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Trial record 7 of 37 for:    ALECTINIB

A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT02838420
Recruitment Status : Active, not recruiting
First Posted : July 20, 2016
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer
Interventions Drug: Alectinib
Drug: Crizotinib
Enrollment 187
Recruitment Details Asian adult participants with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC) were enrolled at 21 study sites in 3 countries - China, Korea, and Thailand.
Pre-assignment Details  
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death. Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Period Title: Overall Study
Started 125 62
Completed 0 0
Not Completed 125 62
Reason Not Completed
Ongoing in Study             113             45
Lost to Follow-up             1             0
Withdrawal by Subject             3             4
Death             8             13
Arm/Group Title Alectinib Crizotinib Total
Hide Arm/Group Description Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death. Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death. Total of all reporting groups
Overall Number of Baseline Participants 125 62 187
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 62 participants 187 participants
50.5  (11.3) 51.1  (12.6) 50.7  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 62 participants 187 participants
Female
61
  48.8%
28
  45.2%
89
  47.6%
Male
64
  51.2%
34
  54.8%
98
  52.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 62 participants 187 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
124
  99.2%
60
  96.8%
184
  98.4%
Unknown or Not Reported
1
   0.8%
2
   3.2%
3
   1.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 62 participants 187 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
125
 100.0%
62
 100.0%
187
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1
Hide Description PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by the investigators, or to death from any cause, whichever occurred first.
Time Frame From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis population for efficacy was the intent-to-treat (ITT) population, defined as all randomized participants.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.
Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Number of Participants Analyzed 125 62
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(20.3 to NA)
11.1
(9.1 to 13.0)
[1]
Median and upper bound of 95% CI could not be estimated as PFS had not been reached at the time of data cutoff for the primary end point.
2.Secondary Outcome
Title PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1
Hide Description PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by an independent review committee, or to death from any cause, whichever occurred first.
Time Frame Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Using RECIST v1.1
Hide Description [Not Specified]
Time Frame Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to Progression of Disease in the CNS as Determined by IRC Using RECIST v1.1
Hide Description [Not Specified]
Time Frame Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to Progression of Disease in the CNS as Determined by IRC Using Response Assessment in Neuro-Oncology (RANO)
Hide Description [Not Specified]
Time Frame Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Duration of Response (DOR) Assessed by Investigator Using RECIST v1.1
Hide Description [Not Specified]
Time Frame Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Overall Survival Time
Hide Description [Not Specified]
Time Frame Baseline, until death (up to overall period of approximately 40 months)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events
Hide Description An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable 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. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame Up to overall period of approximately 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who received at least one dose of study drug.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.
Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Number of Participants Analyzed 125 62
Measure Type: Number
Unit of Measure: Percentage of Participants
Serious Adverse Events 15.2 25.8
Non-Serious Adverse Events 99.2 100.0
9.Secondary Outcome
Title Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Core (QLQ-C30) Score
Hide Description [Not Specified]
Time Frame Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer Module (QLQ-LC13) Score
Hide Description [Not Specified]
Time Frame Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite
Hide Description AUC was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.
Time Frame Baseline and Week 4 predose (within 2 hours before administration of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.
Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Number of Participants Analyzed 20 0
Mean (Standard Deviation)
Unit of Measure: Hours*nanogram/milliliter (hr*ng/mL)
Alectinib Baseline 1590  (852)
M4 Baseline 471  (243)
Alectinib Week 4 7760  (3270)
M4 Week 4 2890  (1130)
12.Secondary Outcome
Title Maximum Plasma Concentration Observed (Cmax) of Alectinib and Its Metabolite
Hide Description Cmax was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.
Time Frame Baseline and Week 4 predose (within 2 hours before administration of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.
Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Number of Participants Analyzed 20 0
Mean (Standard Deviation)
Unit of Measure: Nanograms/milliliter (ng/mL)
Alectinib Baseline 255  (130)
M4 Baseline 71.4  (33.5)
Alectinib Week 4 861  (332)
M4 Week 4 306  (111)
13.Secondary Outcome
Title Time to Cmax (Tmax) of Alectinib and Its Metabolite
Hide Description Tmax was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.
Time Frame Baseline and Week 4 predose (within 2 hours before administration of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm.
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description:
Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.
Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Number of Participants Analyzed 20 0
Mean (Standard Deviation)
Unit of Measure: Hour (hr)
Alectinib Baseline 5.61  (3.02)
M4 Baseline 8.19  (2.30)
Alectinib Week 4 4.30  (2.45)
M4 Week 4 4.11  (3.06)
Time Frame Up to approximately 40 months
Adverse Event Reporting Description The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.
 
Arm/Group Title Alectinib Crizotinib
Hide Arm/Group Description Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death. Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
All-Cause Mortality
Alectinib Crizotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   8/125 (6.40%)   13/62 (20.97%) 
Show Serious Adverse Events Hide Serious Adverse Events
Alectinib Crizotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   19/125 (15.20%)   16/62 (25.81%) 
Blood and lymphatic system disorders     
Anaemia  1  1/125 (0.80%)  0/62 (0.00%) 
Cardiac disorders     
Bradycardia  1  0/125 (0.00%)  2/62 (3.23%) 
Pericardial effusion  1  1/125 (0.80%)  0/62 (0.00%) 
General disorders     
Death  1  1/125 (0.80%)  0/62 (0.00%) 
Fatigue  1  0/125 (0.00%)  1/62 (1.61%) 
Pyrexia  1  1/125 (0.80%)  0/62 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  0/125 (0.00%)  2/62 (3.23%) 
Drug-induced liver injury  1  0/125 (0.00%)  1/62 (1.61%) 
Infections and infestations     
Lung infection  1  1/125 (0.80%)  2/62 (3.23%) 
Pneumonia  1  1/125 (0.80%)  2/62 (3.23%) 
Appendicitis  1  0/125 (0.00%)  1/62 (1.61%) 
Bronchitis  1  1/125 (0.80%)  0/62 (0.00%) 
Escherichia sepsis  1  0/125 (0.00%)  1/62 (1.61%) 
Upper respiratory tract infection  1  1/125 (0.80%)  0/62 (0.00%) 
Wound infection  1  1/125 (0.80%)  0/62 (0.00%) 
Injury, poisoning and procedural complications     
Post procedural ooedema  1  1/125 (0.80%)  0/62 (0.00%) 
Rib fracture  1  1/125 (0.80%)  0/62 (0.00%) 
Wound dehiscence  1  1/125 (0.80%)  0/62 (0.00%) 
Investigations     
Blood uric acid increased  1  3/125 (2.40%)  1/62 (1.61%) 
Blood creatine phosphokinase increased  1  0/125 (0.00%)  2/62 (3.23%) 
Alanine aminotransferase increased  1  0/125 (0.00%)  1/62 (1.61%) 
Blood bilirubin increased  1  1/125 (0.80%)  0/62 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  1/125 (0.80%)  0/62 (0.00%) 
Nervous system disorders     
Brain ooedema  1  1/125 (0.80%)  0/62 (0.00%) 
Cerebral infarction  1  1/125 (0.80%)  0/62 (0.00%) 
Intracranial pressure increased  1  0/125 (0.00%)  1/62 (1.61%) 
Paraplegia  1  1/125 (0.80%)  0/62 (0.00%) 
Spinal cord compression  1  0/125 (0.00%)  1/62 (1.61%) 
Psychiatric disorders     
Suicide attempt  1  1/125 (0.80%)  0/62 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/125 (0.80%)  0/62 (0.00%) 
Reproductive system and breast disorders     
Dysfunctional uterine bleeding  1  0/125 (0.00%)  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease  1  1/125 (0.80%)  3/62 (4.84%) 
Dyspnoea  1  1/125 (0.80%)  0/62 (0.00%) 
Pleural effusion  1  1/125 (0.80%)  0/62 (0.00%) 
Pneumothorax  1  1/125 (0.80%)  0/62 (0.00%) 
Respiratory failure  1  1/125 (0.80%)  0/62 (0.00%) 
Surgical and medical procedures     
Abortion induced  1  1/125 (0.80%)  0/62 (0.00%) 
Vascular disorders     
Venous thrombosis  1  0/125 (0.00%)  1/62 (1.61%) 
1
Term from vocabulary, MedDRA version 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alectinib Crizotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   124/125 (99.20%)   62/62 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  38/125 (30.40%)  14/62 (22.58%) 
Neutropenia  1  0/125 (0.00%)  5/62 (8.06%) 
Cardiac disorders     
Sinus bradycardia  1  37/125 (29.60%)  11/62 (17.74%) 
Bradycardia  1  12/125 (9.60%)  5/62 (8.06%) 
Eye disorders     
Vision blurred  1  2/125 (1.60%)  9/62 (14.52%) 
Gastrointestinal disorders     
Constipation  1  45/125 (36.00%)  31/62 (50.00%) 
Diarrhoea  1  16/125 (12.80%)  31/62 (50.00%) 
Nausea  1  8/125 (6.40%)  21/62 (33.87%) 
Vomiting  1  7/125 (5.60%)  22/62 (35.48%) 
General disorders     
Fatigue  1  11/125 (8.80%)  9/62 (14.52%) 
Pyrexia  1  11/125 (8.80%)  9/62 (14.52%) 
Chest pain  1  10/125 (8.00%)  8/62 (12.90%) 
Oedema peripheral  1  8/125 (6.40%)  10/62 (16.13%) 
Chest discomfort  1  10/125 (8.00%)  3/62 (4.84%) 
Asthenia  1  6/125 (4.80%)  5/62 (8.06%) 
Oedema  1  9/125 (7.20%)  2/62 (3.23%) 
Hepatobiliary disorders     
Liver injury  1  14/125 (11.20%)  4/62 (6.45%) 
Hepatic function abnormal  1  9/125 (7.20%)  4/62 (6.45%) 
Infections and infestations     
Upper respiratory tract infection  1  23/125 (18.40%)  6/62 (9.68%) 
Nasopharyngitis  1  15/125 (12.00%)  3/62 (4.84%) 
Urinary tract infection  1  8/125 (6.40%)  1/62 (1.61%) 
Lung infection  1  2/125 (1.60%)  4/62 (6.45%) 
Investigations     
Aspartate aminotransferase increased  1  65/125 (52.00%)  31/62 (50.00%) 
Alanine aminotransferase increased  1  52/125 (41.60%)  34/62 (54.84%) 
Blood creatine phosphokinase increased  1  55/125 (44.00%)  18/62 (29.03%) 
Blood bilirubin increased  1  61/125 (48.80%)  2/62 (3.23%) 
Blood alkaline phosphatase increased  1  33/125 (26.40%)  8/62 (12.90%) 
Blood creatinine increased  1  25/125 (20.00%)  15/62 (24.19%) 
Bilirubin conjugated increased  1  33/125 (26.40%)  2/62 (3.23%) 
Weight increased  1  23/125 (18.40%)  2/62 (3.23%) 
Gamma-glutamyltransferase increased  1  5/125 (4.00%)  17/62 (27.42%) 
Haemoglobin decreased  1  18/125 (14.40%)  3/62 (4.84%) 
White blood cell count decreased  1  6/125 (4.80%)  15/62 (24.19%) 
Blood lactate dehydrogenase increased  1  11/125 (8.80%)  7/62 (11.29%) 
Neutrophil count decreased  1  4/125 (3.20%)  12/62 (19.35%) 
Blood bilirubin unconjugated increased  1  14/125 (11.20%)  0/62 (0.00%) 
Blood thyroid stimulating hormone increased  1  12/125 (9.60%)  1/62 (1.61%) 
Electrocardiogram QT prolonged  1  4/125 (3.20%)  7/62 (11.29%) 
Blood albumin decreased  1  4/125 (3.20%)  5/62 (8.06%) 
Blood creatine phosphokinase MB increased  1  4/125 (3.20%)  5/62 (8.06%) 
Weight decreased  1  1/125 (0.80%)  5/62 (8.06%) 
Protein total decreased  1  0/125 (0.00%)  4/62 (6.45%) 
Metabolism and nutrition disorders     
Decreased appetite  1  6/125 (4.80%)  22/62 (35.48%) 
Hypoalbuminaemia  1  6/125 (4.80%)  8/62 (12.90%) 
Hypokalaemia  1  10/125 (8.00%)  4/62 (6.45%) 
Hyponatraemia  1  4/125 (3.20%)  9/62 (14.52%) 
Hypoproteinaemia  1  1/125 (0.80%)  4/62 (6.45%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  11/125 (8.80%)  10/62 (16.13%) 
Musculoskeletal pain  1  12/125 (9.60%)  3/62 (4.84%) 
Pain in extremity  1  9/125 (7.20%)  6/62 (9.68%) 
Myalgia  1  11/125 (8.80%)  2/62 (3.23%) 
Nervous system disorders     
Dizziness  1  7/125 (5.60%)  13/62 (20.97%) 
Headache  1  7/125 (5.60%)  10/62 (16.13%) 
Dysgeusia  1  1/125 (0.80%)  10/62 (16.13%) 
Psychiatric disorders     
Insomnia  1  7/125 (5.60%)  6/62 (9.68%) 
Renal and urinary disorders     
Haematuria  1  8/125 (6.40%)  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  27/125 (21.60%)  11/62 (17.74%) 
Dyspnoea  1  12/125 (9.60%)  5/62 (8.06%) 
Productive cough  1  7/125 (5.60%)  3/62 (4.84%) 
Skin and subcutaneous tissue disorders     
Rash  1  21/125 (16.80%)  3/62 (4.84%) 
Pruritis  1  12/125 (9.60%)  5/62 (8.06%) 
1
Term from vocabulary, MedDRA version 21.0
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
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02838420     History of Changes
Other Study ID Numbers: YO29449
First Submitted: July 18, 2016
First Posted: July 20, 2016
Results First Submitted: May 29, 2019
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019