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: 2025-12-25 @ 1:32 AM
Ignite Modification Date: 2025-12-25 @ 11:45 PM
NCT ID: NCT01197794
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01197794
Study Brief: Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic 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
AZD1981 400 mg AZD1981 400 mg twice daily None None 0 164 12 164 View
AZD1981 200 mg AZD1981 200 mg once daily None None 1 159 23 159 View
AZD1981 100 mg AZD1981 100 mg twice daily None None 3 164 22 164 View
AZD1981 80 mg AZD1981 80 mg once daily None None 1 164 21 164 View
AZD1981 40 mg AZD1981 40 mg twice daily None None 0 163 20 163 View
AZD1981 10 mg AZD1981 10 mg twice daily None None 0 163 32 163 View
Placebo Placebo None None 1 163 21 163 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ankle Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Vasculitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.1 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Inguinal Hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Rhinitis Allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View