Adverse Events Module

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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: 2025-12-26 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT01422408
Description: Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).
Frequency Threshold: 0
Time Frame: End of study week 1, 2, 3, 4
Study: NCT01422408
Study Brief: Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Supportive Care (Fluocinonide Cream) This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks. 0 None 0 34 24 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bullous dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE Version 4. View
Flushing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE Version 4. View
Headache SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE Version 4. View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE Version 4. View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE Version 4. View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE Version 4. View
Vaginal discharge SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE Version 4. View
Vaginal inflammation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE Version 4. View