| Primary | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry | Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days * 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. | Posted | | Number | | exacerbation per patient-year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Regression, Cox | Cox regression was for time to first exacerbation and cohort as covariate. | 0.064 | | Hazard Ratio (HR) | 1.133 | | | 2-Sided | 95 | 0.993 | 1.293 | | | | | Other | Comparison of Stiolto (reference group) versus Trelegy for incidence rate of exacerbation. | | | |
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| Primary | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With no Baseline Exacerbation | Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with no baseline exacerbation were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days * 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only subject who had no baseline exacerbation were included in the analysis. | Posted | | Number | | exacerbation per patient-year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| Primary | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 0 or 1 Baseline Exacerbation | Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with 0 or 1 baseline exacerbation were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days * 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only subject who had 0 or 1 baseline exacerbation were included in the analysis. | Posted | | Number | | exacerbation per patient-year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| Primary | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 2 or More Baseline Exacerbations | Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with 2 or more baseline exacerbations were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days * 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only subjects with 2 or more baseline exacerbations were included in the analysis. | Posted | | Number | | exacerbation per patient-year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| Secondary | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days * 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. | Posted | | Number | | pneu. hospitalization per patient-year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| Secondary | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With no Baseline Exacerbation | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with no baseline exacerbation were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days * 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only participants with no baseline exacerbation were included. | Posted | | Number | | pneu. hospitalization per patient-year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| Secondary | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 0 or 1 Baseline Exacerbation | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with 0 or 1 baseline exacerbation were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days * 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only participants with 0 or 1 baseline exacerbation were included. | Posted | | Number | | pneu. hospitalization per patient-year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| Secondary | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 2 or More Baseline Exacerbations | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with 2 or more baseline exacerbations were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days * 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only participants with 2 or more baseline exacerbations were included. | Posted | | Number | | pneu. hospitalization per patient-year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| Secondary | Total Costs of COPD or Pneumonia-related Health Care Cost and Resource Utilization (HCRU) | The total annualized costs of COPD or pneumonia-related health care cost and resource utilization (HCRU) were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. | Posted | | Number | 95% Confidence Interval | dollars per year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| Secondary | Total Costs of COPD-related HCRU | The total annualized costs of COPD-related HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. | Posted | | Number | 95% Confidence Interval | dollars per year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| Secondary | Total Costs of Pneumonia-related HCRU | The total annualized costs of pneumonia-related HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. | Posted | | Number | 95% Confidence Interval | dollars per year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. |
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| Secondary | Total Costs of COPD or Pneumonia Attributable HCRU | The total annualized costs of COPD or pneumonia attributable HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. | Posted | | Number | 95% Confidence Interval | dollars per year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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| Secondary | Total Costs of All-cause HCRU | The total annualized costs of all-cause HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. | Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. | Posted | | Number | 95% Confidence Interval | dollars per year | | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | | | | ID | Title | Description |
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| OG000 | Stiolto Initiators | Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). | | OG001 | Trelegy Initiators | COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020. All participants had enrolled 1 year before the index date (starting from 15 September 2017). |
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