Trial Outcomes & Findings for Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib (NCT NCT03710824)

NCT ID: NCT03710824

Last Updated: 2024-07-31

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 180 participants
• Primary outcome timeframe: At baseline and at 3 months.
• Results posted on: 2024-07-31

Participant Flow

This observational study aimed to collect data on various patient reported outcomes (PROs) in patients with idiopathic pulmonary fibrosis (IPF) under treatment with nintedanib (QUALIFY Idiopathic Pulmonary Fibrosis) over a 52-week period in Greece. Data of 180 newly diagnosed IPF patients enrolled from 10 University Pulmonology Clinics and Reference Centers of the Public Hospital Setting were collected.

Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Treatment interruption and dose reduction were allowed as medically indicated. Rescue medication was allowed for all subjects as required.

Participant milestones

Measure	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.
Overall Study STARTED	180
Overall Study COMPLETED	149
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	3
Overall Study Adverse Event	25
Overall Study Treatment discontinuation	2

Baseline Characteristics

Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib

Baseline characteristics by cohort

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 Participants 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.
Age, Continuous	72.96 Years STANDARD_DEVIATION 7.829 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	136 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	180 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
St. George's Respiratory Questionnaire (SGRQ) scores at baseline SGRQ total score	32.93 Score on a scale STANDARD_DEVIATION 19.319 • n=5 Participants
St. George's Respiratory Questionnaire (SGRQ) scores at baseline symptom domain score	32.09 Score on a scale STANDARD_DEVIATION 21.089 • n=5 Participants
St. George's Respiratory Questionnaire (SGRQ) scores at baseline activity domain score	48.19 Score on a scale STANDARD_DEVIATION 22.956 • n=5 Participants
St. George's Respiratory Questionnaire (SGRQ) scores at baseline psychosocial impact score	24.01 Score on a scale STANDARD_DEVIATION 20.487 • n=5 Participants

PRIMARY outcome

Timeframe: At baseline and at 3 months.

Population: 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.

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.

Outcome measures

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 Participants 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.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months total score	2.08 Score on a scale Interval -2.15 to 6.31
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months symptoms domain score	-2.31 Score on a scale Interval -5.89 to 1.27
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months activity domain score	3.37 Score on a scale Interval -1.15 to 7.89
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months psychosocial impact domain score	2.88 Score on a scale Interval -2.1 to 7.85

PRIMARY outcome

Timeframe: At baseline and at 6 months.

Population: 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.

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.

Outcome measures

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 Participants 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.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months activity domain score	4.18 Score on a scale Interval -0.37 to 8.73
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months psychosocial impact domain score	4.76 Score on a scale Interval -0.25 to 9.77
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months total score	3.55 Score on a scale Interval -0.71 to 7.8
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months symptoms domain score	-1.28 Score on a scale Interval -4.9 to 2.33

PRIMARY outcome

Timeframe: At baseline and at 9 months.

Population: 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.

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.

Outcome measures

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 Participants 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.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months symptoms domain score	-1.07 Score on a scale Interval -4.72 to 2.57
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months total score	4.64 Score on a scale Interval 0.36 to 8.92
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months activity domain score	5.36 Score on a scale Interval 0.78 to 9.94
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months psychosocial impact domain score	6.09 Score on a scale Interval 1.05 to 11.13

PRIMARY outcome

Timeframe: At baseline and at 12 months.

Population: 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.

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.

Outcome measures

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 Participants 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.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months total score	6.00 Score on a scale Interval 1.72 to 10.28
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months symptoms domain score	-1.03 Score on a scale Interval -4.67 to 2.62
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months activity domain score	6.19 Score on a scale Interval 1.61 to 10.77
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months psychosocial impact domain score	8.17 Score on a scale Interval 3.13 to 13.22

SECONDARY outcome

Timeframe: At baseline and at 3, 6, 9, and 12 months.

Population: 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.

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.

Outcome measures

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 Participants 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.
Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score At 3 months	0.30 Score on a scale. Interval 0.09 to 0.51
Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score At 6 months	0.31 Score on a scale. Interval 0.1 to 0.51
Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score At 9 months	0.40 Score on a scale. Interval 0.19 to 0.61
Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score At 12 months	0.39 Score on a scale. Interval 0.18 to 0.6

SECONDARY outcome

Timeframe: At baseline, and at 3, 6, 9, and 12 months.

Population: 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.

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.

Outcome measures

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 Participants 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.
Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) At 3 months	-0.72 Score on a scale. Interval -4.87 to 3.42
Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) At 6 months	-3.73 Score on a scale. Interval -7.92 to 0.45
Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) At 9 months	-2.13 Score on a scale. Interval -6.36 to 2.09
Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) At 12 months	-1.25 Score on a scale. Interval -5.48 to 2.98

SECONDARY outcome

Timeframe: At 3, 6, 9, and 12 months.

Population: 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.

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.

Outcome measures

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 Participants 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.
Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) At 3 months	70.75 Percentage of participants
Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) At 6 months	74.13 Percentage of participants
Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) At 9 months	75.18 Percentage of participants
Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) At 12 months	76.81 Percentage of participants

SECONDARY outcome

Timeframe: At baseline, and at 3, 6, 9, and 12 months.

Population: 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.

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.

Outcome measures

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 Participants 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.
Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire At 3 months	0.09 Score on a scale. Interval -1.19 to 1.38
Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire At 6 months	0.48 Score on a scale. Interval -0.81 to 1.77
Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire At 9 months	0.77 Score on a scale. Interval -0.53 to 2.07
Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire At 12 months	0.97 Score on a scale. Interval -0.33 to 2.26

SECONDARY outcome

Timeframe: At baseline, and at 3, 6, 9, and 12 months.

Population: 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.

Percentage of patients that use Long Term Oxygen Treatment (LTOT) is presented.

Outcome measures

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 Participants 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.
Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) At baseline	17.78 Percentage of participants
Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) At 3 months	16.97 Percentage of participants
Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) At 6 months	16.34 Percentage of participants
Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) At 9 months	15.33 Percentage of participants
Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) At 12 months	15.44 Percentage of participants

Adverse Events

Nintedanib for Patients With Idiopathic Pulmonary Fibrosis

Serious events: 10 serious events

Other events: 12 other events

Deaths: 8 deaths

Serious adverse events

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 participants at risk 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.
Cardiac disorders Cardiac arrest	0.56% 1/180 • Up to 52 weeks. 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.
Cardiac disorders Cardio-respiratory arrest	0.56% 1/180 • Up to 52 weeks. 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.
Cardiac disorders Myocardial infarction	0.56% 1/180 • Up to 52 weeks. 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.
Infections and infestations COVID-19	0.56% 1/180 • Up to 52 weeks. 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.
Infections and infestations Respiratory tract infection	0.56% 1/180 • Up to 52 weeks. 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.
Investigations Blood bilirubin increased	0.56% 1/180 • Up to 52 weeks. 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.
Investigations Transaminases increased	0.56% 1/180 • Up to 52 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.56% 1/180 • Up to 52 weeks. 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.
Nervous system disorders Ischaemic stroke	0.56% 1/180 • Up to 52 weeks. 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.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	1.1% 2/180 • Up to 52 weeks. 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.56% 1/180 • Up to 52 weeks. 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.
General disorders Disease progression	1.1% 2/180 • Up to 52 weeks. 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.

Other adverse events

Measure

Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n=180 participants at risk 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.

Gastrointestinal disorders Diarrhoea

6.7% 12/180 • Up to 52 weeks. 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.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 018002430127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER