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 @ 7:51 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT04997304
Description: Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
Frequency Threshold: 5
Time Frame: Up to 1 year
Study: NCT04997304
Study Brief: Teva Asthma Predictive Analytics Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Not Using Either AirDuo or ProAir Participants used neither inhaler during the course of the trial. 1 None 5 16 7 16 View
After Using AirDuo Data reflects participants who experienced an AE within 1 month of using the AirDuo. 0 None 0 84 7 84 View
After Using ProAir Data reflects participants who experienced an AE within 1 month of using the ProAir. 73 participants used ProAir at all during the trial. 0 None 2 73 1 73 View
After Using Both AirDuo and ProAir Data reflects participants who experienced an AE within 1 month of using both AirDuo and ProAir inhalers together.73 participants used both AirDuo and ProAir during the trial. 0 None 8 73 18 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lung Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tremors & Generalized Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Influenza A SYSTEMATIC_ASSESSMENT Infections and infestations None View
Covid 19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Adrenal Crisis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Graham Negative Rod Bacteremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Asthma Exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Post-surgical low oxygen SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Covid 19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View