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 |
|---|---|---|---|---|---|---|---|---|
| mNavigator - Burkitt Lymphoma (BL) | Prospective cohort of patients diagnosed with BL where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). mNavigator: Allied health providers at BMC will use mNavigator to facilitate compliance with protocol-driven treatment and reduce patient abandonment for patients diagnosed with Burkitt lymphoma, Diffuse large B-cell lymphoma (DLBCL) or retinoblastoma. | 0 | None | 0 | 46 | 0 | 46 | View |
| mNavigator - Retinoblastoma (Rb) | Prospective cohort of patients diagnosed with Rb where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). mNavigator: Allied health providers at BMC will use mNavigator to facilitate compliance with protocol-driven treatment and reduce patient abandonment for patients diagnosed with Burkitt lymphoma, Diffuse large B-cell lymphoma (DLBCL) or retinoblastoma. | 0 | None | 0 | 29 | 0 | 29 | View |
| Historical Controls - Burkitt Lymphoma (BL) | BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC). | 0 | None | 0 | 0 | 0 | 0 | View |
| Historical Controls - Retinoblastoma (Rb) | Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC). | 0 | None | 0 | 0 | 0 | 0 | View |
| mNavigator Users | Health care providers using mNavigator | 0 | None | 0 | 0 | 0 | 0 | View |