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: 2025-12-24 @ 1:37 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT04140695
Description: None
Frequency Threshold: 2
Time Frame: All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
Study: NCT04140695
Study Brief: Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tradipitant Oral Capsule Tradipitant: BID 0 None 1 43 13 43 View
Placebo Oral Capsule Placebo: BID 0 None 1 44 10 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Procedural Complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 21.0 View
Obstructive Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chlamydial Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Otitis Media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Skin Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Angular Cheilitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Feces Discolored NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Obstructive Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Dermatitis Atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 21.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 21.0 View
Dry Skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 21.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 21.0 View
Skin Irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 21.0 View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Arthropod Sting NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 21.0 View
Heart Rate Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 21.0 View
Liver Function Test Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 21.0 View
Periorbital Oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 21.0 View
Dysmenorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 21.0 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Herpes Virus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Procedural Complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 21.0 View