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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:26 PM
NCT ID: NCT02034058
Description: Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Frequency Threshold: 0
Time Frame: Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure.
Study: NCT02034058
Study Brief: Post Market Surveillance Study of the Wingspan Stent 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
Stenting Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use. 3 None 9 152 12 152 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological decompensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Administration site pain SYSTEMATIC_ASSESSMENT General disorders None View
Application site haematoma SYSTEMATIC_ASSESSMENT General disorders None View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscular weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological symptom SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View