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: 2025-12-25 @ 3:20 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT03317405
Description: None
Frequency Threshold: 5
Time Frame: AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.
Study: NCT03317405
Study Brief: Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Endoxifen Hydrochloride Gel 10 mg Daily Participants apply endoxifen hydrochloride gel 5 mg to each breast skin daily and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 5 mg: Apply to each breast daily for total dose of 10 mg daily Questionnaire Administration: Ancillary studies 0 None 0 16 7 16 View
Endoxifen Hydrochloride Gel 20 mg Daily Participants apply endoxifen hydrochloride gel 10 mg to each breast skin daily and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 10 mg: Apply to each breast daily for total dose of 20 mg daily Questionnaire Administration: Ancillary studies 0 None 0 8 3 8 View
Placebo Participants apply placebo to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Placebo Administration: Apply to each breast daily Questionnaire Administration: Ancillary studies 0 None 0 8 5 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperhidrosis 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
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vaginal Infections SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View