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To understand differences in characteristics of Idiopathic Pulmonary Fibrosis (IPF) patients who are prescribed nintedanib compared to those who are prescribed pirfenidone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Idiopathic Pulmonary Fibrosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | Nintedanib initiators |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Patient Characteristics: Age | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic age for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
| Baseline Patient Characteristics: Sex | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic sex for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
| Baseline Patient Characteristics: BMI | The patient characteristic Body mass index (BMI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. |
| Measure | Description | Time Frame |
|---|---|---|
| Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Odds ratio of receiving nintedanib or pirfenidone vs. no antifibrotic treatment, adjusting for patient characteristics; to identify baseline characteristics that drive initiation of a treatment while minimizing prescription bias. Logistic regression models were developed to assess the odds. Baseline patient characteristics that were sufficiently populated, had ASD >10% or p-value <0.05, and were agreed upon as important variables to include, were included as covariates for a full model. Linearity of age was confirmed before including it as a continuous variable in one version of the model. Backward selection was applied to develop a reduced model, only retaining covariates with p<0.1 after forcing age at index, gender, geographic region, BMI, CCI, and Chronic obstructive pulmonary disease (COPD) into the model. Odds presented for key patient characteristics. Odd ratio of >1 indicates increased odds of receiving treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of the following three mutually exclusive cohorts:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plymouth Meeting | Plymouth | Pennsylvania | 19462 | United States |
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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The study includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data.
This retrospective database study was conducted to understand differences in characteristics of Idiopathic pulmonary fibrosis (IPF) patients who were newly prescribed pirfenidone or nintedanib, and those who did not receive a prescription for an antifibrotic treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nintedanib | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 18, 2018 |
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| Pirfenidone |
| Drug |
Pirfenidone initiators |
|
| Untreated Cohort | Other | Untreated |
|
| Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
| Baseline Patient Characteristics: Charlson Comorbidity Index (CCI) | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized HIPPA compliant database populated with patient data from ambulatory care records. Charlson Comorbidity Index (CCI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts. The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero. | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
| Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with inhaled corticosteroids for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
| Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with Proton pump inhibitors for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
| Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
| FG001 | Pirfenidone | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription. |
| FG002 | Untreated | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts. |
| COMPLETED |
|
| NOT COMPLETED |
|
Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nintedanib | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription. |
| BG001 | Pirfenidone | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription. |
| BG002 | Untreated | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Baseline Patient Characteristics: Age | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic age for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. | Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. | Posted | Mean | Standard Deviation | years | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Odds ratio of receiving nintedanib or pirfenidone vs. no antifibrotic treatment, adjusting for patient characteristics; to identify baseline characteristics that drive initiation of a treatment while minimizing prescription bias. Logistic regression models were developed to assess the odds. Baseline patient characteristics that were sufficiently populated, had ASD >10% or p-value <0.05, and were agreed upon as important variables to include, were included as covariates for a full model. Linearity of age was confirmed before including it as a continuous variable in one version of the model. Backward selection was applied to develop a reduced model, only retaining covariates with p<0.1 after forcing age at index, gender, geographic region, BMI, CCI, and Chronic obstructive pulmonary disease (COPD) into the model. Odds presented for key patient characteristics. Odd ratio of >1 indicates increased odds of receiving treatment. | Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. | Posted | Number | 95% Confidence Interval | Odds ratio | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Baseline Patient Characteristics: Sex | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic sex for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. | Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. One patient from the untreated cohort was missing gender information and is not shown in the table | Posted | Count of Participants | Participants | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
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| Primary | Baseline Patient Characteristics: BMI | The patient characteristic Body mass index (BMI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. | Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. | Posted | Mean | Standard Deviation | kilogram/height in meters squared(kg/m²) | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Baseline Patient Characteristics: Charlson Comorbidity Index (CCI) | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized HIPPA compliant database populated with patient data from ambulatory care records. Charlson Comorbidity Index (CCI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts. The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero. | Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. | Posted | Mean | Standard Deviation | Score on a scale | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with inhaled corticosteroids for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. | Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. | Posted | Count of Participants | Participants | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
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| Primary | Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with Proton pump inhibitors for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. | Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. | Posted | Count of Participants | Participants | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). |
|
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Not applicable; the IQVIA GE Centricity EMR database is a secondary database which consists of fully de-identified data. Therefore, it is not possible to identify/report individual case safety reports. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Nintedanib | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Pirfenidone | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Untreated | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts. | 0 | 0 | 0 | 0 | 0 | 0 |
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Limitations common to retrospective database studies: high proportion of missing data and it is possible that patients who received out-of-system care and treatments were not fully captured in the data.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Oct 16, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
| C093844 | pirfenidone |
Not provided
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| Female |
|
| Unknown |
|
| Non-white |
|
| Unknown |
|
| 0.1421 |
| Absolute standardized differences (ASD) |
| -0.0780 |
ASD=(X1-X2)/sqrt((s1^2+s2^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances. |
| Other |
| t-test, 2 sided | 0.0048 | Absolute standardized differences (ASD) | 0.0159 | ASD=(X1-X2)/sqrt((s1^2+s2^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances. | Other |
|
|
| OG001 | Pirfenidone | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription. |
| OG002 | Untreated | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts. |
|
|
|
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription. |
| OG002 | Untreated | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts. |
|
|
|
| OG001 | Pirfenidone | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription. |
| OG002 | Untreated | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts. |
|
|
|
| OG001 | Pirfenidone | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription. |
| OG002 | Untreated | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts. |
|
|
|
| OG001 | Pirfenidone | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription. |
| OG002 | Untreated | Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts. |
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