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 @ 7:02 PM
Ignite Modification Date: 2025-12-25 @ 4:35 PM
NCT ID: NCT01334957
Description: None
Frequency Threshold: 3
Time Frame: During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Study: NCT01334957
Study Brief: Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intravenous Ibuprofen Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes None None 8 300 49 300 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Airway Complication Of Anaesthesia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.0) View
Oxygen Saturation Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (14.0) View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (14.0) View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (14.0) View
Abdominal Compartment Syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Peritoneal Adhesions NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Bile Duct Stone NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (14.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infusion Site Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Anaemia Postoperative NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.0) View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (14.0) View