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 @ 4:25 PM
Ignite Modification Date: 2025-12-25 @ 2:19 PM
NCT ID: NCT01395966
Description: Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
Frequency Threshold: 0
Time Frame: During all the study (22 days)
Study: NCT01395966
Study Brief: Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DF289 Plus DF277 Ear drops DF289 plus DF277: Ear drops None None 0 113 7 113 View
DF289 Ear drops DF289: Ear drops None None 0 108 4 108 View
DF277 Ear drops DF277: Ear drops None None 0 106 9 106 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA 13.0 View
otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedRA 13.0 View
ear canal erythema SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedRA 13.0 View
ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedRA 13.0 View
ear haemorrahage SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedRA 13.0 View
otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedRA 13.0 View
otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedRA 13.0 View
otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedRA 13.0 View
excessive granulation tissue SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA 13.0 View
auricular swelling SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedRA 13.0 View
rash SYSTEMATIC_ASSESSMENT Infections and infestations MedRA 13.0 View
ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedRA 13.0 View
ear infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedRA 13.0 View
dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA 13.0 View