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 @ 12:27 AM
Ignite Modification Date: 2025-12-25 @ 10:33 PM
NCT ID: NCT03226067
Description: Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 28-day follow-up period after the last administration of IMP
Frequency Threshold: 5
Time Frame: .Approximately 6-7 months
Study: NCT03226067
Study Brief: Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GKT137831 400mg Twice Daily GKT137831 400mg twice daily Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. GKT137831: GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily. 0 None 1 36 32 36 View
GKT137831 400mg Once Daily GKT137831 400mg once daily Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. The capsules in the evening will be placebos. GKT137831: GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily. Placebo oral capsule: Matching capsules. 0 None 0 38 34 38 View
Placebo Arm Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. All capsules will be placebos. Placebo oral capsule: Matching capsules. 0 None 1 37 31 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Multiple Fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Urinary Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastrooesoghageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Arthropod Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View