TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01291277

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Per the study design, this predefined outcome that we collected and reported was the serious adverse event of hospitalization (not specific etiologies).
Frequency: 16 affected / 45 at risk

Adverse event: Esophageal
Serious: no
Organ System: Gastrointestinal disorders
Notes: This predefined outcome included any of the esophageal symptoms of dysphagia, odynophagia, and/or chest pain (a composite endpoint).
Frequency: 4 affected / 45 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Per the study design, this predefined outcome that we collected and reported was the serious adverse event of hospitalization (not specific etiologies).
Frequency: 15 affected / 45 at risk

Adverse event: Esophageal
Serious: no
Organ System: Gastrointestinal disorders
Notes: This predefined outcome included any of the esophageal symptoms of dysphagia, odynophagia, and/or chest pain (a composite endpoint).
Frequency: 1 affected / 45 at risk
Study: NCT01291784

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: This event was deemed to not be drug related. Participant progressed to MF
Frequency: 1 affected / 1 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

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

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

Adverse event: Herpes zoster
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1 at risk
Study: NCT01292057

Adverse event: Trouble sleeping
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 47 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 47 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 47 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 47 at risk

Adverse event: Trouble concentrating
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 47 at risk

Adverse event: Feeling depressed
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Low energy
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 47 at risk

Adverse event: Libido increased
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 47 at risk

Adverse event: Decreased libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 47 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 48 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 48 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 48 at risk

Adverse event: Trouble concentrating
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 48 at risk

Adverse event: Feeling depressed
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 48 at risk

Adverse event: Libido increased
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 48 at risk
Study: NCT01292070

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk
Study: NCT01292187

Adverse event: Neoplasms benign, malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Malignant melanoma/ Melanoma On Left Eyelid
Frequency: 3 affected / 86 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Laceration/ Cranial Laceration
Frequency: 2 affected / 86 at risk

Adverse event: Hepatitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Acute Hepatitis
Frequency: 1 affected / 86 at risk

Adverse event: Pericardial effusions
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Intermittent Fever
Frequency: 1 affected / 86 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 86 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 86 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 86 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 86 at risk

Adverse event: Neoplasms benign, malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Malignant melanoma/ Melanoma On Left Eyelid
Frequency: 2 affected / 43 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 43 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk
Study: NCT01292252

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: rapid heart
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: infection of surgical site
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 15 at risk

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

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

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

Adverse event: pain and burning at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: altered mental state
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk
Study: NCT01292265

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT01292447

Adverse event: Acute complication
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 73 at risk

Adverse event: Acute complication
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 72 at risk
Study: NCT01292486

Adverse event: Fever and hypotension
Serious: yes
Organ System: Infections and infestations
Notes: Blood cultures were negative but patient was hospitalized for antibiotic administration. Patient recovered and event judged to unrelated to the device.
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonia/Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Required inpatient hospitalization and antibiotics. Patient recovered. Unrelated to the device.
Frequency: 1 affected / 30 at risk

Adverse event: Citrate toxicity
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Fever post ahpheresis, pre-apheresis and product cultures negative.Patient recovered.Unrelated to the device.

Fever/chills post apheresis, preapheresis blood culture positive.Patient recovered.Unrelated to the device.
Frequency: 2 affected / 30 at risk
Study: NCT01292798

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk
Study: NCT01292837

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 13 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Pneumonia mycoplasmal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Subcutaneous haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Bradykinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Respiratory tract haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Excessive granulation tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk
Study: NCT01293006

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

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Atrioventricular block second degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk
Study: NCT01293396

Adverse event: Mild Hypoglycaemic Event
Serious: no
Organ System: Endocrine disorders
Notes: Hypoglycaemic events blood glucose levels \<70mg/dL
Frequency: 1 affected / 20 at risk

Adverse event: Mild Hypoglycaemic Event
Serious: no
Organ System: Endocrine disorders
Notes: Hypoglycaemic events blood glucose levels \<70mg/dL
Frequency: 2 affected / 20 at risk

Adverse event: Moderate Hypoglycaemic Event
Serious: no
Organ System: Endocrine disorders
Notes: Hypogylcaemic Event \<54mg/dL
Frequency: 1 affected / 20 at risk

Adverse event: Mild Hypoglycaemic Event
Serious: no
Organ System: Endocrine disorders
Notes: Hypoglycaemic events blood glucose levels \<70mg/dL
Frequency: 2 affected / 20 at risk
Study: NCT01293539

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: Eye-disorder, Grade 1
Frequency: 2 affected / 10 at risk

Adverse event: Retinal vascular disorder
Serious: yes
Organ System: Eye disorders
Notes: Eye-disorder, Grade 2
Frequency: 1 affected / 10 at risk

Adverse event: Retinal vascular disorder
Serious: yes
Organ System: Eye disorders
Notes: Eye-disorder, Grade 3
Frequency: 1 affected / 10 at risk

Adverse event: Eyelid edema & erythema
Serious: no
Organ System: Eye disorders
Notes: Eyelid disorder, Grade 1
Frequency: 1 affected / 10 at risk

Adverse event: Eyelid function disorder
Serious: no
Organ System: Eye disorders
Notes: Eye disorder, Grade 1
Frequency: 1 affected / 10 at risk

Adverse event: Injury - cut to lip during play
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Injury, Grade 2
Frequency: 1 affected / 10 at risk

Adverse event: Eyelid function disorder
Serious: no
Organ System: Eye disorders
Notes: Eye disorder, Grade 2
Frequency: 1 affected / 10 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Eye disorder, Grade 1
Frequency: 1 affected / 10 at risk

Adverse event: Mild swelling
Serious: no
Organ System: Eye disorders
Notes: Eye disorders, other, Grade 1
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, Grade 1
Frequency: 2 affected / 10 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Conjunctivitis, Grade 2
Frequency: 1 affected / 10 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Flu-like symptoms, Grade 2
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, Grade 2
Frequency: 2 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting, Grade 1
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever, Grade 2
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever, Grade 1
Frequency: 1 affected / 10 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Otitis media, Grade 2
Frequency: 1 affected / 10 at risk
Study: NCT01293682

Adverse event: Hypercalcaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 12 at risk
Study: NCT01293695

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: mild skin irritation from the skin conductance monitor electrode adhesive, requiring no medical intervention to resolve.
Frequency: 13 affected / 93 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: mild skin irritation from the skin conductance monitor electrode adhesive, requiring no medical intervention to resolve.
Frequency: 12 affected / 94 at risk
Study: NCT01293825

Adverse event: Rashes
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 30 at risk

Adverse event: High Blood Glucose
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Swollen Tongue and Facial Distortion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Car Accident
Serious: yes
Organ System: General disorders
Notes: Participant passed out while driving. The accident may have been related to new-onset elevated blood pressure.
Frequency: 1 affected / 30 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Notes: Participant fell down stairs while carrying dishes. Hospitalized with internal bleeding and a ruptured spleen.
Frequency: 1 affected / 30 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Participant reported having had recurrent abdominal pain for many years. Sought treatment in December 2011 and was found to have gallstones.
Frequency: 1 affected / 30 at risk
Study: NCT01294046

Adverse event: Infection and surgical explant
Serious: yes
Organ System: Nervous system disorders
Notes: Infection and surgical explant
Frequency: 1 affected / 1 at risk
Study: NCT01294241

Adverse event: Wound area increased due to trauma/wound dressing change
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 10 at risk

Adverse event: Wound infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk
Study: NCT01294267

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: death from any cause
Frequency: 2 affected / 20 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: hospitalization for any cause, within 30 days
Frequency: 5 affected / 20 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: an absolute increase in serum creatinine of ≥0.3 mg/dL or percentage increase of 150%-200% from baseline), and all resolved within 72 hours
Frequency: 3 affected / 20 at risk
Study: NCT01294384

Adverse event: Meniere's disease
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 102 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 102 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 101 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk
Study: NCT01294423

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 86 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 86 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 88 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Putamen haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 87 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 87 at risk