TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00204373

Adverse event: Mucosal relapse
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Mucosal relapse was documented in 12 pts (16.7%). The type or relapse included a peptic ulcer in 4.2% (0 gastric, 3 duodenal), reflux oesophagitis in 8 (11.1%) and small bowel perforation in 2 (2.8%).
Frequency: 12 affected / 72 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: The most common cause of death was cardiovascular disease or stroke (9 pts).
Frequency: 9 affected / 72 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 5 patients developed cancer including pancreatic, gallbladder and lung cancers.
Frequency: 5 affected / 72 at risk

Adverse event: Death (metastatic gastrinoma)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Two patients died due to progressive metastatic gastrinoma.
Frequency: 2 affected / 72 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 72 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 72 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 4 patients experienced leg pain.
Frequency: 4 affected / 72 at risk
Study: NCT00204490

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 99 at risk

Adverse event: uterus, cervix, cyst and polyp in cervix
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 99 at risk

Adverse event: Appendicitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 98 at risk

Adverse event: Presynocopy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Ear Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 98 at risk
Study: NCT00204932

Adverse event: blood chemistry: soluble vascular cell adhesion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 24 at risk

Adverse event: blood chemistry: soluble vascular cell adhesion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk
Study: NCT00205179

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Developed seizures secondary to Alzheimer's
Frequency: 1 affected / 32 at risk

Adverse event: other illness not related to treatment
Serious: no
Organ System: General disorders
Frequency: 25 affected / 32 at risk

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Notes: Death due to complications from Alzheimer's disease
Frequency: 2 affected / 33 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: other illness not related to treatment
Serious: no
Organ System: General disorders
Frequency: 23 affected / 33 at risk
Study: NCT00205504

Adverse event: Cholelithotomy
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject had gallstones removed during study, and continued study.
Frequency: 1 affected / 21 at risk

Adverse event: Phlebitis due to catheter insertion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Subject experienced phlebitis at the site of catheter insertion. Subject was discontinued from the study by investigator.
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness due to Ortho Tricyclen
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Subject withdrew after 1 day of study medication (Ortho Tricyclen)due to dizziness.
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Subject felt tired during her last day of study and did not desire to continue that morning's study procedure.
Frequency: 1 affected / 15 at risk

Adverse event: Pain with venipuncture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Subject withdrew withdrew after the first two mornings of study because of pain associated with venipuncture.
Frequency: 1 affected / 15 at risk
Study: NCT00205660

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

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

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 9 affected / 35 at risk

Adverse event: Drowsiness/Somnolence
Serious: no
Organ System: General disorders
Frequency: 7 affected / 35 at risk

Adverse event: Tiredness/Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 35 at risk
Study: NCT00205712

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 20 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 20 at risk

Adverse event: Difficulty Walking
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Trouble Breathing
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 20 at risk

Adverse event: Unpleasant Dreams
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 20 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 20 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 20 at risk

Adverse event: Difficulty Walking
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Trouble Breathing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 20 at risk

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

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 20 at risk
Study: NCT00205855

Adverse event: Lead dislodgement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 65 at risk

Adverse event: Loss of Therapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 65 at risk

Adverse event: New Lead Placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 65 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 65 at risk

Adverse event: Implantable Pulse Generator Movement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 65 at risk

Adverse event: Pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 65 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 65 at risk

Adverse event: Death
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Died in t he hospital due to complications of a broken hip
Frequency: 1 affected / 65 at risk

Adverse event: Abstinence syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: CSF leak
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 65 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 65 at risk

Adverse event: Device malfunction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 65 at risk

Adverse event: Grand-Mal Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nausea & Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Reduced Telemetry Range
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Pain during SCS Trial
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Over and Under stimulation during SCS Trial
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 65 at risk

Adverse event: Unpleasant Stimulation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 65 at risk
Study: NCT00205881

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 31 at risk
Study: NCT00206076

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Constipation alter with diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Increased liver enzymes
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 9 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: change in white blood cell count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Increased liver enzymes
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 10 at risk
Study: NCT00206323

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

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

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

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

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

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

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk
Study: NCT00206336

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT00206427

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Neutrophils/ANC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Infection-oral thrush
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Mucositis-oral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 49 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 49 at risk
Study: NCT00206440

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 21 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

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

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

Adverse event: mild nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: severe nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

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

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

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

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 22 at risk

Adverse event: mild nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 22 at risk

Adverse event: severe nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: mild fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: mild headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk
Study: NCT00206518

Adverse event: ALLERGIC/REACTION
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 83 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 83 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 83 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 83 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 84 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 84 at risk
Study: NCT00207883

Adverse event: Arterial puncture
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 93 at risk

Adverse event: Arterial puncture
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 119 at risk
Study: NCT00208507

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 177 at risk

Adverse event: Endocrine/Metabolic
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 177 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 177 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 177 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 177 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 177 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 177 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 177 at risk

Adverse event: Acetabular liner failure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 177 at risk

Adverse event: Femoral Component Loosening
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 177 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 177 at risk

Adverse event: Wound Problem
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 177 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 68 affected / 177 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 177 at risk

Adverse event: Endocrine/Metabolic
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 87 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 87 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 87 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 87 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 87 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 87 at risk

Adverse event: Wound Problem
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 87 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 87 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 87 at risk
Study: NCT00208767

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Majory injury/accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 80 at risk