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 @ 12:18 AM
Ignite Modification Date: 2025-12-25 @ 10:21 PM
NCT ID: NCT01697358
Description: None
Frequency Threshold: 3
Time Frame: Randomization to 6 months
Study: NCT01697358
Study Brief: Spinal Cord Stimulation for Predominant Low Back Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SCS + OMM Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group. 0 None 18 110 4 110 View
OMM Alone Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized. 0 None 7 108 11 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Implant site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Adjustment disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Drug abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Vestibular disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Implant site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Post laminectomy syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Device extrusion SYSTEMATIC_ASSESSMENT Product Issues MedDRA 19.1 View
Device stimulation issue SYSTEMATIC_ASSESSMENT Product Issues MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View