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 @ 9:43 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT00765232
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were noted during hospitalization (approximately 4 days).
Study: NCT00765232
Study Brief: Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ketorolac 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. None None 0 57 55 57 View
Placebo 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. None None 0 54 53 54 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHOART View
Monocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHOART View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHOART View
Hypochloremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHOART View
Monocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHOART View
Hypercapnia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHOART View
NPN Increased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHOART View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHOART View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHOART View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHOART View
Blood Urea Decreased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WHOART View
Lymphocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHOART View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHOART View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHOART View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHOART View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHOART View