Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study) (apact)
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ClinicalTrials.gov Identifier: NCT01964430 |
Recruitment Status :
Completed
First Posted : October 17, 2013
Results First Posted : January 6, 2020
Last Update Posted : June 28, 2023
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Digestive System Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic |
Interventions |
Drug: nab-Paclitaxel Drug: Gemcitabine |
Enrollment | 866 |
Participant Flow
Recruitment Details | The study randomized participants at 160 sites in 21 countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Netherlands, Portugal, Singapore, Republic of Korea, Spain, Taiwan, United Kingdom and the US. |
Pre-assignment Details | Participants were randomized using a stratified randomization with a 1:1 ratio to either nab-paclitaxel followed by gemcitabine, or gemcitabine alone. Stratification factors were tumor resection status (R0 versus R1), nodal status lymph node positive versus lymph node negative, and region [North America, Europe, and Australia versus Asia Pacific]). |
Arm/Group Title | Nab-Paclitaxel and Gemcitabine | Gemcitabine |
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Arm/Group Description | Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death. | Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death. |
Period Title: Pre-Treatment (Randomization) Period | ||
Started | 432 | 434 |
Completed [1] | 429 | 423 |
Not Completed | 3 | 11 |
Reason Not Completed | ||
Protocol Deviation | 0 | 2 |
Withdrawal by Subject | 2 | 9 |
Adverse Event | 1 | 0 |
[1]
Participants continuing to Treatment
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Period Title: Treatment Period | ||
Started | 429 | 423 |
Completed | 287 | 310 |
Not Completed | 142 | 113 |
Reason Not Completed | ||
Adverse Event | 71 | 37 |
Withdrawal by Subject | 36 | 27 |
Death | 1 | 3 |
Protocol Deviation | 0 | 1 |
Physician Decision | 5 | 4 |
Disease Relapse | 28 | 38 |
Other reasons | 1 | 3 |
Baseline Characteristics
Arm/Group Title | Nab-Paclitaxel and Gemcitabine | Gemcitabine | Total | |
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Arm/Group Description | Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death. | Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death. | Total of all reporting groups | |
Overall Number of Baseline Participants | 432 | 434 | 866 | |
Baseline Analysis Population Description |
The Intent-to-treat (ITT) population consisted of all randomized participants regardless of whether the participant received any investigational product (IP) or had any efficacy assessments collected.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
63.4 (9.58) | 62.9 (8.84) | 63.2 (9.21) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
Female |
204 47.2%
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181 41.7%
|
385 44.5%
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Male |
228 52.8%
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253 58.3%
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481 55.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
Hispanic or Latino |
11 2.5%
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15 3.5%
|
26 3.0%
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Not Hispanic or Latino |
400 92.6%
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393 90.6%
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793 91.6%
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Unknown or Not Reported |
21 4.9%
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26 6.0%
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47 5.4%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
American Indian or Alaska Native |
0 0.0%
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1 0.2%
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1 0.1%
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Asian |
60 13.9%
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56 12.9%
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116 13.4%
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Black or African American |
4 0.9%
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8 1.8%
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12 1.4%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
2 0.5%
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2 0.2%
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White |
333 77.1%
|
339 78.1%
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672 77.6%
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Other |
11 2.5%
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6 1.4%
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17 2.0%
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Not Collected or Reported |
24 5.6%
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22 5.1%
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46 5.3%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
North America |
144 33.3%
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156 35.9%
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300 34.6%
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Europe |
203 47.0%
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205 47.2%
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408 47.1%
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Australia |
30 6.9%
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20 4.6%
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50 5.8%
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Asia Pacific |
55 12.7%
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53 12.2%
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108 12.5%
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Body Surface Area (BSA)
Mean (Standard Deviation) Unit of measure: M² |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
1.77 (0.226) | 1.78 (0.221) | 1.78 (0.224) | ||
Eastern Cooperative Oncology Group (ECOG) Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
0 = Fully Active |
252 58.3%
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268 61.8%
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520 60.0%
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1 = Restricted but Ambulatory |
180 41.7%
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166 38.2%
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346 40.0%
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2 = Ambulatory but Unable to Work |
0 0.0%
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0 0.0%
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0 0.0%
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3 = Limited Self-care |
0 0.0%
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0 0.0%
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0 0.0%
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4 = Completely Disabled |
0 0.0%
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0 0.0%
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0 0.0%
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[1]
Measure Description: ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead
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Physician Assessment of Peripheral Neuropathy
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
Grade 0 |
404 93.5%
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408 94.0%
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812 93.8%
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Grade 1 |
26 6.0%
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21 4.8%
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47 5.4%
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Grade 2 |
0 0.0%
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1 0.2%
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1 0.1%
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Grade 3 |
0 0.0%
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0 0.0%
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0 0.0%
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Grade 4 |
0 0.0%
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0 0.0%
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0 0.0%
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Missing |
2 0.5%
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4 0.9%
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6 0.7%
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[1]
Measure Description: Physician assessment for grading of peripheral neuropathy in participants receiving chemotherapy according to National Cancer Institute Common Toxicity Criteria (NCICTC): - Grade 1 = Asymptomatic: loss of deep tendon reflexes or paresthesia; - Grade 2 = Moderate symptoms: limiting instrumental Activities of Daily Living (ADLs); - Grade 3 = Severe symptoms: limiting self-care ADL; assistance device indicated; - Grade 4 = Life-threatening consequences: urgent intervention indicated.
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Time from Surgery to Randomization
Median (Full Range) Unit of measure: Days |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
57.0
(23.0 to 90.0)
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56.0
(17.0 to 88.0)
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57.0
(17.0 to 90.0)
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TNM Classification
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
T1 = Tumor is 2 cm or smaller |
16 3.7%
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13 3.0%
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29 3.3%
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T2 = Tumor is > 2 cm, but not larger than 5 cm |
38 8.8%
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37 8.5%
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75 8.7%
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T3 = Tumor is larger than 5 cm |
377 87.3%
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384 88.5%
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761 87.9%
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T4 = Tumor is any size, but has spread |
1 0.2%
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0 0.0%
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1 0.1%
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[1]
Measure Description: The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The T refers to the size and extent of the main tumor. The main tumor is usually called the primary tumor and the "T" followed by a number shows the size of the tumor. The N refers to the number of nearby lymph nodes that have cancer. The M refers to whether the cancer has metastasized. This means that the cancer has spread from the primary tumor to other parts of the body.
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Nodal Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
Lymph Node Positive (LN+) |
311 72.0%
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312 71.9%
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623 71.9%
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Lymph Node Negative (LN-) |
121 28.0%
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122 28.1%
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243 28.1%
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[1]
Measure Description: The nodal status refers to the N and includes the number of nearby lymph nodes that are positive or negative for cancer.
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Resection Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 432 participants | 434 participants | 866 participants | |
R0 (tumor-negative resection margin) |
327 75.7%
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334 77.0%
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661 76.3%
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R1 (tumor- positive resection margin) |
105 24.3%
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100 23.0%
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205 23.7%
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[1]
Measure Description: Resection status was based on investigational site data (pathology reports were collected, but central pathology review and/or standardization was not conducted).
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: | Bristol-Myers Squibb Study Director |
Organization: | Bristol-Myers Squibb |
Phone: | Please email |
EMail: | Clinical.Trials@bms.com |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Celgene |
ClinicalTrials.gov Identifier: | NCT01964430 |
Other Study ID Numbers: |
ABI-007-PANC-003 2013-003398-91 ( EudraCT Number ) |
First Submitted: | October 14, 2013 |
First Posted: | October 17, 2013 |
Results First Submitted: | December 17, 2019 |
Results First Posted: | January 6, 2020 |
Last Update Posted: | June 28, 2023 |