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 @ 1:00 PM
Ignite Modification Date: 2025-12-25 @ 12:19 PM
NCT ID: NCT01951261
Description: All adverse events caused the patient to be hospitalized.
Frequency Threshold: 0
Time Frame: During home follow-up until 6 months after the discharge.
Study: NCT01951261
Study Brief: Early Assisted Discharge for COPD Exacerbations With Telemonitoring.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Telemonitoring and Telephone Control Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits. Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist. 1 None 2 58 0 58 View
Home Care Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits). 0 None 2 58 0 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
rapid atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
necrotizing pneumonia. NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pain secondary to vertebral crushing NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):