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 @ 3:02 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT01531959
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected daily from medical records for the period of study drug administration, an average of 59 hours.
Study: NCT01531959
Study Brief: Midodrine for the Treatment of Refractory Hypotension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Midodrine Midodrine: Patients will be randomized to blinded to 20 mg of midodrine 0 None 0 66 20 66 View
Placebo Placebo: Patients will be randomized to blinded placebo control 1 None 1 66 17 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myocardial infarction/ischemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lightheadedness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular ectopic beats NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Subdural hemtoma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Small bowel obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lab parameter change NON_SYSTEMATIC_ASSESSMENT Investigations None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough/dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View