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 @ 7:11 PM
Ignite Modification Date: 2025-12-25 @ 4:46 PM
NCT ID: NCT01282203
Description: None
Frequency Threshold: 0
Time Frame: Physicians reported all serious adverse events occurring during the induction, maintenance, and recovery phases of surgery until 30 days or 5 half-lives following termination of Sevorane. Mean (SD) total duration of anesthesia was 98.4 (67.2) minutes.
Study: NCT01282203
Study Brief: Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane in Adult Patients Required General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on Cardiovascular System in Common Clinical Practice
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adults Requiring Anesthesia for Surgery Adult patients requiring general anesthesia for surgery None None 4 1122 1 1122 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Post-procedural hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood pressure increased SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View