Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:15 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT01681004
Description: None
Frequency Threshold: 5
Time Frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
Study: NCT01681004
Study Brief: Investigation of Sacroiliac Fusion Treatment (INSITE)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
iFuse Implant System Surgical placement of iFuse implants in the affected SI joint iFuse Implant System: Placement of iFuse implant system via surgery 1 None 38 102 69 102 View
Non-Surgical Management This arm includes all subjects randomized to NSM followed to 6 months Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation. 1 None 12 46 35 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Osteoarthritis of the knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Meniscal tear SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Contralateral SIJ pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Degenerative disease - spine SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ankle fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Disc herniation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rotator cuff tear SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ipsilateral - SIJ pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis of the hip SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Avascular necrosis of left hip SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip revision SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Restrolisthesis T12-L1 SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fracture - tibia / fibula SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Labral tear & ilium fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Snapping scapula syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wound hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Revision - SIJ pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Revision - neuropathy SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neuropathy - Resolved with revision SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Atrial fibrillation / respira failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction - fatal SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bowel obstruct, leading to surgery SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
S1 neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Biliary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Benign prostatic hypertrophy SYSTEMATIC_ASSESSMENT General disorders None View
Dysfunctional uterine bleeding SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Kidney disfunction due to nsaid SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Degenerative disease - spine SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
SIJ pain - ipsilateral SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
SIJ pain - contralateral SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Trochanteric bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View