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A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane

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ClinicalTrials.gov Identifier: NCT02658734
Recruitment Status : Completed
First Posted : January 20, 2016
Results First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
Intervention Drug: Trastuzumab emtansine
Enrollment 70
Recruitment Details The study was conducted at 13 centres across India.
Pre-assignment Details  
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Period Title: Overall Study
Started 70
Completed 13
Not Completed 57
Reason Not Completed
Adverse Event             2
Death             4
Lost to Follow-up             7
Withdrawal of Consent             16
Disease Progression             28
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants
50  (11.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
70
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
American Indian or Alaska Native
0
   0.0%
Asian
70
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Severity of Adverse Events
Hide Description Adverse events (AEs) grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
53
  75.7%
Grade 2
40
  57.1%
Grade 3
18
  25.7%
Grade 4
2
   2.9%
Grade 5
12
  17.1%
2.Primary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study were also considered as adverse events.
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Percentage of Participants
90.0
3.Secondary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs)
Hide Description SAEs were defined as any AE that fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Percentage of Participants
40
4.Secondary Outcome
Title Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03
Hide Description Severity refered to the intensity of an AE (e.g., rated as mild, moderate, or severe, or according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria.
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
1
   1.4%
Grade 2
13
  18.6%
Grade 3
10
  14.3%
Grade 4
3
   4.3%
Grade 5
6
   8.6%
5.Secondary Outcome
Title Percentage of Participants With Non-Serious Adverse Events of Special Interest
Hide Description Non-serious AEs of special interest included cases of severe drug-induced liver injury and suspected transmission of an infectious agent by the study drug.
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Percentage of Participants
2.9
6.Secondary Outcome
Title Laboratory Results Abnormalities
Hide Description [Not Specified]
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Number of Participants
Basophils - High Number Analyzed 4 participants
1
Basophils/Leukocytes - Low Number Analyzed 13 participants
13
Basophils/Leukocytes - High Number Analyzed 53 participants
6
Monocytes - High Number Analyzed 4 participants
2
Hematocrit - Low Number Analyzed 70 participants
57
Hematocrit - High Number Analyzed 30 participants
1
Lymphocytes/Leukocytes - Low Number Analyzed 66 participants
38
Lymphocytes/Leukocytes - High Number Analyzed 66 participants
19
Monocytes/Leukocytes - Low Number Analyzed 61 participants
8
Monocytes/Leukocytes - High Number Analyzed 65 participants
21
Neutrophils/Leukocytes - Low Number Analyzed 58 participants
14
Neutrophils/Leukocytes - High Number Analyzed 64 participants
13
Other Cells - High Number Analyzed 4 participants
3
Other Cells/Leukocytes - High Number Analyzed 59 participants
6
Erythrocytes - Low Number Analyzed 70 participants
41
Erythrocytes - High Number Analyzed 70 participants
15
Eosinophils/Leukocytes - Low Number Analyzed 66 participants
33
Eosinophils/Leukocytes - High Number Analyzed 56 participants
13
Bilirubin - Low Number Analyzed 69 participants
5
Bilirubin - High Number Analyzed 70 participants
22
Bicarbonate - Low Number Analyzed 58 participants
4
Bicarbonate - High Number Analyzed 61 participants
11
Direct Bilirubin - High Number Analyzed 69 participants
27
Blood Urea Nitrogen - Low Number Analyzed 64 participants
21
Blood Urea Nitrogen - High Number Analyzed 58 participants
10
Chloride - Low Number Analyzed 61 participants
20
Chloride - High Number Analyzed 64 participants
30
Lactate Dehydrogenase - Low Number Analyzed 69 participants
8
Lactate Dehydrogenase - High Number Analyzed 55 participants
52
Protein - Low Number Analyzed 66 participants
10
Protein - High Number Analyzed 70 participants
30
Urea - Low Number Analyzed 70 participants
21
Urea - High Number Analyzed 66 participants
10
Partial Thromboplastin Time - Low Number Analyzed 70 participants
22
Partial Thromboplastin Time - High Number Analyzed 70 participants
37
7.Secondary Outcome
Title Percentage of Participants With Adverse Events Leading to Discontinuation of Study Medication
Hide Description [Not Specified]
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Percentage of Participants
8.6
8.Secondary Outcome
Title Percentage of Participants With Adverse Events Leading to Modification of Study Medication
Hide Description [Not Specified]
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Count of Participants
Unit of Measure: Participants
Dose Reduced
1
   1.4%
Drug Interrupted
11
  15.7%
9.Secondary Outcome
Title Percentage of Participants With Adverse Events Leading to Interruption of Study Medication
Hide Description [Not Specified]
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Percentage of Participants
15.7
10.Secondary Outcome
Title Exposure to Study Drug
Hide Description Exposure to study drug was the amount of study drug received over time (weeks).
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: Weeks
39.60  (32.00)
11.Secondary Outcome
Title Percentage of Participants With Drug-Induced Liver Injury Meeting Hy's Law Criteria
Hide Description Hy's law criteria for potential drug-induced liver injury included elevated aminotransferase enzymes (ALT/AST) with concurrent elevated serum total bilirubin, gross jaundice, clinical disability and the need for hospital care.
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Percentage of Participants
0
12.Secondary Outcome
Title Percentage of Participants With Congestive Heart Failure
Hide Description [Not Specified]
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Percetnage of Participants
0
13.Secondary Outcome
Title Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram
Hide Description [Not Specified]
Time Frame From baseline to every three cycles of treatment up to Cycle 39 Day 1, and at the 2-days post-treatment, safety follow-up visits 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: Percentage of LVEF
Baseline Number Analyzed 70 participants
59.49  (3.33)
Cycle 03 Day 1 Number Analyzed 62 participants
0.08  (3.26)
Cycle 06 Day 1 Number Analyzed 51 participants
0.20  (4.50)
Cycle 09 Day 1 Number Analyzed 39 participants
0.23  (3.76)
Cycle 12 Day 1 Number Analyzed 34 participants
0.06  (4.24)
Cycle 15 Day 1 Number Analyzed 24 participants
0.38  (4.40)
Cycle 18 Day 1 Number Analyzed 20 participants
0.15  (5.98)
Cycle 21 Day 1 Number Analyzed 14 participants
2.50  (3.78)
Cycle 24 Day 1 Number Analyzed 13 participants
0.23  (2.89)
Cycle 27 Day 1 Number Analyzed 10 participants
-0.60  (3.86)
Cycle 30 Day 1 Number Analyzed 6 participants
-0.17  (1.33)
Cycle 33 Day 1 Number Analyzed 5 participants
-1.20  (2.39)
Cycle 36 Day 1 Number Analyzed 1 participants
0 [1]   (NA)
Cycle 39 Day 1 Number Analyzed 1 participants
0 [1]   (NA)
Safety Follow-Up 1 Number Analyzed 18 participants
1.28  (3.80)
Safety Follow-Up 3 Number Analyzed 16 participants
1.38  (4.00)
[1]
The standard deviation couldn't be calculated from one participant
14.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR was based on the best (confirmed) overall response (BOR). ORR was defined as the number (%) of participants with confirmed complete response (CR) or partial response (PR) where the confirmation was performed no less than 4 weeks after the criteria for response were first met.
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Count of Participants
Unit of Measure: Participants
16
  22.9%
15.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time from the date of enrollment until the date of first documented progression of disease or the date of death (by any cause in the absence of progression) whichever occurred first.
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Median (95% Confidence Interval)
Unit of Measure: Months
14.0
(8.0 to 17.0)
16.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the time from the date of enrollment until the date of death due to any cause. Participants not known to have died at the time of final analysis were censored based on the last recorded date on which the subject was known to be alive.
Time Frame From cycle 1 up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study.
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description:
3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Number of Participants Analyzed 70
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(25.00 to NA)
[1]
The median duration of OS was not estimable since the OS was not achieved.
Time Frame From cycle 1 up to approximately 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trastuzumab Emtansine
Hide Arm/Group Description 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
All-Cause Mortality
Trastuzumab Emtansine
Affected / at Risk (%)
Total   12/70 (17.14%)    
Hide Serious Adverse Events
Trastuzumab Emtansine
Affected / at Risk (%) # Events
Total   28/70 (40.00%)    
Blood and lymphatic system disorders   
THROMBOCYTOPENIA  1  4/70 (5.71%)  4
Cardiac disorders   
CARDIAC ARREST  1  1/70 (1.43%)  1
CARDIO-RESPIRATORY ARREST  1  1/70 (1.43%)  1
Eye disorders   
CATARACT  1  1/70 (1.43%)  1
VISION BLURRED  1  1/70 (1.43%)  1
Gastrointestinal disorders   
ABDOMINAL PAIN  1  1/70 (1.43%)  1
General disorders   
DEATH  1  4/70 (5.71%)  4
PYREXIA  1  1/70 (1.43%)  1
Infections and infestations   
URINARY TRACT INFECTION  1  1/70 (1.43%)  1
Injury, poisoning and procedural complications   
FRACTURE DISPLACEMENT  1  1/70 (1.43%)  1
SUBDURAL HAEMATOMA  1  1/70 (1.43%)  2
Investigations   
BLOOD CREATININE INCREASED  1  1/70 (1.43%)  1
Metabolism and nutrition disorders   
CACHEXIA  1  1/70 (1.43%)  1
DIABETES MELLITUS INADEQUATE CONTROL  1  1/70 (1.43%)  1
HYPERCALCAEMIA  1  1/70 (1.43%)  1
HYPERGLYCAEMIA  1  1/70 (1.43%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
METASTATIC NEOPLASM  1  1/70 (1.43%)  1
Nervous system disorders   
GENERALISED TONIC-CLONIC SEIZURE  1  2/70 (2.86%)  2
HYDROCEPHALUS  1  2/70 (2.86%)  2
SEIZURE  1  2/70 (2.86%)  2
Renal and urinary disorders   
ACUTE KIDNEY INJURY  1  2/70 (2.86%)  2
Reproductive system and breast disorders   
MENORRHAGIA  1  1/70 (1.43%)  1
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA  1  2/70 (2.86%)  2
EPISTAXIS  1  2/70 (2.86%)  2
Vascular disorders   
HYPOTENSION  1  1/70 (1.43%)  1
1
Term from vocabulary, MedDRA version 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab Emtansine
Affected / at Risk (%) # Events
Total   51/70 (72.86%)    
Blood and lymphatic system disorders   
ANAEMIA  1  11/70 (15.71%)  11
THROMBOCYTOPENIA  1  6/70 (8.57%)  11
Gastrointestinal disorders   
ABDOMINAL PAIN  1  6/70 (8.57%)  7
DIARRHOEA  1  5/70 (7.14%)  7
VOMITING  1  4/70 (5.71%)  4
General disorders   
ASTHENIA  1  8/70 (11.43%)  9
PAIN  1  8/70 (11.43%)  8
PYREXIA  1  19/70 (27.14%)  28
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  1  5/70 (7.14%)  5
ASPARTATE AMINOTRANSFERASE INCREASED  1  6/70 (8.57%)  8
HAEMOGLOBIN DECREASED  1  4/70 (5.71%)  9
PLATELET COUNT DECREASED  1  7/70 (10.00%)  9
Metabolism and nutrition disorders   
DECREASED APPETITE  1  4/70 (5.71%)  4
HYPOMAGNESAEMIA  1  4/70 (5.71%)  4
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  4/70 (5.71%)  8
PAIN IN EXTREMITY  1  4/70 (5.71%)  5
Nervous system disorders   
DIZZINESS  1  5/70 (7.14%)  7
HEADACHE  1  11/70 (15.71%)  13
NEUROPATHY PERIPHERAL  1  5/70 (7.14%)  5
Respiratory, thoracic and mediastinal disorders   
COUGH  1  8/70 (11.43%)  9
EPISTAXIS  1  11/70 (15.71%)  14
1
Term from vocabulary, MedDRA version 22.1
Indicates events were collected by systematic assessment
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02658734    
Other Study ID Numbers: ML29662
First Submitted: January 15, 2016
First Posted: January 20, 2016
Results First Submitted: December 10, 2020
Results First Posted: February 9, 2021
Last Update Posted: February 9, 2021