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 |
|---|---|---|---|---|---|---|---|---|
| HER2 Therapies, Cardiac Medications | Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist: * Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week. * Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab. * Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks. Trastuzumab: HER2 therapy Pertuzumab: HER2 therapy Ado Trastuzumab Emtansine: HER2 therapy | 1 | None | 3 | 30 | 0 | 30 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac event | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |