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 @ 12:38 PM
Ignite Modification Date: 2025-12-25 @ 12:12 PM
NCT ID: NCT04353661
Description: None
Frequency Threshold: 5
Time Frame: Baseline up to Week 48
Study: NCT04353661
Study Brief: A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A - SOC + Azithromycin Participants received azithromycin and SOC theraphy for 52 weeks. 0 None 1 3 3 3 View
Cohort A - SOC Participants received SOC theraphy for 52 weeks 0 None 2 5 5 5 View
Cohort B - SOC Participants received SOC theraphy for 52 weeks. 0 None 2 4 2 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra 26.0 View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra 26.0 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 26.0 View
Subcutaneous emphysema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Medra 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoacusis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Medra 26.0 View
Thyroid mass NON_SYSTEMATIC_ASSESSMENT Endocrine disorders Medra 26.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medra 26.0 View
Benign lung neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medra 26.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 26.0 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 26.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 26.0 View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 26.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 26.0 View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Medra 26.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View