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Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.

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ClinicalTrials.gov Identifier: NCT01598987
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : January 24, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Renal Function
Liver Transplant
Intervention Drug: Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.
Enrollment 56
Recruitment Details  
Pre-assignment Details

Overall 62 patients were screened prior to the data monitoring committee (DMC) recommendation to terminate enrolment.

Six patients were screen failures. The other 56 patients were included and treated.

Arm/Group Title Everolimus Based Regimen
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Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).

The dosing schedule was twice daily, 12 hours apart.

Period Title: Baseline to Month 12
Started 56
Completed 50
Not Completed 6
Reason Not Completed
Administrative problems             2
Withdrawal by Subject             4
Period Title: Baseline to 24 Month
Started 56
Completed 48
Not Completed 8
Reason Not Completed
Withdrawal by Subject             5
Administrative problems             2
Lost to Follow-up             1
Arm/Group Title Everolimus Based Regimen
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Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).

The dosing schedule was twice daily, 12 hours apart.

Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
Full analysis set (FAS): consisted of all patients enrolled into the study, including patients who did not receive any everolimus, but were followed beyond baseline.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants
4.9  (4.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
25
  44.6%
Male
31
  55.4%
1.Primary Outcome
Title Change From Baseline in Estimated Glomerular Filtration Rate - Month 12
Hide Description Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 12.
Time Frame Baseline, Month 12
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Full Analysis Set
Arm/Group Title Everolimus Based Regimen
Hide Arm/Group Description:

Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).

The dosing schedule was twice daily, 12 hours apart.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
6.2  (19.52)
2.Secondary Outcome
Title Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Hide Description

The proportion of patients with composite efficacy failure (treated biopsy proven acute rejection[tBPAR], graft loss [GL] , death [D]) before/at Month 12 and Month 24, estimated with Kaplan-Meier (KM) methods and the proportion of patients who experienced any of the components of composite efficacy failure (tBPAR, GL, D) before/at Month 12 and Month 24, separately for each component.

AR: acute rejection; BPAR: biopsy proven acute rejection. Rate = Kaplan-Meier estimate for failure in %; CI = confidence interval for failure rate.

Time Frame At 12-month and 24-month after start of study drug
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Full Analysis Set
Arm/Group Title Everolimus Based Regimen
Hide Arm/Group Description:

Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).

The dosing schedule was twice daily, 12 hours apart.

Overall Number of Participants Analyzed 56
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: Percentages
Month 12: tBPAR,GL,or D
1.9
(0.0 to 4.2)
Month 12: tBPAR,GL,D,or loss to follow-up
1.9
(0.0 to 4.2)
Month 12: Treated BPAR
1.9
(0.0 to 4.2)
Month 12: Graft loss
0.0
(0.0 to 0.0)
Month 12: Death
0.0
(0.0 to 0.0)
Month 12: Graft loss or death
0.0
(0.0 to 0.0)
Month 12: BPAR
3.7
(0.4 to 7.0)
Month 12: Treated AR
3.6
(0.4 to 6.9)
Month 24: tBPAR,GL,or D
5.9
(0.3 to 11.5)
Month 24: tBPAR,GL,D,or loss to follow-up
9.7
(2.5 to 16.9)
Month 24: Treated BPAR
5.9
(0.3 to 11.5)
Month 24: Graft Loss
0.0
(0.0 to 0.0)
Month 24: Death
0.0
(0.0 to 0.0)
Month 24: Graft loss or death
0.0
(0.0 to 0.0)
Month 24: BPAR
11.9
(4.2 to 19.6)
Month 24: Treated AR
7.7
(1.7 to 13.6)
3.Secondary Outcome
Title Change From Baseline in Estimated Glomerular Filtration Rate - Month 24
Hide Description Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 24.
Time Frame Baseline, Month 24
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Hide Analysis Population Description
Full analysis set
Arm/Group Title Everolimus Based Regimen
Hide Arm/Group Description:

Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).

The dosing schedule was twice daily, 12 hours apart.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m2
4.5  (19.55)
4.Secondary Outcome
Title Growth Development - Height at Baseline and Month 12
Hide Description

Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.

Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile).

Time Frame Baseline, Month 12
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Safety Analysis Set
Arm/Group Title <=5% Percentile >5% - 25% Percentile >25% - 50% Percentile >50% - 75% Percentile >75% - 95% Percentile >95% Percentile Total
Hide Arm/Group Description:
Growth percentile category
Growth percentile category
Growth percentile category
Growth percentile categpru
Growth percentile category
Growth percentile category
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
Overall Number of Participants Analyzed 16 15 6 7 4 2 50
Measure Type: Number
Unit of Measure: Percentages
Decrease 0.0 26.7 16.7 14.3 25.0 0.0 14.0
No Change 68.8 20.0 33.3 28.6 50.0 100.0 44.0
Increase >3 to 5% 12.5 6.7 0.0 0.0 25.0 0.0 8.0
Increase >5 to 10% 0.0 20.0 16.7 14.3 0.0 0.0 10.0
Increase >10% 18.8 26.7 33.3 42.9 0.0 0.0 24.0
5.Secondary Outcome
Title Growth Development - Weight at Baseline and Month 12
Hide Description

Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.

Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile).

Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title <=5% Percentile >5% - 25% Percentile >25% - 50% Percentile >50% - 75% Percentile >75% - 95% Percentile >95% Percentile Total
Hide Arm/Group Description:
Growth percentile category
Growth percentile category
Growth percentile category
Growth percentile categpru
Growth percentile category
Growth percentile category
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
Overall Number of Participants Analyzed 15 10 7 11 6 1 50
Measure Type: Number
Unit of Measure: Percentages
Decrease 0.0 20.0 42.9 72.7 16.7 0.0 28.0
No Change 33.3 20.0 0.0 18.2 33.3 100.0 24.0
Increase >3 to 5% 0.0 0.0 0.0 0.0 16.7 0.0 2.0
Increase >5 to 10% 26.7 0.0 0.0 9.1 0.0 0.0 10.0
Increase >10% 40.0 60.0 57.1 0.0 33.3 0.0 36.0
6.Secondary Outcome
Title Growth Development - Weight at Baseline and Month 24
Hide Description

Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.

Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile).

Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title <=5% Percentile >5% - 25% Percentile >25% - 50% Percentile >50% - 75% Percentile >75% - 95% Percentile >95% Percentile Total
Hide Arm/Group Description:
Growth percentile category
Growth percentile category
Growth percentile category
Growth percentile categpru
Growth percentile category
Growth percentile category
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
Overall Number of Participants Analyzed 6 5 2 8 0 1 22
Measure Type: Number
Unit of Measure: Percentages
Decrease 0.0 40.0 100.0 12.5 0.0 22.7
No Change 50.0 0 0.0 25.0 100.0 27.3
Increase >3 to 5% 16.7 0 0.0 12.5 0.0 9.1
Increase >5 to 10% 16.7 20.0 0.0 12.5 0.0 13.6
Increase >10% 16.7 40.0 0.0 37.5 0.0 27.3
7.Secondary Outcome
Title Growth Development - Height at Baseline and Month 24
Hide Description

Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.

Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile).

Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title <=5% Percentile >5% - 25% Percentile >25% - 50% Percentile >50% - 75% Percentile >75% - 95% Percentile >95% Percentile Total
Hide Arm/Group Description:
Growth percentile category
Growth percentile category
Growth percentile category
Growth percentile categpru
Growth percentile category
Growth percentile category
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
Overall Number of Participants Analyzed 6 8 3 2 2 1 22
Measure Type: Number
Unit of Measure: Percentages
Decrease 0.0 12.5 33.3 0.0 0.0 0.0 9.00
No Change 50.0 12.5 0.0 0.0 50.0 100.0 27.3
Increase >3 to 5% 33.3 12.5 0.0 0.0 50.0 0.0 18.2
Increase >5 to 10% 0.0 0.0 33.3 0.0 0.0 0.0 4.5
Increase >10% 16.7 62.5 33.3 100.0 0.0 0.0 40.9
Time Frame Day 1 to month 24.
Adverse Event Reporting Description The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   43/56 (76.79%) 
Blood and lymphatic system disorders   
Anaemia  1  1/56 (1.79%) 
Haemolytic uraemic syndrome  1  1/56 (1.79%) 
Lymphadenopathy  1  1/56 (1.79%) 
Neutropenia  1  1/56 (1.79%) 
Splenic lesion  1  1/56 (1.79%) 
Cardiac disorders   
Tachycardia  1  1/56 (1.79%) 
Gastrointestinal disorders   
Abdominal adhesions  1  1/56 (1.79%) 
Abdominal pain  1  1/56 (1.79%) 
Aphthous ulcer  1  1/56 (1.79%) 
Constipation  1  1/56 (1.79%) 
Diarrhoea  1  1/56 (1.79%) 
Enterocolitis haemorrhagic  1  1/56 (1.79%) 
Internal hernia  1  1/56 (1.79%) 
Intestinal haemorrhage  1  1/56 (1.79%) 
Mouth ulceration  1  3/56 (5.36%) 
Oesophagitis  1  1/56 (1.79%) 
Small intestinal obstruction  1  1/56 (1.79%) 
Stomatitis  1  2/56 (3.57%) 
Vomiting  1  1/56 (1.79%) 
General disorders   
Chest pain  1  1/56 (1.79%) 
General physical health deterioration  1  1/56 (1.79%) 
Pyrexia  1  9/56 (16.07%) 
Hepatobiliary disorders   
Bile duct stenosis  1  2/56 (3.57%) 
Cholangitis  1  6/56 (10.71%) 
Hepatic function abnormal  1  1/56 (1.79%) 
Hepatic steatosis  1  2/56 (3.57%) 
Hepatic vein occlusion  1  1/56 (1.79%) 
Hepatocellular injury  1  1/56 (1.79%) 
Portal fibrosis  1  1/56 (1.79%) 
Immune system disorders   
Food allergy  1  1/56 (1.79%) 
Transplant rejection  1  2/56 (3.57%) 
Infections and infestations   
Adenoviral upper respiratory infection  1  1/56 (1.79%) 
Adenovirus infection  1  3/56 (5.36%) 
Alpha haemolytic streptococcal infection  1  1/56 (1.79%) 
Bacterial pyelonephritis  1  1/56 (1.79%) 
Bronchitis  1  1/56 (1.79%) 
Catheter site infection  1  1/56 (1.79%) 
Cholangitis infective  1  1/56 (1.79%) 
Clostridium difficile infection  1  1/56 (1.79%) 
Croup infectious  1  1/56 (1.79%) 
Cytomegalovirus viraemia  1  1/56 (1.79%) 
Diarrhoea infectious  1  1/56 (1.79%) 
Ear infection  1  1/56 (1.79%) 
Enteritis infectious  1  1/56 (1.79%) 
Enterovirus infection  1  2/56 (3.57%) 
Epstein-Barr viraemia  1  3/56 (5.36%) 
Epstein-Barr virus infection  1  2/56 (3.57%) 
Escherichia infection  1  1/56 (1.79%) 
Gastroenteritis  1  6/56 (10.71%) 
Gastroenteritis adenovirus  1  1/56 (1.79%) 
Gastroenteritis rotavirus  1  1/56 (1.79%) 
Gastroenteritis sapovirus  1  2/56 (3.57%) 
Gastrointestinal infection  1  1/56 (1.79%) 
Infection  1  2/56 (3.57%) 
Lower respiratory tract infection  1  2/56 (3.57%) 
Mastoiditis  1  1/56 (1.79%) 
Oral candidiasis  1  1/56 (1.79%) 
Oral viral infection  1  1/56 (1.79%) 
Otitis media  1  1/56 (1.79%) 
Paronychia  1  1/56 (1.79%) 
Pneumonia  1  7/56 (12.50%) 
Pneumonia respiratory syncytial viral  1  1/56 (1.79%) 
Puncture site infection  1  1/56 (1.79%) 
Respiratory tract infection  1  2/56 (3.57%) 
Rhinovirus infection  1  1/56 (1.79%) 
Rotavirus infection  1  1/56 (1.79%) 
Scarlet fever  1  1/56 (1.79%) 
Sepsis  1  2/56 (3.57%) 
Staphylococcal infection  1  1/56 (1.79%) 
Tonsillitis  1  1/56 (1.79%) 
Upper respiratory tract infection  1  3/56 (5.36%) 
Urinary tract infection  1  3/56 (5.36%) 
Varicella zoster virus infection  1  1/56 (1.79%) 
Viral infection  1  1/56 (1.79%) 
Wound infection  1  1/56 (1.79%) 
Injury, poisoning and procedural complications   
Biliary anastomosis complication  1  2/56 (3.57%) 
Complications of transplanted liver  1  1/56 (1.79%) 
Fibula fracture  1  1/56 (1.79%) 
Incisional hernia  1  1/56 (1.79%) 
Tibia fracture  1  1/56 (1.79%) 
Transplant failure  1  1/56 (1.79%) 
Investigations   
Alanine aminotransferase increased  1  2/56 (3.57%) 
Blood creatinine increased  1  1/56 (1.79%) 
Body temperature increased  1  1/56 (1.79%) 
C-reactive protein increased  1  1/56 (1.79%) 
Drug level increased  1  1/56 (1.79%) 
Hepatic enzyme increased  1  5/56 (8.93%) 
Liver function test increased  1  2/56 (3.57%) 
Weight decreased  1  1/56 (1.79%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/56 (1.79%) 
Dehydration  1  4/56 (7.14%) 
Hypovolaemia  1  1/56 (1.79%) 
Metabolic acidosis  1  1/56 (1.79%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Post transplant lymphoproliferative disorder  1  5/56 (8.93%) 
Nervous system disorders   
Headache  1  1/56 (1.79%) 
Psychiatric disorders   
Food aversion  1  1/56 (1.79%) 
Renal and urinary disorders   
Acute kidney injury  1  1/56 (1.79%) 
Proteinuria  1  1/56 (1.79%) 
Renal failure  1  1/56 (1.79%) 
Respiratory, thoracic and mediastinal disorders   
Adenoidal hypertrophy  1  1/56 (1.79%) 
Cough  1  2/56 (3.57%) 
Lung infiltration  1  1/56 (1.79%) 
Organising pneumonia  1  1/56 (1.79%) 
Stridor  1  1/56 (1.79%) 
Skin and subcutaneous tissue disorders   
Angioedema  1  1/56 (1.79%) 
Dermal cyst  1  1/56 (1.79%) 
Swelling face  1  1/56 (1.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   51/56 (91.07%) 
Blood and lymphatic system disorders   
Anaemia  1  6/56 (10.71%) 
Neutropenia  1  4/56 (7.14%) 
Ear and labyrinth disorders   
Ear pain  1  3/56 (5.36%) 
Gastrointestinal disorders   
Abdominal pain  1  7/56 (12.50%) 
Abdominal pain upper  1  3/56 (5.36%) 
Constipation  1  3/56 (5.36%) 
Diarrhoea  1  22/56 (39.29%) 
Mouth ulceration  1  6/56 (10.71%) 
Nausea  1  4/56 (7.14%) 
Stomatitis  1  5/56 (8.93%) 
Vomiting  1  15/56 (26.79%) 
General disorders   
Fatigue  1  4/56 (7.14%) 
Pain  1  3/56 (5.36%) 
Pyrexia  1  22/56 (39.29%) 
Infections and infestations   
Bronchitis  1  5/56 (8.93%) 
Conjunctivitis  1  6/56 (10.71%) 
Cytomegalovirus viraemia  1  5/56 (8.93%) 
Diarrhoea infectious  1  3/56 (5.36%) 
Ear infection  1  6/56 (10.71%) 
Epstein-Barr viraemia  1  10/56 (17.86%) 
Epstein-Barr virus infection  1  7/56 (12.50%) 
Eye infection  1  3/56 (5.36%) 
Gastroenteritis  1  5/56 (8.93%) 
Influenza  1  5/56 (8.93%) 
Nasopharyngitis  1  15/56 (26.79%) 
Otitis media  1  3/56 (5.36%) 
Rhinitis  1  5/56 (8.93%) 
Tonsillitis  1  5/56 (8.93%) 
Upper respiratory tract infection  1  14/56 (25.00%) 
Injury, poisoning and procedural complications   
Contusion  1  4/56 (7.14%) 
Fall  1  3/56 (5.36%) 
Investigations   
Alanine aminotransferase increased  1  3/56 (5.36%) 
Blood creatine phosphokinase increased  1  7/56 (12.50%) 
Hepatic enzyme increased  1  4/56 (7.14%) 
Metabolism and nutrition disorders   
Hypokalaemia  1  4/56 (7.14%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  4/56 (7.14%) 
Nervous system disorders   
Headache  1  3/56 (5.36%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  7/56 (12.50%) 
Epistaxis  1  3/56 (5.36%) 
Oropharyngeal pain  1  3/56 (5.36%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  4/56 (7.14%) 
Rash  1  3/56 (5.36%) 
Vascular disorders   
Hypertension  1  3/56 (5.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 19.0
Based on DMC recommendation, enrolment was terminated and patients below 7 years were converted form study medication to local standard of care but patients were followed up until Month 24.
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01598987     History of Changes
Other Study ID Numbers: CRAD001H2305
2011-003069-14
First Submitted: March 1, 2012
First Posted: May 15, 2012
Results First Submitted: November 30, 2016
Results First Posted: January 24, 2017
Last Update Posted: May 16, 2017