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 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:10 AM
NCT ID: NCT01895634
Description: None
Frequency Threshold: 5
Time Frame: 90 days post procedure
Study: NCT01895634
Study Brief: Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Intervention Device: Rev-01 Rev-01: Treatment arm patients have used Rev-01 at least once None None 16 49 47 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Burns third degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Brain stem infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Carotid artery occlusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypercapnia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Femoral artery aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haemorrhagic infarction SYSTEMATIC_ASSESSMENT Vascular disorders None View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Iliac artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral vasoconstriction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Intraoperative cerebral artery occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View