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 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT02493660
Description: The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Frequency Threshold: 1
Time Frame: Collected over 12 months and 24 months visit.
Study: NCT02493660
Study Brief: A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tendon Repair Arthroscopic partial repair of rotator cuff Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff 1 None 22 91 69 91 View
InSpace Implantation Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system 0 None 22 93 67 93 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
eg. Pain or inflammation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders System Organ Class View
eg. dizziness, Aphasia, Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders System Organ Class View
eg.Prostate cancer, leukemia, Parathyroid tumor NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class View
eg. Multi-vessel Coronary Artery Disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders System Organ Class View
eg.Laryngeal granuloma, Chronic obstructive pulmonary disease, pulmonary mass NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders System Organ Class View
eg. Gastrointestinal haemorrhage, short-bowel syndrome, small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders System Organ Class View
eg. Event leading to Death, non-cardiac chest pain, surgical failure NON_SYSTEMATIC_ASSESSMENT General disorders System Organ Class View
Angina Pectoris (Chest pain-Cardiac) SYSTEMATIC_ASSESSMENT Cardiac disorders System Organ Class View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders System Organ Class View
Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders System Organ Class View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain, Local swelling NON_SYSTEMATIC_ASSESSMENT General disorders System Organ Class View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders System Organ Class View
Musculoskeletal pain, Arthralgia, back pain (anywhere in body) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders System Organ Class View
Fall and injury, meniscus injury, Tendon rupture (anywhere in body) NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications System Organ Class View
UTI, Bronchitis, pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations System Organ Class View
Headache, dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders System Organ Class View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders System Organ Class View
Squamous cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders System Organ Class View
Pre-Ventricular Contractions NON_SYSTEMATIC_ASSESSMENT Cardiac disorders System Organ Class View