care | 0 | None | 0 | 0 | 0 | 0 | View |
| Pilot Practices Utilization Cohort | Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania Intervention: Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance. | 0 | None | 0 | 0 | 0 | 0 | View |