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 @ 7:04 PM
Ignite Modification Date: 2025-12-25 @ 4:37 PM
NCT ID: NCT02872857
Description: Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
Frequency Threshold: 0
Time Frame: 90 days
Study: NCT02872857
Study Brief: Subarachnoid Hemorrhage Recovery And Galantamine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Galantamine 8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days. 1 None 17 30 26 30 View
Placebo Placebo: Placebo will match drug capsules. 4 None 17 30 29 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cerebral Edema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Delayed Cerebral Ischemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Clinical Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Angio Complication SYSTEMATIC_ASSESSMENT Vascular disorders None View
Surgical Complication SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Univary Tract Infections SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Angio Complication SYSTEMATIC_ASSESSMENT Vascular disorders None View
Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Clinical Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View