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: 2025-12-25 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:07 AM
NCT ID: NCT00746018
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT00746018
Study Brief: Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Total Hysterectomy The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices. 4 None 0 39 34 39 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Aspartate Aminotransferase (AST) Test SYSTEMATIC_ASSESSMENT Investigations None View
Alanine Aminotransferase (ALT) Test SYSTEMATIC_ASSESSMENT Investigations None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
INR SYSTEMATIC_ASSESSMENT Investigations None View
Platelets SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Bicarbonate, serum-low SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View