A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

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ClinicalTrials.gov Identifier: NCT01100502

Recruitment Status : Completed

First Posted : April 9, 2010

Results First Posted : November 11, 2015

Last Update Posted : May 14, 2021

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Sponsor:

Collaborator:

Millennium Pharmaceuticals, Inc.

Information provided by (Responsible Party):

Seagen Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Disease, Hodgkin
Interventions	Drug: brentuximab vedotin Drug: placebo
Enrollment	329

Participant Flow

Recruitment Details	Apr 2010-Aug 2014
Pre-assignment Details


Arm/Group Title	Brentuximab Vedotin	Placebo
Arm/Group Description	brentuximab vedotin 1.8 mg/kg every...	placebo every 3 weeks by IV infusio...
Arm/Group Description	brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion	placebo every 3 weeks by IV infusion
Period Title: Overall Study
Started	165	164
Completed	89 ^[1]	70 ^[1]
Not Completed	76	94
Reason Not Completed
Withdrawal by Subject	18	25
Lost to Follow-up	13	28
Site request to end participation in study	0	1
Death	45	40
[1] Completed due to study closure by sponsor

Baseline Characteristics

Arm/Group Title		Brentuximab Vedotin	Placebo	Total
Arm/Group Description		brentuximab vedotin 1.8 mg/kg every...	placebo every 3 weeks by IV infusio...	Total of all reporting groups
Arm/Group Description		brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion	placebo every 3 weeks by IV infusion	Total of all reporting groups
Overall Number of Baseline Participants		165	164	329
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Intention-to-Treat analysis set
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	165 participants	164 participants	329 participants
		33 (18 to 71)	32 (18 to 76)	32 (18 to 76)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	165 participants	164 participants	329 participants
	Female	89 53.9%	67 40.9%	156 47.4%
	Male	76 46.1%	97 59.1%	173 52.6%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	165 participants	164 participants	329 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	2 1.2%	3 1.8%	5 1.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	10 6.1%	2 1.2%	12 3.6%
	White	153 92.7%	156 95.1%	309 93.9%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	3 1.8%	3 0.9%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	165 participants	164 participants	329 participants
Russian Federation		20 12.1%	19 11.6%	39 11.9%
Romania		4 2.4%	6 3.7%	10 3.0%
Hungary		9 5.5%	11 6.7%	20 6.1%
United States		67 40.6%	68 41.5%	135 41.0%
United Kingdom		3 1.8%	3 1.8%	6 1.8%
Spain		4 2.4%	6 3.7%	10 3.0%
Czech Republic		5 3.0%	0 0.0%	5 1.5%
Poland		26 15.8%	28 17.1%	54 16.4%
Italy		9 5.5%	7 4.3%	16 4.9%
France		8 4.8%	5 3.0%	13 4.0%
Serbia		3 1.8%	6 3.7%	9 2.7%
Bulgaria		7 4.2%	2 1.2%	9 2.7%
Germany		0 0.0%	3 1.8%	3 0.9%
Eastern Cooperative Oncology Group Performance Status ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	165 participants	164 participants	329 participants
0		87 52.7%	97 59.1%	184 55.9%
1		77 46.7%	67 40.9%	144 43.8%
2		1 0.6%	0 0.0%	1 0.3%
		[1] Measure Description: 0=Normal activity; 1=Symptoms but ambulatory; 2=In bed <50% of the time; 3= In bed >50% of the time; 4=100% bedridden; 5=Dead
Hodgkin Lymphoma Status after end of Frontline Therapy Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	165 participants	164 participants	329 participants
Refractory		99 60.0%	97 59.1%	196 59.6%
Relapse in less than 12 months		53 32.1%	54 32.9%	107 32.5%
Relapse 12 months or later with extranodal disease		13 7.9%	13 7.9%	26 7.9%
Best Response to Salvage Therapy pre-ASCT Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	165 participants	164 participants	329 participants
Complete remission		61 37.0%	62 37.8%	123 37.4%
Partial remission		57 34.5%	56 34.1%	113 34.3%
Stable disease		47 28.5%	46 28.0%	93 28.3%

Outcome Measures

1.Primary Outcome


Title	Progression-free Survival by Independent Review
Description	Time from date of randomization to the first documentation of disease ...
Description	Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first
Time Frame	Up to approximately 4 years

Outcome Measure Data

Analysis Population Description

Intention-to-Treat analysis set


Arm/Group Title	Brentuximab Vedotin	Placebo
Arm/Group Description:	brentuximab vedotin 1.8 mg/kg every...	placebo every 3 weeks by IV infusio...
Arm/Group Description:	brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion	placebo every 3 weeks by IV infusion
Overall Number of Participants Analyzed	165	164
Median (95% Confidence Interval) Unit of Measure: months
	42.9 (30.4 to 42.9)	24.1 ^[1] (11.5 to NA)

[1]

Follow-up is not long enough to estimate an upper bound for median progression-free survival

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brentuximab Vedotin, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 95% 0.40 to 0.81
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival
Description	Time from date of randomization to date of death due to any cause
Description	Time from date of randomization to date of death due to any cause
Time Frame	Up to approximately 10 years

Outcome Measure Data

Analysis Population Description

Intention-to-Treat analysis set


Arm/Group Title	Brentuximab Vedotin	Placebo
Arm/Group Description:	brentuximab vedotin 1.8 mg/kg every...	placebo every 3 weeks by IV infusio...
Arm/Group Description:	brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion	placebo every 3 weeks by IV infusion
Overall Number of Participants Analyzed	165	164
Median (Full Range) Unit of Measure: months
	NA ^[1] (1.31 to 117.88)	NA ^[2] (0.03 to 119.23)

[1]

Due to patients lost to follow up, patient withdrawal of consent and post ASCT therapies; there were less deaths on study than anticipated. Therefore, median OS was not reached.

[2]

Due to patients lost to follow up, patient withdrawal of consent and post ASCT therapies; there were less deaths on study than anticipated. Therefore, median OS was not reached

3.Secondary Outcome


Title	Incidence of Adverse Events or Laboratory Abnormalities
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis


Arm/Group Title	Brentuximab Vedotin	Placebo
Arm/Group Description:	brentuximab vedotin 1.8 mg/kg every...	placebo every 3 weeks by IV infusio...
Arm/Group Description:	brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion	placebo every 3 weeks by IV infusion
Overall Number of Participants Analyzed	167	160
Measure Type: Number Unit of Measure: participants
Any Treatment-Emergent Adverse Event	163	142
Any Treatment-Related Adverse Event	147	79
Any Adverse Event with Severity >= Grade 3	93	51
Any Serious Adverse Event	41	20
Any Treatment-Related Serious Adverse Events	19	7
Treatment Discontinuation Due to Adverse Event	54	10
Any Laboratory Abnormalities Severity >=Grade 3	69	29

4.Secondary Outcome


Title	Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample)


Arm/Group Title	Brentuximab Vedotin	Placebo
Arm/Group Description:	brentuximab vedotin 1.8 mg/kg every...	placebo every 3 weeks by IV infusio...
Arm/Group Description:	brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion	placebo every 3 weeks by IV infusion
Overall Number of Participants Analyzed	157	154
Measure Type: Number Unit of Measure: participants
Baseline Negative	138	142
Baseline Negative: -'ve Postbaseline	92	104
Baseline Negative: Transiently +'ve Postbaseline	36	27
Baseline Negative: Persistently +'ve Postbaseline	10	11
Baseline Positive	19	12
Baseline Positive: -'ve Postbaseline	7	0
Baseline Positive: Transiently +'ve Postbaseline	9	5
Baseline Positive: Persistently +'ve Postbaseline	3	7

Adverse Events

Time Frame	Non-serious adverse events were followed for up to 15 months. Serious adverse event data were collected for up to approximately 10 years (116 months).
Adverse Event Reporting Description	Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis

Arm/Group Title	Placebo	Brentuximab Vedotin
Arm/Group Description	placebo every 3 weeks by IV infusio...	brentuximab vedotin 1.8 mg/kg every...
Arm/Group Description	placebo every 3 weeks by IV infusion	brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
All-Cause Mortality
	Placebo	Brentuximab Vedotin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	40/160 (25.00%)	45/167 (26.95%)
Serious Adverse Events Serious Adverse Events
	Placebo	Brentuximab Vedotin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	21/160 (13.13%)	43/167 (25.75%)
Blood and lymphatic system disorders
Bone marrow failure ^† 1	1/160 (0.63%)	0/167 (0.00%)
Neutropenia ^† 1	1/160 (0.63%)	1/167 (0.60%)
Thrombocytopenia ^† 1	2/160 (1.25%)	0/167 (0.00%)
Cardiac disorders
Bradycardia ^† 1	0/160 (0.00%)	1/167 (0.60%)
Cardiac failure congestive ^† 1	0/160 (0.00%)	1/167 (0.60%)
Myocardial infarction ^† 1	0/160 (0.00%)	1/167 (0.60%)
Pericardial effusion ^† 1	1/160 (0.63%)	0/167 (0.00%)
Sinus tachycardia ^† 1	0/160 (0.00%)	1/167 (0.60%)
Gastrointestinal disorders
Abdominal pain ^† 1	1/160 (0.63%)	1/167 (0.60%)
Constipation ^† 1	0/160 (0.00%)	2/167 (1.20%)
Diarrhoea ^† 1	1/160 (0.63%)	1/167 (0.60%)
Epigastric discomfort ^† 1	0/160 (0.00%)	1/167 (0.60%)
Erosive duodenitis ^† 1	0/160 (0.00%)	1/167 (0.60%)
Gastrointestinal haemorrhage ^† 1	1/160 (0.63%)	0/167 (0.00%)
Nausea ^† 1	1/160 (0.63%)	4/167 (2.40%)
Pancreatitis acute ^† 1	0/160 (0.00%)	1/167 (0.60%)
Vomiting ^† 1	1/160 (0.63%)	5/167 (2.99%)
General disorders
Asthenia ^† 1	0/160 (0.00%)	1/167 (0.60%)
Disease progression ^† 1	0/160 (0.00%)	1/167 (0.60%)
Pyrexia ^† 1	2/160 (1.25%)	6/167 (3.59%)
Hepatobiliary disorders
Hepatotoxicity ^† 1	1/160 (0.63%)	3/167 (1.80%)
Infections and infestations
Acute hepatitis b ^† 1	0/160 (0.00%)	1/167 (0.60%)
Appendicitis ^† 1	0/160 (0.00%)	1/167 (0.60%)
Hepatic candidiasis ^† 1	0/160 (0.00%)	1/167 (0.60%)
Herpes zoster ^† 1	1/160 (0.63%)	2/167 (1.20%)
Pneumocystis jirovecii pneumonia ^† 1	0/160 (0.00%)	1/167 (0.60%)
Pneumonia ^† 1	4/160 (2.50%)	7/167 (4.19%)
Septic shock ^† 1	1/160 (0.63%)	0/167 (0.00%)
Sinusitis ^† 1	1/160 (0.63%)	0/167 (0.00%)
Upper respiratory tract infection ^† 1	1/160 (0.63%)	1/167 (0.60%)
Injury, poisoning and procedural complications
Radiation myelopathy ^† 1	0/160 (0.00%)	1/167 (0.60%)
Investigations
Blood bilirubin increased ^† 1	1/160 (0.63%)	0/167 (0.00%)
Metabolism and nutrition disorders
Hyperglycaemia ^† 1	0/160 (0.00%)	1/167 (0.60%)
Musculoskeletal and connective tissue disorders
Bone pain ^† 1	1/160 (0.63%)	0/167 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia ^† 1	1/160 (0.63%)	1/167 (0.60%)
Anogenital warts ^† 1	0/160 (0.00%)	1/167 (0.60%)
Bladder cancer ^† 1	0/160 (0.00%)	1/167 (0.60%)
Brain neoplasm ^† 1	0/160 (0.00%)	1/167 (0.60%)
Mantle cell lymphoma ^† 1	1/160 (0.63%)	0/167 (0.00%)
Metastases to spine ^† 1	1/160 (0.63%)	0/167 (0.00%)
Myelodysplastic syndrome ^† 1	1/160 (0.63%)	1/167 (0.60%)
Nervous system disorders
Basilar migraine ^† 1	0/160 (0.00%)	1/167 (0.60%)
Headache ^† 1	0/160 (0.00%)	2/167 (1.20%)
Neuralgia ^† 1	0/160 (0.00%)	1/167 (0.60%)
Peripheral motor neuropathy ^† 1	0/160 (0.00%)	1/167 (0.60%)
Peripheral sensory neuropathy ^† 1	0/160 (0.00%)	3/167 (1.80%)
Presyncope ^† 1	0/160 (0.00%)	1/167 (0.60%)
Syncope ^† 1	0/160 (0.00%)	1/167 (0.60%)
Psychiatric disorders
Anxiety ^† 1	1/160 (0.63%)	0/167 (0.00%)
Depression ^† 1	0/160 (0.00%)	1/167 (0.60%)
Depression suicidal ^† 1	1/160 (0.63%)	0/167 (0.00%)
Suicidal ideation ^† 1	0/160 (0.00%)	1/167 (0.60%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome ^† 1	1/160 (0.63%)	2/167 (1.20%)
Asthma ^† 1	1/160 (0.63%)	0/167 (0.00%)
Bronchospasm ^† 1	0/160 (0.00%)	1/167 (0.60%)
Idiopathic pneumonia syndrome ^† 1	1/160 (0.63%)	0/167 (0.00%)
Lung infiltration ^† 1	1/160 (0.63%)	0/167 (0.00%)
Pneumonitis ^† 1	0/160 (0.00%)	2/167 (1.20%)
Pulmonary embolism ^† 1	0/160 (0.00%)	1/167 (0.60%)
Pulmonary toxicity ^† 1	0/160 (0.00%)	1/167 (0.60%)
Skin and subcutaneous tissue disorders
Pruritus ^† 1	0/160 (0.00%)	1/167 (0.60%)
Rash ^† 1	0/160 (0.00%)	1/167 (0.60%)
Dermatitis allergic ^† 1	0/160 (0.00%)	2/167 (1.20%)
Vascular disorders
Pelvic venous thrombosis ^† 1	0/160 (0.00%)	1/167 (0.60%)
Hypotension ^† 1	0/160 (0.00%)	1/167 (0.60%)
1 Term from vocabulary, MedDRA 23.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	Brentuximab Vedotin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	127/160 (79.38%)	151/167 (90.42%)
Blood and lymphatic system disorders
Anaemia ^† 1	4/160 (2.50%)	14/167 (8.38%)
Leukopenia ^† 1	3/160 (1.88%)	9/167 (5.39%)
Neutropenia ^† 1	18/160 (11.25%)	58/167 (34.73%)
Thrombocytopenia ^† 1	3/160 (1.88%)	12/167 (7.19%)
Cardiac disorders
Sinus tachycardia ^† 1	3/160 (1.88%)	9/167 (5.39%)
Gastrointestinal disorders
Abdominal pain ^† 1	5/160 (3.13%)	20/167 (11.98%)
Constipation ^† 1	5/160 (3.13%)	20/167 (11.98%)
Diarrhoea ^† 1	15/160 (9.38%)	33/167 (19.76%)
Dyspepsia ^† 1	6/160 (3.75%)	11/167 (6.59%)
Nausea ^† 1	12/160 (7.50%)	34/167 (20.36%)
Vomiting ^† 1	11/160 (6.88%)	24/167 (14.37%)
General disorders
Asthenia ^† 1	7/160 (4.38%)	13/167 (7.78%)
Chills ^† 1	8/160 (5.00%)	17/167 (10.18%)
Fatigue ^† 1	29/160 (18.13%)	40/167 (23.95%)
Non-cardiac chest pain ^† 1	9/160 (5.63%)	6/167 (3.59%)
Oedema peripheral ^† 1	10/160 (6.25%)	8/167 (4.79%)
Pain ^† 1	5/160 (3.13%)	11/167 (6.59%)
Pyrexia ^† 1	23/160 (14.37%)	27/167 (16.17%)
Infections and infestations
Bronchitis ^† 1	10/160 (6.25%)	10/167 (5.99%)
Herpes zoster ^† 1	3/160 (1.88%)	10/167 (5.99%)
Pharyngitis ^† 1	4/160 (2.50%)	8/167 (4.79%)
Sinusitis ^† 1	10/160 (6.25%)	4/167 (2.40%)
Upper respiratory tract infection ^† 1	37/160 (23.13%)	43/167 (25.75%)
Investigations
Weight decreased ^† 1	9/160 (5.63%)	31/167 (18.56%)
Weight increased ^† 1	14/160 (8.75%)	5/167 (2.99%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	9/160 (5.63%)	20/167 (11.98%)
Hypokalaemia ^† 1	6/160 (3.75%)	10/167 (5.99%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	15/160 (9.38%)	30/167 (17.96%)
Back pain ^† 1	16/160 (10.00%)	15/167 (8.98%)
Muscle spasms ^† 1	9/160 (5.63%)	18/167 (10.78%)
Muscular weakness ^† 1	1/160 (0.63%)	8/167 (4.79%)
Myalgia ^† 1	7/160 (4.38%)	15/167 (8.98%)
Pain in extremity ^† 1	8/160 (5.00%)	11/167 (6.59%)
Nervous system disorders
Headache ^† 1	13/160 (8.13%)	18/167 (10.78%)
Paraesthesia ^† 1	2/160 (1.25%)	16/167 (9.58%)
Peripheral motor neuropathy ^† 1	3/160 (1.88%)	37/167 (22.16%)
Peripheral sensory neuropathy ^† 1	25/160 (15.63%)	92/167 (55.09%)
Psychiatric disorders
Anxiety ^† 1	13/160 (8.13%)	14/167 (8.38%)
Insomnia ^† 1	5/160 (3.13%)	14/167 (8.38%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	26/160 (16.25%)	35/167 (20.96%)
Dyspnoea ^† 1	10/160 (6.25%)	21/167 (12.57%)
Oropharyngeal pain ^† 1	8/160 (5.00%)	8/167 (4.79%)
Skin and subcutaneous tissue disorders
Dry skin ^† 1	7/160 (4.38%)	10/167 (5.99%)
Night sweats ^† 1	18/160 (11.25%)	12/167 (7.19%)
Pruritus ^† 1	14/160 (8.75%)	22/167 (13.17%)
Rash ^† 1	5/160 (3.13%)	14/167 (8.38%)
Vascular disorders
Hypotension ^† 1	4/160 (2.50%)	9/167 (5.39%)
1 Term from vocabulary, MedDRA 17.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Chief Medical Officer
Organization:	Seagen Inc.
Phone:	(855)473-2436
EMail:	medinfo@seagen.com

Publications of Results:

Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. doi: 10.1016/S0140-6736(15)60165-9. Epub 2015 Mar 19. Erratum In: Lancet. 2015 Aug 8;386(9993):532. Lancet. 2015 Aug 8;386(9993):532.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. doi: 10.1182/blood-2018-07-861641. Epub 2018 Sep 28.

Layout table for additonal information

Responsible Party:	Seagen Inc.
ClinicalTrials.gov Identifier:	NCT01100502
Other Study ID Numbers:	SGN35-005 2009-016947-20 ( EudraCT Number )
First Submitted:	April 6, 2010
First Posted:	April 9, 2010
Results First Submitted:	July 31, 2015
Results First Posted:	November 11, 2015
Last Update Posted:	May 14, 2021

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