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 @ 11:53 PM
Ignite Modification Date: 2025-12-25 @ 9:49 PM
NCT ID: NCT04806451
Description: Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received at least 1 dose of study drug. Only DB period was complete at the time of data cutoff date.
Frequency Threshold: 5
Time Frame: Baseline up to Week 28
Study: NCT04806451
Study Brief: Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DB Period: Placebo Participants received crinecerfont-matched placebo orally twice daily for 28 weeks during the DB placebo-controlled treatment period. 0 None 4 33 22 33 View
DB Period: Crinecerfont Participants received crinecerfont orally twice daily for 28 weeks during the DB placebo-controlled treatment period. Dose assignment from Day 1 to Week 28 was based on the participant's weight at Day 1. 0 None 1 69 51 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
17-hydroxyprogesterone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Blood androstenedione increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Blood insulin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Blood corticotrophin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View