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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT03898960
Description: Safety set included all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device).
Frequency Threshold: 0
Time Frame: Up to Day 90
Study: NCT03898960
Study Brief: Post Marketing Study to Evaluate the NIMBUS Device
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mechanical Thrombectomy: NIMBUS Device Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device. 10 None 21 54 6 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke in evolution SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hemorrhagic transformation stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cerebral hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Ischemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Subarachnoid hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis hemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemianopia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Stroke in evolution SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Vascular access site pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View