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 @ 2:29 AM
Ignite Modification Date: 2025-12-26 @ 1:04 AM
NCT ID: NCT03718234
Description: None
Frequency Threshold: 0
Time Frame: 20 weeks
Study: NCT03718234
Study Brief: Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Subcutaneous Hydrocortisone Via Infusion Pump Patients will receive a subcutaneous injection of hydrocortisone (HC). Each patient's total daily dose (TDD) of oral tablet hydrocortisone to determine the doses to be delivered of the study drug. The 24-hr schedule and percentage of the TDD of HC will be as follows: approximately 60% of the TDD of HC will be delivered in 3 equal pulses at 0300, 0600 and 0900. Another 35% will be delivered in 3 equal pulses at 1200, 1500 and 1800 and the remaining 5% at 2100 and 2400. Subcutaneous hydrocortisone: Patients will be monitored and receive an interval bolus SQHC dosing regimen that more closely mimics cortisol, 17OHP and D4A circadian and ultradian rhythms than conventional oral HC dosing. 0 None 0 11 9 11 View
Standard Glucocorticoid Therapy Subjects in this arm will continue on standard oral hydrocortisone therapy Standard glucocorticoid therapy: Subjects in this arm will continue on standard oral hydrocortisone therapy 0 None 0 11 9 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stinging/Burning sensation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Itching SYSTEMATIC_ASSESSMENT General disorders None View
Skin rash SYSTEMATIC_ASSESSMENT General disorders None View
Excoriation SYSTEMATIC_ASSESSMENT General disorders None View
Hives SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT General disorders None View
covid SYSTEMATIC_ASSESSMENT General disorders None View
Heartburn SYSTEMATIC_ASSESSMENT General disorders None View
Ear infection SYSTEMATIC_ASSESSMENT General disorders None View
Streptococcal pharyngitis SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory virus (RSV) SYSTEMATIC_ASSESSMENT General disorders None View
stomach ache SYSTEMATIC_ASSESSMENT General disorders None View
vasovagal syndrome SYSTEMATIC_ASSESSMENT General disorders None View