Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03281200
• Collaborator: (none)
• Enrollment: 172
• Location: 1
• Actual Duration (Months): 7.4
• Patients Per Site Per Month: 23.2

Study Details

Study Description

Brief Summary

The present study has been designed to characterize IPF patients treated with nintedanib (OFEV®), at time of treatment initiation, with respect to their clinical profile based on real-world data from January 2016 in Spanish Pulmonology Services.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: L - Antineoplastic and immunomodulating agents; Drug: L01 - Antineoplastic agents; Drug: L01X - Other antineoplastic agents; Drug: L01XE - Protein kinase inhibitors; Drug: L01XE31 - Nintedanib

Study Design

• Study Type: Observational
• Actual Enrollment: 172 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: A Multicentre, Retrospective Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain.
• Actual Study Start Date: Oct 24, 2017
• Actual Primary Completion Date: Jun 7, 2018
• Actual Study Completion Date: Jun 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Anatomical main group:	Drug: L - Antineoplastic and immunomodulating agents; L - Antineoplastic and immunomodulating agents
Therapeutic subgroup	Drug: L01 - Antineoplastic agents; L01 - Antineoplastic agents
Pharmacological subgroup	Drug: L01X - Other antineoplastic agents; L01X - Other antineoplastic agents
Chemical subgroup	Drug: L01XE - Protein kinase inhibitors; L01XE - Protein kinase inhibitors
Chemical substance	Drug: L01XE31 - Nintedanib; L01XE31 - Nintedanib; Other Names: OVEF

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity)) [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.

2. Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)) [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.

Secondary Outcome Measures

1. The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

2. The Clinical Baseline Characteristics - Duration of the Disease [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   Duration of the disease of IPF patients, calculated as the time elapsed from the date of diagnosis until the start date of treatment with OFEV® (years).

3. The Clinical Baseline Characteristics - Percentage of Patients With Emphysema [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.

4. The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

5. The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

6. The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV® [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.

7. The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.

8. The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.

9. The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

   The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.

10. The Demographic Baseline Characteristics - 6-minute Walk Test [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

    The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

11. The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

    The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.

12. The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

    The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.

13. The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

    The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.

14. The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

    The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.

15. Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

    The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.

16. Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation. [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

    The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.

17. Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC) [From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.]

    The distribution of patients across different lung function categories based on the reimbursement threshold (FVC >80%, 50-80%, and <50%).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The patient is at least 18 years old

• The patient has IPF diagnosis according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management [5]

• The patient newly initiated treatment with nintedanib (OFEV®) since 01 January 2016 up to end of data collection date, according to the approved local Summary of Product Characteristics (SmPC)

Exclusion Criteria:

• Patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dynamic solutions	Barcelona		Spain	08029

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 11, 2017

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03281200
• Other Study ID Numbers: 1199-0295
• First Posted: Sep 13, 2017
• Last Update Posted: Aug 1, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Nintedanib; Antineoplastic Agents; Protein Kinase Inhibitors

Study Results

Participant Flow

Recruitment Details	Non-interventional study based on medical charts was conducted in approximately 35 pulmonology services in Spanish hospitals. Idiopathic pulmonary fibrosis (IPF) patients were characterized at the time of nintedanib initiation. Analysis of this report was performed using the data collected in the database from 21October2017 up to 31January2018.
Pre-assignment Detail	All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be analyzed if any one of the specific entry criteria were not met.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Period Title: Overall Study
STARTED	172
COMPLETED	172
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Participants	172
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	71.0 (8.1)
Sex/Gender, Customized (Particpants) [Number]
Male	131
Female	40
No data	1
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
Not Hispanic or Latino
Unknown or Not Reported
Race/Ethnicity, Customized (Number) [Number]
Caucasian	170 98.8%
Asiatic	1 0.6%
Arab	1 0.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))
Description	The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
Mild IPF: FVC ≥ 70%	57.0
Moderate IPF: FVC between 50% and 69%	38.4
Severe IPF: FVC < 50%	4.7

2. Primary Outcome

Title	Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))
Description	The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.Include only those patients DLCO value who has been answered in the case report form (CRF).

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	153
Mild IPF: DLCO ≥ 50%	42.5
Moderate IPF: DLCO between 35% and 49%	35.3
Severe IPF: DLCO < 35%	22.2

3. Secondary Outcome

Title	The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation
Description	The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
Mean (Standard Deviation) [Years]	70.1 (8.1)

4. Secondary Outcome

Title	The Clinical Baseline Characteristics - Duration of the Disease
Description	Duration of the disease of IPF patients, calculated as the time elapsed from the date of diagnosis until the start date of treatment with OFEV® (years).
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
Mean (Standard Deviation) [Years]	1.5 (3.8)

5. Secondary Outcome

Title	The Clinical Baseline Characteristics - Percentage of Patients With Emphysema
Description	The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
No	84.3
Yes	15.7

6. Secondary Outcome

Title	The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern
Description	The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
No	13.4
Yes	30.8
No data	55.8

7. Secondary Outcome

Title	The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern
Description	The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
No	9.9
Yes	89.0
No data	1.2

8. Secondary Outcome

Title	The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®
Description	The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
150 mg/12 h	88.4
100 mg/12 h	11.0
No data	0.6

9. Secondary Outcome

Title	The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy
Description	The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	160
Mean (Standard Deviation) [Kilogram (Kg)]	77.1 (13.2)

10. Secondary Outcome

Title	The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy
Description	The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	159
Mean (Standard Deviation) [Centimeters (cm)]	164.5 (8.9)

11. Secondary Outcome

Title	The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy
Description	The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	159
Mean (Standard Deviation) [Kilogram/ meter^2 (kg/m^2)]	28.4 (3.8)

12. Secondary Outcome

Title	The Demographic Baseline Characteristics - 6-minute Walk Test
Description	The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	136
Mean (Standard Deviation) [Meter (m)]	421.7 (118.6)

13. Secondary Outcome

Title	The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit
Description	The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
Never smoker	33.1 19.2%
Former smoker	64.0 37.2%
Active smoker	2.9 1.7%

14. Secondary Outcome

Title	The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea
Description	The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
No	5.2
Yes	93.0
No data	1.7

15. Secondary Outcome

Title	The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations
Description	The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
No	84.9
Yes	11.6
No data	3.5

16. Secondary Outcome

Title	The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments
Description	The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
No	20.3
Yes	79.7

17. Secondary Outcome

Title	Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.
Description	The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
Hypertension	45.9
Dyslipidaemia	42.4
Gastroesophageal reflux	25.6
Diabetes mellitus	19.8
Emphysema	15.7
Cardiovascular disease	15.7
Obstructive sleep apnoea	11.6
Pulmonary hypertension	5.8
Lung cancer	1.7
Pulmonary infection	1.2

18. Secondary Outcome

Title	Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.
Description	The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
Number [Percentages of Patients]	41.9

19. Secondary Outcome

Title	Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)
Description	The distribution of patients across different lung function categories based on the reimbursement threshold (FVC >80%, 50-80%, and <50%).
Time Frame	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Outcome Measure Data

Analysis Population Description

All enrolled patients who met the selection criteria.

Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Measure Participants	172
Mild IPF: FVC > 80%	33.1
Moderate IPF: FVC between 50% and 80%	62.2
Severe IPF: FVC < 50%	4.7

Adverse Events

Time Frame	From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days
Adverse Event Reporting Description	Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Arm/Group Title	Total Patients With IPF
Arm/Group Description	The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
All Cause Mortality
	Total Patients With IPF
	Affected / at Risk (%)	# Events
Total	10/172 (5.8%)
Serious Adverse Events
	Total Patients With IPF
	Affected / at Risk (%)	# Events
Total	13/172 (7.6%)
Cardiac disorders
Acute coronary syndrome	1/172 (0.6%)
Cardiac failure congestive	1/172 (0.6%)
Gastrointestinal disorders
Diarrhoea	1/172 (0.6%)
General disorders
Death	2/172 (1.2%)
Hepatobiliary disorders
Hepatotoxicity	1/172 (0.6%)
Infections and infestations
Pneumonia pneumococcal	1/172 (0.6%)
Investigations
Weight decreased	1/172 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma	1/172 (0.6%)
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis	3/172 (1.7%)
Pneumothorax	1/172 (0.6%)
Pulmonary arterial hypertension	1/172 (0.6%)
Vascular disorders
Hypertensive crisis	1/172 (0.6%)
Other (Not Including Serious) Adverse Events
	Total Patients With IPF
	Affected / at Risk (%)	# Events
Total	38/172 (22.1%)
Gastrointestinal disorders
Diarrhoea	38/172 (22.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.