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 @ 9:06 PM
Ignite Modification Date: 2025-12-25 @ 6:57 PM
NCT ID: NCT01566604
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01566604
Study Brief: Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NVA237 NVA237 50 µg once daily delivered via a single dose dry powder inhaler None None 17 305 81 305 View
Placebo Placebo once daily delivered via a single dose dry powder inhaler None None 14 154 48 154 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders 16.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders 16.0 View
Cor pulmonale chronic SYSTEMATIC_ASSESSMENT Cardiac disorders 16.0 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders 16.0 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Death SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders 16.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Dupuytren's contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 16.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 16.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 16.0 View
Cerebral arteriosclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders 16.0 View
Thalamus haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders 16.0 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders 16.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Bronchitis chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View