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 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT02658656
Description: Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.
Frequency Threshold: 0
Time Frame: From consent to 4 month post intervention.
Study: NCT02658656
Study Brief: Powered Exoskeletons in Persons With SCI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exoskeleton + SOC Patient will receive exoskeletal-assisted walking device for in home use for 4 months ReWalk 6.0: Exoskeletal Assisted Walking Device 0 None 11 78 54 78 View
Standard of Care Patient will receive standard of care (wheelchair use) 0 None 14 83 44 83 View
Prior to Randomization Consented patients prior to randomization 2 None 27 424 86 424 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Adverse drug reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Colonoscopy NON_SYSTEMATIC_ASSESSMENT Investigations None View
Diabetic ketoacidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anaplastic large-cell lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Carpal tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle spasticity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alcohol abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Drug use disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Self-injurious ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sleep apnoea syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decubitus ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Botulinum toxin injection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Heart valve operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalisation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Medical device implantation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Penile prosthesis insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syringomyelia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Catheter site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cyst NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Granuloma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Medical device site bruise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Medical device site erythema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Medical device site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Medical device site injury NON_SYSTEMATIC_ASSESSMENT General disorders None View
Medical device site pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Medical device site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Prostate infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Autonomic dysreflexia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Burns second degree NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Buttock injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Chemical burn of skin NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nail avulsion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Product administration error NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Scratch NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tibia fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood glucose abnormal NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Colonoscopy NON_SYSTEMATIC_ASSESSMENT Investigations None View
Heart rate increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Oxygen consumption increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Scan NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Diabetic ketoacidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone infarction NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Limb discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Posture abnormal NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anaplastic large-cell lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Autonomic nervous system imbalance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Brachial plexopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Carpal tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cervical radiculopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle spasticity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychogenic seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Device malfunction NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Device occlusion NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Alcohol abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Conversion disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Drug abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nightmare NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Panic attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Self-injurious ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypertonic bladder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urine abnormality NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Prostatitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Laryngeal atrophy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decubitus ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin haemorrhage NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Apicectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Botulinum toxin injection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Breast conserving surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cyst removal NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Elective surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalisation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Incisional hernia repair NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Medical device removal NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Skin neoplasm excision NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View