Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 190 for:    Oral Cancer | ( Map: Mexico )

An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01339260
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : November 26, 2014
Last Update Posted : November 26, 2014
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Helsinn Healthcare SA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Chemotherapy-Induced Nausea and Vomiting
Interventions Drug: Netupitant and Palonosetron
Drug: Palonosetron
Drug: Dexamethasone
Enrollment 1455
Recruitment Details  
Pre-assignment Details 1455 patients randomized (ITT population), 1450 received study drug i.e. netupitant/palonosetron combination or palonosetron, both with dexamethasone, in cycle 1 (safety population-cycle 1), 1449 received chemotherapy and study drug (FAS), 1286 received study drug in multi-cycle extension (safety population-multi-cycle extension)
Arm/Group Title Netupitant and Palonosetron Plus Dexamethasone Palonosetron Plus Dexamethasone
Hide Arm/Group Description

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle

Netupitant and Palonosetron

Dexamethasone

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle

Palonosetron

Dexamethasone

Period Title: Cycle 1
Started 726 [1] 729 [1]
Safety Population 725 [2] 725 [3]
Full Analysis Set 724 [4] 725 [5]
Completed 719 719
Not Completed 7 10
[1]
Intent-To-Treat: randomized patients
[2]
Patients receiving netupitant/palonosetron combination
[3]
Patients receiving palonosetron
[4]
Patients receiving chemotherapy and randomized to netupitant/palonosetron combination
[5]
Patients receiving chemotherapy and randomized to palonosetron
Period Title: Multi-cycle Extension
Started 635 [1] 651 [2]
Safety Population 635 [3] 651 [4]
Completed 449 [5] 458 [5]
Not Completed 186 193
[1]
Patients scheduled to netupitant/palonosetron combination
[2]
Patients scheduled to palonosetron
[3]
Patients receiving netupitant/palonosetron combination
[4]
Patients receiving palonosetron
[5]
Patients completing at least number of cycles they were scheduled to
Arm/Group Title Netupitant and Palonosetron Plus Dexamethasone Palonosetron Plus Dexamethasone Total
Hide Arm/Group Description

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle

Netupitant and Palonosetron

Dexamethasone

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle

Palonosetron

Dexamethasone

Total of all reporting groups
Overall Number of Baseline Participants 725 725 1450
Hide Baseline Analysis Population Description
Safety population ie patients receiving either netupitant/palonosetron combination or palonosetron, both plus dexamethasone
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 725 participants 725 participants 1450 participants
53.7  (10.66) 54.1  (10.65) 53.9  (10.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 725 participants 725 participants 1450 participants
Female
711
  98.1%
711
  98.1%
1422
  98.1%
Male
14
   1.9%
14
   1.9%
28
   1.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 725 participants 725 participants 1450 participants
White 574 579 1153
Black 1 3 4
Asian 101 103 204
Hispanic 46 36 82
Other 3 4 7
1.Primary Outcome
Title Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
Hide Description [Not Specified]
Time Frame 25-120 hours
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Netupitant and Palonosetron Plus Dexamethasone Palonosetron Plus Dexamethasone
Hide Arm/Group Description:

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle

Netupitant and Palonosetron

Dexamethasone

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle

Palonosetron

Dexamethasone

Overall Number of Participants Analyzed 724 725
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
76.9
(73.7 to 79.9)
69.5
(66.1 to 72.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Netupitant and Palonosetron Plus Dexamethasone, Palonosetron Plus Dexamethasone
Comments The null hypothesis was rejected if the 2 sided p value from the Cochran Mantel Haenszel test was less than or equal to 0.050 and in the right direction i.e., the Odds Ratio (OR) was in favor of netupitant/palonosetron. Power was 90%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments If superiority of netupitant/palonosetron was established for the CR delayed, CR acute and then CR overall at cycle 1 were to be tested according to a hierarchical procedure;no adjustment for multiplicity was needed.The a priori threshold was 0.050
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
1.16 to 1.87
Estimation Comments Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.
2.Secondary Outcome
Title Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1
Hide Description [Not Specified]
Time Frame 0-24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Netupitant and Palonosetron Plus Dexamethasone Palonosetron Plus Dexamethasone
Hide Arm/Group Description:

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle

Netupitant and Palonosetron

Dexamethasone

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle

Palonosetron

Dexamethasone

Overall Number of Participants Analyzed 724 725
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
88.4
(85.9 to 90.5)
85.0
(82.2 to 87.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Netupitant and Palonosetron Plus Dexamethasone, Palonosetron Plus Dexamethasone
Comments CR in the acute phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the acute phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments If the null hypothesis for CR delayed was rejected, analysis of the first key secondary endpoint CR acute was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.
Method Cochran-Mantel-Haenszel
Comments Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
1.0 to 1.87
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
Hide Description [Not Specified]
Time Frame 0-120 hours
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Netupitant and Palonosetron Plus Dexamethasone Palonosetron Plus Dexamethasone
Hide Arm/Group Description:

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle

Netupitant and Palonosetron

Dexamethasone

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle

Palonosetron

Dexamethasone

Overall Number of Participants Analyzed 724 725
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
74.3
(71.0 to 77.4)
66.6
(63.1 to 70.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Netupitant and Palonosetron Plus Dexamethasone, Palonosetron Plus Dexamethasone
Comments CR in the overall phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the overall phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments If the null hypothesis for CR acute was rejected, analysis of the 2nd key secondary endpoint CR overall was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.
Method Cochran-Mantel-Haenszel
Comments Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
1.17 to 1.85
Estimation Comments [Not Specified]
Time Frame Period from time of informed consent signature until 21 days post study drugs (Day 1 of the last cycle). Upon Investigator's judgment, all non resolved, non serious Adverse Events (AEs) beyond this date could have been followed for an additional 14 days
Adverse Event Reporting Description AEs are presented separately for cycle 1 and for multi-cycle extension (i.e. without Cycle 1), consistent with Analysis Plan and Clinical Study Report
 
Arm/Group Title Netupitant and Palonosetron+Dexamethasone-cycle 1 Palonosetron+Dexamethasone-cycle 1 Netupitant and Palonosetron+Dexamethasone-multicycle Extension Palonosetron+Dexamethasone-multicycle Extension
Hide Arm/Group Description Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
All-Cause Mortality
Netupitant and Palonosetron+Dexamethasone-cycle 1 Palonosetron+Dexamethasone-cycle 1 Netupitant and Palonosetron+Dexamethasone-multicycle Extension Palonosetron+Dexamethasone-multicycle Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Netupitant and Palonosetron+Dexamethasone-cycle 1 Palonosetron+Dexamethasone-cycle 1 Netupitant and Palonosetron+Dexamethasone-multicycle Extension Palonosetron+Dexamethasone-multicycle Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/725 (1.79%)   12/725 (1.66%)   23/635 (3.62%)   15/651 (2.30%) 
Blood and lymphatic system disorders         
Febrile neutropenia * 1  4/725 (0.55%)  3/725 (0.41%)  6/635 (0.94%)  4/651 (0.61%) 
Leukopenia * 1  2/725 (0.28%)  0/725 (0.00%)  1/635 (0.16%)  2/651 (0.31%) 
Neutropenia * 1  2/725 (0.28%)  1/725 (0.14%)  6/635 (0.94%)  1/651 (0.15%) 
Anaemia * 1  0/725 (0.00%)  0/725 (0.00%)  2/635 (0.31%)  0/651 (0.00%) 
Thrombocytopenia * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Cardiac disorders         
Atrial fibrillation * 1  0/725 (0.00%)  1/725 (0.14%)  0/635 (0.00%)  1/651 (0.15%) 
Cytotoxic cardiomyopathy * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Cardiac failure acute * 1  0/725 (0.00%)  1/725 (0.14%)  0/635 (0.00%)  0/651 (0.00%) 
Gastrointestinal disorders         
Vomiting * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  1/651 (0.15%) 
Gastrooesophageal reflux disease * 1  1/725 (0.14%)  0/725 (0.00%)  0/635 (0.00%)  0/651 (0.00%) 
Mouth ulceration * 1  1/725 (0.14%)  0/725 (0.00%)  0/635 (0.00%)  0/651 (0.00%) 
Nausea * 1  0/725 (0.00%)  1/725 (0.14%)  0/635 (0.00%)  0/651 (0.00%) 
Stomatitis * 1  2/725 (0.28%)  0/725 (0.00%)  0/635 (0.00%)  0/651 (0.00%) 
Anal fissure * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
General disorders         
Asthenia * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
General physical health deterioration * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Mucosal inflammation * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Pyrexia * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Chills * 1  0/725 (0.00%)  1/725 (0.14%)  0/635 (0.00%)  0/651 (0.00%) 
Infections and infestations         
Pneumonia * 1  1/725 (0.14%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Appendicitis * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Device relatet infections * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Erysipelas * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Gastrointestinal infection * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Herpes zoster * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Septic shock * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Skin infection * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Soft tissue infection * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Cellulitis * 1  0/725 (0.00%)  1/725 (0.14%)  0/635 (0.00%)  0/651 (0.00%) 
Urinary tract infection * 1  2/725 (0.28%)  0/725 (0.00%)  0/635 (0.00%)  0/651 (0.00%) 
Injury, poisoning and procedural complications         
Femoral neck fracture * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Femur fracture * 1  1/725 (0.14%)  0/725 (0.00%)  0/635 (0.00%)  0/651 (0.00%) 
Investigations         
Fibrin D dimer increased * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Metabolism and nutrition disorders         
Hypokalaemia * 1  1/725 (0.14%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Dehydration * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Electrolyte imbalance * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Musculoskeletal and connective tissue disorders         
Pathological fracture * 1  1/725 (0.14%)  0/725 (0.00%)  0/635 (0.00%)  0/651 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer metastatic * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Cervix carcinoma * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Metastases to central nervous system * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Nervous system disorders         
Hypoaesthesia * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Reproductive system and breast disorders         
Metrorrhagia * 1  1/725 (0.14%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Endometrial hyperplasia * 1  0/725 (0.00%)  1/725 (0.14%)  0/635 (0.00%)  0/651 (0.00%) 
Ovarian cyst * 1  0/725 (0.00%)  1/725 (0.14%)  0/635 (0.00%)  0/651 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Acute respiratory failure * 1  0/725 (0.00%)  1/725 (0.14%)  0/635 (0.00%)  0/651 (0.00%) 
Haemoptysis * 1  1/725 (0.14%)  0/725 (0.00%)  0/635 (0.00%)  0/651 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis contact * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Surgical and medical procedures         
Central venous catheterisation * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Catheterisation venous * 1  0/725 (0.00%)  1/725 (0.14%)  0/635 (0.00%)  0/651 (0.00%) 
Vascular disorders         
Arterial thrombosis limb * 1  0/725 (0.00%)  0/725 (0.00%)  1/635 (0.16%)  0/651 (0.00%) 
Venous recanalisation * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Venous thrombosis * 1  0/725 (0.00%)  0/725 (0.00%)  0/635 (0.00%)  1/651 (0.15%) 
Thrombophlebitis * 1  0/725 (0.00%)  1/725 (0.14%)  0/635 (0.00%)  0/651 (0.00%) 
Thrombosis * 1  0/725 (0.00%)  2/725 (0.28%)  0/635 (0.00%)  0/651 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Netupitant and Palonosetron+Dexamethasone-cycle 1 Palonosetron+Dexamethasone-cycle 1 Netupitant and Palonosetron+Dexamethasone-multicycle Extension Palonosetron+Dexamethasone-multicycle Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   551/725 (76.00%)   507/725 (69.93%)   533/635 (83.94%)   527/651 (80.95%) 
Blood and lymphatic system disorders         
Leukopenia * 1  96/725 (13.24%)  90/725 (12.41%)  138/635 (21.73%)  141/651 (21.66%) 
Neutropenia * 1  173/725 (23.86%)  182/725 (25.10%)  226/635 (35.59%)  238/651 (36.56%) 
Anaemia * 1  26/725 (3.59%)  24/725 (3.31%)  47/635 (7.40%)  41/651 (6.30%) 
Gastrointestinal disorders         
Constipation * 1  31/725 (4.28%)  26/725 (3.59%)  27/635 (4.25%)  33/651 (5.07%) 
Diarrhoea * 1  13/725 (1.79%)  10/725 (1.38%)  33/635 (5.20%)  21/651 (3.23%) 
Nausea * 1  22/725 (3.03%)  27/725 (3.72%)  27/635 (4.25%)  35/651 (5.38%) 
General disorders         
Asthenia * 1  59/725 (8.14%)  50/725 (6.90%)  70/635 (11.02%)  69/651 (10.60%) 
Fatigue * 1  47/725 (6.48%)  38/725 (5.24%)  49/635 (7.72%)  49/651 (7.53%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  25/725 (3.45%)  32/725 (4.41%)  28/635 (4.41%)  42/651 (6.45%) 
Hyperglycaemia * 1  24/725 (3.31%)  25/725 (3.45%)  45/635 (7.09%)  43/651 (6.61%) 
Nervous system disorders         
Headache * 1  64/725 (8.83%)  52/725 (7.17%)  53/635 (8.35%)  57/651 (8.76%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  253/725 (34.90%)  253/725 (34.90%)  152/635 (23.94%)  151/651 (23.20%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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.
Sponsor and investigator(s) agree that no publications discussing trials' results will occur until release of final report. Sponsor has no objections if the investigators publish study results, however the investigator is requested to contact the sponsor before publishing, to prevent premature disclosure of data and is not intended as a restrictive measure concerning results or opinions of investigators.
Results Point of Contact
Name/Title: Head of Clinical Development
Organization: Helsinn Healthcare SA
Phone: +41 91 9852121
Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT01339260     History of Changes
Other Study ID Numbers: NETU-08-18
First Submitted: April 19, 2011
First Posted: April 20, 2011
Results First Submitted: November 6, 2014
Results First Posted: November 26, 2014
Last Update Posted: November 26, 2014