TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03053492

Adverse event: Visit to ER Unrelated to Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Fall Unrelated to Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk
Study: NCT03054064

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient was admitted to hospital for urinary retention that was resolved with foley catheter. Adverse Event determined to be unrelated to study and device.Subject withdrew from study.
Frequency: 1 affected / 48 at risk

Adverse event: High blood pressure
Serious: yes
Organ System: General disorders
Notes: Patient came to first Indego session and had BP 180/125. Patient admitted to hospital and they indicated that they forgot to take their BP medication that morning. Adverse Event determined to be unrelated to study/device. Subject withdrew from study.
Frequency: 1 affected / 48 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: General disorders
Notes: Patient was admitted to hospital for lower extremity deep vein thrombosis after being consented for study but before beginning first session. Adverse Event determined to be unrelated to study and device. Subject withdrew from study.
Frequency: 1 affected / 48 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 48 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: Patient noted posterior loss of balance falling after attempting to retrieve pillow off ground at home while gripping walker. Determined to be unrelated to study and device.
Frequency: 1 affected / 48 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject had skin abrasion from personal AFO use on left lateral calf. Area did not come in contact with Indego and was present prior to use.
Frequency: 1 affected / 48 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Additional areas of breakdown and blisters from subject's personal AFO developed over the weekend (between Indego sessions).
Frequency: 1 affected / 48 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: Patient reported fall out of wheelchair. Determined to be unrelated to study and device.
Frequency: 1 affected / 48 at risk

Adverse event: Change in status
Serious: no
Organ System: General disorders
Notes: Patient had been consented for study but upon arriving for first session subject had poor verbal responsiveness with increased pushing behavior. Change in status determined to be unrelated to study and device. Subject withdrew from study.
Frequency: 1 affected / 48 at risk
Study: NCT03054428

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 85 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 85 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 85 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 85 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 83 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 83 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 83 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 83 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 82 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 82 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 82 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 82 at risk
Study: NCT03054506

Adverse event: Constipation and back pain caused by constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Subject experienced several bowel movements per day coupled with a sense of urgency, but never able to have a complete bowel movement. Subject also developed back pain attributed to constipation.
Frequency: 1 affected / 20 at risk
Study: NCT03054649

Adverse event: Eye complication associated with device
Serious: yes
Organ System: General disorders
Notes: Implantation attempted but discontinued due to capsular instability.
Frequency: 1 affected / 27 at risk
Study: NCT03054844

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk
Study: NCT03054857

Adverse event: dysrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 49 at risk

Adverse event: Cerebrovascular events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: dysrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 50 at risk
Study: NCT03054870

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 210 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 210 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk
Study: NCT03055195

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Staphylococcal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Skin plaque
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk
Study: NCT03055624

Adverse event: Dysuria
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Patient experienced painful urination 1.5 days after the procedure. Symptom resolved without treatment.
Frequency: 1 affected / 9 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: Patient experienced urinary retention after the procedure requiring temporary catheter placement.
Frequency: 1 affected / 9 at risk

Adverse event: Skin wound
Serious: no
Organ System: Renal and urinary disorders
Notes: Patient experienced a penile skin wound after treatment.
Frequency: 1 affected / 9 at risk
Study: NCT03055832

Adverse event: Other
Serious: no
Organ System: Eye disorders
Notes: Includes: burning sensation, itching, stinging, petechial hemorrhage, superficial punctate keratitis, and blurred vision
Frequency: 5 affected / 71 at risk

Adverse event: Other
Serious: no
Organ System: Eye disorders
Notes: Includes: burning sensation, itching, stinging, petechial hemorrhage, superficial punctate keratitis, and blurred vision
Frequency: 4 affected / 71 at risk
Study: NCT03055988

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 70 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Osteoporotic fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 74 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 74 at risk
Study: NCT03056157

Adverse event: Right small toe was amputated due to an infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Increase in psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 89 at risk

Adverse event: Hospitalization due to hypertension/elevated heart rate
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization due to hypertension/elevated heart rate. Hx of high BP \& other physical health concerns noted in chart. Issue ongoing as of 9/30/2019
Frequency: 1 affected / 85 at risk

Adverse event: Pt relapsed on alcohol and self-admitted to a 30-day rehabilitation program
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 85 at risk

Adverse event: Increase in psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 85 at risk
Study: NCT03056300

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Chylothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 50 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pulmonary air leakage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Subcutaneous emphysema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk
Study: NCT03056352

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk
Study: NCT03056443

Adverse event: Readmission
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Readmission
Serious: yes
Organ System: General disorders
Notes: Morphine Overdose
Frequency: 1 affected / 13 at risk
Study: NCT03056456

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 24 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 24 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 24 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 24 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 24 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 24 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 24 at risk

Adverse event: Cold sweat
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 24 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 24 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 24 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 24 at risk

Adverse event: Cold sweat
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk
Study: NCT03056638

Adverse event: Cardiac disorders - Other, specify
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk
Study: NCT03056690

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 94 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 94 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 94 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 94 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 94 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 94 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 94 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 90 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 90 at risk
Study: NCT03057431

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 102 at risk

Adverse event: New onset diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 102 at risk

Adverse event: New onset diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 105 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 108 at risk

Adverse event: New onset diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 108 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 101 at risk

Adverse event: New onset diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 101 at risk
Study: NCT03057496

Adverse event: Minor contact with object in the environment
Serious: no
Organ System: General disorders
Notes: A minor contact, brushing against or bumping into an object (e.g., bushes, overhanging branches) in the environment when walking
Frequency: 6 affected / 36 at risk
Study: NCT03057847

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Haematochezia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Teeth sensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk
Study: NCT03058146

Adverse event: Non serious adverse event
Serious: no
Organ System: Renal and urinary disorders
Notes: Participant had to undergo emergency surgery for a renal/urinary issue. Unrelated to the study
Frequency: 1 affected / 21 at risk

Adverse event: Non serious adverse event
Serious: no
Organ System: Eye disorders
Notes: Participant reported experiencing blurry vision while at home. Not study related.
Frequency: 1 affected / 21 at risk

Adverse event: Non serious adverse event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain during treadmill walking at home.
Frequency: 1 affected / 21 at risk

Adverse event: Non serious adverse event
Serious: no
Organ System: Social circumstances
Notes: Participant tripped and scraped leg.
Frequency: 1 affected / 22 at risk

Adverse event: Non serious adverse event
Serious: no
Organ System: Social circumstances
Notes: Tripped during treadmill test.
Frequency: 1 affected / 22 at risk