TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00781599

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 36 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 36 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 36 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 7 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: General disorders
Frequency: 9 affected / 36 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 36 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 36 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 36 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 36 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 13 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 36 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: General disorders
Frequency: 14 affected / 36 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 13 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 36 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 7 affected / 36 at risk
Study: NCT00781768

Adverse event: Viral Pneumonia/Encephalitis and fungal Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 89 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 46 affected / 89 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 34 affected / 89 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 89 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 89 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 20 affected / 89 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 89 at risk

Adverse event: Lightheartedness/dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 89 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Veno-occlusive disease of the liver
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 44 affected / 90 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 37 affected / 90 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 90 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 21 affected / 90 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 90 at risk

Adverse event: Lightheartedness/dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 90 at risk
Study: NCT00781898

Adverse event: Depression or suicidality
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 153 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 153 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 153 at risk

Adverse event: Musculoskeletal symptom
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 153 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 153 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 153 at risk

Adverse event: Opioid Withdrawal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Hospitalization Unknown
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 29 affected / 153 at risk

Adverse event: Depression or suicidality
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 155 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 155 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 155 at risk

Adverse event: Musculoskeletal symptom
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 155 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 155 at risk

Adverse event: Abscess
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 155 at risk

Adverse event: Nonfatal Overdose
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 155 at risk

Adverse event: Exacerbation of Pre-existing condition
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 155 at risk

Adverse event: Surgery for Colon Cancer
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 155 at risk

Adverse event: Any Overdose
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 155 at risk

Adverse event: Fatal Overdose
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 155 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 155 at risk
Study: NCT00781950

Adverse event: Increased Claudication
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Iliac artery stenosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Increased Numbess in Extremities
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 52 at risk

Adverse event: Increased Claudication
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 58 at risk

Adverse event: Rest Pain in Limbs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 58 at risk

Adverse event: Ulcerative Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 58 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 58 at risk
Study: NCT00782171

Adverse event: Ulcerative keratitis
Serious: yes
Organ System: Eye disorders
Notes: DUE TO PSEUDOMONAS AEGUINOSA INFECTION or PSEUDOMONAS AERGINOSA
Frequency: 1 affected / 146 at risk

Adverse event: stomach canser
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Prosthetic related complication
Serious: no
Organ System: Surgical and medical procedures
Notes: Failure, fracture, lost of provisional crown. Recementation. Excess of cement removal
Frequency: 13 affected / 146 at risk

Adverse event: Pain, discomfort
Serious: no
Organ System: General disorders
Frequency: 7 affected / 146 at risk

Adverse event: PERI - IMPLANT INFECTION
Serious: yes
Organ System: Infections and infestations
Notes: not of the study implant
Frequency: 1 affected / 134 at risk

Adverse event: Prosthetic related complication
Serious: no
Organ System: Surgical and medical procedures
Notes: Failure, fracture, lost of provisional crown. Recementation. Excess of cement removal
Frequency: 12 affected / 134 at risk
Study: NCT00782184

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 130 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 130 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT00782340

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 263 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 263 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Neurogenic bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 263 at risk

Adverse event: Ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 263 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 263 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 263 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 81 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 81 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 81 at risk
Study: NCT00782496

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 106 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 106 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 106 at risk

Adverse event: Adrenal growth
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 106 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 106 at risk

Adverse event: GI Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 106 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Eating disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 106 at risk

Adverse event: Trachial infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Mastectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 105 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Lymphadema of arm
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk
Study: NCT00782717

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Device failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 126 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 126 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 126 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 126 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Labyrnthitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 127 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 127 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 127 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 127 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 127 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 127 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 127 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 127 at risk
Study: NCT00782795

Adverse event: chronic vertigo exacerbation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: Trauma to head
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: non-specific neck swelling
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 8 at risk
Study: NCT00783224

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 143 at risk

Adverse event: Wisdom teeth removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 142 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 142 at risk
Study: NCT00783263

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 121 at risk
Study: NCT00783302

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 874 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 874 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 874 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 874 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 874 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 874 at risk
Study: NCT00783835

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 60 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 60 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 8 affected / 60 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 60 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 60 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Affect lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 60 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 60 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 60 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 60 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 60 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk
Study: NCT00783965

Adverse event: Inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: prostate cancer diagnosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: cellulitis and maxillary sinusitis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk
Study: NCT00784043

Adverse event: high fever during surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery aborted due to high fever.
Frequency: 1 affected / 31 at risk

Adverse event: Device failure due to impact
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: head trauma which led to device failure
Frequency: 1 affected / 31 at risk

Adverse event: Device failure
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Electrode failure determined by device telemetry and/or intermittent responsiveness
Frequency: 4 affected / 31 at risk

Adverse event: Changes in device telemetry
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 31 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 31 at risk
Study: NCT00784095

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: All patients in the trial were had advanced life-limiting illness. This was deemed not to be an unexpected event.
Frequency: 1 affected / 12 at risk
Study: NCT00784563

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: knee or hip pain. Resolved with rest and analgesics
Frequency: 1 affected / 38 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: knee or hip pain. Resolved with rest and analgesics
Frequency: 3 affected / 22 at risk
Study: NCT00784784

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Broken bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk