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 @ 4:32 PM
Ignite Modification Date: 2025-12-25 @ 2:24 PM
NCT ID: NCT03890666
Description: Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.
Frequency Threshold: 5
Time Frame: Baseline up to Week 14
Study: NCT03890666
Study Brief: A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Concurrent Control (CC) Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications. 0 None 1 166 8 166 View
Digital System (DS) Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks. 0 None 1 150 11 150 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
SARS-CoV-2 sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View