Study: NCT01422850

Adverse event: Back pain radiating to legs
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain in pelvis area radiating to leg. Not associated with the study product.
Frequency: 1 affected / 21 at risk

Adverse event: Increased blood Creatinine
Serious: yes
Organ System: Renal and urinary disorders
Notes: Hospitalization due to elevated Serum Creatinine. Not associated with the study product.
Frequency: 1 affected / 21 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Increased thigh pain bilateral. Withdrawn by PI due to skeletal metastasis. Referred to external radiotherapy. Not associated with the study product.
Frequency: 1 affected / 21 at risk

Adverse event: Ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: Stone in urethra BEFORE first dose of the study product. Not associated with the study product.
Frequency: 1 affected / 21 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Notes: Shortness of breath and blurred vision. Thorax scanning verifies vertebral metastasis in the lung level. Withdrawn from the study due to progressive disease. Not associated with the study product.
Frequency: 1 affected / 21 at risk

Adverse event: Peripheral artery bypass
Serious: yes
Organ System: Vascular disorders
Notes: Femoral bypass due to thrombosis. Not associated with the study product.
Frequency: 1 affected / 21 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fracture due to accidental fall. Not associated with the study product.
Frequency: 1 affected / 21 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Elective surgery/excision of malignant melanoma performed at three times due to node metastasis. Not associated with the study product.
Frequency: 1 affected / 21 at risk

Adverse event: Paroysmal atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Noose bleed
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk

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

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

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

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hydronephros
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

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

Adverse event: Lip sore/cold
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Micturition disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 21 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Blurred visison
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 21 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Gout
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Increased creatinine level
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Knee surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Elective knee surgery
Frequency: 1 affected / 21 at risk

Adverse event: Malignant melanom
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: elective surgery; removal of glandulae
Frequency: 1 affected / 21 at risk