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: 2025-12-25 @ 2:29 AM
Ignite Modification Date: 2025-12-26 @ 1:04 AM
NCT ID: NCT03788434
Description: None
Frequency Threshold: 5
Time Frame: 24 weeks
Study: NCT03788434
Study Brief: Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
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 Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. 0 None 2 22 21 22 View
VE303 High Dose Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions. 0 None 1 29 28 29 View
VE303 Low Dose Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions. 0 None 4 27 27 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain Lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CDI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Escherichia Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Transfusion Reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Breast Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebrovascular Accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chronic Obstructive Pulmonary Disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain Lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Irritable Bowel Syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eructation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oedema Peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood Potassium Increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View