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 @ 11:32 PM
Ignite Modification Date: 2025-12-25 @ 9:21 PM
NCT ID: NCT03906656
Description: For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
Frequency Threshold: 0
Time Frame: For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
Study: NCT03906656
Study Brief: Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
KAFO/SCO Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO). May also include a period of time when the C-Brace was being fabricated prior to the C-Brace home use of 3 months. KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline 0 None 10 102 66 102 View
C-Brace Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint. 2 None 6 88 57 88 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholecystolithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hip Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nasal septum deviation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hand operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Systemic scleroderma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Increased fall frequency SYSTEMATIC_ASSESSMENT General disorders Sponsor View
Swelling of legs SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Immunodeficiency syndromes SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Multiple sclerosis aggravated SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Psoriasis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cold symptoms SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Flu SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Klebsiella Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Stomach Virus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Injurious Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Sponsor View
Open Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tendon injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ankle sprain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fibula Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Foot Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint Swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Juvenile idiopathic arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Leg Cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in hip SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in leg SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in toe SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Patella Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Post polio syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Shoulder Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Additional strap necessary SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Alignment Issue SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Battery holder defect SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Beeping SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Bluetooth Malfunction SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Broken Spring SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Broken Strap SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Broken foot stirrup SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Charging Malfunction SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Clicking/cracking noises SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Delamination SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Foot plate fracture SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Insufficient Padding SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Joint Malfunction SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Loose Screw SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Loss of oil SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Modified foot plate SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Poor Fit SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Service Light SYSTEMATIC_ASSESSMENT Product Issues Sponsor View
Unexpected mode switch SYSTEMATIC_ASSESSMENT Product Issues MedDRA View
Vaginal bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nail bed inflammation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin Abrasion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View