Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-24 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT02314156
Description: None
Frequency Threshold: 5
Time Frame: AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
Study: NCT02314156
Study Brief: Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (Transdermal Telapristone Acetate) Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks. Telapristone Acetate: Given transdermally applied to both breast skin Placebo: Given PO 0 None 0 33 25 33 View
Arm II (Oral Telapristone Acetate) Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks. Telapristone Acetate: Given PO Placebo: Given transdermally applied to both breast skin 0 None 0 34 21 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
General disorders and administrative site condition - other specify SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View