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 @ 2:51 AM
Ignite Modification Date: 2025-12-26 @ 1:32 AM
NCT ID: NCT01222533
Description: None
Frequency Threshold: 5
Time Frame: 4 weeks + 30 days if in last period
Study: NCT01222533
Study Brief: Tiotropium Respimat Pharmacokinetic Study in COPD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tio R1.25 Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning None None 2 147 11 147 View
Tio R2.5 Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning None None 0 145 4 145 View
Placebo Matching Placebo once daily (qd) delivered by the Respimat inhaler None None 3 147 20 147 View
Tio R5 Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning None None 3 150 16 150 View
Tio HH18 Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning None None 2 146 10 146 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis ischaemic None Gastrointestinal disorders MEDDRA 15.0 View
Haemorrhoidal haemorrhage None Gastrointestinal disorders MEDDRA 15.0 View
Pancreatitis None Gastrointestinal disorders MEDDRA 15.0 View
Infective exacerbation of chronic obstructive airways disease None Infections and infestations MEDDRA 15.0 View
Pneumonia None Infections and infestations MEDDRA 15.0 View
Tendon rupture None Injury, poisoning and procedural complications MEDDRA 15.0 View
Spinal column stenosis None Musculoskeletal and connective tissue disorders MEDDRA 15.0 View
Prostate cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.0 View
Cerebrovascular accident None Nervous system disorders MEDDRA 15.0 View
Azotaemia None Renal and urinary disorders MEDDRA 15.0 View
Renal tubular necrosis None Renal and urinary disorders MEDDRA 15.0 View
Chronic obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders MEDDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 15.0 View