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 @ 4:09 PM
Ignite Modification Date: 2025-12-25 @ 2:09 PM
NCT ID: NCT03517566
Description: Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Frequency Threshold: 5
Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks
Study: NCT03517566
Study Brief: A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo 0 None 2 72 27 72 View
ZPL389 3 mg ZPL389 3 mg oral powder 0 None 1 37 14 37 View
ZPL389 10 mg ZPL389 10 mg oral powder 0 None 3 36 8 36 View
ZPL389 30 mg ZPL389 30 mg oral powder 0 None 1 73 30 73 View
ZPL389 50 mg ZPL389 50 mg oral powder 0 None 3 73 26 73 View
All Patients All Patients 0 None 10 291 105 291 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (23.0) View
Herpes dermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Risk of future pregnancy miscarriage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (23.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (23.0) View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.0) View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (23.0) View