Adverse Events Module

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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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:16 AM
NCT ID: NCT03948334
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 in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).
Study: NCT03948334
Study Brief: A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ZPL389 50mg in the First 16 Weeks of This Extension Study AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study) 0 None 5 63 8 63 View
ZPL389 30mg in the First 16 Weeks of This Extension Study AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study) 0 None 2 60 6 60 View
ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study) 0 None 0 60 9 60 View
ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study) 0 None 2 63 6 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Steatohepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (23.0) View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (23.0) View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (23.0) View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (23.0) View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.0) View
Pneumothorax spontaneous SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.0) View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (23.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (23.0) View