TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00485472

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Liver disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 72 at risk

Adverse event: Shock hypoglycaemic
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Breast cancer in situ
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 72 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 72 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 72 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 72 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 72 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 72 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 76 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 76 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 76 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 76 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 76 at risk
Study: NCT00485485

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: PEG SITE INFECTION G3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: ANEMIA G3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Swelling G3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Thrombocytopenia (Grade 3)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Mucositis G3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dysphagia G3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Cardiovascular Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 7 at risk

Adverse event: Dermatology/Skin (Other)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 7 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Edema: Head and Neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Neutrophils (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 7 at risk
Study: NCT00486044

Adverse event: Elevated creatine kinase (CK) (> 2 times upper limit of normal)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Elevated liver transaminases (>2 times upper limit of normal)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 51 at risk

Adverse event: Mixed anxiety and depressive disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk
Study: NCT00486226

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Ischemic Stroke in a different territory than the stented one
Frequency: 1 affected / 105 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: retroperitoneal hematoma requiring additional hospitalization
Frequency: 1 affected / 105 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Notes: Left superior limb thrombophlebitis and atrial fibrillation Headache and right hemiparesis
Frequency: 1 affected / 105 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Incomplete stent thrombosis started after stent and first coil placement.
Frequency: 1 affected / 105 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Lung metastasis
Frequency: 1 affected / 105 at risk

Adverse event: Vascular stent thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 105 at risk

Adverse event: embolization/ re-embolization of non-study aneurysm
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 105 at risk

Adverse event: coil protrusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: In four subjects coil protrusion occurred before placement of the Enterprise stent and was hence not related to the device. In the remaining subject the timing of coil protrusion (before/after stent placement) was not specified by the investigator.
Frequency: 5 affected / 105 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 105 at risk

Adverse event: cholangitis with septicemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: moderate sclerosing cholangitis post cholecystectomy and septicemia
Frequency: 1 affected / 105 at risk

Adverse event: stretched/unravelled coil
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 105 at risk

Adverse event: perforator infarction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Subdural haematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: visual disturbances with cintilating scotoma
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Phasic Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: temporo-spatial disorientation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 105 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk
Study: NCT00486252

Adverse event: Abnormal sensation in eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 996 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 996 at risk

Adverse event: Conjunctival irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 996 at risk

Adverse event: Conjunctival oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 996 at risk

Adverse event: Conjunctival pigmentation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 996 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 996 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 996 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 996 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 996 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 996 at risk

Adverse event: Eyelash discolouration
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 996 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 996 at risk

Adverse event: Sicca syndrome
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 996 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 996 at risk

Adverse event: Adverse event
Serious: no
Organ System: General disorders
Frequency: 34 affected / 996 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 996 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 996 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 996 at risk

Adverse event: Hyperaemia
Serious: no
Organ System: Vascular disorders
Frequency: 62 affected / 996 at risk
Study: NCT00486330

Adverse event: Elevated transaminases
Serious: no
Organ System: Hepatobiliary disorders
Notes: one subject withdrew due to elevated hepatic transaminases (\>5x ULN; DAIDS Grade 3) detected during routine screening on day 4 which was attributed to known hepatic effects of tipranavir (2005).
Frequency: 1 affected / 12 at risk

Adverse event: Perioral numbness and lightheadedness
Serious: no
Organ System: Nervous system disorders
Notes: One subject withdrew due to perioral numbness and lightheadedness likely due to RTV after the first day of study drug administration (Ritonavir Package Insert 2007)
Frequency: 1 affected / 12 at risk
Study: NCT00486525

Adverse event: Recurrence of chronic back and/or shoulder problems
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 100 at risk
Study: NCT00486824

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk
Study: NCT00486837

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 37 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 37 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Vasculitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 35 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk
Study: NCT00486902

Adverse event: Spontaneous complaint of psycho-mimetic reaction
Serious: no
Organ System: Psychiatric disorders
Notes: Spontaneous complaint of psycho-mimetic reaction (feeling clumsy or weird feeling) reported by subject 5 minutes after administration of study drug.
Frequency: 30 affected / 85 at risk

Adverse event: Spontaneous complaint of psycho-mimetic reaction
Serious: no
Organ System: Psychiatric disorders
Notes: Spontaneous complaint of psycho-mimetic reaction (feeling clumsy or weird feeling) reported by subject 5 minutes after administration of study drug.
Frequency: 7 affected / 89 at risk
Study: NCT00487162

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: subject's serum blood glucose level dropped to \<60. Insulin discontinued
Frequency: 1 affected / 21 at risk
Study: NCT00487279

Adverse event: Lead Dislodgment or Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Serious adverse events were defined as those events related to the device or its implantation. Therefore the control group was not at risk for a serious adverse event per the protocol definition.
Frequency: 3 affected / 3 at risk

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

Adverse event: Lead Dislodgment or Migration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1 at risk
Study: NCT00487396

Adverse event: Capsule Retention
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Capsule retention
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 80 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 80 at risk
Study: NCT00487552

Adverse event: Death
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Death was due to peritonitis/sepsis subsequent to stent migration.
Frequency: 1 affected / 12 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Deaths were due to progressive malignancy.
Frequency: 8 affected / 12 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Death was due to co-morbidity.
Frequency: 1 affected / 12 at risk

Adverse event: Migration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 12 at risk
Study: NCT00487565

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 210 at risk

Adverse event: Haemarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 210 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 210 at risk

Adverse event: Other-Arthrofibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Other - Dehiscence Arthrotomy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Other - Distal Screw Failed at the Tuberocitas Osteotomy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Other - Loose Cement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Other - Polyethylene Spin Out After Fainting
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Other- Subpatellar Crepitation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Other - Wound Dehiscence
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 210 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 210 at risk

Adverse event: Respiratory System
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 210 at risk
Study: NCT00487669

Adverse event: Neutropenia Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Neutropenia Grade 4
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue Grade 3
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 6 at risk
Study: NCT00487695

Adverse event: post-procedure pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk
Study: NCT00487721

Adverse event: Hospitalization or Prolonged Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk
Study: NCT00487747

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk
Study: NCT00488033

Adverse event: Non-Fatal MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 447 at risk

Adverse event: Hospitalization for Unstable Angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 447 at risk

Adverse event: Hospitalization for Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 447 at risk

Adverse event: Stroke or Carotid Revascularization Procedure
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 447 at risk

Adverse event: Non-Fatal MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 452 at risk

Adverse event: Hospitalization for Unstable Angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 452 at risk

Adverse event: Hospitalization for Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 452 at risk

Adverse event: Stroke or Carotid Revascularization Procedure
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 452 at risk

Adverse event: Limb Amputation or Peripheral Vascular Revascularization Procedure
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 452 at risk
Study: NCT00488059

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

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

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Rash morbilliform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk
Study: NCT00488293

Adverse event: Death Unrelated to Study Participation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 196 at risk

Adverse event: Rash from Sunscreen
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 196 at risk

Adverse event: Death Unrelated to Study Participation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 196 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 196 at risk

Adverse event: Infection at Biopsy Site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 196 at risk