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 |
|---|---|---|---|---|---|---|---|---|
| Estrogen Patch | 17Beta-estradiol transdermal patch twice weekly application for 12 months Transdermal 17Beta-estradiol, progesterone: 100 mcg/day 17Beta-estradiol; transdermal twice weekly application for 12 months (with cyclic micronized progesterone pills (Prometrium): 200 mg taken orally daily Day 1 to Day 12 each month) + Elemental calcium 1200 mg and Vit D 400 IU taken orally daily | 0 | None | 3 | 43 | 10 | 43 | View |
| Estrogen Pill | One pill containing estrogen and progesterone taken daily for 21 days followed by placebo pills only for 7 days; regimen repeated for 12 months. Ethinyl Estradiol + Desogestrel: Oral ethinyl estradiol (0.03 mg) + desogestrel (0.15 mg) + Elemental calcium 1200 mg and Vit D 400 IU taken once daily | 0 | None | 0 | 40 | 13 | 40 | View |
| Control | Elemental calcium 1200 mg and Vit D 400 IU taken orally daily Sham Comparator: Elemental calcium 1200 mg and Vit D 400 IU taken orally daily | 0 | None | 1 | 38 | 1 | 38 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Breast tenderness | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Bloating | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Early menses | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Yeast infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Worsening depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Mood swings | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Generalized discomfort | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vasovagal response | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Skin rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Decreased libido | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mononucleosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory symptoms | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin tags | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Electrolyte changes | SYSTEMATIC_ASSESSMENT | Investigations | None | View |