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 @ 10:12 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT01006135
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT01006135
Study Brief: Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients Treated With Spiriva Treatment with 18 mcg tiotropium inhalation capsules of Spiriva None None 15 4852 0 4852 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Tongue neoplasm malignant stage unspecified SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Radiation skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Other Events(If Any):