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Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT01824342
Collaborator
(none)
18
Enrollment
9
Locations
1
Arm
37
Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-national, multi-center, open-label, single-arm extension study for the prolongation of bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer. Patients currently participating in the phase 3 study 20050147 (NCT00286091) will be offered this study if a positive benefit:risk compared with placebo is determined in the 20050147 study. The primary endpoint of the 20050147 study is bone metastases-free survival determined by the time to first occurrence of bone metastases (either symptomatic or asymptomatic) or death from any cause. Participants will receive open-label denosumab administered once every 4 weeks (Q4W) subcutaneously (SC) until they developed a bone metastasis or for up to 3 years, whichever comes first.

Condition or Disease Intervention/Treatment Phase
  • Biological: Denosumab
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Denosumab

Participants received denosumab 120 mg subcutaneously every 4 weeks for up to 3 years in this open-label extension study.

Biological: Denosumab
Administered by subcutaneous injection
Other Names:
  • XGEVA®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths [From the first dose of open-label denosumab until 4 weeks after the last; maximum time on study was 37 months. Follow-up survival information was collected for up to 3 years after the last dose of blinded investigation product in the 20050147 study.]

      A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard. The adverse event severity grading scale used was the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The investigator assessed whether each adverse event was possibly related to the investigational product (IP).

    2. Percent Change From Baseline in Laboratory Values [Baseline and Week 49]

    3. Number of Participants With Anti-denosumab Neutralizing Antibody Formation [3 years]

    Secondary Outcome Measures

    1. Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [Baseline and Week 49]

      A scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work); 2 = Ambulatory and capable of all self care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair; 5 = Dead.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects currently undergoing every 4 weeks scheduled assessments in the phase 3 study 20050147

    • Subjects must sign the informed consent before any study specific procedures are performed

    Exclusion Criteria:

    • Developed sensitivity to mammalian cell derived drug products during the 20050147 study

    • Currently receiving any unapproved investigational product other than denosumab

    • Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Hradec Kralove Czech Republic 500 05
    2 Research Site Pelhrimov Czech Republic 393 38
    3 Research Site Praha 2 Czech Republic 128 08
    4 Research Site Praha 6 Czech Republic 160 00
    5 Research Site Tabor Czech Republic 390 03
    6 Research Site Newcastle United Kingdom NE7 7DN
    7 Research Site Northwood United Kingdom HA6 2RN
    8 Research Site Sheffield United Kingdom S10 2SJ
    9 Research Site Sutton United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT01824342
    Other Study ID Numbers:
    • 20080585
    • 2010-021846-23
    First Posted:
    Apr 4, 2013
    Last Update Posted:
    Mar 5, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Denosumab

    Study Results

    Participant Flow

    Recruitment Details This was a single-arm, open-label extension (OLE) phase of a phase 3, randomized, double-blind study (Study 20050147; NCT00286091) comparing denosumab with placebo on prolonging bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer.
    Pre-assignment Detail All participants received denosumab during the OLE phase; in the parent study participants were initially randomized in a blinded manner to receive denosumab at a dose of 120 mg or placebo every 4 weeks.
    Arm/Group Title Placebo/Denosumab Denosumab/Denosumab
    Arm/Group Description Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years. Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
    Period Title: Overall Study
    STARTED 11 7
    COMPLETED 2 2
    NOT COMPLETED 9 5

    Baseline Characteristics

    Arm/Group Title Placebo/Denosumab Denosumab/Denosumab Total
    Arm/Group Description Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years. Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years. Total of all reporting groups
    Overall Participants 11 7 18
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    71.6
    (4.3)
    70.3
    (7.4)
    71.1
    (5.6)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    11
    100%
    7
    100%
    18
    100%
    Race/Ethnicity, Customized (participants) [Number]
    White or Caucasian
    11
    100%
    7
    100%
    18
    100%
    Eastern Cooperative Oncology Group (ECOG) Performance Status (participants) [Number]
    Grade 0
    7
    63.6%
    5
    71.4%
    12
    66.7%
    Grade 1
    4
    36.4%
    1
    14.3%
    5
    27.8%
    Grade 2
    0
    0%
    1
    14.3%
    1
    5.6%
    Grade 3
    0
    0%
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    0
    0%
    Albumin-adjusted calcium (mmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmol/L]
    2.44
    (0.10)
    2.42
    (0.04)
    2.43
    (0.08)
    Creatinine (umol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [umol/L]
    88.40
    (14.25)
    89.66
    (23.63)
    88.89
    (17.80)
    Phosphorus (mmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmol/L]
    1.09
    (0.22)
    1.01
    (0.24)
    1.06
    (0.22)

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths
    Description A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard. The adverse event severity grading scale used was the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The investigator assessed whether each adverse event was possibly related to the investigational product (IP).
    Time Frame From the first dose of open-label denosumab until 4 weeks after the last; maximum time on study was 37 months. Follow-up survival information was collected for up to 3 years after the last dose of blinded investigation product in the 20050147 study.

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set, which included participants who had properly documented informed consent for protocol 20080585 and received at least 1 dose of open-label denosumab.
    Arm/Group Title Placebo/Denosumab Denosumab/Denosumab
    Arm/Group Description Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years. Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
    Measure Participants 11 7
    Any adverse event (AE)
    11
    100%
    7
    100%
    Serious adverse event
    7
    63.6%
    4
    57.1%
    Fatal adverse event
    2
    18.2%
    0
    0%
    AE leading to study discontinuation
    2
    18.2%
    1
    14.3%
    AE leading to IP discontinuation
    4
    36.4%
    1
    14.3%
    CTCAE Grade 3, 4, or 5
    6
    54.5%
    2
    28.6%
    AE related to investigational product (IP)
    2
    18.2%
    3
    42.9%
    Serious AE related to IP
    0
    0%
    2
    28.6%
    Fatal AE related to IP
    0
    0%
    0
    0%
    AE related to IP leading to study discontinuation
    1
    9.1%
    1
    14.3%
    AE related to IP leading to IP discontinuation
    1
    9.1%
    1
    14.3%
    AE related to IP and CTCAE Grade 3, 4, or 5
    0
    0%
    1
    14.3%
    Deaths
    4
    36.4%
    1
    14.3%
    Deaths on study
    2
    18.2%
    0
    0%
    Deaths during the safety follow-up
    2
    18.2%
    1
    14.3%
    2. Primary Outcome
    Title Percent Change From Baseline in Laboratory Values
    Description
    Time Frame Baseline and Week 49

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set with available laboratory data at each time point.
    Arm/Group Title Placebo/Denosumab Denosumab/Denosumab
    Arm/Group Description Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years. Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
    Measure Participants 10 6
    Albumin-adjusted Calcium
    -0.9
    (2.5)
    1.1
    (3.1)
    Alkaline Phosphatase
    -23.8
    (21.8)
    -1.6
    (20.5)
    Creatinine
    16.3
    (31.5)
    2.4
    (5.8)
    Phosphorus
    -2.6
    (25.2)
    0.0
    (10.4)
    3. Primary Outcome
    Title Number of Participants With Anti-denosumab Neutralizing Antibody Formation
    Description
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    Participants exposed to open-label denosumab with ≥ 1 antibody sample
    Arm/Group Title Placebo/Denosumab Denosumab/Denosumab
    Arm/Group Description Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years. Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
    Measure Participants 10 7
    Number [participants]
    0
    0%
    0
    0%
    4. Secondary Outcome
    Title Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    Description A scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work); 2 = Ambulatory and capable of all self care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair; 5 = Dead.
    Time Frame Baseline and Week 49

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set with available data at both time points
    Arm/Group Title Placebo/Denosumab Denosumab/Denosumab
    Arm/Group Description Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years. Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
    Measure Participants 10 6
    4-point increase in PS
    0
    0%
    0
    0%
    3-point increase in PS
    0
    0%
    0
    0%
    2-point increase in PS
    0
    0%
    0
    0%
    1-point increase in PS
    0
    0%
    1
    14.3%
    No change
    10
    90.9%
    5
    71.4%
    1-point decrease in PS
    0
    0%
    0
    0%
    2-point decrease in PS
    0
    0%
    0
    0%

    Adverse Events

    Time Frame 3 years
    Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    Arm/Group Title Placebo/ Denosumab 120 mg Q4W Denosumab/ Denosumab 120 mg Q4W
    Arm/Group Description Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years. Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
    All Cause Mortality
    Placebo/ Denosumab 120 mg Q4W Denosumab/ Denosumab 120 mg Q4W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Placebo/ Denosumab 120 mg Q4W Denosumab/ Denosumab 120 mg Q4W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/11 (63.6%) 4/7 (57.1%)
    Cardiac disorders
    Mitral valve incompetence 1/11 (9.1%) 0/7 (0%)
    Myocardial infarction 1/11 (9.1%) 0/7 (0%)
    Congenital, familial and genetic disorders
    Phimosis 0/11 (0%) 1/7 (14.3%)
    Gastrointestinal disorders
    Constipation 1/11 (9.1%) 0/7 (0%)
    General disorders
    Death 1/11 (9.1%) 0/7 (0%)
    Medical device complication 1/11 (9.1%) 0/7 (0%)
    Infections and infestations
    Cystitis 1/11 (9.1%) 0/7 (0%)
    Lower respiratory tract infection 1/11 (9.1%) 0/7 (0%)
    Urinary tract infection 2/11 (18.2%) 0/7 (0%)
    Investigations
    Haemoglobin decreased 1/11 (9.1%) 0/7 (0%)
    Urinary sediment present 1/11 (9.1%) 0/7 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 1/11 (9.1%) 0/7 (0%)
    Muscular weakness 1/11 (9.1%) 0/7 (0%)
    Osteonecrosis of jaw 0/11 (0%) 2/7 (28.6%)
    Pain in extremity 1/11 (9.1%) 0/7 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bowen's disease 1/11 (9.1%) 0/7 (0%)
    Bronchial carcinoma 1/11 (9.1%) 0/7 (0%)
    Malignant anorectal neoplasm 1/11 (9.1%) 0/7 (0%)
    Metastatic pain 2/11 (18.2%) 0/7 (0%)
    Squamous cell carcinoma of skin 1/11 (9.1%) 0/7 (0%)
    Nervous system disorders
    Hypoaesthesia 1/11 (9.1%) 0/7 (0%)
    Renal and urinary disorders
    Bladder neck obstruction 1/11 (9.1%) 0/7 (0%)
    Calculus bladder 1/11 (9.1%) 0/7 (0%)
    Dysuria 1/11 (9.1%) 0/7 (0%)
    Haematuria 1/11 (9.1%) 0/7 (0%)
    Hydronephrosis 2/11 (18.2%) 0/7 (0%)
    Nocturia 1/11 (9.1%) 0/7 (0%)
    Renal impairment 1/11 (9.1%) 0/7 (0%)
    Urethral haemorrhage 1/11 (9.1%) 0/7 (0%)
    Urethral stenosis 1/11 (9.1%) 0/7 (0%)
    Urinary incontinence 1/11 (9.1%) 0/7 (0%)
    Urinary retention 2/11 (18.2%) 0/7 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/11 (0%) 1/7 (14.3%)
    Haemoptysis 0/11 (0%) 1/7 (14.3%)
    Other (Not Including Serious) Adverse Events
    Placebo/ Denosumab 120 mg Q4W Denosumab/ Denosumab 120 mg Q4W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 11/11 (100%) 6/7 (85.7%)
    Blood and lymphatic system disorders
    Anaemia 3/11 (27.3%) 0/7 (0%)
    Cardiac disorders
    Arrhythmia 1/11 (9.1%) 1/7 (14.3%)
    Congenital, familial and genetic disorders
    Phimosis 1/11 (9.1%) 0/7 (0%)
    Ear and labyrinth disorders
    Deafness 1/11 (9.1%) 0/7 (0%)
    Meniere's disease 1/11 (9.1%) 0/7 (0%)
    Vertigo 1/11 (9.1%) 0/7 (0%)
    Endocrine disorders
    Hypothyroidism 1/11 (9.1%) 0/7 (0%)
    Eye disorders
    Cataract 1/11 (9.1%) 0/7 (0%)
    Dry eye 1/11 (9.1%) 0/7 (0%)
    Gastrointestinal disorders
    Abdominal pain 1/11 (9.1%) 0/7 (0%)
    Constipation 1/11 (9.1%) 0/7 (0%)
    Diarrhoea 2/11 (18.2%) 0/7 (0%)
    Dyspepsia 0/11 (0%) 1/7 (14.3%)
    Faecal incontinence 1/11 (9.1%) 0/7 (0%)
    Gingival pain 0/11 (0%) 1/7 (14.3%)
    Haemorrhoids 1/11 (9.1%) 0/7 (0%)
    Intestinal haemorrhage 1/11 (9.1%) 0/7 (0%)
    Loose tooth 0/11 (0%) 1/7 (14.3%)
    Nausea 1/11 (9.1%) 1/7 (14.3%)
    Tooth disorder 1/11 (9.1%) 0/7 (0%)
    Tooth loss 0/11 (0%) 1/7 (14.3%)
    Toothache 0/11 (0%) 1/7 (14.3%)
    Vomiting 2/11 (18.2%) 1/7 (14.3%)
    General disorders
    Catheter site pain 2/11 (18.2%) 0/7 (0%)
    Device expulsion 1/11 (9.1%) 0/7 (0%)
    Device leakage 1/11 (9.1%) 0/7 (0%)
    Face oedema 0/11 (0%) 1/7 (14.3%)
    Fatigue 3/11 (27.3%) 0/7 (0%)
    Malaise 1/11 (9.1%) 0/7 (0%)
    Oedema peripheral 3/11 (27.3%) 1/7 (14.3%)
    Pain 0/11 (0%) 1/7 (14.3%)
    Pyrexia 1/11 (9.1%) 0/7 (0%)
    Infections and infestations
    Abscess of salivary gland 0/11 (0%) 1/7 (14.3%)
    Bronchitis 1/11 (9.1%) 0/7 (0%)
    Cellulitis 1/11 (9.1%) 0/7 (0%)
    Gingivitis 0/11 (0%) 1/7 (14.3%)
    Localised infection 1/11 (9.1%) 0/7 (0%)
    Lower respiratory tract infection 2/11 (18.2%) 0/7 (0%)
    Nasopharyngitis 1/11 (9.1%) 0/7 (0%)
    Oral fungal infection 0/11 (0%) 1/7 (14.3%)
    Post procedural infection 1/11 (9.1%) 0/7 (0%)
    Upper respiratory tract infection 0/11 (0%) 1/7 (14.3%)
    Urinary tract infection 3/11 (27.3%) 2/7 (28.6%)
    Viral infection 1/11 (9.1%) 0/7 (0%)
    Injury, poisoning and procedural complications
    Animal bite 1/11 (9.1%) 0/7 (0%)
    Arthropod bite 1/11 (9.1%) 0/7 (0%)
    Contusion 1/11 (9.1%) 0/7 (0%)
    Procedural pain 2/11 (18.2%) 0/7 (0%)
    Radiation injury 1/11 (9.1%) 0/7 (0%)
    Rib fracture 1/11 (9.1%) 0/7 (0%)
    Sunburn 1/11 (9.1%) 0/7 (0%)
    Tooth fracture 1/11 (9.1%) 0/7 (0%)
    Investigations
    Eastern Cooperative Oncology Group performance status worsened 1/11 (9.1%) 0/7 (0%)
    Haemoglobin decreased 1/11 (9.1%) 0/7 (0%)
    Prostatic specific antigen increased 2/11 (18.2%) 2/7 (28.6%)
    Urinary sediment present 1/11 (9.1%) 0/7 (0%)
    Weight decreased 1/11 (9.1%) 0/7 (0%)
    Weight increased 1/11 (9.1%) 1/7 (14.3%)
    Metabolism and nutrition disorders
    Decreased appetite 1/11 (9.1%) 1/7 (14.3%)
    Diabetes mellitus 1/11 (9.1%) 1/7 (14.3%)
    Hypercholesterolaemia 1/11 (9.1%) 0/7 (0%)
    Hyperglycaemia 0/11 (0%) 1/7 (14.3%)
    Vitamin B12 deficiency 1/11 (9.1%) 0/7 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/11 (0%) 1/7 (14.3%)
    Back pain 4/11 (36.4%) 0/7 (0%)
    Flank pain 1/11 (9.1%) 0/7 (0%)
    Fracture pain 1/11 (9.1%) 0/7 (0%)
    Muscular weakness 1/11 (9.1%) 0/7 (0%)
    Musculoskeletal chest pain 2/11 (18.2%) 0/7 (0%)
    Musculoskeletal pain 2/11 (18.2%) 0/7 (0%)
    Musculoskeletal stiffness 1/11 (9.1%) 0/7 (0%)
    Myalgia 1/11 (9.1%) 0/7 (0%)
    Osteonecrosis of jaw 1/11 (9.1%) 1/7 (14.3%)
    Pain in extremity 1/11 (9.1%) 0/7 (0%)
    Rheumatic disorder 1/11 (9.1%) 0/7 (0%)
    Sensation of heaviness 1/11 (9.1%) 0/7 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to bone 2/11 (18.2%) 0/7 (0%)
    Metastatic pain 1/11 (9.1%) 0/7 (0%)
    Skin papilloma 1/11 (9.1%) 0/7 (0%)
    Squamous cell carcinoma of skin 1/11 (9.1%) 0/7 (0%)
    Nervous system disorders
    Cervicobrachial syndrome 1/11 (9.1%) 0/7 (0%)
    Dizziness 3/11 (27.3%) 0/7 (0%)
    Hypoaesthesia 1/11 (9.1%) 0/7 (0%)
    Muscle contractions involuntary 1/11 (9.1%) 1/7 (14.3%)
    Poor quality sleep 1/11 (9.1%) 0/7 (0%)
    Sciatica 1/11 (9.1%) 0/7 (0%)
    Psychiatric disorders
    Depressed mood 1/11 (9.1%) 0/7 (0%)
    Depression 1/11 (9.1%) 0/7 (0%)
    Renal and urinary disorders
    Bladder spasm 1/11 (9.1%) 0/7 (0%)
    Calculus bladder 1/11 (9.1%) 0/7 (0%)
    Dysuria 2/11 (18.2%) 0/7 (0%)
    Haematuria 3/11 (27.3%) 1/7 (14.3%)
    Hypertonic bladder 1/11 (9.1%) 1/7 (14.3%)
    Nocturia 2/11 (18.2%) 0/7 (0%)
    Renal cyst 0/11 (0%) 1/7 (14.3%)
    Renal failure chronic 0/11 (0%) 1/7 (14.3%)
    Renal impairment 1/11 (9.1%) 0/7 (0%)
    Renal pain 1/11 (9.1%) 0/7 (0%)
    Urethral haemorrhage 1/11 (9.1%) 0/7 (0%)
    Urethral stenosis 1/11 (9.1%) 0/7 (0%)
    Urinary incontinence 1/11 (9.1%) 0/7 (0%)
    Urinary retention 2/11 (18.2%) 1/7 (14.3%)
    Reproductive system and breast disorders
    Pelvic pain 0/11 (0%) 1/7 (14.3%)
    Prostatic pain 1/11 (9.1%) 0/7 (0%)
    Respiratory, thoracic and mediastinal disorders
    Atelectasis 1/11 (9.1%) 0/7 (0%)
    Cough 2/11 (18.2%) 0/7 (0%)
    Dyspnoea 0/11 (0%) 1/7 (14.3%)
    Dyspnoea exertional 1/11 (9.1%) 0/7 (0%)
    Epistaxis 1/11 (9.1%) 0/7 (0%)
    Haemoptysis 1/11 (9.1%) 0/7 (0%)
    Hydrothorax 1/11 (9.1%) 0/7 (0%)
    Productive cough 1/11 (9.1%) 0/7 (0%)
    Skin and subcutaneous tissue disorders
    Dry skin 2/11 (18.2%) 0/7 (0%)
    Pruritus generalised 1/11 (9.1%) 0/7 (0%)
    Skin exfoliation 1/11 (9.1%) 0/7 (0%)
    Skin lesion 1/11 (9.1%) 0/7 (0%)
    Surgical and medical procedures
    Tooth extraction 1/11 (9.1%) 0/7 (0%)
    Vascular disorders
    Hypertension 2/11 (18.2%) 0/7 (0%)
    Peripheral arterial occlusive disease 1/11 (9.1%) 0/7 (0%)
    Thrombosis 1/11 (9.1%) 0/7 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.

    Results Point of Contact

    Name/Title Study Director
    Organization Amgen Inc.
    Phone 866-572-6436
    Email
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT01824342
    Other Study ID Numbers:
    • 20080585
    • 2010-021846-23
    First Posted:
    Apr 4, 2013
    Last Update Posted:
    Mar 5, 2015
    Last Verified:
    Feb 1, 2015