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: 2025-12-26 @ 11:11 AM
Ignite Modification Date: 2025-12-26 @ 11:11 AM
NCT ID: NCT01040728
Description: None
Frequency Threshold: 5
Time Frame: 6 weeks
Study: NCT01040728
Study Brief: A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide 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
Placebo Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler. None None 5 109 8 109 View
Olo 5 mcg Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. None None 3 115 14 115 View
Olo 10 mcg Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. None None 8 113 6 113 View
Tiotropium (Tio) 18 mcg qd Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler None None 2 113 4 113 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cardiac ventricular disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Cellulitis staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Fracture displacement SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Neuroendocrine carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View