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Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium

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ClinicalTrials.gov Identifier: NCT00896454
Recruitment Status : Completed
First Posted : May 11, 2009
Results First Posted : January 1, 2015
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Hypercalcemia of Malignancy
Colon Cancer
Endocrine Cancer
Head and Neck Cancer
Kidney Cancer
Lung Cancer
Lymphoma
Metastatic Cancer
Multiple Myeloma
Parathyroid Neoplasms
Renal Cancer
Thyroid Cancer
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Non-Small Cell Lung Cancer
Intervention Drug: denosumab
Enrollment 33
Recruitment Details First patient was enrolled on 16 November 2009 and the last patient enrolled on 02 July 2012. Data are reported as of the primary analysis cut-off date of 13 September 2012.
Pre-assignment Details  
Arm/Group Title Denosumab
Hide Arm/Group Description Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Period Title: Overall Study
Started 33
Completed 0
Not Completed 33
Reason Not Completed
Death             10
Adverse Event             8
Disease Progression             5
Other             4
Requirement for alternative therapy             3
Ongoing in study             2
Withdrawal by Subject             1
Arm/Group Title Denosumab
Hide Arm/Group Description Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
60.3  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
12
  36.4%
Male
21
  63.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
White or Caucasian 23
Black or African American 7
Hispanic or Latino 1
Asian 1
Other 1
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
0 1
1 7
2 14
3 8
4 3
[1]
Measure Description: Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
Primary Tumor Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Bladder 1
Breast 6
Head and neck 2
Liver 1
Neuroendocrine/carcinoid 4
Non-hodgkin's 2
Non-small cell lung cancer 3
Ovarian 1
Renal 3
Small cell lung cancer 1
Soft tissue sarcoma 1
Unknown (primary tumor) 1
Multiple myeloma 3
Chronic lymphocytic leukemia 2
IGG kappa multiple myeloma 1
Myeloma 1
Time from initial cancer diagnosis to enrollment  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 33 participants
56.9  (68.8)
Presence of metastatic disease at enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Yes 30
No 3
Presence of bone metastatic disease at enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Yes 13
No 20
Baseline Hypercalcemia of Malignancy (HCM) Symptoms   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Fatigue 9
Anorexia 5
Nausea 4
Depressed level of consciousness 2
Vomiting 2
Dry mouth 1
Constipation 4
Lethargy 4
Confusion 3
Polyuria 2
Abdominal pain 1
Decreased mental acuity 1
Dyspnea 1
General weakness 1
Insomnolence 1
Light headedness (dizziness) 1
Listlessness/muscle weakness 1
Polyuro-polydipsic syndrome 1
Psychomotor retardation 1
Retching 1
Urinary frequency 1
Weight loss 1
[1]
Measure Description: Participants may have had more than one symptom
Calcium (corrected)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 33 participants
13.89  (1.27)
1.Primary Outcome
Title Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab
Hide Description Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL]))
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Response Analysis Subset including all participants who received at least 1 dose of denosumab and had a screening CSC (from local lab) > 12.5 mg/dL (3.1 mmol/L).
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.6
(45.1 to 79.6)
2.Secondary Outcome
Title Percentage of Participants With a Response by Visit
Hide Description Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL]))
Time Frame Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
Response Analysis Subset
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
By Day 2
9.1
(1.9 to 24.3)
By Day 4
24.2
(11.1 to 42.3)
By Day 8
48.5
(30.8 to 66.5)
By Day 10
63.6
(45.1 to 79.6)
By Day 15
63.6
(45.1 to 79.6)
By Day 19
69.7
(51.3 to 84.4)
By Day 23
69.7
(51.3 to 84.4)
By Day 29
69.7
(51.3 to 84.4)
By Day 36
69.7
(51.3 to 84.4)
By Day 43
69.7
(51.3 to 84.4)
By Day 50
69.7
(51.3 to 84.4)
By Day 57
69.7
(51.3 to 84.4)
3.Secondary Outcome
Title Percentage of Participants With a Complete Response by Visit
Hide Description Response is defined as corrected serum calcium (CSC) ≤ 10.8 mg/dL (2.7 mmol/L). For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL])).
Time Frame Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
Response Analysis Subset
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
By Day 2
3.0
(0.1 to 15.8)
By Day 4
15.2
(5.1 to 31.9)
By Day 8
27.3
(13.3 to 45.5)
By Day 10
36.4
(20.4 to 54.9)
By Day 15
45.5
(28.1 to 63.6)
By Day 19
45.5
(28.1 to 63.6)
By Day 23
51.5
(33.5 to 69.2)
By Day 29
51.5
(33.5 to 69.2)
By Day 36
60.6
(42.1 to 77.1)
By Day 43
63.6
(45.1 to 79.6)
By Day 50
63.6
(45.1 to 79.6)
By Day 57
63.6
(45.1 to 79.6)
4.Secondary Outcome
Title Time to Response
Hide Description

Time to Response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if no response was observed. If there was no post-baseline CSC assessment, time to response was censored on study Day 1.

Time to response was analyzed using Kaplan–Meier methods.

Time Frame From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Response Analysis Subset
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: days
9.0
(5.00 to 19.00)
5.Secondary Outcome
Title Time to Complete Response
Hide Description Time to complete response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) was ≤ 10.8 mg/dL (2.7 mmol/L). Participants were censored on the last CSC assessment day if no complete response was observed. If there was no post-baseline CSC assessment, time to complete response was censored on study Day 1. Time to complete response was analyzed using Kaplan–Meier methods.
Time Frame From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Response Analysis Subset
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: days
23.0
(11.00 to 43.00)
6.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined as the number of days from the first day of corrected serum calcium ≤ 11.5 mg/dL (2.9 millimoles/L) to the last day of corrected serum calcium ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached > 11.5 mg/dL after the first response. If a participant had no CSC assessment after the first response, duration of response was set to zero and censored. Duration of response was summarized for participants who achieved a response using the Kaplan-Meier method.
Time Frame From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a response in the Response Analysis Subset
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: days
104.0 [1] 
(9.00 to NA)
[1]
Not estimable due to the low number of events
7.Secondary Outcome
Title Duration of Complete Response
Hide Description Duration of complete response is defined as the number of days from the first day of of corrected serum calcium ≤ 10.8 mg/dL (2.7 millimoles/L) to the last day of corrected serum calcium ≤ 10.8 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached > 10.8 mg/dL after the complete response. If a participant had no CSC assessment after the complete response, duration of complete response was set to zero and censored. Duration of complete response was summarized for participants who achieved a complete response using the Kaplan-Meier method.
Time Frame From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a complete response in the Response Analysis Subset
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: days
34.0
(1.00 to 134.00)
8.Secondary Outcome
Title Time to Relapse/Nonresponse of Hypercalcemia of Malignancy
Hide Description Time to relapse/nonresponse was defined as the number of days from study Day 1 until the last day of CSC ≤ 11.5 mg/dL for all particiipants with relapse after the first response. Participants were censored on the last CSC assessment day if their CSC level never reached > 11.5 mg/dL after first response. For participants who never achieved response, time to relapse/nonresponse was set to zero. Otherwise, if there was no post-baseline CSC assessment, time to relapse/nonresponse was censored on study Day 1. Time to relapse/nonresponse was estimated using the Kaplan-Meier method.
Time Frame From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Response Analysis Subset
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: days
19.0
(5.00 to 114.00)
9.Secondary Outcome
Title Change From Baseline in Corrected Serum Calcium
Hide Description [Not Specified]
Time Frame Baseline and Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Subset included all participants who received at least 1 dose of denosumab. n = Number of participants who had non-missing data at Baseline and the time point of interest.
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
Overall Number of Participants Analyzed 33
Median (Inter-Quartile Range)
Unit of Measure: mmol/L
Change from Baseline to Day 2 (n = 32)
-0.13
(-0.31 to 0.09)
Change from Baseline to Day 4 (n = 32)
-0.25
(-0.44 to -0.14)
Change form Baseline to Day 8 (n = 27)
-0.43
(-0.73 to -0.20)
Change from Baseline to Day 10 (n = 28)
-0.54
(-0.77 to -0.25)
Change from Baseline to Day 15 (n = 24)
-0.51
(-0.89 to -0.15)
Change from Baseline to Day 19 (n = 22)
-0.64
(-0.80 to -0.30)
Change from Baseline to Day 23 (n = 21)
-0.60
(-0.85 to -0.40)
Change from Baseline to Day 29 (n = 22)
-0.53
(-0.75 to -0.30)
Change from Baseline to Day 36 (n = 20)
-0.61
(-0.84 to -0.15)
Change from Baseline to Day 43 (n = 19)
-0.75
(-0.98 to -0.10)
Change from Baseline to Day 50 (n = 15)
-0.83
(-1.03 to -0.20)
Change from Baseline to Day 57 (n = 17)
-0.73
(-1.03 to -0.25)
Time Frame Median time on study was 1.8 months.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Denosumab 120 mg Q4W
Hide Arm/Group Description Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
All-Cause Mortality
Denosumab 120 mg Q4W
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Denosumab 120 mg Q4W
Affected / at Risk (%)
Total   29/33 (87.88%) 
Blood and lymphatic system disorders   
Anaemia  1  1/33 (3.03%) 
Pancytopenia  1  1/33 (3.03%) 
Cardiac disorders   
Cardiac arrest  1  1/33 (3.03%) 
Tachycardia  1  2/33 (6.06%) 
Endocrine disorders   
Hypercalcaemia of malignancy  1  1/33 (3.03%) 
Gastrointestinal disorders   
Colitis  1  1/33 (3.03%) 
Diarrhoea  1  2/33 (6.06%) 
Nausea  1  1/33 (3.03%) 
Oesophageal obstruction  1  1/33 (3.03%) 
Vomiting  1  1/33 (3.03%) 
General disorders   
Pyrexia  1  1/33 (3.03%) 
Hepatobiliary disorders   
Hepatic failure  1  1/33 (3.03%) 
Infections and infestations   
Septic shock  1  1/33 (3.03%) 
Urinary tract infection  1  1/33 (3.03%) 
Investigations   
Urine output decreased  1  1/33 (3.03%) 
Metabolism and nutrition disorders   
Dehydration  1  1/33 (3.03%) 
Failure to thrive  1  1/33 (3.03%) 
Hypercalcaemia  1  5/33 (15.15%) 
Hypokalaemia  1  1/33 (3.03%) 
Hyponatraemia  1  1/33 (3.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer  1  1/33 (3.03%) 
Breast cancer  1  1/33 (3.03%) 
Breast cancer metastatic  1  1/33 (3.03%) 
Chronic lymphocytic leukaemia  1  1/33 (3.03%) 
Diffuse large B-cell lymphoma  1  1/33 (3.03%) 
Gastrointestinal stromal tumour  1  1/33 (3.03%) 
Head and neck cancer  1  2/33 (6.06%) 
Hepatic neoplasm malignant  1  1/33 (3.03%) 
Lung neoplasm malignant  1  2/33 (6.06%) 
Multiple myeloma  1  2/33 (6.06%) 
Non-small cell lung cancer  1  2/33 (6.06%) 
Ovarian cancer  1  1/33 (3.03%) 
Renal cell carcinoma  1  1/33 (3.03%) 
Nervous system disorders   
Lethargy  1  1/33 (3.03%) 
Psychiatric disorders   
Confusional state  1  1/33 (3.03%) 
Mental status changes  1  1/33 (3.03%) 
Renal and urinary disorders   
Renal failure  1  1/33 (3.03%) 
Renal failure acute  1  1/33 (3.03%) 
Renal tubular necrosis  1  1/33 (3.03%) 
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema  1  1/33 (3.03%) 
Dyspnoea  1  3/33 (9.09%) 
Hypoxia  1  1/33 (3.03%) 
Pleural effusion  1  1/33 (3.03%) 
Pneumonia aspiration  1  1/33 (3.03%) 
Respiratory distress  1  1/33 (3.03%) 
Respiratory failure  1  1/33 (3.03%) 
Vascular disorders   
Hypotension  1  1/33 (3.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Denosumab 120 mg Q4W
Affected / at Risk (%)
Total   26/33 (78.79%) 
Blood and lymphatic system disorders   
Anaemia  1  5/33 (15.15%) 
Febrile neutropenia  1  2/33 (6.06%) 
Neutropenia  1  2/33 (6.06%) 
Thrombocytopenia  1  3/33 (9.09%) 
Gastrointestinal disorders   
Abdominal distension  1  3/33 (9.09%) 
Abdominal pain  1  3/33 (9.09%) 
Constipation  1  7/33 (21.21%) 
Diarrhoea  1  7/33 (21.21%) 
Dry mouth  1  2/33 (6.06%) 
Nausea  1  10/33 (30.30%) 
Vomiting  1  7/33 (21.21%) 
General disorders   
Asthenia  1  2/33 (6.06%) 
Fatigue  1  6/33 (18.18%) 
Oedema peripheral  1  8/33 (24.24%) 
Pyrexia  1  4/33 (12.12%) 
Infections and infestations   
Pneumonia  1  3/33 (9.09%) 
Injury, poisoning and procedural complications   
Fall  1  2/33 (6.06%) 
Investigations   
Haemoglobin decreased  1  3/33 (9.09%) 
Weight decreased  1  4/33 (12.12%) 
Metabolism and nutrition disorders   
Decreased appetite  1  7/33 (21.21%) 
Fluid overload  1  5/33 (15.15%) 
Hyperkalaemia  1  2/33 (6.06%) 
Hypocalcaemia  1  3/33 (9.09%) 
Hypophosphataemia  1  4/33 (12.12%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  4/33 (12.12%) 
Back pain  1  4/33 (12.12%) 
Musculoskeletal pain  1  2/33 (6.06%) 
Myalgia  1  3/33 (9.09%) 
Pain in extremity  1  2/33 (6.06%) 
Nervous system disorders   
Depressed level of consciousness  1  2/33 (6.06%) 
Dizziness  1  2/33 (6.06%) 
Headache  1  8/33 (24.24%) 
Psychiatric disorders   
Confusional state  1  3/33 (9.09%) 
Insomnia  1  2/33 (6.06%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  6/33 (18.18%) 
Dysphonia  1  2/33 (6.06%) 
Dyspnoea  1  6/33 (18.18%) 
Epistaxis  1  3/33 (9.09%) 
Oropharyngeal pain  1  2/33 (6.06%) 
Pleural effusion  1  4/33 (12.12%) 
Pulmonary oedema  1  4/33 (12.12%) 
Rhinorrhoea  1  2/33 (6.06%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  3/33 (9.09%) 
Palmar-plantar erythrodysaesthesia syndrome  1  2/33 (6.06%) 
Rash  1  3/33 (9.09%) 
Rash pruritic  1  2/33 (6.06%) 
Vascular disorders   
Hypotension  1  3/33 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00896454     History of Changes
Other Study ID Numbers: 20070315
First Submitted: May 7, 2009
First Posted: May 11, 2009
Results First Submitted: December 19, 2014
Results First Posted: January 1, 2015
Last Update Posted: October 17, 2018