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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
NCT ID:
NCT03323658
Description:
None
Frequency Threshold:
0
Time Frame:
4 weeks of treatment, Up to 30 days after completion of study drug for AE assessments
Study:
NCT03323658
Study Brief:
Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Expansion Cohort | Bexarotene 1 % gel 10 mg every other day | 0 | None | 0 | 10 | 10 | 10 | View |
| Dose Level 1 | Bexarotene 1 % gel 10 mg every other day | 0 | None | 0 | 10 | 9 | 10 | View |
| Dose Level 2 | Bexarotene 1 % gel 10 mg daily | 0 | None | 0 | 4 | 4 | 4 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Motion Sickness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Tired(Fatigue) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Tongue Swelling/soreness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Dermatitis (blistering) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| Allergic reaction, small itchy lump on right arm at allergy shot injection site | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Absolute neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Sleep disturbance/insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Breast Tenderness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Reproductive System and Breast Disorders-Other, Specify | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Reproductive System and Breast Disorders-Other, Specify | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Cough/Coughing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Pain of Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Rash Maculopapular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Rash Maculopapular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Skin and Subcutaneous Tissue Disorders - Other, Specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Skin and Subcutaneous Tissue Disorders- Other, Specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Skin and Subcutaneous Tissue Disorders - Other, Specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Skin and Subcutaneous Tissue Disorders - Other, Specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| General Disorders and Administration Site Conditions-Other, Specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Skin and Subcutaneous Tissue Disorders - Other, Specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |