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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:04 AM
NCT ID: NCT01001494
Description: None
Frequency Threshold: 5
Time Frame: 24 Weeks
Study: NCT01001494
Study Brief: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo via inhalation None None 15 273 56 273 View
Aclidinium Bromide 200 μg Bid Aclidinium bromide 200 μg twice-daily via inhalation None None 12 277 44 277 View
Aclidinium Bromide 400 μg Bid Aclidinium bromide 400 μg twice-daily via inhalation None None 15 269 38 269 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.1) View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.1) View
Acute Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.1) View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Cardiac discomfort SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Left vetricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Ligament ruptures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.1) View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.1) View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.1) View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.1) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Bladder transitional cell carcinoma stage III SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.1) View
Mycosis fungoides SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.1) View
Benign lung neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.1) View
Pancreatic neuroendocrine tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.1) View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.1) View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.1) View
Invertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.1) View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.1) View
Aortis stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.1) View
Subclavian atery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.1) View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.1) View
Demyelinating polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.1) View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (13.1) View
Mixed deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (13.1) View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (13.1) View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (13.1) View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (13.1) View
Erythema nodosum SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chronic obstructivce pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View