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 @ 2:05 PM
Ignite Modification Date: 2025-12-25 @ 12:48 PM
NCT ID: NCT01839695
Description: Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
Frequency Threshold: 5
Time Frame: Through 30 days
Study: NCT01839695
Study Brief: Safety and Efficacy of Valiant Mona LSA Stent Graft System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Valiant Mona LSA Stent Graft System TEVAR procedure using Medtronic Stent Graft \> \> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device None None 7 9 3 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardiovascular Deconditioning SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Abdominal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Vascular Pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Cerebellar Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hemianopia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Musculoskeletal Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Peripheral Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View