An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy

• ClinicalTrials.gov Identifier: NCT00938912
• Recruitment Status: Completed
• First Posted: July 14, 2009
• Results First Posted: January 18, 2022
• Last Update Posted: January 18, 2022
• Sponsor: UCB BIOSCIENCES, Inc.
• Information provided by (Responsible Party): UCB Pharma ( UCB BIOSCIENCES, Inc. )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy
• Intervention: Drug: Lacosamide
• Enrollment: 366

Participant Flow

Recruitment Details	The study started to enroll study participants in December 2009 and concluded in May 2021. Eligible study participants were allowed to roll over from study SP0847 (NCT00938431), SP0966 (NCT01969851) and EP0060 (NCT02710890) and eligible study participants were also allowed to directly enroll into the study.
Pre-assignment Details	Total 366 participants were enrolled. Among 366, 365 participants received treatment. One participant was enrolled, but did not receive treatment prior to discontinuing due to ineligibility.

Arm/Group Title	Lacosamide (All Participants)
Arm/Group Description	Participants aged greater than or equal to (≥1) month received either lacosamide (LCM) 2-12 milligrams/kilograms/day (mg/kg/day) (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years.
Period Title: Overall Study
Started	365
Completed	254
Not Completed	111
Reason Not Completed
Withdrawal by Subject	28
Lost to Follow-up	4
Lack of Efficacy	43
Adverse event, non-fatal	24
Adverse event, fatal	1
Participant self adjusted antiepileptic medication	1
Participant had a creatinine clearance less than 30 mL/min	1
Participant needed prohibit medication	1
Participant was scheduled for lobal resection	1
Did not meet Eligibility criteria	1
Participant relocated not related to AE	1
Participant moved to another city	1
Participant experienced break through seizures	1
No longer wished to participate in the study	1
Protocol Deviation	2

Baseline Characteristics

Arm/Group Title		Lacosamide (All Participants)
Arm/Group Description		Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years.
Overall Number of Baseline Participants		365
Baseline Analysis Population Description		Baseline Characteristics refer to the SS which consisted of all enrolled study participants who took at least 1 dose of LCM in this study.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	365 participants
	<=18 years	365 100.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	365 participants
		9.28 (4.55)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	365 participants
	Female	173 47.4%
	Male	192 52.6%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	365 participants
	American Indian/Alaskan native	1 0.3%
	Asian	111 30.4%
	Black	26 7.1%
	White	201 55.1%
	Other/Mixed	26 7.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
Description	An AE is any untoward medical occurrence in a participant or clinical investigation study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Time Frame	From Baseline to End of Safety Follow-Up (up to 4.3 years)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of LCM in this study.

Arm/Group Title	Lacosamide (All Participants) (SS)
Arm/Group Description:	Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
Overall Number of Participants Analyzed	365
Measure Type: Count of Participants; Unit of Measure: Participants
	336 92.1%

2. Primary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs)
Description	SAE was any untoward medical occurrence that at any dose resulted in death, is life-threatening, required in participant hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, is an infection that requires treatment with parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above.
Time Frame	From Baseline to End of Safety Follow-Up (up to 4.3 years)

Outcome Measure Data

Analysis Population Description

The SS consisted of all enrolled study participants who took at least 1 dose of LCM in this study.

Arm/Group Title	Lacosamide (All Participants) (SS)
Arm/Group Description:	Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the SS which included all enrolled study participants who took at least 1 dose of LCM in this study.
Overall Number of Participants Analyzed	365
Measure Type: Count of Participants; Unit of Measure: Participants
	82 22.5%

3. Primary Outcome

Title	Number of Participants That Withdraw Due to a Treatment-Emergent Adverse Event
Description	TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Time Frame	From Baseline to End of Safety Follow-Up (up to 4.3 years)

Outcome Measure Data

Analysis Population Description

The SS consisted of all enrolled study participants who took at least 1 dose of LCM in this study.

Arm/Group Title	Lacosamide (All Participants) (SS)
Arm/Group Description:	Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the SS which included all enrolled study participants who took at least 1 dose of LCM in this study.
Overall Number of Participants Analyzed	365
Measure Type: Count of Participants; Unit of Measure: Participants
	27 7.4%

4. Secondary Outcome

Title	Percent Change From Baseline in 28 Day Partial-onset Seizure Frequency to the End of the Treatment Period
Description	Percent change in seizure frequency per 28 days (PCH) from the Baseline value (B) to Treatment Period interval (T) was defined as:PCH = [(SFT - SFB)/SFB] x 100 where, SFT corresponded to seizure frequency during Treatment Period for relative interval in open-label study and SFB corresponded to Baseline seizure frequency. For both periods, the frequency was standardized to the number of seizures per 28 days. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count case report form/electronic case report form (CRF/eCRF) module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.
Time Frame	From Baseline to End of Treatment Period (up to 4.2 years)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm/Group Title	Lacosamide (All Participants) (FAS)
Arm/Group Description:	Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Full Analysis Set (FAS) which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
Overall Number of Participants Analyzed	308
Mean (Standard Deviation); Unit of Measure: percent change
	-24.13 (112.08)

5. Secondary Outcome

Title	Percentage of Participants With ≥50% Reduction in 28-day Partial-onset Seizure Frequency
Description	A 50% responder is a participant experiencing a ≥50% reduction in partial-onset seizure frequency per 28 days from Baseline to end of the specified time interval, otherwise a participant is a non-responder. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count CRF/eCRF module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.
Time Frame	From Baseline to End of Treatment Period (up to 4.2 years)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm/Group Title	Lacosamide (All Participants) (FAS)
Arm/Group Description:	Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the FAS which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
Overall Number of Participants Analyzed	308
Measure Type: Number; Unit of Measure: percentage of participants
	53.6

6. Secondary Outcome

Title	Percentage of Participants With ≥75% Reduction in 28-day Partial-onset Seizure Frequency
Description	A 75% responder is a participant experiencing a ≥75% reduction in partial-onset seizure frequency per 28 days from Baseline to end of the specified time interval, otherwise a participant is a non-responder. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count CRF/eCRF module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.
Time Frame	From Baseline to End of Treatment Period (up to 4.2 years)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm/Group Title	Lacosamide (All Participants) (FAS)
Arm/Group Description:	Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the FAS which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
Overall Number of Participants Analyzed	308
Measure Type: Number; Unit of Measure: percentage of participants
	40.3

7. Secondary Outcome

Title	Number of Seizure Days Per 28 Days for Participants With Generalized Seizures
Description	A seizure day was defined as a day where any type of seizure was reported in the seizure diary and seizures were assessed. Days in the seizure diary which were marked as "not done" on the CRF/eCRF were not counted as seizure-free days.
Time Frame	Weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 72, 84 and 96

Outcome Measure Data

Analysis Population Description

The FAS consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment and number analyzed signifies participants who were evaluable at specified time points.

Arm/Group Title		Lacosamide (All Participants) (FAS)
Arm/Group Description:		Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the FAS which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
Overall Number of Participants Analyzed		47
Mean (Standard Deviation); Unit of Measure: seizure days per 28 days
Week 4	Number Analyzed	47 participants
		14.59 (11.94)
Week 8	Number Analyzed	46 participants
		14.83 (12.24)
Week 12	Number Analyzed	46 participants
		13.68 (12.62)
Week 20	Number Analyzed	46 participants
		12.57 (12.58)
Week 28	Number Analyzed	43 participants
		13.10 (12.63)
Week 36	Number Analyzed	43 participants
		11.43 (11.93)
Week 44	Number Analyzed	40 participants
		9.24 (11.23)
Week 52	Number Analyzed	41 participants
		10.48 (11.68)
Week 60	Number Analyzed	39 participants
		10.31 (11.84)
Week 72	Number Analyzed	39 participants
		11.15 (12.10)
Week 84	Number Analyzed	38 participants
		11.87 (12.45)
Week 96	Number Analyzed	37 participants
		10.73 (11.77)

8. Secondary Outcome

Title	Percentage of Participants Who Achieved a Seizure-free Status
Description	Study participants were considered seizure-free for a given period if they completed the period, reported zero seizures during the period, and had no more than 10% of days in the period for which seizure data were not available (ie, "not done" was noted on the Seizure Frequency CRF/eCRF module).
Time Frame	From Baseline to End of Treatment Period (up to 4.2 years)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm/Group Title	Lacosamide (All Participants) (FAS)
Arm/Group Description:	Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the FAS which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
Overall Number of Participants Analyzed	323
Measure Type: Number; Unit of Measure: percentage of participants
	7.4

Adverse Events

Time Frame	From Baseline to End of Safety Follow-Up (up to 4.3 years)
Adverse Event Reporting Description	TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Arm/Group Title	Lacosamide (All Participants) (SS)
Arm/Group Description	Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the SS which included all enrolled study participants who took at least 1 dose of LCM in this study.
All-Cause Mortality
	Lacosamide (All Participants) (SS)
	Affected / at Risk (%)
Total	1/365 (0.27%)
Serious Adverse Events
	Lacosamide (All Participants) (SS)
	Affected / at Risk (%)	# Events
Total	82/365 (22.47%)
Blood and lymphatic system disorders
Coagulopathy * 1	1/365 (0.27%)	1
Cardiac disorders
Bradycardia * 1	1/365 (0.27%)	1
Cyanosis * 1	1/365 (0.27%)	1
Gastrointestinal disorders
Vomiting * 1	8/365 (2.19%)	19
Constipation * 1	3/365 (0.82%)	3
Diarrhoea * 1	3/365 (0.82%)	3
Abdominal pain * 1	2/365 (0.55%)	2
Haematemesis * 1	2/365 (0.55%)	2
Gastritis * 1	1/365 (0.27%)	1
Intussusception * 1	1/365 (0.27%)	1
Mallory-Weiss syndrome * 1	1/365 (0.27%)	1
Pancreatitis * 1	1/365 (0.27%)	1
Traumatic tooth displacement * 1	1/365 (0.27%)	1
General disorders
Pyrexia * 1	4/365 (1.10%)	5
Adverse drug reaction * 1	1/365 (0.27%)	1
Chest pain * 1	1/365 (0.27%)	1
Hypothermia * 1	1/365 (0.27%)	1
Sudden death * 1	1/365 (0.27%)	1
Infections and infestations
Pneumonia * 1	6/365 (1.64%)	6
Bronchitis * 1	4/365 (1.10%)	4
Bronchopneumonia * 1	3/365 (0.82%)	3
Gastroenteritis * 1	3/365 (0.82%)	3
Sepsis * 1	3/365 (0.82%)	3
Upper respiratory tract infection * 1	3/365 (0.82%)	3
Urinary tract infection * 1	3/365 (0.82%)	3
Otitis media * 1	2/365 (0.55%)	2
Tonsillitis * 1	2/365 (0.55%)	3
Acute tonsillitis * 1	1/365 (0.27%)	1
Bronchiolitis * 1	1/365 (0.27%)	1
Erythema infectiosum * 1	1/365 (0.27%)	1
Pneumonia mycoplasmal * 1	1/365 (0.27%)	1
Pneumonia viral * 1	1/365 (0.27%)	1
Urinary tract infection fungal * 1	1/365 (0.27%)	1
Viral infection * 1	1/365 (0.27%)	2
Injury, poisoning and procedural complications
Endotracheal intubation complication * 1	1/365 (0.27%)	1
Foreign body aspiration * 1	1/365 (0.27%)	1
Head injury * 1	1/365 (0.27%)	1
Limb traumatic amputation * 1	1/365 (0.27%)	1
Skull fracture * 1	1/365 (0.27%)	1
Investigations
Weight decreased * 1	1/365 (0.27%)	1
Metabolism and nutrition disorders
Dehydration * 1	4/365 (1.10%)	4
Decreased appetite * 1	2/365 (0.55%)	2
Hyperammonaemia * 1	1/365 (0.27%)	1
Malnutrition * 1	1/365 (0.27%)	1
Musculoskeletal and connective tissue disorders
Atlantoaxial instability * 1	1/365 (0.27%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma, low grade * 1	1/365 (0.27%)	1
Nervous system disorders
Convulsion * 1	21/365 (5.75%)	29
Status epilepticus * 1	11/365 (3.01%)	16
Epilepsy * 1	6/365 (1.64%)	6
Complex partial seizures * 1	5/365 (1.37%)	6
Partial seizures with secondary generalisation * 1	4/365 (1.10%)	12
Partial seizures * 1	3/365 (0.82%)	3
Seizure cluster * 1	3/365 (0.82%)	5
Headache * 1	2/365 (0.55%)	2
Altered state of consciousness * 1	1/365 (0.27%)	1
Clonic convulsion * 1	1/365 (0.27%)	1
Encephalitis autoimmune * 1	1/365 (0.27%)	1
Grand mal convulsion * 1	1/365 (0.27%)	1
Haemorrhage intracranial * 1	1/365 (0.27%)	1
Lethargy * 1	1/365 (0.27%)	1
Neurotoxicity * 1	1/365 (0.27%)	1
Paraesthesia * 1	1/365 (0.27%)	1
Psychomotor skills impaired * 1	1/365 (0.27%)	1
Psychomotor hyperactivity * 1	1/365 (0.27%)	1
Simple partial seizures * 1	1/365 (0.27%)	2
Somnolence * 1	1/365 (0.27%)	1
VIIth nerve paralysis * 1	1/365 (0.27%)	1
Psychiatric disorders
Mental status changes * 1	3/365 (0.82%)	5
Affective disorder * 1	1/365 (0.27%)	2
Agitation * 1	1/365 (0.27%)	1
Anxiety disorder * 1	1/365 (0.27%)	2
Hallucination, visual * 1	1/365 (0.27%)	1
Hallucination, auditory * 1	1/365 (0.27%)	1
Nightmare * 1	1/365 (0.27%)	1
Sleep disorder * 1	1/365 (0.27%)	1
Substance-induced psychotic disorder * 1	1/365 (0.27%)	1
Suicidal ideation * 1	1/365 (0.27%)	1
Renal and urinary disorders
Haematuria * 1	1/365 (0.27%)	1
Nephrolithiasis * 1	1/365 (0.27%)	1
Nephrotic syndrome * 1	1/365 (0.27%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory distress * 1	2/365 (0.55%)	2
Hypoxia * 1	1/365 (0.27%)	1
Pneumonia aspiration * 1	1/365 (0.27%)	1
Sleep apnoea syndrome * 1	1/365 (0.27%)	1
Skin and subcutaneous tissue disorders
Drug eruption * 1	1/365 (0.27%)	1
Rash * 1	1/365 (0.27%)	1
Vascular disorders
Haematoma * 1	1/365 (0.27%)	1
1 Term from vocabulary, MedDRA v16.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Lacosamide (All Participants) (SS)
	Affected / at Risk (%)	# Events
Total	291/365 (79.73%)
Gastrointestinal disorders
Vomiting * 1	77/365 (21.10%)	149
Diarrhoea * 1	40/365 (10.96%)	52
Constipation * 1	25/365 (6.85%)	34
Nausea * 1	25/365 (6.85%)	35
Abdominal pain * 1	21/365 (5.75%)	32
Abdominal pain upper * 1	19/365 (5.21%)	29
General disorders
Pyrexia * 1	80/365 (21.92%)	126
Fatigue * 1	21/365 (5.75%)	31
Infections and infestations
Nasopharyngitis * 1	91/365 (24.93%)	253
Upper respiratory tract infection * 1	86/365 (23.56%)	167
Pharyngitis * 1	37/365 (10.14%)	48
Gastroenteritis * 1	29/365 (7.95%)	35
Influenza * 1	29/365 (7.95%)	38
Bronchitis * 1	26/365 (7.12%)	40
Viral infection * 1	21/365 (5.75%)	36
Sinusitis * 1	20/365 (5.48%)	29
Urinary tract infection * 1	20/365 (5.48%)	24
Ear infection * 1	19/365 (5.21%)	27
Injury, poisoning and procedural complications
Contusion * 1	25/365 (6.85%)	55
Metabolism and nutrition disorders
Decreased appetite * 1	26/365 (7.12%)	28
Nervous system disorders
Somnolence * 1	74/365 (20.27%)	100
Dizziness * 1	69/365 (18.90%)	114
Headache * 1	45/365 (12.33%)	97
Tremor * 1	21/365 (5.75%)	23
Respiratory, thoracic and mediastinal disorders
Cough * 1	36/365 (9.86%)	43
1 Term from vocabulary, MedDRA v16.1; * Indicates events were collected by non-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

• Name/Title: UCB
• Organization: Cares
• Phone: 001-844-599-2273
• EMail: UCBCares@ucb.com

• Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
• ClinicalTrials.gov Identifier: NCT00938912
• Other Study ID Numbers: SP848; 2011-001559-35 ( EudraCT Number )
• First Submitted: July 10, 2009
• First Posted: July 14, 2009
• Results First Submitted: December 17, 2021
• Results First Posted: January 18, 2022
• Last Update Posted: January 18, 2022