Study: NCT00348816

Adverse event: Infection - other:
Serious: yes
Organ System: Infections and infestations
Notes: URI, Lung (pneumonia), Pleura (empyema)
Frequency: 1 affected / 20 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Stricture/Stenosis GU: Bladder Neck
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 20 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: yes
Organ System: Infections and infestations
Notes: Thigh abscess, port, uroma
Frequency: 3 affected / 20 at risk

Adverse event: Pain - Other: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Colitis Infectious
Serious: yes
Organ System: Infections and infestations
Notes: Clostridium difficile
Frequency: 1 affected / 20 at risk

Adverse event: Cardiac General - Other:
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac Artery Bypass
Frequency: 2 affected / 20 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Lisinopril
Frequency: 1 affected / 20 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: total knee arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Left femoral head
Frequency: 1 affected / 20 at risk

Adverse event: Mood alteration
Serious: yes
Organ System: Psychiatric disorders
Notes: Bipolar, off medication (hospitalized twice) and anxiety attack
Frequency: 2 affected / 20 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Subdural
Frequency: 1 affected / 20 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Renal/Genitourinary-Other: Artificial Urinary Sphincter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Renal/Genitourinary-Other: Removal of foreign body
Serious: yes
Organ System: Renal and urinary disorders
Notes: Surgery clips
Frequency: 1 affected / 20 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 20 at risk

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

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 20 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 20 at risk

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

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

Adverse event: Dry mouth/salivary gland (xerotomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dermatology/Skin-Other: Boil on back, I&D no growth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dermatology/Skin-Other: Rash with pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Preexisting on arms, legs and back that worsened during treatment
Frequency: 1 affected / 20 at risk

Adverse event: Dermatology/Skin-Other: seborrheic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Erectile dysfuncion
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 20 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 20 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 10 affected / 20 at risk

Adverse event: Gastrointestinal, other: teeth grinding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 20 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 20 at risk

Adverse event: Hemorrhage, GI: rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 20 at risk

Adverse event: Hemorrhage, GU: Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 20 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension (episode after infusion)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 20 at risk

Adverse event: Infection, other: URI
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 20 at risk

Adverse event: Infection, other: tooth
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Infection, other: urinary
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Infection, other: perineal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Infection with normal ANC (port)(UTI)(balanitis-penis)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 20 at risk

Adverse event: Joint and/or muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 20 at risk

Adverse event: Libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Mood alteration (anxiety, emotion, irritability, depression, mood swings)
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 20 at risk

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

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 20 at risk

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

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

Adverse event: Neurology, other: Dementia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Neutrophiles/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: Ocular/Visual-Other: light sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Otitis (non-infectious)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain: Breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Cardiac/heart
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pain: Extremity/limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 20 at risk

Adverse event: Pain: Oral cavity (gum soreness under dentures)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Pain: Port
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Scrotum
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pain: Shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Pain: Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 20 at risk

Adverse event: Pulmonary/Upper Respiratory, other: Viral bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary/Upper Respiratory, other: sinus fullness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rash: dermatitis associated with radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 20 at risk

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

Adverse event: Sexual/Reproductive Function-Other: Erection, involunary, painful)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Stricture/stenosis GU: bladder neck
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 20 at risk

Adverse event: Stricture/stenosis GU: urethra
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 20 at risk

Adverse event: Supraventricular and nodal arrhythmia: tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 20 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 20 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 20 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hepatitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Vision-flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

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