TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02226367

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant was psychiatrically hospitalized for suicidal ideation.
Frequency: 1 affected / 46 at risk

Adverse event: anxiety associated with occupational stressors
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant was hospitalized due to anxiety associated with occupational stressors.
Frequency: 1 affected / 46 at risk

Adverse event: dizziness on standing
Serious: no
Organ System: General disorders
Frequency: 18 affected / 46 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 24 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 46 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 22 affected / 46 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 46 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 46 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 46 at risk

Adverse event: skull fracture and subdural hematoma
Serious: yes
Organ System: General disorders
Notes: One participant randomized to placebo suffered a fractured skull and subdural hematoma resulting from a fall while alcohol intoxicated.
Frequency: 1 affected / 56 at risk

Adverse event: dizziness on standing
Serious: no
Organ System: General disorders
Frequency: 9 affected / 56 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 18 affected / 56 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 56 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 16 affected / 56 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 56 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 56 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 56 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 56 at risk
Study: NCT02226549

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

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

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 24 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk
Study: NCT02226562

Adverse event: Hyperaesthesia teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 95 at risk

Adverse event: Tooth impacted
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 95 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Traumatic ulcer
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 95 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 95 at risk

Adverse event: Mouth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 95 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 95 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 95 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hyperaesthesia teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 96 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk

Adverse event: Traumatic ulcer
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 96 at risk

Adverse event: Device failure
Serious: no
Organ System: General disorders
Frequency: 1 affected / 96 at risk
Study: NCT02226653

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 23 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 23 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 23 at risk
Study: NCT02227121

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Post-traumatic headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk
Study: NCT02227329

Adverse event: Catheter-related bloodstream infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 18 at risk

Adverse event: Catheter-related bloodstream infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk
Study: NCT02227368

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 24 at risk

Adverse event: Arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 24 at risk
Study: NCT02227394

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk
Study: NCT02227446

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 499 at risk

Adverse event: Abdominal injury
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Venous thromboembolism (VTE)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 499 at risk

Adverse event: Nonunion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 499 at risk

Adverse event: Manipulation under anesthesia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Amputation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 499 at risk

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Reaction to antibiotic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 499 at risk

Adverse event: Seizure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Thoracic injury
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 481 at risk

Adverse event: Abdominal injury
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 481 at risk

Adverse event: Venous thromboembolism (VTE)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 481 at risk

Adverse event: Nonunion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 481 at risk

Adverse event: Manipulation under anesthesia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 481 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 481 at risk
Study: NCT02227485

Adverse event: Unpleasant taste
Serious: no
Organ System: Surgical and medical procedures
Frequency: 14 affected / 36 at risk

Adverse event: Other side effects
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 36 at risk

Adverse event: Discolored
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 36 at risk

Adverse event: Unpleasant taste
Serious: no
Organ System: Surgical and medical procedures
Frequency: 15 affected / 38 at risk

Adverse event: Bad Odor
Serious: no
Organ System: Surgical and medical procedures
Notes: Bad odor of the mouth wash
Frequency: 1 affected / 38 at risk
Study: NCT02227758

Adverse event: Breakage/facture of the extension
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 112 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 112 at risk

Adverse event: IPG migration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 112 at risk

Adverse event: Infection: IPG and lead site
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Infection: lead site only
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 112 at risk

Adverse event: Lead breakage/fracture
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 112 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 112 at risk

Adverse event: persistant pain and/or numbness: IPG site only
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: persistant pain and/or numbness: lead site only
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: persistent pain at connector site
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Skin erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 112 at risk

Adverse event: Wound site complications
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 112 at risk

Adverse event: Persistent pain and/or numbness
Serious: no
Organ System: Surgical and medical procedures
Notes: For 7 patients, there were reports of persistent pain and/or numbness at the lead and/or IPG site
Frequency: 7 affected / 112 at risk
Study: NCT02227849

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 71 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 71 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 71 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 71 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 71 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 71 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 71 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 71 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 71 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 71 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 71 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 71 at risk
Study: NCT02228174

Adverse event: Deep Vein Thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 147 at risk

Adverse event: Vaginal Discharge with Overnight Hospital Stay
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 147 at risk

Adverse event: Cramping/Pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 147 at risk

Adverse event: Fibroid Shedding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 45 affected / 147 at risk

Adverse event: Genitourinary Infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 147 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 147 at risk
Study: NCT02228395

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 6 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Penis disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 9 at risk

Adverse event: Faeces hard
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 9 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk
Study: NCT02228408

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: cv hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: gi bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 7 at risk

Adverse event: vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: cv hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: av fisula thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 10 at risk

Adverse event: vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk