Clinical and Economic Burden of Uncontrolled Epilepsy: An... | NCT01390909

Clinical and Economic Burden of Uncontrolled Epilepsy: An... | NCT01390909 | Trialant

Description Module

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Medicaid patients with uncontrolled epilepsy	Database records for patients with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the 365 days	Drug: Anti-epileptic drug (AED)
Medicaid patients with well-controlled epilepsy	Database records for patients with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits	Drug: Anti-epileptic drug (AED)
Medicaid patients with intermediate epilepsy	Database records for patients who are not classified as uncontrolled or well-controlled	Drug: Anti-epileptic drug (AED)
Patients in a private health plan with uncontrolled epilepsy	Database records for patients with 2 or more consecutive changes in AED therapy occuring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within 365 days	Drug: Anti-epileptic drug (AED)
Patients in a private health plan with well-controlled epileps	Database records for patients with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-epileptic drug (AED)	Drug	Prescription claim for at least one AED including lamotrigine, tiagabine, pregabalin, ethosuximide, lacosamide, phenytoin, carbamazepine, valproic acid, felbamate, levetiracetam, zonisamide, primidone, oxcarbazepine, vigabatrin, phenobarbital, gabapentin, topiramate.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average Annualized Costs	Average annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009.	1 year

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Arm/Group Information

ID	Title	Description
FG000	Medicaid, Well Controlled	Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
FG001	Medicaid, Uncontrolled	Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
FG002	Medicaid, Intermediate	Database records for participants who are not classified as uncontrolled or well controlled
FG003	Private, Well Controlled	Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
FG004	Private, Uncontrolled	Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
FG005	Private, Intermediate	Database records for participants who are not classified as uncontrolled or well controlled

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0003454 subjects FG0013552 subjects FG0023552 subjects FG003602 subjects FG004613 subjects FG005613 subjects
Participants in Subgroup		FG0000 subjects FG0013454 subjects FG0020 subjects FG0030 subjects FG004
COMPLETED		FG0003454 subjects FG0013552 subjects FG0023552 subjects FG003602 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Medicaid, Well Controlled	Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
BG001	Medicaid, Uncontrolled

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous	For the total population and the subgroup total population, a weighted average of the individual study group means and number of participants was used. The standard deviation (SD) is the SD of the study group means.

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Average Annualized Costs

Average annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009.

For Arms 1 - 4, Medicaid-enrolled participants with uncontrolled epilepsy (see Arm Descriptions for Arm Title 1 and Arm Title 3) or matched participants with well-controlled or intermediate epilepsy. For Arms 5 - 8, privately-insured participants with uncontrolled epilepsy or matched participants with well-controlled or intermediate epilepsy.

Posted

Mean

Standard Deviation

United States dollars

1 year

ID	Title	Description
OG000	Medicaid, Uncontrolled, Subgroup	Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Medicaid, Uncontrolled, Subgroup	Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
GSK Response Center	GlaxoSmithKline	866-435-7343

Condition Browse Module

ID	Term
D004827	Epilepsy

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Intervention Browse Module

ID	Term
D000927	Anticonvulsants

ID	Term
D002491	Central Nervous System Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Title

Denominators

Categories

Overall Study

Title	Measurements
	BG00041.5± 15.4 BG00141.3± 14.1 BG00241.2± 14.6 BG00354.2± 17.1 BG00454.1± 17.3 BG00554.6± 16.7 BG00643.2± 6.5

Subgroup

Title	Measurements
	BG000NA± NAThere are no subgroup participants. BG00141.4± 14.2 BG002NA± NAThere are no subgroup participants. BG003

Sex/Gender, Customized

Number

Participants

Title

Denominators

Categories

Female, Overall Study

Title	Measurements
	BG0002106 BG0012171 BG0022159 BG003341 BG004351 BG005332 BG0067460

Male, Overall Study

Title	Measurements
	BG0001348 BG0011381 BG0021393 BG003

Female, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG0012091 BG002NAThere are no subgroup participants. BG003

Male, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG001345 BG002NAThere are no subgroup participants. BG003

Number of Days of Observation

For the total population and subgroups, a weighted average of the individual study group means and number of participants was used. The SDs reflect the SDs of the study group means.

Mean

Standard Deviation

days of observation

Title

Denominators

Categories

Overall Study

Title	Measurements
	BG0002184± 1181 BG0012296± 1132 BG0022502± 1124 BG0031572± 847 BG0041478± 749 BG0051739± 792 BG0062221± 385

Subgroup

Title	Measurements
	BG000NA± NAThere are no subgroup participants. BG0012290± 1133 BG002NA± NAThere are no subgroup participants. BG003

Charlson Comorbidity Index (CCI) Scores

The Charlson Comorbidity Index estimates 10-year mortality risk. Scores range from 0 - 37, with a lower score indicating a higher chance of survival. For the total population and the subgroup, a weighted average of the study group means was used. The standard deviation (SD) is the SD of the study group means.

Mean

Standard Deviation

scores on a scale

Title

Denominators

Categories

Overall Study

Title	Measurements
	BG0000.98± 1.83 BG0011.09± 1.84 BG0021.00± 1.78 BG0031.13± 1.65 BG0041.32± 1.91 BG0051.20± 1.82 BG0061.05± 0.11

Subgroup

Title	Measurements
	BG000NA± NAThere are no subgroup participants. BG0011.08± 1.83 BG002NA± NAThere are no subgroup participants. BG003

Number of participant records with diagnosis codes for the indicated diseases or disorders

Number

participant records

Title

Denominators

Categories

Alzheimer's Disease, Overall Study

Title	Measurements
	BG00094 BG00193 BG00284 BG00312 BG00420 BG00519 BG006322

Alzheimer's Disease Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG00193 BG002NAThere are no subgroup participants. BG003

Brain Tumor, Overall Study

Title	Measurements
	BG00053 BG00163 BG00240 BG003

Brain Tumor, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG00162 BG002NAThere are no subgroup participants. BG003

Meningitis, Overall Study

Title	Measurements
	BG00012 BG00116 BG00213 BG003

Meningitis, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG00115 BG002NAThere are no subgroup participants. BG003

Migraine, Overall Study

Title	Measurements
	BG000198 BG001262 BG002262 BG003

Migraine, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG001239 BG002NAThere are no subgroup participants. BG003

Stroke, Overall Study

Title	Measurements
	BG000267 BG001303 BG002264 BG003

Stroke, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG001302 BG002NAThere are no subgroup participants. BG003

Anxiety Disorders, Overall Study

Title	Measurements
	BG000356 BG001447 BG002440 BG003

Anxiety Disorders, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG001410 BG002NAThere are no subgroup participants. BG003

Bipolar Disorder, Overall Study

Title	Measurements
	BG000428 BG001439 BG002472 BG003

Bipolar Disorder, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG001397 BG002NAThere are no subgroup participants. BG003

Depression, Overall Study

Title	Measurements
	BG000821 BG001890 BG002897 BG003

Depression, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG001833 BG002NAThere are no subgroup participants. BG003

Psychosis, Overall Study

Title	Measurements
	BG000809 BG001794 BG002816 BG003

Psychosis, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG001754 BG002NAThere are no subgroup participants. BG003

Personality Disorder, Overall Study

Title	Measurements
	BG000951 BG0011062 BG0021024 BG003

Personality Disorder, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG0011001 BG002NAThere are no subgroup participants. BG003

Mental Retardation, Overall Study

Title	Measurements
	BG000482 BG001322 BG002434 BG003

Mental Retardation, Subgroup

Title	Measurements
	BG000NAThere are no subgroup participants. BG001312 BG002NAThere are no subgroup participants. BG003

Title

Denominators

Categories

AEDs

Title	Measurements
	OG0001352± 4580 OG001462± 2072 OG0021357± 4590 OG0031050± 4297 OG0041697± 3979 OG005639± 2248 OG0061713± 3989 OG0071299± 3949

Non-AEDs

Title	Measurements
	OG0005615± 15730 OG0013657± 11702 OG0025725± 16016 OG003

Hospitalizations; AMC

Title	Measurements
	OG0006902± 31181 OG001958± 9518 OG0027041± 31499 OG003

ED Visits; AMC

Title	Measurements
	OG000400± 1496 OG00197± 731 OG002421± 1661 OG003

Outpatient Visits; AMC

Title	Measurements
	OG0002416± 11759 OG0011258± 9953 OG0022466± 11829 OG003

Neurology Visits; AMC

Title	Measurements
	OG00086± 850 OG00121± 425 OG00286± 839 OG003

Other Healthcare Services; AMC

Title	Measurements
	OG00022022± 106033 OG00123202± 103595 OG00222113± 107291 OG003

Hospitalizations; Ep Rel

Title	Measurements
	OG0004102± 19775 OG001NA± NANone of the participants in this study arm incurred the indicated type of healthcare encounter during the study period. OG0024135± 19915 OG003

ED Visits; Ep Rel

Title	Measurements
	OG000109± 610 OG001NA± NANone of the participants in this study arm incurred the indicated type of healthcare encounter during the study period. OG002111± 616 OG003

Outpatient Visits; Ep Rel

Title	Measurements
	OG000467± 2218 OG00168± 490 OG002469± 2239 OG003

Neurology Visits; Ep Rel

Title	Measurements
	OG00060± 712 OG0019± 143 OG00259± 703 OG003

Other Healthcare Costs; Ep Rel

Title	Measurements
	OG0001502± 14424 OG001754± 10724 OG0021475± 14265 OG003

Total Healthcare Costs; AMC

Title	Measurements
	OG00038708± 114904 OG00129635± 105644 OG00239123± 116204 OG003

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Prescription Drug Costs, AEDs	Median Difference (Final Values)	849	2-Sided	95	786	921	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Prescription Drug Costs, nonAEDs	Median Difference (Final Values)	1879	2-Sided	95	1636	2112	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Hospitalizations, All Medical Costs	Median Difference (Final Values)	5681	2-Sided	95	5257	6077	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Emergency Department Visits, All Medical Costs	Median Difference (Final Values)	273	2-Sided	95	251	295	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Outpatient Services, All Medical Costs	Median Difference (Final Values)	1021	2-Sided	95	819	1211	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Neurologist Visits, All Medical Costs	Median Difference (Final Values)	60	2-Sided	95	48	72	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	0.0080	Adjusted Cost Differences in Other Healthcare Services, All Medical Costs	Median Difference (Final Values)	2555	2-Sided	95	834	4281	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Hospitalizations	Mean Difference (Final Values)	4041	2-Sided	95	3776	4305	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits	Median Difference (Final Values)	105	2-Sided	95	97	114	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Outpatient Services	Median Difference (Final Values)	384	2-Sided	95	358	413	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Neurologist Visits	Mean Difference (Final Values)	47	2-Sided	95	40	56	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs	Mean Difference (Final Values)	892	2-Sided	95	584	1192	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG000 OG001	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Total Healthcare Costs	Median Difference (Final Values)	12258	2-Sided	95	10482	14083	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Prescription Drug Costs, AEDs	Mean Difference (Final Values)	322	2-Sided	95	245	398		No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Prescription Drug Costs, non-AEDs	Mean Difference (Final Values)	841	2-Sided	95	556	1078		No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Hospitalizations, All Medical Costs	Mean Difference (Final Values)	3248	2-Sided	95	2790	3714		No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Emergency Department Visits, All Medical Costs	Mean Difference (Final Values)	164	2-Sided	95	138	190		No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Outpatient Services, All Medical Costs	Median Difference (Final Values)	628	2-Sided	95	409	819		No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Neurologist Visits, All Medical Costs	Mean Difference (Final Values)	29	2-Sided	95	18	42		No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	0.7628	Adjusted Cost Differences in Other Healthcare Services, All Medical Costs	Mean Difference (Final Values)	235	2-Sided	95	-1367	1798		No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Hospitalizations	Mean Difference (Final Values)	2306	2-Sided	95	2016	2603	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits	Median Difference (Final Values)	63	2-Sided	95	52	74	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Outpatient Services	Mean Difference (Final Values)	211	2-Sided	95	179	245	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Neurologist Visits	Mean Difference (Final Values)	23	2-Sided	95	15	33	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	0.0581	Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs	Median Difference (Final Values)	277	2-Sided	95	-19	581	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG002 OG003	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Total Healthcare Costs	Mean Difference (Final Values)	5437	2-Sided	95	3672	7142		No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Prescription Drug Costs, AEDs	Mean Difference (Final Values)	1019	2-Sided	95	836	1191		No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs	Median Difference (Final Values)	1047	2-Sided	95	564	1486		No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Hospitalizations	Median Difference (Final Values)	9128	2-Sided	95	7346	11125		No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Emergency Department Visits	Mean Difference (Final Values)	459	2-Sided	95	326	622		No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Outpatient Services	Median Difference (Final Values)	2427	2-Sided	95	1587	3290		No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Neurologists Visits	Median Difference (Final Values)	357	2-Sided	95	225	525		No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Other Healthcare Services	Median Difference (Final Values)	502	2-Sided	95	234	768		No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Hospitalizations	Mean Difference (Final Values)	6483	2-Sided	95	5329	7927	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits	Mean Difference (Final Values)	150	2-Sided	95	112	199	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Outpatient Services	Mean Difference (Final Values)	516	2-Sided	95	401	645	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Epilepsy-Related Neurologist Visits	Median Difference (Final Values)	158	2-Sided	95	97	231	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.	<0.0001	Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs	Median Difference (Final Values)	83	2-Sided	95	58	113	Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.	No	Superiority or Other
OG004 OG005	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Total Healthcare Costs	Mean Difference (Final Values)	14582	2-Sided	95	12019	17097		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Prescription Drug Costs, AEDs	Mean Difference (Final Values)	420	2-Sided	95	210	630		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs	Mean Difference (Final Values)	658	2-Sided	95	217	1131		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Hospitalizations, All Medical Costs	Mean Difference (Final Values)	6040	2-Sided	95	3442	8795		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	0.0020	Adjusted Cost Differences in Emergency Department Visits, All Medical Costs	Mean Difference (Final Values)	268	2-Sided	95	81	425		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	0.9670	Adjusted Cost Differences in Outpatient Services, All Medical Costs	Mean Difference (Final Values)	-40	2-Sided	95	-991	944		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	0.2563	Adjusted Cost Differences in Neurologist Visits, All Medical Costs	Mean Difference (Final Values)	97	2-Sided	95	-77	302		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	0.0100	Adjusted Cost Differences in Other Healthcare Services, All Medical Costs	Mean Difference (Final Values)	328	2-Sided	95	90	588		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Hospitalizations, Epilepsy-Related	Mean Difference (Final Values)	4984	2-Sided	95	3168	7335		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Emergency Department Visits, Epilepsy-Related	Mean Difference (Final Values)	112	2-Sided	95	70	166		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	0.01	Adjusted Cost Differences in Outpatient Services, Epilepsy-Related	Mean Difference (Final Values)	236	2-Sided	95	70	403		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	0.1061	Adjusted Cost Differences in Neurologist Visits, Epilepsy-Related	Mean Difference (Final Values)	65	2-Sided	95	-22	145		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Other Healthcare Services, Epilepsy-Related	Mean Difference (Final Values)	58	2-Sided	95	28	93		No	Superiority or Other
OG006 OG007	Ordinary Least Squares Regression	Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.	<0.0001	Adjusted Cost Differences in Total Healthcare Costs	Mean Difference (Final Values)	7673	2-Sided	95	4571	10989		No	Superiority or Other