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 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:42 AM
NCT ID: NCT02995733
Description: SAE was defined as any event that resulted in death, hospitalization, persistent/significant disability, or congenital anomaly/birth defect; or was otherwise life-threatening. Data on adverse events that resulted in hospitalization or death were obtained by participant report or site report. Adverse events were not monitored/assessed with regard to the specific Adverse Event Term.
Frequency Threshold: 0
Time Frame: From enrollment to study completion, an average of 15 months per participant.
Study: NCT02995733
Study Brief: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Provider-enhanced usual care arm; no change in asthma management 4 None 74 611 0 611 View
PARTICS addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use 3 None 75 609 0 609 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac events NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infections and infestations NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal and connective tissue disorders NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nervous system disorders NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal/urinary disorders NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Reproductive system and breast disorders NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Skin and subcutaneous tissue disorders NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Substance abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vascular disorders NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Psychiatric disorders NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Respiratory, thoracic, mediastinal disorders NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Unclassified elsewhere NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hematology/oncology NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Immune system disorders NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Metabolism and nutrition disorders NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):