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: 2025-12-24 @ 3:00 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT03462459
Description: None
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT03462459
Study Brief: Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium 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 125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days Placebo: Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule 2 None 10 42 42 42 View
Vancomycin 125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days Vancomycin: Vancomycin capsule, 125 mg 1 None 9 37 37 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sickle Cell Pain Crisis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED CT View
Small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Pneumonia with associated shock SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Bacteremia/Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Elevated liver function tests due to transplant SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Recurrent C difficile Infection (rCDI) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Congestive Heart Failure Exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders SNOMED CT View
Whipple Procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures SNOMED CT View
General weakness/malaise SYSTEMATIC_ASSESSMENT General disorders SNOMED CT View
Toe Infection SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Altered Mental Status SYSTEMATIC_ASSESSMENT Psychiatric disorders SNOMED CT View
Traumatic fall with sequelae SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications SNOMED CT View
Carotid endarctectomy with stents SYSTEMATIC_ASSESSMENT Vascular disorders SNOMED CT View
Peripheral autologous stem cell transplant SYSTEMATIC_ASSESSMENT Surgical and medical procedures SNOMED CT View
Sigmoid resection surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures SNOMED CT View
Vaginal Polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders SNOMED CT View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders SNOMED CT View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Fever/Flu-Like Symptoms SYSTEMATIC_ASSESSMENT General disorders SNOMED CT View
UTI SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
Joint pain and swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders SNOMED CT View
Abdominal Pain/Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Bloody stool/loose stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Bloating/flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View