TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01346085

Adverse event: Leukopenia
Serious: yes
Organ System: Immune system disorders
Frequency: 8 affected / 10 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Gastrointestinal conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: ATG reaction during third infusion
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hemorrhage/bleeding from percutaneous transhepatic portal access
Serious: no
Organ System: Surgical and medical procedures
Notes: Procedure-related adverse events included hemorrhage/bleeding from percutaneous transhepatic portal access in 6 of 20 islet infusions (30%)
Frequency: 5 affected / 10 at risk

Adverse event: Transient liver enzyme increase exceeding 5 times the baseline level
Serious: no
Organ System: Gastrointestinal disorders
Notes: Transient liver enzyme increase was always observed after each islet infusion, and in 2 out of 20 procedures (10%) the observed increase exceeded 5 times the baseline level
Frequency: 2 affected / 10 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Mouth ulcers
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 10 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 10 at risk

Adverse event: Acne or rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 10 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 10 at risk

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

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: Oral or vaginal candidiasis
Frequency: 3 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk
Study: NCT01346189

Adverse event: Pancreatic mass
Serious: yes
Organ System: Surgical and medical procedures
Notes: Follow up CT scan revealed a large pancreatic obstructing mass compressing the common bile duct. With this clinical picture, this is the most likely cause for the transaminase elevation, and not statin related, as verified by subject's PCP
Frequency: 1 affected / 346 at risk

Adverse event: Elevated Alanine Aminotransferase (ALT)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Elevated ALT lab result. ALT was determined by subject's PCP to not be study related; but rather due to methotrexate medication, which was stopped.
Frequency: 1 affected / 366 at risk
Study: NCT01346371

Adverse event: Ocular Irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 20 at risk

Adverse event: Ocular Burning
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 20 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 20 at risk

Adverse event: Cold like symptoms
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: Stomach problems
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: General eye discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Joint/muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ocular Irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ocular Burning
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 20 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 20 at risk

Adverse event: Cold like symptoms
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Stomach problems
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Bad Taste in mouth
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: General eye discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Joint/muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT01346397

Adverse event: kidney graft loss
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 85 at risk

Adverse event: patient death
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 85 at risk

Adverse event: clinical acute rejection
Serious: no
Organ System: Immune system disorders
Notes: rejection accompanied by disturbances of the kidney graft function
Frequency: 30 affected / 85 at risk

Adverse event: all rejection rate, including subclinical rejections.
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 85 at risk

Adverse event: kidney graft loss
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 85 at risk

Adverse event: patient death
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 85 at risk

Adverse event: clinical acute rejection
Serious: no
Organ System: Immune system disorders
Notes: rejection accompanied by disturbances of the kidney graft function
Frequency: 7 affected / 85 at risk

Adverse event: all rejection rate, including subclinical rejections.
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 85 at risk
Study: NCT01346475

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 44 at risk
Study: NCT01346514

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Medical Hospitalization
Serious: yes
Organ System: General disorders
Notes: Number of patients hospitalized on an acute medical unit between baseline and month 12.
Frequency: 19 affected / 91 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: Number of patients with suicide attempt between baseline and month 12
Frequency: 2 affected / 91 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Number of patients hospitalized on an acute psychiatric unit between baseline and month 12.
Frequency: 20 affected / 91 at risk

Adverse event: Inpatient Detoxification
Serious: yes
Organ System: Psychiatric disorders
Notes: Number of patients hospitalized for alcohol/drug detoxification between baseline and month 12.
Frequency: 11 affected / 91 at risk

Adverse event: Imprisonment
Serious: no
Organ System: Social circumstances
Notes: Number of patients incarcerated between baseline and month 12
Frequency: 18 affected / 91 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 90 at risk

Adverse event: Medical Hospitalization
Serious: yes
Organ System: General disorders
Notes: Number of patients hospitalized on an acute medical unit between baseline and month 12.
Frequency: 16 affected / 90 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: Number of patients with suicide attempt between baseline and month 12
Frequency: 3 affected / 90 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Number of patients hospitalized on an acute psychiatric unit between baseline and month 12.
Frequency: 8 affected / 90 at risk

Adverse event: Inpatient Detoxification
Serious: yes
Organ System: Psychiatric disorders
Notes: Number of patients hospitalized for alcohol/drug detoxification between baseline and month 12.
Frequency: 12 affected / 90 at risk

Adverse event: Imprisonment
Serious: no
Organ System: Social circumstances
Notes: Number of patients incarcerated between baseline and month 12
Frequency: 13 affected / 90 at risk
Study: NCT01346683

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk
Study: NCT01346696

Adverse event: Right femoral neck fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hepatic hilum cholangiocarcinoma
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 45 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Study implant not stable - implant lost
Serious: no
Organ System: Investigations
Notes: 4 subjects lost one of their implants due to insufficient osseointegration. Those were all lost during the healing phase, before loading of the implant.
Frequency: 4 affected / 45 at risk

Adverse event: Study implant not stable - extended healing time
Serious: no
Organ System: Investigations
Notes: 3 subjects had implants that required extended healing time in order to achieve stability.
Frequency: 3 affected / 45 at risk
Study: NCT01347008

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk
Study: NCT01347086

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk
Study: NCT01347112

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk
Study: NCT01347255

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 24 at risk
Study: NCT01347307

Adverse event: Self limiting nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Esophagitis requiring management with triple mix (Benadryl/Maalox/Lidocaine), oral steroids, Vicodin, and a soft diet, and resulted in \< 10 pound weight loss.
Frequency: 1 affected / 28 at risk

Adverse event: Self limiting nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: skin redness and peeling
Frequency: 1 affected / 28 at risk

Adverse event: mild esophagitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: esophagitis lasting less than 7 days, not interfering with eating, no or minimal intervention required
Frequency: 2 affected / 28 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: temporary increased pain at treated site
Frequency: 1 affected / 28 at risk
Study: NCT01347632

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea is commonly associated with metronidazole treatment
Frequency: 2 affected / 35 at risk
Study: NCT01347788

Adverse event: venous thromboembolic event
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: resulted in treatment discontinuation in 3 subjects
Frequency: 2 affected / 11 at risk

Adverse event: venous thromboembolic event
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: resulted in treatment discontinuation in 3 subjects
Frequency: 2 affected / 13 at risk
Study: NCT01348139

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 26 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 25 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 25 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 25 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 25 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk
Study: NCT01348165

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 10 at risk

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

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

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

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Hypervigilance
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 6 at risk

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

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT01348425

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Notes: failed hemodialysis shunt requiring revision (Due to a pre-existing condition.)
Frequency: 1 affected / 45 at risk

Adverse event: Pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: exacerbation of COPD (Due to a pre-existing condition.)
Frequency: 1 affected / 45 at risk

Adverse event: Orthopedic/vascular repair
Serious: yes
Organ System: Surgical and medical procedures
Notes: lumbar protrusion (Due to other medical problems.)
Frequency: 1 affected / 45 at risk

Adverse event: Restenosis/occlusion of study lesion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Restenosis/occlusion of non-study limb
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk
Study: NCT01348607

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT01348698

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 74 at risk
Study: NCT01348776

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Severe Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 87 at risk