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 |
|---|---|---|---|---|---|---|---|---|
| Single Arm | Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes | 0 | None | 5 | 39 | 0 | 39 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Basilar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| JC Virus/Progressive Multifocal Leukoencephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Secondary malignancy | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |