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 @ 5:04 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT03028350
Description: The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
Frequency Threshold: 3
Time Frame: Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
Study: NCT03028350
Study Brief: Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
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 Oral Capsule Oral placebo daily for 8 weeks Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks 0 None 0 29 11 29 View
Ifetroban Oral Capsule Oral ifetroban, 200 mg daily for 8 weeks Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks 0 None 1 25 7 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View