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 |
|---|---|---|---|---|---|---|---|---|
| Arm I (Lenalidomide, Rituximab) | Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies | None | None | 2 | 3 | 0 | 3 | View |
| Arm II (Lenalidomide) | Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies | None | None | 0 | 0 | 0 | 0 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperglycemia | None | Metabolism and nutrition disorders | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Rash >50% BSA | None | Skin and subcutaneous tissue disorders | None | View |
| Superior vena cava obstruction | None | Vascular disorders | None | View |
| Tumor flare syndrome | None | Metabolism and nutrition disorders | None | View |