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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:09 PM
NCT ID: NCT01240356
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT01240356
Study Brief: CLOTBUST Hands-Free: A Phase I/II Pilot Safety Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase I: Healthy Volunteers Phase I - 15 non-stroke healthy volunteers. None None 0 15 0 15 View
Phase II - Ischemic Stroke Patients Phase II - 20 patient with ischemic stroke treated with IV-tPA None None 9 20 19 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intracranial hemohhrage secondary to bacterial endocarditis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Death SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral edema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia/respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stroke progression/Nuero-worsening SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fewer SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anemia/decreased hemoglobin and hematocrit SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Electrolyze imbalance SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right lung atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elevated CK SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated white blood count SYSTEMATIC_ASSESSMENT Infections and infestations None View
Utinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Asymptomatic ICH SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Elevated Coag lab test SYSTEMATIC_ASSESSMENT Nervous system disorders None View
New diagnosis of PFO SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Positive sputum culture SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View