| Primary | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months | St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction. | Treated Set (TS): all patients who were enrolled in the trial and have received at least once nintedanib during the trial. Any analysis on primary, secondary and safety endpoints was performed in the TS. The number of participants analysed displays the number of participants with available data at the timepoint of interest, at 3 months. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | At baseline and at 3 months. | | | | ID | Title | Description |
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| OG000 | Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Patients were considered eligible if they were ≥40 years old y/o, had signed informed consent form, were treatment-naïve with an initial IPF diagnosis no more than 3 months prior to enrolment and were initiating treatment with nintedanib (as monotherapy) the latest on the enrolment day or had initiated it within the past 7 days prior to enrolment, and for whom the decision to prescribe treatment with nintedanib was according to the locally approved treatment label. |
| | | Title | Denominators | Categories |
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| total score | | | | symptoms domain score | |
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| Secondary | Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score | The modified Medical Research Council (mMRC) consists of a 5-level rating scale (grades 0-4) based on the patient's perception of dyspnoea (perception of breathlessness) in daily activities, with grade 4 representing the most severe category. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction. | Treated Set (TS): all patients who were enrolled in the trial and have received at least once nintedanib during the trial. Any analysis on primary, secondary and safety endpoints was performed in the TS. The number of participants analysed displays the number of participants with available data at the timepoint of interest. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale. | | At baseline and at 3, 6, 9, and 12 months. | | | | ID | Title | Description |
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| OG000 | Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Patients were considered eligible if they were ≥40 years old y/o, had signed informed consent form, were treatment-naïve with an initial IPF diagnosis no more than 3 months prior to enrolment and were initiating treatment with nintedanib (as monotherapy) the latest on the enrolment day or had initiated it within the past 7 days prior to enrolment, and for whom the decision to prescribe treatment with nintedanib was according to the locally approved treatment label. |
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| Secondary | Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) | Patients were asked at each study visit to rate their perceived intensity of cough due to their IPF on a vertical VAS ranging from 0 to 100, with endpoints labelled as 'no cough' ('100'), 'moderate cough' ('50'), and 'intense cough' ('0'). Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction. | Treated Set (TS): all patients who were enrolled in the trial and have received at least once nintedanib during the trial. Any analysis on primary, secondary and safety endpoints was performed in the TS. The number of participants analysed displays the number of participants with available data at the timepoint of interest. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale. | | At baseline, and at 3, 6, 9, and 12 months. | | | | ID | Title | Description |
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| OG000 | Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Patients were considered eligible if they were ≥40 years old y/o, had signed informed consent form, were treatment-naïve with an initial IPF diagnosis no more than 3 months prior to enrolment and were initiating treatment with nintedanib (as monotherapy) the latest on the enrolment day or had initiated it within the past 7 days prior to enrolment, and for whom the decision to prescribe treatment with nintedanib was according to the locally approved treatment label. |
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| Secondary | Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) | SMAQ consisted of 6 items of which, four were dichotomous (Yes/No), one was Likert-type and one was an open question. A patient was considered as non-adherent, if he/she gave a positive response to any of the qualitative questions, and in terms of quantification, if the patient had lost one of the two daily doses for more than 2 days or had not taken medication for more than four complete days during the past 3 months. | Treated Set (TS): all patients who were enrolled in the trial and have received at least once nintedanib during the trial. Any analysis on primary, secondary and safety endpoints was performed in the TS. The number of participants analysed displays the number of participants with available data at the timepoint of interest. | Posted | | Number | | Percentage of participants | | At 3, 6, 9, and 12 months. | | | | ID | Title | Description |
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| OG000 | Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Patients were considered eligible if they were ≥40 years old y/o, had signed informed consent form, were treatment-naïve with an initial IPF diagnosis no more than 3 months prior to enrolment and were initiating treatment with nintedanib (as monotherapy) the latest on the enrolment day or had initiated it within the past 7 days prior to enrolment, and for whom the decision to prescribe treatment with nintedanib was according to the locally approved treatment label. |
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| Secondary | Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire | Generalized Anxiety Disorder Screener (GAD-7) is a 7-item instrument validated for anxiety evaluation that could be used in an outpatient setting. Patients were asked at all study visits to indicate how often they experienced anxiety symptoms over the previous two weeks on a 4-point Likert scale as follows: 0 = 'not at all'; 1 = 'several days'; 2 = 'more than half the days'; and 3 = 'nearly every day'. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction. | Treated Set (TS): all patients who were enrolled in the trial and have received at least once nintedanib during the trial. Any analysis on primary, secondary and safety endpoints was performed in the TS. The number of participants analysed displays the number of participants with available data at the timepoint of interest. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale. | | At baseline, and at 3, 6, 9, and 12 months. | | | | ID | Title | Description |
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| OG000 | Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Patients were considered eligible if they were ≥40 years old y/o, had signed informed consent form, were treatment-naïve with an initial IPF diagnosis no more than 3 months prior to enrolment and were initiating treatment with nintedanib (as monotherapy) the latest on the enrolment day or had initiated it within the past 7 days prior to enrolment, and for whom the decision to prescribe treatment with nintedanib was according to the locally approved treatment label. |
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| Secondary | Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) | Percentage of patients that use Long Term Oxygen Treatment (LTOT) is presented. | Treated Set (TS): all patients who were enrolled in the trial and have received at least once nintedanib during the trial. Any analysis on primary, secondary and safety endpoints was performed in the TS. The number of participants analysed displays the number of participants with available data at the timepoint of interest. | Posted | | Number | | Percentage of participants | | At baseline, and at 3, 6, 9, and 12 months. | | | | ID | Title | Description |
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| OG000 | Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Patients were considered eligible if they were ≥40 years old y/o, had signed informed consent form, were treatment-naïve with an initial IPF diagnosis no more than 3 months prior to enrolment and were initiating treatment with nintedanib (as monotherapy) the latest on the enrolment day or had initiated it within the past 7 days prior to enrolment, and for whom the decision to prescribe treatment with nintedanib was according to the locally approved treatment label. |
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| Primary | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months | St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction. | Treated Set (TS): all patients who were enrolled in the trial and have received at least once nintedanib during the trial. Any analysis on primary, secondary and safety endpoints was performed in the TS. The number of participants analysed displays the number of participants with available data at the timepoint of interest, at 6 months. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | At baseline and at 6 months. | | | | ID | Title | Description |
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| OG000 | Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Patients were considered eligible if they were ≥40 years old y/o, had signed informed consent form, were treatment-naïve with an initial IPF diagnosis no more than 3 months prior to enrolment and were initiating treatment with nintedanib (as monotherapy) the latest on the enrolment day or had initiated it within the past 7 days prior to enrolment, and for whom the decision to prescribe treatment with nintedanib was according to the locally approved treatment label. |
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| Primary | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months | St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction. | Treated Set (TS): all patients who were enrolled in the trial and have received at least once nintedanib during the trial. Any analysis on primary, secondary and safety endpoints was performed in the TS. The number of participants analysed displays the number of participants with available data at the timepoint of interest, at 9 months. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | At baseline and at 9 months. | | | | ID | Title | Description |
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| OG000 | Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Patients were considered eligible if they were ≥40 years old y/o, had signed informed consent form, were treatment-naïve with an initial IPF diagnosis no more than 3 months prior to enrolment and were initiating treatment with nintedanib (as monotherapy) the latest on the enrolment day or had initiated it within the past 7 days prior to enrolment, and for whom the decision to prescribe treatment with nintedanib was according to the locally approved treatment label. |
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| Primary | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months | St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction. | Treated Set (TS): all patients who were enrolled in the trial and have received at least once nintedanib during the trial. Any analysis on primary, secondary and safety endpoints was performed in the TS. The number of participants analysed displays the number of participants with available data at the timepoint of interest, at 12 months. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | At baseline and at 12 months. | | | | ID | Title | Description |
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| OG000 | Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Patients were considered eligible if they were ≥40 years old y/o, had signed informed consent form, were treatment-naïve with an initial IPF diagnosis no more than 3 months prior to enrolment and were initiating treatment with nintedanib (as monotherapy) the latest on the enrolment day or had initiated it within the past 7 days prior to enrolment, and for whom the decision to prescribe treatment with nintedanib was according to the locally approved treatment label. |
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