TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01864174

Adverse event: Hypocoagulable state
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 283 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 283 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 283 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 283 at risk

Adverse event: Delayed recovery from anaesthesia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 283 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 283 at risk

Adverse event: Malignant melanoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 283 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 283 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 283 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 283 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 285 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 285 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 285 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 285 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 285 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 285 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 285 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 285 at risk

Adverse event: Prostatic adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 285 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 285 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 285 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 285 at risk
Study: NCT01864200

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 45 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Venom poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk
Study: NCT01864291

Adverse event: Device failure
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 9 at risk

Adverse event: no auditory perception
Serious: yes
Organ System: Product Issues
Notes: no auditory perception at awake activation
Frequency: 2 affected / 9 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: admitted to hospital for management of symptoms
Frequency: 2 affected / 9 at risk

Adverse event: oxygen desaturation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: oxygen desaturation in PICU treated with steroids, one case associated with reactive airway disease
Frequency: 2 affected / 9 at risk

Adverse event: upper respiratory infection with shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: incidental finding per pre-op labs
Frequency: 1 affected / 9 at risk

Adverse event: post-intubation airway edema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2-3cm right heel blister
Frequency: 1 affected / 9 at risk

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

Adverse event: swelling after fall
Serious: no
Organ System: General disorders
Notes: fell out of crib, developed swelling that later resolved
Frequency: 1 affected / 9 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: post-surgical pain
Frequency: 1 affected / 9 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: postoperative edema
Serious: no
Organ System: General disorders
Notes: Fluid accumulation around incision site
Frequency: 1 affected / 9 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Bruxism
Serious: no
Organ System: General disorders
Notes: increase in grinding teeth while using the device
Frequency: 1 affected / 9 at risk

Adverse event: ear drainage
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 9 at risk
Study: NCT01864525

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk
Study: NCT01864564

Adverse event: Fetal or Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 463 at risk

Adverse event: Other - Preterm Delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Preterm delivery
Frequency: 1 affected / 463 at risk

Adverse event: Fetal or Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 22 affected / 459 at risk
Study: NCT01865448

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation, vomiting, diarrhea, stomachache, heartburn
Frequency: 7 affected / 17 at risk

Adverse event: Musculokeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle pain, bone pain, muscular weakness
Frequency: 2 affected / 17 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Halitosis, asthenia, heaviness, tiredness, cramps, hyperuricemia
Frequency: 2 affected / 17 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hypotension
Frequency: 2 affected / 17 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Hair loss, urticaria
Frequency: 1 affected / 17 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation, vomiting, diarrhea, stomachache, heartburn
Frequency: 7 affected / 17 at risk

Adverse event: Musculokeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle pain, bone pain, muscular weakness
Frequency: 1 affected / 17 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Halitosis, asthenia, heaviness, tiredness, cramps, hyperuricemia
Frequency: 6 affected / 17 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Hair loss, urticaria
Frequency: 3 affected / 17 at risk

Adverse event: Nervous System disorders
Serious: no
Organ System: Nervous system disorders
Notes: Cephalea, migraine, headache effort
Frequency: 2 affected / 17 at risk
Study: NCT01865708

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Microscopic hematuria (\>100 RBC/HPF) detected by lab analysis of urine specimen.
Frequency: 4 affected / 10 at risk
Study: NCT01866150

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

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

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk
Study: NCT01866163

Adverse event: Substance induced psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 323 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 323 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 323 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 3 affected / 323 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 323 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 323 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 323 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 323 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 2 affected / 103 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Streptococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Application site erosion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Application site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Angioedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk
Study: NCT01866592

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 81 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 81 at risk
Study: NCT01866709

Adverse event: Prolonged QT Interval
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: ST elevation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

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

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

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk
Study: NCT01867008

Adverse event: Irregular heartbeat
Serious: yes
Organ System: Cardiac disorders
Notes: Admitted overnight for irregular heartbeat
Frequency: 1 affected / 55 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Vertigo or dizziness
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Vertigo started 1 day post-op after discharged from surgery. Admitted for observation and provided steroids.
Frequency: 1 affected / 55 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Admitted to hospital for atrial fibrillation. Discharged without further episodes.
Frequency: 1 affected / 55 at risk

Adverse event: Revision surgery
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 55 at risk

Adverse event: New or worsened tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 55 at risk

Adverse event: Vertigo or dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 55 at risk

Adverse event: Skin flap
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 55 at risk

Adverse event: Device related/programming problems
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 55 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 55 at risk

Adverse event: Earmold or acoustic component sores
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 14 affected / 55 at risk
Study: NCT01867164

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

Adverse event: Fungal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk
Study: NCT01867242

Adverse event: Hospitalisation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Auto accident unrelated to study product
Frequency: 1 affected / 64 at risk

Adverse event: Hearburn/reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Gum sensitivity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 64 at risk

Adverse event: Hearburn/reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gum sensitivity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk
Study: NCT01867424

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT01868243

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Ischemic Stroke
Frequency: 1 affected / 15 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal bleeding
Frequency: 1 affected / 15 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal bleeding
Frequency: 1 affected / 12 at risk
Study: NCT01868425

Adverse event: Light Headed After Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 57 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk
Study: NCT01868503

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fever-Possible sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 7 at risk
Study: NCT01868542

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 23 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 23 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 23 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk
Study: NCT01869348

Adverse event: Exostosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Stitches to hand
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nerve damage during blood draw
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Asthenia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk
Study: NCT01869491

Adverse event: Gastro-oesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 549 at risk
Study: NCT01869686

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 12 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 12 at risk