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 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT01680458
Description: The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT01680458
Study Brief: Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluconazole Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert. None None 2 27 9 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Oral disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Liver disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Catheter site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Mucous membrane disorder NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Graft versus host disease NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.0 View
Feeding disorder neonatal NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Capillary leak syndrome NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View