Trial Outcomes & Findings for Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database (NCT NCT01390909)
NCT ID: NCT01390909
Last Updated: 2012-10-08
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
12386 participants
Primary outcome timeframe
1 year
Results posted on
2012-10-08
Participant Flow
Participant milestones
| Measure |
Medicaid, Well Controlled
Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
|
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.
|
Medicaid, Intermediate
Database records for participants who are not classified as uncontrolled or well controlled
|
Private, Well Controlled
Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
|
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.
|
Private, Intermediate
Database records for participants who are not classified as uncontrolled or well controlled
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3454
|
3552
|
3552
|
602
|
613
|
613
|
|
Overall Study
Participants in Subgroup
|
0
|
3454
|
0
|
0
|
602
|
0
|
|
Overall Study
COMPLETED
|
3454
|
3552
|
3552
|
602
|
613
|
613
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database
Baseline characteristics by cohort
| Measure |
Medicaid, Well Controlled
n=3454 Participants
Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
|
Medicaid, Uncontrolled
n=3552 Participants
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 (3454 participants) were matched with participant records in the Medicaid, well-controlled cohort.
|
Medicaid, Intermediate
n=3552 Participants
Database records for participants who are not classified as uncontrolled or well controlled
|
Private, Well Controlled
n=602 Participants
Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
|
Private, Uncontrolled
n=613 Participants
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 (602 participants) were matched with participant records in the Medicaid, well-controlled cohort.
|
Private, Intermediate
n=613 Participants
Database records for participants who are not classified as uncontrolled or well controlled
|
Total
n=12386 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
Overall Study
|
41.5 Years
STANDARD_DEVIATION 15.4 • n=93 Participants
|
41.3 Years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
41.2 Years
STANDARD_DEVIATION 14.6 • n=27 Participants
|
54.2 Years
STANDARD_DEVIATION 17.1 • n=483 Participants
|
54.1 Years
STANDARD_DEVIATION 17.3 • n=36 Participants
|
54.6 Years
STANDARD_DEVIATION 16.7 • n=10 Participants
|
43.2 Years
STANDARD_DEVIATION 6.5 • n=115 Participants
|
|
Age Continuous
Subgroup
|
NA Years
STANDARD_DEVIATION NA • n=93 Participants
|
41.4 Years
STANDARD_DEVIATION 14.2 • n=4 Participants
|
NA Years
STANDARD_DEVIATION NA • n=27 Participants
|
NA Years
STANDARD_DEVIATION NA • n=483 Participants
|
54.0 Years
STANDARD_DEVIATION 17.4 • n=36 Participants
|
NA Years
STANDARD_DEVIATION NA • n=10 Participants
|
43.3 Years
STANDARD_DEVIATION 6.3 • n=115 Participants
|
|
Sex/Gender, Customized
Female, Overall Study
|
2106 Participants
n=93 Participants
|
2171 Participants
n=4 Participants
|
2159 Participants
n=27 Participants
|
341 Participants
n=483 Participants
|
351 Participants
n=36 Participants
|
332 Participants
n=10 Participants
|
7460 Participants
n=115 Participants
|
|
Sex/Gender, Customized
Male, Overall Study
|
1348 Participants
n=93 Participants
|
1381 Participants
n=4 Participants
|
1393 Participants
n=27 Participants
|
261 Participants
n=483 Participants
|
262 Participants
n=36 Participants
|
281 Participants
n=10 Participants
|
4926 Participants
n=115 Participants
|
|
Sex/Gender, Customized
Female, Subgroup
|
NA Participants
n=93 Participants
|
2091 Participants
n=4 Participants
|
NA Participants
n=27 Participants
|
NA Participants
n=483 Participants
|
345 Participants
n=36 Participants
|
NA Participants
n=10 Participants
|
2436 Participants
n=115 Participants
|
|
Sex/Gender, Customized
Male, Subgroup
|
NA Participants
n=93 Participants
|
345 Participants
n=4 Participants
|
NA Participants
n=27 Participants
|
NA Participants
n=483 Participants
|
257 Participants
n=36 Participants
|
NA Participants
n=10 Participants
|
602 Participants
n=115 Participants
|
|
Number of Days of Observation
Overall Study
|
2184 days of observation
STANDARD_DEVIATION 1181 • n=93 Participants
|
2296 days of observation
STANDARD_DEVIATION 1132 • n=4 Participants
|
2502 days of observation
STANDARD_DEVIATION 1124 • n=27 Participants
|
1572 days of observation
STANDARD_DEVIATION 847 • n=483 Participants
|
1478 days of observation
STANDARD_DEVIATION 749 • n=36 Participants
|
1739 days of observation
STANDARD_DEVIATION 792 • n=10 Participants
|
2221 days of observation
STANDARD_DEVIATION 385 • n=115 Participants
|
|
Number of Days of Observation
Subgroup
|
NA days of observation
STANDARD_DEVIATION NA • n=93 Participants
|
2290 days of observation
STANDARD_DEVIATION 1133 • n=4 Participants
|
NA days of observation
STANDARD_DEVIATION NA • n=27 Participants
|
NA days of observation
STANDARD_DEVIATION NA • n=483 Participants
|
1485 days of observation
STANDARD_DEVIATION 751 • n=36 Participants
|
NA days of observation
STANDARD_DEVIATION NA • n=10 Participants
|
2170.5 days of observation
STANDARD_DEVIATION 402.5 • n=115 Participants
|
|
Charlson Comorbidity Index (CCI) Scores
Overall Study
|
0.98 scores on a scale
STANDARD_DEVIATION 1.83 • n=93 Participants
|
1.09 scores on a scale
STANDARD_DEVIATION 1.84 • n=4 Participants
|
1.00 scores on a scale
STANDARD_DEVIATION 1.78 • n=27 Participants
|
1.13 scores on a scale
STANDARD_DEVIATION 1.65 • n=483 Participants
|
1.32 scores on a scale
STANDARD_DEVIATION 1.91 • n=36 Participants
|
1.20 scores on a scale
STANDARD_DEVIATION 1.82 • n=10 Participants
|
1.05 scores on a scale
STANDARD_DEVIATION 0.11 • n=115 Participants
|
|
Charlson Comorbidity Index (CCI) Scores
Subgroup
|
NA scores on a scale
STANDARD_DEVIATION NA • n=93 Participants
|
1.08 scores on a scale
STANDARD_DEVIATION 1.83 • n=4 Participants
|
NA scores on a scale
STANDARD_DEVIATION NA • n=27 Participants
|
NA scores on a scale
STANDARD_DEVIATION NA • n=483 Participants
|
1.29 scores on a scale
STANDARD_DEVIATION 1.88 • n=36 Participants
|
NA scores on a scale
STANDARD_DEVIATION NA • n=10 Participants
|
1.11 scores on a scale
STANDARD_DEVIATION 1.66 • n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Alzheimer's Disease, Overall Study
|
94 participant records
n=93 Participants
|
93 participant records
n=4 Participants
|
84 participant records
n=27 Participants
|
12 participant records
n=483 Participants
|
20 participant records
n=36 Participants
|
19 participant records
n=10 Participants
|
322 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Alzheimer's Disease Subgroup
|
NA participant records
n=93 Participants
|
93 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
20 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
113 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Brain Tumor, Overall Study
|
53 participant records
n=93 Participants
|
63 participant records
n=4 Participants
|
40 participant records
n=27 Participants
|
38 participant records
n=483 Participants
|
50 participant records
n=36 Participants
|
43 participant records
n=10 Participants
|
287 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Brain Tumor, Subgroup
|
NA participant records
n=93 Participants
|
62 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
44 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
106 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Meningitis, Overall Study
|
12 participant records
n=93 Participants
|
16 participant records
n=4 Participants
|
13 participant records
n=27 Participants
|
11 participant records
n=483 Participants
|
10 participant records
n=36 Participants
|
6 participant records
n=10 Participants
|
68 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Meningitis, Subgroup
|
NA participant records
n=93 Participants
|
15 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
9 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
24 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Migraine, Overall Study
|
198 participant records
n=93 Participants
|
262 participant records
n=4 Participants
|
262 participant records
n=27 Participants
|
41 participant records
n=483 Participants
|
42 participant records
n=36 Participants
|
35 participant records
n=10 Participants
|
840 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Migraine, Subgroup
|
NA participant records
n=93 Participants
|
239 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
41 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
280 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Stroke, Overall Study
|
267 participant records
n=93 Participants
|
303 participant records
n=4 Participants
|
264 participant records
n=27 Participants
|
123 participant records
n=483 Participants
|
134 participant records
n=36 Participants
|
154 participant records
n=10 Participants
|
1245 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Stroke, Subgroup
|
NA participant records
n=93 Participants
|
302 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
128 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
430 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Anxiety Disorders, Overall Study
|
356 participant records
n=93 Participants
|
447 participant records
n=4 Participants
|
440 participant records
n=27 Participants
|
32 participant records
n=483 Participants
|
41 participant records
n=36 Participants
|
28 participant records
n=10 Participants
|
1344 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Anxiety Disorders, Subgroup
|
NA participant records
n=93 Participants
|
410 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
38 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
448 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Bipolar Disorder, Overall Study
|
428 participant records
n=93 Participants
|
439 participant records
n=4 Participants
|
472 participant records
n=27 Participants
|
22 participant records
n=483 Participants
|
18 participant records
n=36 Participants
|
15 participant records
n=10 Participants
|
1394 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Bipolar Disorder, Subgroup
|
NA participant records
n=93 Participants
|
397 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
17 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
414 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Depression, Overall Study
|
821 participant records
n=93 Participants
|
890 participant records
n=4 Participants
|
897 participant records
n=27 Participants
|
90 participant records
n=483 Participants
|
95 participant records
n=36 Participants
|
102 participant records
n=10 Participants
|
2895 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Depression, Subgroup
|
NA participant records
n=93 Participants
|
833 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
90 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
923 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Psychosis, Overall Study
|
809 participant records
n=93 Participants
|
794 participant records
n=4 Participants
|
816 participant records
n=27 Participants
|
62 participant records
n=483 Participants
|
65 participant records
n=36 Participants
|
65 participant records
n=10 Participants
|
2611 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Psychosis, Subgroup
|
NA participant records
n=93 Participants
|
754 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
65 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
819 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Personality Disorder, Overall Study
|
951 participant records
n=93 Participants
|
1062 participant records
n=4 Participants
|
1024 participant records
n=27 Participants
|
51 participant records
n=483 Participants
|
68 participant records
n=36 Participants
|
58 participant records
n=10 Participants
|
3214 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Personality Disorder, Subgroup
|
NA participant records
n=93 Participants
|
1001 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
67 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
1068 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Mental Retardation, Overall Study
|
482 participant records
n=93 Participants
|
322 participant records
n=4 Participants
|
434 participant records
n=27 Participants
|
5 participant records
n=483 Participants
|
11 participant records
n=36 Participants
|
8 participant records
n=10 Participants
|
1262 participant records
n=115 Participants
|
|
Number of participant records with diagnosis codes for the indicated diseases or disorders
Mental Retardation, Subgroup
|
NA participant records
n=93 Participants
|
312 participant records
n=4 Participants
|
NA participant records
n=27 Participants
|
NA participant records
n=483 Participants
|
11 participant records
n=36 Participants
|
NA participant records
n=10 Participants
|
323 participant records
n=115 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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.
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.
Outcome measures
| Measure |
Medicaid, Uncontrolled, Subgroup
n=3454 Participants
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
|
Medicaid, Well Controlled
n=3454 Participants
Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
|
Medicaid, Uncontrolled
n=3552 Participants
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
|
Medicaid, Intermediate
n=3552 Participants
Database records for participants who are not classified as uncontrolled or well controlled
|
Private, Uncontrolled, Subgroup
n=602 Participants
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 subgroup was matched with participant records in the private, well-controlled cohort.
|
Private, Well Controlled
n=602 Participants
Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
|
Private, Uncontrolled
n=613 Participants
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.
|
Private, Intermediate
n=613 Participants
Database records for participants who are not classified as uncontrolled or well controlled
|
|---|---|---|---|---|---|---|---|---|
|
Average Annualized Costs
ED Visits; AMC
|
400 United States dollars
Standard Deviation 1496
|
97 United States dollars
Standard Deviation 731
|
421 United States dollars
Standard Deviation 1661
|
242 United States dollars
Standard Deviation 1371
|
586 United States dollars
Standard Deviation 4392
|
76 United States dollars
Standard Deviation 804
|
603 United States dollars
Standard Deviation 4422
|
254 United States dollars
Standard Deviation 2898
|
|
Average Annualized Costs
Outpatient Visits; Ep Rel
|
467 United States dollars
Standard Deviation 2218
|
68 United States dollars
Standard Deviation 490
|
469 United States dollars
Standard Deviation 2239
|
248 United States dollars
Standard Deviation 1660
|
703 United States dollars
Standard Deviation 3072
|
179 United States dollars
Standard Deviation 1042
|
702 United States dollars
Standard Deviation 3082
|
479 United States dollars
Standard Deviation 6624
|
|
Average Annualized Costs
Other Healthcare Costs; Ep Rel
|
1502 United States dollars
Standard Deviation 14424
|
754 United States dollars
Standard Deviation 10724
|
1475 United States dollars
Standard Deviation 14265
|
1273 United States dollars
Standard Deviation 14072
|
103 United States dollars
Standard Deviation 752
|
17 United States dollars
Standard Deviation 204
|
102 United States dollars
Standard Deviation 746
|
42 United States dollars
Standard Deviation 472
|
|
Average Annualized Costs
Total Healthcare Costs; AMC
|
38708 United States dollars
Standard Deviation 114904
|
29635 United States dollars
Standard Deviation 105644
|
39123 United States dollars
Standard Deviation 116204
|
34839 United States dollars
Standard Deviation 123866
|
24853 United States dollars
Standard Deviation 81299
|
9005 United States dollars
Standard Deviation 28038
|
26057 United States dollars
Standard Deviation 100777
|
17719 United States dollars
Standard Deviation 69241
|
|
Average Annualized Costs
AEDs
|
1352 United States dollars
Standard Deviation 4580
|
462 United States dollars
Standard Deviation 2072
|
1357 United States dollars
Standard Deviation 4590
|
1050 United States dollars
Standard Deviation 4297
|
1697 United States dollars
Standard Deviation 3979
|
639 United States dollars
Standard Deviation 2248
|
1713 United States dollars
Standard Deviation 3989
|
1299 United States dollars
Standard Deviation 3949
|
|
Average Annualized Costs
Non-AEDs
|
5615 United States dollars
Standard Deviation 15730
|
3657 United States dollars
Standard Deviation 11702
|
5725 United States dollars
Standard Deviation 16016
|
4801 United States dollars
Standard Deviation 15357
|
4497 United States dollars
Standard Deviation 11374
|
3096 United States dollars
Standard Deviation 10692
|
4587 United States dollars
Standard Deviation 11972
|
3883 United States dollars
Standard Deviation 9436
|
|
Average Annualized Costs
Hospitalizations; AMC
|
6902 United States dollars
Standard Deviation 31181
|
958 United States dollars
Standard Deviation 9518
|
7041 United States dollars
Standard Deviation 31499
|
3513 United States dollars
Standard Deviation 22265
|
11308 United States dollars
Standard Deviation 62399
|
1697 United States dollars
Standard Deviation 12292
|
12357 United States dollars
Standard Deviation 84898
|
5858 United States dollars
Standard Deviation 37310
|
|
Average Annualized Costs
Outpatient Visits; AMC
|
2416 United States dollars
Standard Deviation 11759
|
1258 United States dollars
Standard Deviation 9953
|
2466 United States dollars
Standard Deviation 11829
|
1804 United States dollars
Standard Deviation 11649
|
5757 United States dollars
Standard Deviation 24888
|
3061 United States dollars
Standard Deviation 13353
|
5771 United States dollars
Standard Deviation 24883
|
5780 United States dollars
Standard Deviation 37154
|
|
Average Annualized Costs
Neurology Visits; AMC
|
86 United States dollars
Standard Deviation 850
|
21 United States dollars
Standard Deviation 425
|
86 United States dollars
Standard Deviation 839
|
52 United States dollars
Standard Deviation 666
|
556 United States dollars
Standard Deviation 4306
|
175 United States dollars
Standard Deviation 1593
|
566 United States dollars
Standard Deviation 4352
|
442 United States dollars
Standard Deviation 4263
|
|
Average Annualized Costs
Other Healthcare Services; AMC
|
22022 United States dollars
Standard Deviation 106033
|
23202 United States dollars
Standard Deviation 103595
|
22113 United States dollars
Standard Deviation 107291
|
23428 United States dollars
Standard Deviation 119218
|
1008 United States dollars
Standard Deviation 5428
|
436 United States dollars
Standard Deviation 4444
|
1026 United States dollars
Standard Deviation 5472
|
645 United States dollars
Standard Deviation 3910
|
|
Average Annualized Costs
Hospitalizations; Ep Rel
|
4102 United States dollars
Standard Deviation 19775
|
NA United States dollars
Standard Deviation NA
None of the participants in this study arm incurred the indicated type of healthcare encounter during the study period.
|
4135 United States dollars
Standard Deviation 19915
|
1702 United States dollars
Standard Deviation 13344
|
6700 United States dollars
Standard Deviation 48095
|
NA United States dollars
Standard Deviation NA
None of the participants in this study arm incurred the indicated type of healthcare encounter during the study period.
|
7646 United States dollars
Standard Deviation 70525
|
2413 United States dollars
Standard Deviation 23487
|
|
Average Annualized Costs
ED Visits; Ep Rel
|
109 United States dollars
Standard Deviation 610
|
NA United States dollars
Standard Deviation NA
None of the participants in this study arm incurred the indicated type of healthcare encounter during the study period.
|
111 United States dollars
Standard Deviation 616
|
46 United States dollars
Standard Deviation 540
|
152 United States dollars
Standard Deviation 972
|
NA United States dollars
Standard Deviation NA
None of the participants in this study arm incurred the indicated type of healthcare encounter during the study period.
|
153 United States dollars
Standard Deviation 968
|
39 United States dollars
Standard Deviation 635
|
|
Average Annualized Costs
Neurology Visits; Ep Rel
|
60 United States dollars
Standard Deviation 712
|
9 United States dollars
Standard Deviation 143
|
59 United States dollars
Standard Deviation 703
|
33 United States dollars
Standard Deviation 472
|
235 United States dollars
Standard Deviation 1797
|
68 United States dollars
Standard Deviation 577
|
237 United States dollars
Standard Deviation 1845
|
165 United States dollars
Standard Deviation 1670
|
Adverse Events
Medicaid, Uncontrolled, Subgroup
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medicaid, Well Controlled
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medicaid, Uncontrolled
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medicaid, Intermediate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Private, Uncontrolled, Subgroup
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Private, Well Controlled
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Private, Uncontrolled
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Private, Intermediate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER