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This is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among Rheumatoid Arthritis patients initiating treatment comparator groups of interest between January 2014 and September 2016 across three United States insurance claims databases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Truven Health MarketScan | The Truven Health MarketScan Research Databases reflects the combined healthcare service use of individuals covered by Truven Health clients (including employers, health plans, and hospitals) nationwide. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date | Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Index medications were tofacitinib, adalimumab or etanercept. | During 12 months post-index date |
| Percentage of Participants Who Immediately Switched Index Medication During 12 Months Post-index Date | Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept. | During 12 months post-index date |
| Percentage of Participants Who Discontinued Then Switched Index Medication During 12 Months Post-index Date | Participants who discontinued index medication then switched from index medication were those who had gap in the index medication therapy of at least 60 days and then after the gap they switched to an advanced therapy different from index medication. Index medications were tofacitinib, adalimumab or etanercept. | During 12 months post-index date |
| Percentage of Participants Who Discontinued Then Restarted Index Medication During 12 Months Post-index Date | Participants who discontinued index medication and then restarted index medication were those who had a gap in the index medication therapy of at least 60 days and the first advanced therapy observed after the gap was the index medication. Index medications were tofacitinib, adalimumab or etanercept. | During 12 months post index date |
| Percentage of Participants Who Discontinued Without Switching or Restarting Index Medication During 12 Months Post-index Date |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Switched Index Medication Any Time During 12 Months Post-index Date | Participants who switched from index medication at any time during the 12-month follow-up post-index period were evaluated. Index medications were tofacitinib, adalimumab or etanercept. | During 12 months post-index date |
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Inclusion Criteria:
Exclusion Criteria:
-None
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Patients
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Collegeville | Pennsylvania | 19426 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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5-years (January 2012 to September 2017) included pre-index of 2 years, 2 years to capture treatment initiation (index date), and 1 year for follow-up post-index. Index date was first prescription date of treatment (tofacitinib, adalimumab or etanercept) from January 2014 to September 2016.
5-years data were retrieved from insurance claims Truven Health MarketScan Research Databases and were evaluated in 5 months of this retrospective, observational study. Participants who initiated treatment with tofacitinib, adalimumab or etanercept for rheumatoid arthritis (RA), between January 2014 and September 2016 were involved in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib Low Out of Pocket (OOP) Cost | Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. |
| FG001 | Tofacitinib High OOP Cost | Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. |
| FG002 | Switch From Adalimumab to Etanercept | Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. |
| FG003 | Switch From Adalimumab to Tofacitinib | Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. |
| FG004 | Switch From Etanercept to Adalimumab | Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. |
| FG005 | Switch From Etanercept to Tofacitinib | Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib Low OOP Cost | Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. |
| BG001 | Tofacitinib High OOP Cost |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date | Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post-index date |
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Not applicable as safety data was not planned to be collected and evaluated during the study
Study used de-identified structured data. Minimum criteria for reporting an adverse event (identifiable participant, identifiable reporter, a suspect product/treatment, and event) could not be met. Hence, due to the nature of claims database from which data were queried, no adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib Low OOP Cost | Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. |
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Prioritization for outcome measures was per study team's discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2019 | Sep 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Participants who discontinued index medication without switching or restarting index medication were those who had a gap in index medication therapy of at least 60 days and there were no claims for either the index medication or a different advanced therapy for the remainder of the follow-up period. Index medications were tofacitinib, adalimumab or etanercept.
| During 12 months post index date |
| Mean of Number of Days to Immediate Switch From Index Medication During 12 Months Post-index Date |
Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before the end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept. Number of days to immediately switch from index medication = immediate switch date - index date + 1. |
| During 12 months post-index date |
| Mean of Number of Days to Immediate or Delayed Switch Index Medication During 12 Months Post-index Date | Number of days to immediate or delayed switch from index medication any time during the 12-month follow-up period = immediate or delayed switch date - index date + 1. Index medications were tofacitinib, adalimumab or etanercept. | During 12 month post-index date |
| Mean of Number of Days to Discontinue Index Medication During 12 Months Post-index Date | Number of days to discontinue index medication = date of last persistent index medication prescription/administration + days supply- index date + 1. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. | During 12 months post-index date |
| Duration of Index Medication Persistent Therapy During 12 Months Post-index Date | Index medication persistent therapy duration was defined as days to discontinue or immediate switch or end of 12 months post-index follow if participants remained persistent, whichever came first. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication: not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Discontinuation from index medication: gap in the index medication therapy of at least 60 days. Immediate switch from index medication: initiation of a non-index advanced therapy before end of a 60-day gap in index medication. | During 12 months post-index date |
| Percentage of Participants Who Were Persistent With Main Non-Biologic Disease Modifying Antirheumatic Drugs (NB-DMARD) During 12 Months Post-index Date: Combination Therapy | Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who were persistent with main NB-DMARDs use. Main NB-DMARDs considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Persistence with main NB-DMARDs was defined as not having a gap of at least 60 days between prescription fill dates and their administration. | During 12 months post-index date |
| Percentage of Participants Who Immediately Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy | Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who immediately switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Immediate switch from main NB-DMARDs was defined as initiation of other medication than main NB-DMARDs, before end of a 60-day gap. | During 12 months post-index date |
| Percentage of Participants Who Discontinued Then Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy | Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued then switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs then switched from main NB-DMARDS were those who had gap in the main NB-DMARDs medication of at least 60 days and then after the gap switched to other medication than main NB-DMARDs. | During 12 months post-index date |
| Percentage of Participants Who Discontinued Then Restarted Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy | Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued then restarted main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs and then restarted main NB-DMARDs were those who had a gap in main NB-DMARDs of at least 60 days and after the gap, they started main NB-DMARDs again. | During 12 months post-index date |
| Percentage of Participants Who Discontinued Without Switching or Restarting Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy | Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued without switching or restarting main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs without switching or restarting main NB-DMARDs were those who had a gap in main NB-DMARDs of at least 60 days and there were no claims for either the main NB-DMARDs or a different therapy for the remainder of the follow-up period. | During 12 months post-index date |
| Percentage of Participants Who Initiated Index Medication as Monotherapy and Eventually Added NB-DMARDs During 12 Months Post-index Date | Percentage of participants who initiated only index medication and then eventually also added any NB-DMARDs, 1 of the 4 mains NB-DMARDs or other than these 4 NB-DMARDs in their therapy, were evaluated. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Any NB-DMARDs included those participants who received any of the NB-DMARDs and participant was counted only once if took different NB-DMARDs during the follow-up period. Participants might be counted more than once in categories except category "Any NB-DMARDs". Index medications were tofacitinib, adalimumab or etanercept. | During 12 months post-index date |
| Percentage of Participants Who Met Adherence Effectiveness Criteria During 12 Months Post-index Date | A proportion of days covered (PDC) was calculated based on total days' supply over the 12 months post-index. The PDC was calculated by using the date of service and the day supply for each fill of the index medication. Participants with early refills were allowed to stockpile medications up to a maximum of 14 days total for later use. Participants who met adherence effective criteria were those who had PDC >=0.8. Index medications were tofacitinib, adalimumab or etanercept. | During 12 months post-index date |
| Percentage of Participants Who Met Dose Escalation Effectiveness Criteria During 12 Months Post-index Date | Dose escalation for index medication was defined as: 1) for adalimumab: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 40 milligram per week (mg/week), 2) for etanercept: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 100 mg/week, 3) for tofacitinib: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 20 milligram per day (mg/day) for immediate release and 22 mg/day for extended release. Participants who met dose escalation effectiveness criteria were those who did not have any dose escalation for index medication compared to the starting dose. | During 12 months post-index date |
| Percentage of Participants Who Met Switched Effectiveness Criteria During 12 Months Post-index Date | A switch for this outcome measure was defined as use of a different biologic disease modifying antirheumatic drug (B-DMARDs) or Janus kinase inhibitor (JAKi), any time during the 12 months post-index follow-up. Participants who met switched effectiveness criteria were those who did not switch from the index medication to B-DMARDs or JAKi. Index medications were tofacitinib, adalimumab or etanercept. | During 12 months post-index date |
| Percentage of Participants Who Met NB-DMARD Effectiveness Criteria During 12 Months Post-index Date | Participants who started only index medication regimen (as monotherapy), but eventually initiated main NB-DMARDs were identified in the 12 months post-index follow-up period as adding new NB-DMARD. Participants who started index medication regimen along with any of the main NB-DMARDs (combination therapy), presence of a different NB-DMARD in 12 months post-index was identified as adding new NB-DMARD. Participants who met NB-DMARD effectiveness criteria were those who did not add a new NB-DMARD in the 12 months post-index follow up. Index medications were tofacitinib, adalimumab or etanercept. | During 12 months post-index date |
| Percentage of Participants Who Met Oral Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date | Oral glucocorticoid effectiveness criteria for participants with no claims for oral glucocorticoid prescriptions in the 6 months prior to the index date = did not receive more than 30 days of oral glucocorticoids between (index date + 89 days) to (index date + 359 days). 30 days of oral glucocorticoids was determined by summing up the day supply of all glucocorticoids claims with a fill date between (index date + 89 days) to (index date + 359 days). Oral glucocorticoid effectiveness criteria for participants with claims for oral glucocorticoids during the 6 months prior to the index date = no increase in oral glucocorticoid dose >=20% during months 6-12 after index compared to the 6 months before the index date. Increase in oral glucocorticoids was determined from the prednisone equivalent dose for all glucocorticoid claims filled. | During 12 months post-index date |
| Percentage of Participants Who Met Infusion Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date | Glucocorticoid infusion effectiveness criteria was receiving of maximum of 1 parenteral or intra-articular glucocorticoid joint injection on unique days (between [index date + 89 days] to [index date + 359 days]) after the participants had been on treatment with index medication for more than 3 months. Index medications were tofacitinib, adalimumab or etanercept. | During 12 months post-index date |
| Mean of Rheumatoid Arthritis (RA) Related Inpatient Visits During 12 Months Pre-index Date | Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits related to RA during 12 months pre-index were evaluated. | During 12 months pre-index date |
| Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Pre-Index Date | In this outcome measure, mean of number of emergency department visits related to RA during 12 months pre-index were evaluated. | During 12 months pre-index date |
| Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Pre-index Date | Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits related to RA during 12 months pre-index were evaluated. | During 12 months pre-index date |
| Mean of Rheumatoid Arthritis-Related Pharmacy Visits During 12 Months Pre-index Date | In this outcome measure, mean of number of pharmacy visits related to RA during 12 months pre-index were evaluated. | During 12 months pre-index date |
| Mean of Rheumatoid Arthritis Related Inpatient Visits During 12 Months Post-index Date | Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits related to RA during 12 months post-index were evaluated. | During 12 months post-index date |
| Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Post-index Date | In this outcome measure, mean of number of emergency department visits related to RA during 12 months post-index were evaluated. | During 12 months post-index date |
| Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Post-index Date | Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits related to RA during 12 months post-index were evaluated. | During 12 months post-index date |
| Mean of Rheumatoid Arthritis Related Pharmacy Visits During 12 Months Post-index Date | In this outcome measure, mean of number of pharmacy visits related to RA during 12 months post-index were evaluated. | During 12 months post-index date |
| Mean of All Cause Inpatient Visits During 12 Months Pre-Index Date | Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits regardless of reason (including related to RA) during 12 months pre-index were evaluated. | During 12 months pre-index date |
| Mean of All Cause Emergency Department (ED) Visits During 12 Months Pre-index Date | In this outcome measure, mean of number of emergency department visits regardless of reason (including related to RA) during 12 months pre-index were evaluated. | During 12 months pre-index date |
| Mean of All Cause Outpatient Visits During 12 Months Pre-Index Date | Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits regardless of reason (including related to RA) during 12 months pre-index were evaluated. | During 12 months pre-index date |
| Mean of All Cause Pharmacy Visits During 12 Months Pre-index Date | In this outcome measure, mean of number of pharmacy visits regardless of reason (including related to RA) during 12 months pre-index were evaluated. | During 12 months pre-index date |
| Mean of All Cause Inpatient Visits During 12 Months Post-index Date | Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits regardless of reason (including related to RA) during 12 months post-index were evaluated. | During 12 months post-index date |
| Mean of All Cause Emergency Department (ED) Visits During 12 Months Post-index Date | In this outcome measure, mean of number of emergency department visits regardless of reason (including related to RA) during 12 months post-index were evaluated. | During 12 months post-index date |
| Mean of All Cause Outpatient Visits During 12 Months Post-index Date | Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits regardless of reason (including related to RA) during 12 months post-index were evaluated. | During 12 months post-index date |
| Mean of All Cause Pharmacy Visits During 12 Months Post-index Date | In this outcome measure, mean of number of pharmacy visits regardless of reason (including related to RA) during 12 months post-index were evaluated. | During 12 months post-index date |
| Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Pre-index Date | Total health care cost related to RA was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment costs (pharmacy cost) related to rheumatoid arthritis. | During 12 months pre-index date |
| Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Post-index Date | Total health care cost related to RA was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment costs (pharmacy cost) related to rheumatoid arthritis. | During 12 months post-index date |
| All Cause Total Health Care Cost During 12 Months Pre-index Date | All cause total health care cost was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment cost (pharmacy cost) regardless of reason including RA. | During 12 months pre-index date |
| All Cause Total Health Care Cost During 12 Months Post-index Date | All cause total health care cost was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment cost (pharmacy cost) regardless of reason including RA. | During 12 months post-index date |
Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. |
| BG002 | Switch From Adalimumab to Etanercept | Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. |
| BG003 | Switch From Adalimumab to Tofacitinib | Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. |
| BG004 | Switch From Etanercept to Adalimumab | Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. |
| BG005 | Switch From Etanercept to Tofacitinib | Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases. |
| BG006 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Geographic Region | Count of Participants | Participants |
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| Pre-index Biologic Disease Modifying Antirheumatic Drugs (bDMARDs) Use | Participants who took bDMARDs before index date were reported. | Count of Participants | Participants |
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| Pre-index Non-biological Disease Modifying Antirheumatic Drug (NB-DMARDs) Use | Participants who took NB-DMARDs before index date were reported. | Count of Participants | Participants |
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| Disease Duration | The number of days from the earliest claim with a diagnosis of RA within pre-index duration until the index date were identified and reported. | Mean | Standard Deviation | Days |
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| Pre-index Claims-based Index For Rheumatoid Arthritis Severity (CIRAS) | CIRAS provided a single value of rheumatoid arthritis severity using the following 9 measures: age, gender, inflammatory marker tests, rehabilitation visits, felty Syndrome, platelet orders, rheumatoid factor tests, chemistry panels, and rheumatologist visits. Type, or amount present, of all 9 measures was used to derive the overall CIRAS score by applying a weighted average. The CIRAS score was observed to range from 0-9.58 in this study, with higher values indicating generally greater severity of RA. | Mean | Standard Deviation | Units on a scale |
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| Quan-Charlson Score | The Quan-Charlson comorbidity index (QCCI) score predicts the probability of death in participants and was based on the presence of any International Classification of Diseases (ICD) diagnosis codes on medical claims at any time during pre-index period. Total score ranges from 0 to 9.0. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome could result in mortality. Here, participants with QCCI score 0, 1 to 2, 3 to 4, and 5 or more were reported. | Count of Participants | Participants |
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| OG001 | Tofacitinib High OOP Cost | Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. |
| OG002 | Switch From Adalimumab to Etanercept | Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. |
| OG003 | Switch From Adalimumab to Tofacitinib | Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. |
| OG004 | Switch From Etanercept to Adalimumab | Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. |
| OG005 | Switch From Etanercept to Tofacitinib | Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases. |
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| Primary | Percentage of Participants Who Immediately Switched Index Medication During 12 Months Post-index Date | Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Primary | Percentage of Participants Who Discontinued Then Switched Index Medication During 12 Months Post-index Date | Participants who discontinued index medication then switched from index medication were those who had gap in the index medication therapy of at least 60 days and then after the gap they switched to an advanced therapy different from index medication. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Primary | Percentage of Participants Who Discontinued Then Restarted Index Medication During 12 Months Post-index Date | Participants who discontinued index medication and then restarted index medication were those who had a gap in the index medication therapy of at least 60 days and the first advanced therapy observed after the gap was the index medication. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post index date |
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| Primary | Percentage of Participants Who Discontinued Without Switching or Restarting Index Medication During 12 Months Post-index Date | Participants who discontinued index medication without switching or restarting index medication were those who had a gap in index medication therapy of at least 60 days and there were no claims for either the index medication or a different advanced therapy for the remainder of the follow-up period. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post index date |
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| Secondary | Percentage of Participants Who Switched Index Medication Any Time During 12 Months Post-index Date | Participants who switched from index medication at any time during the 12-month follow-up post-index period were evaluated. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Mean of Number of Days to Immediate Switch From Index Medication During 12 Months Post-index Date | Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before the end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept. Number of days to immediately switch from index medication = immediate switch date - index date + 1. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Days | During 12 months post-index date |
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| Secondary | Mean of Number of Days to Immediate or Delayed Switch Index Medication During 12 Months Post-index Date | Number of days to immediate or delayed switch from index medication any time during the 12-month follow-up period = immediate or delayed switch date - index date + 1. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Days | During 12 month post-index date |
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| Secondary | Mean of Number of Days to Discontinue Index Medication During 12 Months Post-index Date | Number of days to discontinue index medication = date of last persistent index medication prescription/administration + days supply- index date + 1. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Days | During 12 months post-index date |
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| Secondary | Duration of Index Medication Persistent Therapy During 12 Months Post-index Date | Index medication persistent therapy duration was defined as days to discontinue or immediate switch or end of 12 months post-index follow if participants remained persistent, whichever came first. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication: not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Discontinuation from index medication: gap in the index medication therapy of at least 60 days. Immediate switch from index medication: initiation of a non-index advanced therapy before end of a 60-day gap in index medication. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Days | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Were Persistent With Main Non-Biologic Disease Modifying Antirheumatic Drugs (NB-DMARD) During 12 Months Post-index Date: Combination Therapy | Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who were persistent with main NB-DMARDs use. Main NB-DMARDs considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Persistence with main NB-DMARDs was defined as not having a gap of at least 60 days between prescription fill dates and their administration. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Immediately Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy | Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who immediately switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Immediate switch from main NB-DMARDs was defined as initiation of other medication than main NB-DMARDs, before end of a 60-day gap. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Discontinued Then Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy | Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued then switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs then switched from main NB-DMARDS were those who had gap in the main NB-DMARDs medication of at least 60 days and then after the gap switched to other medication than main NB-DMARDs. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Discontinued Then Restarted Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy | Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued then restarted main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs and then restarted main NB-DMARDs were those who had a gap in main NB-DMARDs of at least 60 days and after the gap, they started main NB-DMARDs again. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Discontinued Without Switching or Restarting Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy | Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued without switching or restarting main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs without switching or restarting main NB-DMARDs were those who had a gap in main NB-DMARDs of at least 60 days and there were no claims for either the main NB-DMARDs or a different therapy for the remainder of the follow-up period. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Initiated Index Medication as Monotherapy and Eventually Added NB-DMARDs During 12 Months Post-index Date | Percentage of participants who initiated only index medication and then eventually also added any NB-DMARDs, 1 of the 4 mains NB-DMARDs or other than these 4 NB-DMARDs in their therapy, were evaluated. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Any NB-DMARDs included those participants who received any of the NB-DMARDs and participant was counted only once if took different NB-DMARDs during the follow-up period. Participants might be counted more than once in categories except category "Any NB-DMARDs". Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Met Adherence Effectiveness Criteria During 12 Months Post-index Date | A proportion of days covered (PDC) was calculated based on total days' supply over the 12 months post-index. The PDC was calculated by using the date of service and the day supply for each fill of the index medication. Participants with early refills were allowed to stockpile medications up to a maximum of 14 days total for later use. Participants who met adherence effective criteria were those who had PDC >=0.8. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Met Dose Escalation Effectiveness Criteria During 12 Months Post-index Date | Dose escalation for index medication was defined as: 1) for adalimumab: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 40 milligram per week (mg/week), 2) for etanercept: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 100 mg/week, 3) for tofacitinib: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 20 milligram per day (mg/day) for immediate release and 22 mg/day for extended release. Participants who met dose escalation effectiveness criteria were those who did not have any dose escalation for index medication compared to the starting dose. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Met Switched Effectiveness Criteria During 12 Months Post-index Date | A switch for this outcome measure was defined as use of a different biologic disease modifying antirheumatic drug (B-DMARDs) or Janus kinase inhibitor (JAKi), any time during the 12 months post-index follow-up. Participants who met switched effectiveness criteria were those who did not switch from the index medication to B-DMARDs or JAKi. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Met NB-DMARD Effectiveness Criteria During 12 Months Post-index Date | Participants who started only index medication regimen (as monotherapy), but eventually initiated main NB-DMARDs were identified in the 12 months post-index follow-up period as adding new NB-DMARD. Participants who started index medication regimen along with any of the main NB-DMARDs (combination therapy), presence of a different NB-DMARD in 12 months post-index was identified as adding new NB-DMARD. Participants who met NB-DMARD effectiveness criteria were those who did not add a new NB-DMARD in the 12 months post-index follow up. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Met Oral Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date | Oral glucocorticoid effectiveness criteria for participants with no claims for oral glucocorticoid prescriptions in the 6 months prior to the index date = did not receive more than 30 days of oral glucocorticoids between (index date + 89 days) to (index date + 359 days). 30 days of oral glucocorticoids was determined by summing up the day supply of all glucocorticoids claims with a fill date between (index date + 89 days) to (index date + 359 days). Oral glucocorticoid effectiveness criteria for participants with claims for oral glucocorticoids during the 6 months prior to the index date = no increase in oral glucocorticoid dose >=20% during months 6-12 after index compared to the 6 months before the index date. Increase in oral glucocorticoids was determined from the prednisone equivalent dose for all glucocorticoid claims filled. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Percentage of Participants Who Met Infusion Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date | Glucocorticoid infusion effectiveness criteria was receiving of maximum of 1 parenteral or intra-articular glucocorticoid joint injection on unique days (between [index date + 89 days] to [index date + 359 days]) after the participants had been on treatment with index medication for more than 3 months. Index medications were tofacitinib, adalimumab or etanercept. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation | Posted | Number | Percentage of participants | During 12 months post-index date |
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| Secondary | Mean of Rheumatoid Arthritis (RA) Related Inpatient Visits During 12 Months Pre-index Date | Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits related to RA during 12 months pre-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Inpatient visits | During 12 months pre-index date |
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| Secondary | Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Pre-Index Date | In this outcome measure, mean of number of emergency department visits related to RA during 12 months pre-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Emergency department visits | During 12 months pre-index date |
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| Secondary | Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Pre-index Date | Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits related to RA during 12 months pre-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Outpatient visits | During 12 months pre-index date |
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| Secondary | Mean of Rheumatoid Arthritis-Related Pharmacy Visits During 12 Months Pre-index Date | In this outcome measure, mean of number of pharmacy visits related to RA during 12 months pre-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Pharmacy visits | During 12 months pre-index date |
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| Secondary | Mean of Rheumatoid Arthritis Related Inpatient Visits During 12 Months Post-index Date | Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits related to RA during 12 months post-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Inpatient visits | During 12 months post-index date |
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| Secondary | Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Post-index Date | In this outcome measure, mean of number of emergency department visits related to RA during 12 months post-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Emergency department visits | During 12 months post-index date |
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| Secondary | Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Post-index Date | Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits related to RA during 12 months post-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Outpatient visits | During 12 months post-index date |
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| Secondary | Mean of Rheumatoid Arthritis Related Pharmacy Visits During 12 Months Post-index Date | In this outcome measure, mean of number of pharmacy visits related to RA during 12 months post-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Pharmacy visits | During 12 months post-index date |
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| Secondary | Mean of All Cause Inpatient Visits During 12 Months Pre-Index Date | Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits regardless of reason (including related to RA) during 12 months pre-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Inpatient visits | During 12 months pre-index date |
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| Secondary | Mean of All Cause Emergency Department (ED) Visits During 12 Months Pre-index Date | In this outcome measure, mean of number of emergency department visits regardless of reason (including related to RA) during 12 months pre-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Emergency department visits | During 12 months pre-index date |
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| Secondary | Mean of All Cause Outpatient Visits During 12 Months Pre-Index Date | Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits regardless of reason (including related to RA) during 12 months pre-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Outpatient visits | During 12 months pre-index date |
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| Secondary | Mean of All Cause Pharmacy Visits During 12 Months Pre-index Date | In this outcome measure, mean of number of pharmacy visits regardless of reason (including related to RA) during 12 months pre-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Pharmacy visits | During 12 months pre-index date |
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| Secondary | Mean of All Cause Inpatient Visits During 12 Months Post-index Date | Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits regardless of reason (including related to RA) during 12 months post-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Inpatient visits | During 12 months post-index date |
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| Secondary | Mean of All Cause Emergency Department (ED) Visits During 12 Months Post-index Date | In this outcome measure, mean of number of emergency department visits regardless of reason (including related to RA) during 12 months post-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Emergency department visits | During 12 months post-index date |
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| Secondary | Mean of All Cause Outpatient Visits During 12 Months Post-index Date | Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits regardless of reason (including related to RA) during 12 months post-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Outpatient visits | During 12 months post-index date |
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| Secondary | Mean of All Cause Pharmacy Visits During 12 Months Post-index Date | In this outcome measure, mean of number of pharmacy visits regardless of reason (including related to RA) during 12 months post-index were evaluated. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Pharmacy visits | During 12 months post-index date |
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| Secondary | Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Pre-index Date | Total health care cost related to RA was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment costs (pharmacy cost) related to rheumatoid arthritis. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Dollars | During 12 months pre-index date |
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| Secondary | Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Post-index Date | Total health care cost related to RA was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment costs (pharmacy cost) related to rheumatoid arthritis. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Dollars | During 12 months post-index date |
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| Secondary | All Cause Total Health Care Cost During 12 Months Pre-index Date | All cause total health care cost was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment cost (pharmacy cost) regardless of reason including RA. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Dollars | During 12 months pre-index date |
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| Secondary | All Cause Total Health Care Cost During 12 Months Post-index Date | All cause total health care cost was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment cost (pharmacy cost) regardless of reason including RA. | Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. | Posted | Mean | Standard Deviation | Dollars | During 12 months post-index date |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Tofacitinib High OOP Cost | Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Switch From Adalimumab to Etanercept | Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Switch From Adalimumab to Tofacitinib | Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Switch From Etanercept to Adalimumab | Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Switch From Etanercept to Tofacitinib | Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases. | 0 | 0 | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Male |
|
| North Central Region |
|
| South Region |
|
| West Region |
|
| Unknown Region |
|
| 1-2 |
|
| 3-4 |
|
| Greater than or equal to (>=) 5 |
|
| Superiority |
| Chi-squared | 0.5337 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.9212 | Odds Ratio (OR) | 1.0283 | 2-Sided | 95 | 0.5911 | 1.7890 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.4693 | Odds Ratio (OR) | 0.7464 | 2-Sided | 95 | 0.3380 | 1.6482 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5593 | Odds Ratio (OR) | 0.8212 | 2-Sided | 95 | 0.4239 | 1.5910 | Superiority |
| Superiority |
| Chi-squared | 0.4982 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5494 | Odds Ratio (OR) | 1.3182 | 2-Sided | 95 | 0.5335 | 3.2570 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.7830 | Odds Ratio (OR) | 1.1664 | 2-Sided | 95 | 0.3900 | 3.4883 | Superiority |
| Superiority |
| Chi-squared | 0.7942 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.7924 | Odds Ratio (OR) | 1.0682 | 2-Sided | 95 | 0.6537 | 1.7455 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.9339 | Odds Ratio (OR) | 1.0414 | 2-Sided | 95 | 0.3997 | 2.7134 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.6497 | Odds Ratio (OR) | 0.8195 | 2-Sided | 95 | 0.3470 | 1.9350 | Superiority |
| Superiority |
| Chi-squared | 0.6800 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5051 | Odds Ratio (OR) | 1.1438 | 2-Sided | 95 | 0.7705 | 1.6978 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.7131 | Odds Ratio (OR) | 0.8576 | 2-Sided | 95 | 0.3781 | 1.9452 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.6490 | Odds Ratio (OR) | 0.8415 | 2-Sided | 95 | 0.4003 | 1.7690 | Superiority |
| Superiority |
| Chi-squared | 0.2573 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5368 | Odds Ratio (OR) | 1.1637 | 2-Sided | 95 | 0.7193 | 1.8827 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.4685 | Odds Ratio (OR) | 0.7757 | 2-Sided | 95 | 0.3904 | 1.5413 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.3112 | Odds Ratio (OR) | 0.7354 | 2-Sided | 95 | 0.4057 | 1.3330 | Superiority |
| Superiority |
| Log Rank | 0.8305 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.1845 | Hazard Ratio (HR) | 0.5814 | 2-Sided | 95 | 0.2610 | 1.2952 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.2951 | Hazard Ratio (HR) | 1.5908 | 2-Sided | 95 | 0.6671 | 3.7936 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.4907 | Hazard Ratio (HR) | 1.3546 | 2-Sided | 95 | 0.6584 | 2.7870 | Superiority |
| Superiority |
| Log Rank | 0.9610 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.0455 | Hazard Ratio (HR) | 0.5571 | 2-Sided | 95 | 0.3140 | 0.9884 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.0274 | Hazard Ratio (HR) | 2.1781 | 2-Sided | 95 | 1.0904 | 4.3506 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.6787 | Hazard Ratio (HR) | 0.8896 | 2-Sided | 95 | 0.5114 | 1.5475 | Superiority |
| Superiority |
| Log Rank | 0.9630 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.7909 | Hazard Ratio (HR) | 1.0508 | 2-Sided | 95 | 0.7284 | 1.5160 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.6027 | Hazard Ratio (HR) | 0.8117 | 2-Sided | 95 | 0.3700 | 1.7808 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.6978 | Hazard Ratio (HR) | 1.1742 | 2-Sided | 95 | 0.5222 | 2.6404 | Superiority |
| Superiority |
| Log Rank | 0.2104 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.1670 | Hazard Ratio (HR) | 1.1723 | 2-Sided | 95 | 0.9357 | 1.4687 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.1087 | Hazard Ratio (HR) | 0.7228 | 2-Sided | 95 | 0.4861 | 1.0747 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Cox | 0.3212 | Hazard Ratio (HR) | 0.8402 | 2-Sided | 95 | 0.5957 | 1.1852 | Superiority |
| Superiority |
| Chi-squared | 0.5990 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.9860 | Odds Ratio (OR) | 0.9954 | 2-Sided | 95 | 0.5962 | 1.6620 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5813 | Odds Ratio (OR) | 1.2959 | 2-Sided | 95 | 0.5158 | 3.2558 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.1789 | Odds Ratio (OR) | 1.8182 | 2-Sided | 95 | 0.7604 | 4.3473 | Superiority |
| Superiority |
| Chi-squared | 0.2849 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5289 | Odds Ratio (OR) | 0.8252 | 2-Sided | 95 | 0.4538 | 1.5007 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.9270 | Odds Ratio (OR) | 0.9408 | 2-Sided | 95 | 0.2553 | 3.4678 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.0707 | Odds Ratio (OR) | 0.3968 | 2-Sided | 95 | 0.1456 | 1.0812 | Superiority |
| Superiority |
| Superiority |
| Chi-squared | 0.6477 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5509 | Odds Ratio (OR) | 0.7948 | 2-Sided | 95 | 0.3736 | 1.6907 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.6216 | Odds Ratio (OR) | 0.6814 | 2-Sided | 95 | 0.1486 | 3.1250 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5506 | Odds Ratio (OR) | 0.6974 | 2-Sided | 95 | 0.2135 | 2.2781 | Superiority |
| Superiority |
| Chi-squared | 0.2420 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.0869 | Odds Ratio (OR) | 1.7474 | 2-Sided | 95 | 0.9222 | 3.3107 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.8228 | Odds Ratio (OR) | 1.1346 | 2-Sided | 95 | 0.3757 | 3.4266 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.4855 | Odds Ratio (OR) | 1.5650 | 2-Sided | 95 | 0.4446 | 5.5086 | Superiority |
| Methotrexate |
|
| Sulfasalazine |
|
| Leflunomide |
|
| Hydroxychloroquine |
|
| Other NB-DMARD |
|
| Superiority |
| Chi-squared | 0.2799 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5772 | Odds Ratio (OR) | 0.9021 | 2-Sided | 95 | 0.6281 | 1.2958 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.3272 | Odds Ratio (OR) | 1.3953 | 2-Sided | 95 | 0.7166 | 2.7169 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.3011 | Odds Ratio (OR) | 1.3527 | 2-Sided | 95 | 0.7630 | 2.3983 | Superiority |
| Superiority |
| Chi-squared | <0.0001 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.6772 | Odds Ratio (OR) | 0.8369 | 2-Sided | 95 | 0.3618 | 1.9356 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.0013 | Odds Ratio (OR) | 5.2530 | 2-Sided | 95 | 1.9061 | 14.4770 | Superiority |
| Superiority |
| Chi-squared | 0.2573 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5368 | Odds Ratio (OR) | 0.8593 | 2-Sided | 95 | 0.5311 | 1.3902 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.4685 | Odds Ratio (OR) | 1.2892 | 2-Sided | 95 | 0.6488 | 2.5616 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.3112 | Odds Ratio (OR) | 1.3598 | 2-Sided | 95 | 0.7502 | 2.4648 | Superiority |
| Superiority |
| Chi-squared | 0.0103 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5415 | Odds Ratio (OR) | 1.1302 | 2-Sided | 95 | 0.7630 | 1.6741 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.0596 | Odds Ratio (OR) | 2.0118 | 2-Sided | 95 | 0.9722 | 4.1632 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.0002 | Odds Ratio (OR) | 3.4823 | 2-Sided | 95 | 1.7930 | 6.7633 | Superiority |
| Superiority |
| Chi-squared | 0.2118 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.1978 | Odds Ratio (OR) | 1.3811 | 2-Sided | 95 | 0.8449 | 2.2576 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.8893 | Odds Ratio (OR) | 1.0614 | 2-Sided | 95 | 0.4587 | 2.4559 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.1553 | Odds Ratio (OR) | 0.5811 | 2-Sided | 95 | 0.2748 | 1.2286 | Superiority |
| Superiority |
| Chi-squared | 0.1497 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.5228 | Odds Ratio (OR) | 0.8556 | 2-Sided | 95 | 0.5303 | 1.3804 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.0277 | Odds Ratio (OR) | 2.5125 | 2-Sided | 95 | 1.1062 | 5.7063 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.3240 | Odds Ratio (OR) | 0.6993 | 2-Sided | 95 | 0.3435 | 1.4236 | Superiority |
| Superiority |
| t-test, 2 sided | 0.2424 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.1753 | Odds Ratio (OR) | 0.0347 | 2-Sided | 95 | -0.0155 | 0.0848 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.6114 | Odds Ratio (OR) | 0.0194 | 2-Sided | 95 | -0.0553 | 0.0941 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.2977 | Odds Ratio (OR) | 0.0345 | 2-Sided | 95 | -0.0304 | 0.0993 | Superiority |
| Superiority |
| t-test, 2 sided | 0.5265 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.2522 | Odds Ratio (OR) | -0.0457 | 2-Sided | 95 | -0.1239 | 0.0325 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.6701 | Odds Ratio (OR) | 0.0278 | 2-Sided | 95 | -0.1003 | 0.1559 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.1017 | Odds Ratio (OR) | 0.1693 | 2-Sided | 95 | -0.0334 | 0.3720 | Superiority |
| Superiority |
| t-test, 2 sided | 0.0030 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.3324 | Odds Ratio (OR) | 0.4140 | 2-Sided | 95 | -0.4231 | 1.2511 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.1367 | Odds Ratio (OR) | 1.1712 | 2-Sided | 95 | -0.3713 | 2.7138 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.0028 | Odds Ratio (OR) | 1.8099 | 2-Sided | 95 | 0.6219 | 2.9978 | Superiority |
| Superiority |
| t-test, 2 sided | 0.5403 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.1167 | Odds Ratio (OR) | 0.9159 | 2-Sided | 95 | -0.2283 | 2.0600 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.9722 | Odds Ratio (OR) | -0.0336 | 2-Sided | 95 | -1.9238 | 1.8567 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Logistic | 0.8455 | Odds Ratio (OR) | 0.2064 | 2-Sided | 95 | -1.8689 | 2.2817 | Superiority |
| Superiority |
| t-test, 2 sided | 0.5933 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.7815 | Odds Ratio (OR) | -0.0089 | 2-Sided | 95 | -0.0716 | 0.0538 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.4446 | Odds Ratio (OR) | 0.0337 | 2-Sided | 95 | -0.0528 | 0.1202 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.4733 | Odds Ratio (OR) | -0.0333 | 2-Sided | 95 | -0.1243 | 0.0577 | Superiority |
| Superiority |
| t-test, 2 sided | 0.6202 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.2523 | Odds Ratio (OR) | -0.0425 | 2-Sided | 95 | -0.1154 | 0.0303 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.4068 | Odds Ratio (OR) | -0.0388 | 2-Sided | 95 | -0.1305 | 0.0529 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.5858 | Odds Ratio (OR) | 0.0706 | 2-Sided | 95 | -0.1833 | 0.3244 | Superiority |
| Superiority |
| t-test, 2 sided | 0.6202 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.3158 | Odds Ratio (OR) | -0.5353 | 2-Sided | 95 | -1.5812 | 0.5107 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.1016 | Odds Ratio (OR) | 1.3543 | 2-Sided | 95 | -0.2669 | 2.9755 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.2576 | Odds Ratio (OR) | 0.8677 | 2-Sided | 95 | -0.6347 | 2.3700 | Superiority |
| Superiority |
| t-test, 2 sided | 0.3863 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.1918 | Odds Ratio (OR) | -1.0337 | 2-Sided | 95 | -2.5858 | 0.5184 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.4281 | Odds Ratio (OR) | -0.9749 | 2-Sided | 95 | -3.3864 | 1.4366 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.1014 | Odds Ratio (OR) | -1.8599 | 2-Sided | 95 | -4.0854 | 0.3657 | Superiority |
| Superiority |
| t-test, 2 sided | 0.2456 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.0962 | Odds Ratio (OR) | 0.0568 | 2-Sided | 95 | -0.0101 | 0.1238 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.3844 | Odds Ratio (OR) | -0.0432 | 2-Sided | 95 | -0.1405 | 0.0541 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.5899 | Odds Ratio (OR) | 0.0233 | 2-Sided | 95 | -0.0615 | 0.1082 | Superiority |
| Superiority |
| t-test, 2 sided | 0.8609 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.6224 | Odds Ratio (OR) | -0.0445 | 2-Sided | 95 | -0.2218 | 0.1327 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.5655 | Odds Ratio (OR) | -0.0884 | 2-Sided | 95 | -0.3900 | 0.2132 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.4044 | Odds Ratio (OR) | 0.1809 | 2-Sided | 95 | -0.2444 | 0.6062 | Superiority |
| Superiority |
| t-test, 2 sided | 0.0801 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.0072 | Odds Ratio (OR) | -3.7075 | 2-Sided | 95 | -6.4110 | -1.0040 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.5406 | Odds Ratio (OR) | -1.4296 | 2-Sided | 95 | -6.0080 | 3.1489 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.8603 | Odds Ratio (OR) | -0.3527 | 2-Sided | 95 | -4.2790 | 3.5737 | Superiority |
| Superiority |
| t-test, 2 sided | 0.1344 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.5092 | Odds Ratio (OR) | 1.2586 | 2-Sided | 95 | -2.4787 | 4.9958 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.8047 | Odds Ratio (OR) | -0.7696 | 2-Sided | 95 | -6.8683 | 5.3292 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.9757 | Odds Ratio (OR) | 0.0940 | 2-Sided | 95 | -5.9628 | 6.1507 | Superiority |
| Superiority |
| t-test, 2 sided | 0.9497 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.4873 | Odds Ratio (OR) | -0.0310 | 2-Sided | 95 | -0.1185 | 0.0565 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.6780 | Odds Ratio (OR) | -0.0312 | 2-Sided | 95 | -0.1783 | 0.1159 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.9327 | Odds Ratio (OR) | 0.0099 | 2-Sided | 95 | -0.2207 | 0.2406 | Superiority |
| Superiority |
| t-test, 2 sided | 0.6121 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.0303 | Odds Ratio (OR) | -0.1895 | 2-Sided | 95 | -0.3610 | -0.0181 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.1807 | Odds Ratio (OR) | -0.1901 | 2-Sided | 95 | -0.4685 | 0.0883 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.7445 | Odds Ratio (OR) | 0.1594 | 2-Sided | 95 | -0.7991 | 1.1178 | Superiority |
| Superiority |
| t-test, 2 sided | 0.1366 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.0820 | Odds Ratio (OR) | -3.4084 | 2-Sided | 95 | -7.2497 | 0.4330 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.5845 | Odds Ratio (OR) | -1.5342 | 2-Sided | 95 | -7.0336 | 3.9652 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.7284 | Odds Ratio (OR) | 0.9870 | 2-Sided | 95 | -4.5830 | 6.5570 | Superiority |
| Superiority |
| t-test, 2 sided | 0.2056 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.4288 | Odds Ratio (OR) | -1.8061 | 2-Sided | 95 | -6.2797 | 2.6675 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.6303 | Odds Ratio (OR) | -1.6946 | 2-Sided | 95 | -8.5962 | 5.2069 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.7477 | Odds Ratio (OR) | -0.9873 | 2-Sided | 95 | -7.0028 | 5.0281 | Superiority |
| Superiority |
| t-test, 2 sided | 0.0193 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.0570 | Cost Ratio | 1.2232 | 2-Sided | 95 | 0.9940 | 1.5053 | Since health care costs were skewed, hence estimated cost was modeled using a generalized linear model (GLM). Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | <0.0001 | Cost Ratio | 1.8479 | 2-Sided | 95 | 1.4378 | 2.3749 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.0924 | Cost Ratio | 1.1868 | 2-Sided | 95 | 0.9722 | 1.4487 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| Superiority |
| t-test, 2 sided | 0.1638 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.6732 | Cost Ratio | 0.9773 | 2-Sided | 95 | 0.8782 | 1.0875 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.6345 | Cost Ratio | 0.9629 | 2-Sided | 95 | 0.8240 | 1.1253 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.0029 | Cost Ratio | 0.8327 | 2-Sided | 95 | 0.7380 | 0.9395 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| Superiority |
| t-test, 2 sided | 0.0647 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.7684 | Cost Ratio | 0.9762 | 2-Sided | 95 | 0.8316 | 1.1460 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.0012 | Cost Ratio | 1.3862 | 2-Sided | 95 | 1.1379 | 1.6886 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.9422 | Cost Ratio | 1.0065 | 2-Sided | 95 | 0.8452 | 1.1985 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| Superiority |
| t-test, 2 sided | 0.9416 | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.3190 | Cost Ratio | 0.9515 | 2-Sided | 95 | 0.8628 | 1.0493 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.1368 | Cost Ratio | 0.8991 | 2-Sided | 95 | 0.7815 | 1.0343 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |
| To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed. | Regression, Linear | 0.0231 | Cost Ratio | 0.8514 | 2-Sided | 95 | 0.7411 | 0.9782 | Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios. | Superiority |