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 (BBT Intervention) | Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6. Brief Behavioral Therapy: Undergo BBT intervention Telephone-Based Intervention: Undergo BBT intervention | None | None | 0 | 34 | 0 | 34 | View |
| Arm II (Control) | Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6. Educational Intervention: Undergo HEAL Telephone-Based Intervention: Undergo HEAL | None | None | 0 | 37 | 3 | 37 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| mucositis stomastitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Sore Throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |