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 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:43 PM
NCT ID: NCT02085551
Description: None
Frequency Threshold: 0
Time Frame: up to 24 hours after procedure.
Study: NCT02085551
Study Brief: Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
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 by the Indigo System Mechanical Thrombectomy by the Indigo System 0 None 15 85 27 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal Compartment Syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Leg Amputation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Intestinal Ischaemia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pulseless Electrical Activity NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Renal Failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Systemic Inflammatory Response Syndrome NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Vascular Pseudoaneurysm Ruptured NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vessel Puncture Site Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Compartment Syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Clostridium Difficule Colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fluid Overload NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gastrointestinal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematuria NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Heparin-Induced Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Intestinal Ischaemia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Leg Amputation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Mental Status Changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulseless Electrical Activity NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Renal Failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Failure Acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Shock NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Systemic Inflammatory Response Syndrome NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vascular Pseudoaneurysm Ruptured NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vasospasm NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vessel Puncture Site Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Visual Impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders None View