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: 2025-12-26 @ 10:19 PM
Ignite Modification Date: 2025-12-26 @ 10:19 PM
NCT ID: NCT03622112
Description: An AE was the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition could be symptoms (e.g: nausea, chest pain), signs (e.g: tachycardia, enlarged liver) or abnormal results of an investigation (e.g., laboratory findings, electrocardiogram). SAEs were recorded from the time of informed consent.
Frequency Threshold: 5
Time Frame: From Screening to follow-up period (7 to 10 days after visit 7), maximum up to 1 year.
Study: NCT03622112
Study Brief: A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD7594 50 μg Oral inhalation of AZD5794 55 microgram/ 50 microgram (nominal dose/delivered dose) once daily. 0 None 0 110 14 110 View
AZD7594 90 μg Oral inhalation of AZD5794 99 microgram/ 90 microgram (nominal dose/delivered dose) once daily. 0 None 3 112 15 112 View
AZD7594 180 μg Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily. 0 None 1 111 8 111 View
AZD7594 360 μg Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. 1 None 3 113 14 113 View
AZD7594 720 μg Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. 0 None 3 134 8 134 View
Placebo to AZD7594 Oral inhalation of placebo to AZD7594 once daily. 0 None 0 113 24 113 View
Fluticasone Furoate Oral inhalation of fluticasone furoate 100 microgram once daily. 0 None 1 112 11 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cholecystitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal compression fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View