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 @ 2:01 AM
Ignite Modification Date: 2025-12-26 @ 12:25 AM
NCT ID: NCT02943460
Description: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: Blinded Phase: First dose date up to last dose date plus 30 days (Up to 17 weeks); OLE Phase: First dose date up to last dose date plus 30 days (Up to 102 weeks)
Study: NCT02943460
Study Brief: Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cilofexor 100 mg (Blinded Phase) Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily with food for up to 12.6 weeks 0 None 3 22 18 22 View
Cilofexor 30 mg (Blinded Phase) Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily with food for up to 12.7 weeks 0 None 0 20 14 20 View
Placebo (Blinded Phase) Placebo to match cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily with food for up to 12.3 weeks 0 None 0 10 10 10 View
Cilofexor 100 mg (Open Label Extension Phase) Following the Blinded Phase, eligible participants received cilofexor 100 mg tablet orally once daily for an additional up to 97.4 weeks 0 None 10 47 41 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Cholangitis sclerosing SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Organising pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Faeces pale SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Noninfective sialoadenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pouchitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Tongue disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatitis cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Stoma site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Benign neoplasm of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Haemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Melanocytic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Seborrhoeic keratosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View