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: 2025-12-24 @ 9:22 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT02436304
Description: An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study participants and as observations by the Investigator as outlined in the study protocol.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 28 days). AEs are reported as pretreatment and treatment-emergent.
Study: NCT02436304
Study Brief: Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pretreatment All who consented to participate in the study prior to randomization 0 None 0 404 2 404 View
EXE844 7 Days All participants exposed to EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion 0 None 0 153 39 153 View
EXE844 3 Days All participants exposed to EXE844 Sterile Otic Suspension, 0.3%, for 3 days after Tympanostomy Tube Insertion 0 None 0 102 19 102 View
Tubes Only All participants who underwent bilateral myringotomy and tympanostomy tube insertion only 0 None 0 101 13 101 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (18.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View