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: 2025-12-25 @ 2:23 AM
Ignite Modification Date: 2025-12-26 @ 12:55 AM
NCT ID: NCT03004534
Description: The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
Frequency Threshold: 5
Time Frame: 1 year, 6 months.
Study: NCT03004534
Study Brief: A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Presurgical Molecular Assessment Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d. darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg. 0 None 0 36 26 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ASAT Increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Breast Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nasea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
ALAT Increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View