Study: NCT00591123

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis associated with neutropenic fever (103°F), hypotension, dehydration, hyponatremia, intermittent gr. 2 diarrhea.
Frequency: 1 affected / 38 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: Nausea, vomiting, diarrhea, altered mental status, neutropenia with fever, septic shock, renal failure. Participant expired in hospital on 12/26/09.
Frequency: 1 affected / 38 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Altered Mental State
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Inability to Urinate
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Intractable Back Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sacral Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Cranial Hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: hematoma to head, small acute lacunar infarction.
Frequency: 1 affected / 38 at risk

Adverse event: Finger Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Elevated International Normalized Ratio (INR)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: diskectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Anterior cervical diskectomy for spinal cord decompression at C5-C6. Diskitis/osteomyelitis at C5-C6. Grade 3 tear of posterior horn of lateral meniscus and a moderate effusion.
Frequency: 1 affected / 38 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Alkaline Phosphatase - elevated
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 38 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Alanine Aminotransferase - elevated
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 38 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 38 at risk

Adverse event: Aspartate Aminotransferase - elevated
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 38 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 38 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cachexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cardiac infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cold sensitivity
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Cold-like symptoms
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 14 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 38 at risk

Adverse event: Cramps - limbs
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Creatinine - elevated
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 14 affected / 38 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Dry eye
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Retching
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dry skin
Serious: no
Organ System: General disorders
Frequency: 9 affected / 38 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 38 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 38 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Folliculitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Gait-Walking
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Glossitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Heart burn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hemorrhage (GI, gums, nose, upper GI)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Hemorrhage (nose, oral cavity)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hemorrhoid
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hot flush
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 38 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 38 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 38 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 38 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 38 at risk

Adverse event: Hypomagnesia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 38 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: GI NOS, paronychia, picc line, sinus, skin, skin fungal, ungual, cellulitis, upper airway NOS, urinary tract NOS, J-tube site
Frequency: 10 affected / 38 at risk

Adverse event: Infection (skin, upper airway, pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: International Normalized Ratio (INR) - elevated
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Joint effusion - Elbow
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 38 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 38 at risk

Adverse event: Mental status
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: General disorders
Frequency: 7 affected / 38 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Mucositis - oral cavity
Serious: no
Organ System: General disorders
Frequency: 15 affected / 38 at risk

Adverse event: Myotonia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nail disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 21 affected / 38 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Neuropathy - motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 38 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 38 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Obstruction - GI small bowel NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Ocular - drainage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Ocular - ruptured vessel
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: abdomen, around J-tube, back, buttock, chest, epigastric, flank, hip, knee, limbs, neck, NOS, rib, shoulder, stomach, throat, right upper quadrant
Frequency: 29 affected / 38 at risk

Adverse event: Pallor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Perforation gastrointestinal tract
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Performance Status Decrease
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: limbs, chest, scalp, portacath site, facial
Frequency: 30 affected / 38 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 38 at risk

Adverse event: Rigors-Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Sepsis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Serum Chloride - Decrease
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Serum Protein - Decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperpigmentation - portacath site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: picc line site
Frequency: 1 affected / 38 at risk

Adverse event: Papule lower extremities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Papule upper chest
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Stomatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 38 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Thrombosis-Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 38 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Urinary retention
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Vitiligo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Voice changes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 16 affected / 38 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 38 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 17 affected / 38 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk