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 |
|---|---|---|---|---|---|---|---|---|
| B - Immediate Surgery | Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) | None | None | 5 | 255 | 0 | 255 | View |
| C- Immediate Surgery - Nonrandomized | Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) | None | None | 1 | 230 | 0 | 230 | View |
| A - Scheduled Surgery | Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) | None | None | 0 | 244 | 0 | 244 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Endocervical cancer | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Venous thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Nosocomial pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |