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
Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
NCT ID:
NCT04079218
Description:
The Division of AIDS (DAIDS) Female Genital Grading Table for Use in Microbicide Studies will be the primary tool for grading adverse events (https://rsc.niaid.nih.gov/sites/default/files/addendum-1-female-genitalgrading-table-v1-nov-2007.pdf.)
Frequency Threshold:
0
Time Frame:
Up to 13 weeks following randomization
Study:
NCT04079218
Study Brief:
Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Estradiol Vaginal Insert | Using a pre-loaded single-use plastic applicator, participants will insert one 10 microgram estradiol tablet intravaginally daily for 2 weeks and then one tablet twice weekly for the remainder of the study for a total of 12 weeks. Estradiol Vaginal Insert: Using a pre-loaded single-use plastic applicator, participants will insert one 10 microgram estradiol tablet intravaginally daily for 2 weeks and then one tablet twice weekly for the remainder of the study for a total of 12 weeks. | 1 | None | 4 | 33 | 20 | 33 | View |
| No Treatment | No intervention | 0 | None | 2 | 27 | 10 | 27 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalization for Gastrointestinal Bleed (GIB) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fractured Right Distal Fibula | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hospitalization for Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Liver Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pigmentation loss | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Hemoglobin Decreased | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leg weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Groin Pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Vaginal Discharge | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Urinary Frequency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Brown (Vaginal) Discharge | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Vaginal Cramping | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Rash maculopapular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Edema Limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vulvar Erythema | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Trichomonas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Yeast Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Bacterial Vaginosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dark Stools | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hemoglobin decreased 8.7 | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Epigastric pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea and abdominal cramping | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Tooth extraction | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Sinus infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| COPD exacerbation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Healing Biopsy Sites | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |