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 @ 1:04 PM
Ignite Modification Date: 2025-12-25 @ 12:20 PM
NCT ID: NCT04179461
Description: Review for possible adverse events was completed at study visits and follow-up phone calls by the research coordinator. If adverse events were identified, they were documented on the Adverse Event Reporting Form and reviewed at the meeting of the Steering committee.
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT04179461
Study Brief: Personalized Treatment Algorithms for Difficult-to-treat 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
Personalized Treatment Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention. Cholecalciferol: Oral administration antihistamine: Oral administration Azithromycin: Oral administration emollient cream: Topical Fluticasone Propionate: Nasal spray Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan. 0 None 1 21 12 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Major Depressive Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychiatric Evaluation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Asthma Exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ankle Injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Streptococcal Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View