Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary... | NCT00514683 | Trialant
NCT00514683
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Jan 6, 2015Estimated
Enrollment
432Actual
Phase
Phase 2
Conditions
Pulmonary Fibrosis
Interventions
low dose BIBF1120 once daily
low dose BIBF 1120 twice daily
intermediate dose BIBF 1120 twice daily
high dose BIBF 1120 twice daily
placebo
Countries
Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
Chile
China
Czechia
France
Germany
Greece
Hungary
Ireland
Italy
Mexico
Netherlands
Portugal
Russia
South Africa
South Korea
Spain
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00514683
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1199.30
Secondary IDs
Not provided
Brief Title
Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis
Official Title
A 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out.
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Jan 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2007
Primary Completion Date
Jun 2010Actual
Completion Date
Not provided
First Submitted Date
Aug 9, 2007
First Submission Date that Met QC Criteria
Aug 9, 2007
First Posted Date
Aug 10, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 14, 2014
Results First Submitted that Met QC Criteria
Jan 5, 2015
Results First Posted Date
Jan 6, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 2, 2014
Certification/Extension First Submitted that Passed QC Review
Jun 2, 2014
Certification/Extension First Posted Date
Jun 17, 2014Estimated
Last Update Submitted Date
Jan 5, 2015
Last Update Posted Date
Jan 6, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis.
The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).
As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy
Detailed Description
Not provided
Conditions Module
Conditions
Pulmonary Fibrosis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
432Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
dose 1
Experimental
low dose BIBF1120 once daily
Drug: low dose BIBF1120 once daily
dose 2
Experimental
low dose BIBF 1120 twice daily
Drug: low dose BIBF 1120 twice daily
dose 3
Experimental
intermediate dose BIBF 1120 twice daily
Drug: intermediate dose BIBF 1120 twice daily
dose 4
Experimental
high dose BIBF 1120 twice daily
Drug: high dose BIBF 1120 twice daily
placebo
Placebo Comparator
placebo
Drug: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
low dose BIBF1120 once daily
Drug
low dose BIBF1120 once daily
dose 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Rate of Decline in FVC
Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment.
The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.
Baseline until 52 weeks
Secondary Outcomes
Measure
Description
Time Frame
Absolute Change From Baseline in FVC%Pred
Change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
Baseline and 52 weeks
Absolute Change From Baseline in FVC
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient >40 years
Written informed consent signed prior to entry into the study
IPF diagnosed (according to ATS / ERS criteria) less than 5 years prior to screening visit.
HRCT within 12 months of randomisation and biopsy (the latter if needed to fulfil ATS/ERS criteria) centrally reviewed and consistent with diagnosis.
FVC>50 % of predicted value
Predicted normal values will be calculated according to ESCS (R94-1408):
Males :
FVC predicted (L) = 5.76 x height (meters)- 0.026 x age (years) -4.34
Females :
FVC predicted (L) = 4.43 x height (meters)- 0.026 x age (years) -2.89
Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted .
Different sites may use different prediction formulas, based on the method used to measure DLco. In any case, the method used must be in compliance with the ATS/ERS guideline on DLCO measurements (R06-2002), and the prediction formula appropriate for that method. Raw data (gas mixture, equation used for prediction of normal, further adjustments made if so) must be traced.
Adjustment for haemoglobin (R06-2002):
Males :
DLCO predicted for Hb = DLCO predicted x (1.7Hb/[10.22+Hb])
Females :
DLCO predicted for Hb = DLCO predicted x (1.7Hb/[9.38+Hb]) where Hb is expressed in g/dL-1
PaO2 >= 55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air
Exclusion Criteria:
AST, ALT > 1.5 x ULN ;
Bilirubin > 1.5 x ULN
Relevant airways obstruction
Continuous oxygen supplementation at randomisation (defined as > 15 hours supplemental oxygen per day).
Active infection at screening or randomisation.
Neutrophils < 1500 / mm3
International normalised ratio (INR) > 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN ;
Platelets < 100 000 /mL
Haemoglobin < 9.0 g/dL
In the opinion of the Investigator, patient is likely to have lung transplantation during study
Life expectancy for disease other than IPF < 2.5 years (Investigator assessment).
Other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial.
Myocardial infarction during the previous 6 months
Unstable angina during the previous month
Other investigational therapy received within 8 weeks prior to screening visit.
Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrolment.
Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential).
Known or suspected active alcohol or drug abuse.
Bleeding risk : Known inherited predisposition to bleeding, patients who require full-dose anticoagulation, Patients who require full-dose antiplatelet therapy, History of hemorrhagic CNS event within 12 months prior to screening , Any of the following within 3 months prior to screening : Gross / frank haemoptysis or haematuria, Active gastro-intestinal bleeding or ulcers, Major injury or surgery
Thrombotic risk
Surgical procedures planned to occur during trial period.
Coagulopathy
Uncontrolled systemic arterial hypertension
known hypersensitivity to lactose or any component of the study medication
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
40 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
1199.30.54002 Boehringer Ingelheim Investigational Site
Mendoza
Argentina
1199.30.61005 Boehringer Ingelheim Investigational Site
Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.
Patients were treated with 50mg nintedanib once daily
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
El Salvador
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
Not provided
low dose BIBF 1120 twice daily
Drug
low dose BIBF 1120 twice daily
dose 2
intermediate dose BIBF 1120 twice daily
Drug
intermediate dose BIBF 1120 twice daily
dose 3
high dose BIBF 1120 twice daily
Drug
high dose BIBF 1120 twice daily
dose 4
placebo
Drug
placebo
placebo
Change from baseline in percentage of absolute Forced Vital Capacity (FVC) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
Baseline and 52 weeks
Relative Change From Baseline in FVC%Pred
Percent change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
Baseline and 52 weeks
Relative Change From Baseline in FVC
Percent change from baseline in absolute Forced Vital Capacity (FVC) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region
Baseline and 52 weeks
Number of Participants With Change From Baseline in FVC by Categories
Change from baseline in percentage of Forced Vital Capacity (FVC) at 52 weeks in below mentioned categories:
Decrease > 10% or 200mL
Change within <= 10% or <=200 mL
Increase > 10% or 200mL
Baseline and 52 weeks
Survival (All Causes of Death and Lung-transplant Free)
Survival (all causes of death and lung-transplant free) at 52 weeks, based on overall mortality and on-treatment survival.
Failure means participants with event and Censored means participants with no event.
52 weeks
Absolute Change From Baseline in SpO2 at Rest
Absolute change from baseline in oxygen saturation (SpO2) at rest.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Absolute Change From Baseline in SpO2 at Rest by Categories
Absolute change from baseline in oxygen saturation (SpO2) at rest by below mentioned categories:
SpO2 (non-invasive) at 52 weeks:
Decrease > 4% SpO2
Change within +/- 4% SpO2
Increase > 4% SpO2
Baseline and 52 weeks
Absolute Change From Baseline in PaO2
Absolute change from baseline in Arterial oxygen partial pressure (PaO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Absolute Change From Baseline in P(A-a)O2
Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a)O2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Absolute Change From Baseline in PaCO2
Absolute change from baseline in Arterial carbon dioxyde partial pressure (PaCO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Absolute Change From Baseline in PaO2 by Categories
Absolute change from baseline in Arterial oxygen partial pressure (PaO2) by below mentioned categories:
Decrease > 4 mmHg
Change within +/- 4 mmHg
Increase > 4 mmHg
Baseline and 52 weeks
Absolute Change From Baseline in P(A-a) O2 by Categories
Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a) O2) by below mentioned categories:
Decrease > 4 mmHg
Change within +/- 4 mmHg
Increase > 4 mmHg
Baseline and 52 weeks
Absolute Change From Baseline in DLCO
Absolute change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Absolute Change From Baseline in DLCO by Categories
Absolute change from baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) by below mentioned categories:
Decrease > 15% or > 1
Change <= 15% or <= 1
Increase > 15% or > 1
Baseline and 52 weeks
Absolute Change From Baseline in Distance Walk (6-MWT)
Absolute change from baseline in distance walk (6-MWT) at 52 weeks. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT)
Absolute change from baseline in Dyspnoea rating before exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :
0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).
The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT)
Change from baseline in Dyspnoea rating after exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :
0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).
The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Absolute Change From Baseline in MRC Dyspnea Scale by Categories
Absolute change from baseline in Medical Research Council (MRC) dyspnea scale by below mentioned categories:
Decrease
No Change
Increase
Baseline and 52 weeks
Absolute Change From Baseline in FEV1/FVC
Change from baseline of percentage of FVC expelled in the first second of a forced expiration (FEV1/FVC) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Change From Baseline in SGRQ Total Score
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score. Total score is defined as sum of the three domain scores symptoms, activities and impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Change From Baseline in SGRQ Domain Score Symptoms
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score symptoms. Scores range from 0 to 100, with higher scores indicating more limitations.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Change From Baseline in SGRQ Domain Score Impacts
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score activities. Scores range from 0 to 100, with higher scores indicating worst possible health status.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
St George's Respiratory Questionnaire (SGRQ) Responder
St George's Respiratory Questionnaire (SGRQ) responder (<= -4 points change) (%) at 52 weeks-worst case
52 weeks
Change From Baseline in TLC
Change from Baseline in Total Lung Capacity (TLC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Change From Baseline in RV
Change from Baseline in Residual volume (RV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Change From Baseline in TGV
Change from Baseline in Thoracic gas volume (TGV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Change From Baseline in VC
Change from baseline in Vital capacity (VC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Change From Baseline in IC
Change from Baseline in Inspiratory Capacity (IC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Baseline and 52 weeks
Number of Patients With at Least One IPF Exacerbation
Number of patients with at least one Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks
52 weeks
Occurrences of IPF Exacerbations Per Patient Per Year
Occurrences of Idiopathic Pulmonary Fibrosis (IPF) exacerbations per patient per year at 52 weeks
52 weeks
Time to First Occurrence of IPF Exacerbation
This endpoint is called time to first occurrence of IPF exacerbation however it was actually analysed as the proportion of patients having occurrence of Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks.
Failure means participants with event and Censored means participants with no event.
52 weeks
Survival (Death Due to Respiratory Cause, and Lung-transplant Free)
Survival (death due to respiratory cause, and lung-transplant free) at 52 weeks.
Failure means participants with event and Censored means participants with no event.
52 weeks
Time to Progression
Time to progression. Progression was defined as at least one of the following: 5mmHg increase in the alveolo-arterial pressure difference in oxygen (P(A-a)O2), 10% decrease in FVC (FVC(baseline)-FVC(progression) >= 10%) or Death.
Failure means participants with event and Censored means participants with no event.
52 weeks
Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729).
Cpre,ss,729 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 729 and Cpre,ss,365 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 365. At day 365, values only for Nintedanib 50 qd group are presented as no values reported for other groups and at day 729, values are presented for all group except for Nintedanib 50 qd group as no values reported for it.
day 365 and day 729
South Brisbane
Queensland
Australia
1199.30.61003 Boehringer Ingelheim Investigational Site
Toorak Gardens
South Australia
Australia
1199.30.61004 Boehringer Ingelheim Investigational Site
Woodville
South Australia
Australia
1199.30.61001 Royal Perth Hospital
Perth
Western Australia
Australia
1199.30.32004 Boehringer Ingelheim Investigational Site
Brussels
Belgium
1199.30.32001 Boehringer Ingelheim Investigational Site
Leuven
Belgium
1199.30.32002 Boehringer Ingelheim Investigational Site
Yvoir
Belgium
1199.30.55002 Boehringer Ingelheim Investigational Site
Porto Alegre
Brazil
1199.30.55001 Boehringer Ingelheim Investigational Site
Vila Clementino
Brazil
1199.30.06004 Boehringer Ingelheim Investigational Site
Sofia
Bulgaria
1199.30.06005 Boehringer Ingelheim Investigational Site
Sofia
Bulgaria
1199.30.01003 Division of Respirology
Halifax
Nova Scotia
Canada
1199.30.01002 St. Joseph's Healthcare
Hamilton
Ontario
Canada
1199.30.56001 Boehringer Ingelheim Investigational Site
Providencia
Chile
1199.30.86001 Boehringer Ingelheim Investigational Site
Beijing
China
1199.30.86002 Boehringer Ingelheim Investigational Site
Beijing
China
1199.30.86005 Boehringer Ingelheim Investigational Site
Nanjing
China
1199.30.86003 Boehringer Ingelheim Investigational Site
Shanghai
China
1199.30.86004 Boehringer Ingelheim Investigational Site
Shenyang
China
1199.30.42002 Boehringer Ingelheim Investigational Site
Prague
Czechia
1199.30.42001 Boehringer Ingelheim Investigational Site
Ústà nad Labem
Czechia
1199.30.3302A Boehringer Ingelheim Investigational Site
Bobigny
France
1199.30.3306A Boehringer Ingelheim Investigational Site
Dijon
France
1199.30.3303A Boehringer Ingelheim Investigational Site
Grenoble
France
1199.30.3305A Boehringer Ingelheim Investigational Site
Lille
France
1199.30.3305B Boehringer Ingelheim Investigational Site
Lille
France
1199.30.3305C Boehringer Ingelheim Investigational Site
Lille
France
1199.30.3304C Boehringer Ingelheim Investigational Site
Montpellier
France
1199.30.3307A Boehringer Ingelheim Investigational Site
Nice
France
1199.30.3301A Boehringer Ingelheim Investigational Site
Paris
France
1199.30.49008 Boehringer Ingelheim Investigational Site
Bad Berka
Germany
1199.30.49007 Boehringer Ingelheim Investigational Site
Berlin
Germany
1199.30.49006 Boehringer Ingelheim Investigational Site
Donaustauf
Germany
1199.30.49001 Boehringer Ingelheim Investigational Site
Essen
Germany
1199.30.49002 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau
Germany
1199.30.49003 Boehringer Ingelheim Investigational Site
Großhansdorf
Germany
1199.30.49009 Boehringer Ingelheim Investigational Site
Leipzig
Germany
1199.30.49004 Boehringer Ingelheim Investigational Site
Mainz
Germany
1199.30.49005 Boehringer Ingelheim Investigational Site
München
Germany
1199.30.30004 Boehringer Ingelheim Investigational Site
Alexandroupoli
Greece
1199.30.30001 Boehringer Ingelheim Investigational Site
Heraklion
Greece
1199.30.30002 Boehringer Ingelheim Investigational Site
Larissa
Greece
1199.30.36002 Boehringer Ingelheim Investigational Site
Budapest
Hungary
1199.30.36003 Boehringer Ingelheim Investigational Site
Budapest
Hungary
1199.30.36004 Boehringer Ingelheim Investigational Site
Deszk
Hungary
1199.30.36001 Boehringer Ingelheim Investigational Site
1199.30.39008 Boehringer Ingelheim Investigational Site
Ascoli Piceno
Italy
1199.30.39013 Boehringer Ingelheim Investigational Site
Busto Arsizio (va)
Italy
1199.30.39007 Boehringer Ingelheim Investigational Site
Milan
Italy
1199.30.39001 Boehringer Ingelheim Investigational Site
Modena
Italy
1199.30.39012 Boehringer Ingelheim Investigational Site
Naples
Italy
1199.30.39009 Boehringer Ingelheim Investigational Site
Pavia
Italy
1199.30.39011 Boehringer Ingelheim Investigational Site
Roma
Italy
1199.30.39010 Boehringer Ingelheim Investigational Site
Siena
Italy
1199.30.39003 Boehringer Ingelheim Investigational Site
Terni
Italy
1199.30.39004 Boehringer Ingelheim Investigational Site
Trieste
Italy
1199.30.52001 Boehringer Ingelheim Investigational Site
Distrito Federal
Mexico
1199.30.31002 Boehringer Ingelheim Investigational Site
Nieuwegein
Netherlands
1199.30.35105 Boehringer Ingelheim Investigational Site
Coimbra
Portugal
1199.30.35106 Boehringer Ingelheim Investigational Site
Coimbra
Portugal
1199.30.35107 Boehringer Ingelheim Investigational Site
Lisbon
Portugal
1199.30.35108 Boehringer Ingelheim Investigational Site
Lisbon
Portugal
1199.30.35109 Boehringer Ingelheim Investigational Site
Lisbon
Portugal
1199.30.35101 Boehringer Ingelheim Investigational Site
Porto
Portugal
1199.30.07001 Boehringer Ingelheim Investigational Site
Moscow
Russia
1199.30.07002 Boehringer Ingelheim Investigational Site
Moscow
Russia
1199.30.07003 Boehringer Ingelheim Investigational Site
Saint Petersburg
Russia
1199.30.27001 Boehringer Ingelheim Investigational Site
Bellville
South Africa
1199.30.27003 Boehringer Ingelheim Investigational Site
Cape Town
South Africa
1199.30.27002 Boehringer Ingelheim Investigational Site
Tygerberg
South Africa
1199.30.82002 Boehringer Ingelheim Investigational Site
Gyunggido
South Korea
1199.30.82004 Boehringer Ingelheim Investigational Site
Incheon
South Korea
1199.30.82001 Boehringer Ingelheim Investigational Site
Seoul
South Korea
1199.30.82003 Boehringer Ingelheim Investigational Site
Seoul
South Korea
1199.30.82005 Boehringer Ingelheim Investigational Site
Seoul
South Korea
1199.30.34001 Boehringer Ingelheim Investigational Site
Barcelona
Spain
1199.30.34002 Boehringer Ingelheim Investigational Site
Valencia
Spain
1199.30.88605 Boehringer Ingelheim Investigational Site
Taichung
Taiwan
1199.30.88601 National Taiwan University
Taipei
Taiwan
1199.30.88603 Tri-service General Hospital
Taipei
Taiwan
1199.30.88606 Boehringer Ingelheim Investigational Site
Taipei
Taiwan
1199.30.88604 Chang Gung Memorial Hosp-Linkou
Taoyuan
Taiwan
1199.30.90001 Boehringer Ingelheim Investigational Site
Ankara
Turkey (Türkiye)
1199.30.90002 Boehringer Ingelheim Investigational Site
Istanbul
Turkey (Türkiye)
1199.30.44006 Boehringer Ingelheim Investigational Site
Aberdeen
United Kingdom
1199.30.44003 Boehringer Ingelheim Investigational Site
Birmingham
United Kingdom
1199.30.44005 Boehringer Ingelheim Investigational Site
Birmingham
United Kingdom
1199.30.44007 Boehringer Ingelheim Investigational Site
Manchester
United Kingdom
1199.30.44001 Boehringer Ingelheim Investigational Site
Westbury on Trym
United Kingdom
Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.
Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.
Richeldi L, Costabel U, Selman M, Kim DS, Hansell DM, Nicholson AG, Brown KK, Flaherty KR, Noble PW, Raghu G, Brun M, Gupta A, Juhel N, Kluglich M, du Bois RM. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011 Sep 22;365(12):1079-87. doi: 10.1056/NEJMoa1103690.
FG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
FG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
FG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
FG00087 subjectsRandomised
FG00187 subjectsRandomised
FG00286 subjectsRandomised
FG00386 subjectsRandomised
FG00486 subjectsRandomised
COMPLETED
FG00061 subjects
FG00162 subjects
FG00268 subjects
FG00372 subjects
FG00453 subjects
NOT COMPLETED
FG00026 subjects
FG00125 subjects
FG00218 subjects
FG00314 subjects
FG00433 subjects
Type
Comment
Reasons
Not treated
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Adverse Event
FG00021 subjects
FG00120 subjects
FG00215 subjects
FG00313 subjects
FG004
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Reason other than listed above
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Treated Set: This patient set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Patients were treated with matching Placebo.
BG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
BG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
BG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
BG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00085
BG00186
BG00286
BG00386
BG00485
BG005428
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00064.8± 8.57
BG00165.3± 9.42
BG00264.9± 8.48
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00121
BG002
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
Rate of Decline in FVC
Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment.
The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.
Observed Case (OC): This method was used for the replacement of missing values.
Randomised set: This patient set includes all randomised patients whether treated or not.
Posted
Mean
Standard Error
Liters/year
Baseline until 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00083
OG00185
OG00286
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.190± 0.036
OG001-0.174± 0.037
OG002-0.210± 0.035
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.
0.8530
The p-value presented is computed in the course of the closing testing procedure.
Mean Difference (Final Values)
0.016
Standard Error of the Mean
0.052
2-Sided
95
-0.086
0.118
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Secondary
Absolute Change From Baseline in FVC%Pred
Change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
Last Observation Carried Forward (LOCF): This method was used for the replacement of missing values.
Randomised set: This patient set includes all randomised patients whether treated or not.
Posted
Mean
Standard Error
percentage of predicted FVC
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Secondary
Absolute Change From Baseline in FVC
Change from baseline in percentage of absolute Forced Vital Capacity (FVC) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
LOCF-Randomised set
Posted
Mean
Standard Error
Liters
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Relative Change From Baseline in FVC%Pred
Percent change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
LOCF-Randomised set
Posted
Mean
Standard Error
percentage of change
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Relative Change From Baseline in FVC
Percent change from baseline in absolute Forced Vital Capacity (FVC) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region
LOCF-Randomised set
Posted
Mean
Standard Error
percentage change
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Number of Participants With Change From Baseline in FVC by Categories
Change from baseline in percentage of Forced Vital Capacity (FVC) at 52 weeks in below mentioned categories:
Decrease > 10% or 200mL
Change within <= 10% or <=200 mL
Increase > 10% or 200mL
LOCF-Randomised set
Posted
Number
participants
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Survival (All Causes of Death and Lung-transplant Free)
Survival (all causes of death and lung-transplant free) at 52 weeks, based on overall mortality and on-treatment survival.
Failure means participants with event and Censored means participants with no event.
OC-Randomised set
Posted
Number
participants
52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Absolute Change From Baseline in SpO2 at Rest
Absolute change from baseline in oxygen saturation (SpO2) at rest.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
Percentage of SpO2
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Absolute Change From Baseline in SpO2 at Rest by Categories
Absolute change from baseline in oxygen saturation (SpO2) at rest by below mentioned categories:
SpO2 (non-invasive) at 52 weeks:
Decrease > 4% SpO2
Change within +/- 4% SpO2
Increase > 4% SpO2
LOCF-Randomised set
Posted
Number
percentage of participants
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Absolute Change From Baseline in PaO2
Absolute change from baseline in Arterial oxygen partial pressure (PaO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
OC-Randomised set
Posted
Mean
Standard Error
mmHg
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Absolute Change From Baseline in P(A-a)O2
Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a)O2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
OC-Randomised set
Posted
Mean
Standard Error
mmHg
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Absolute Change From Baseline in PaCO2
Absolute change from baseline in Arterial carbon dioxyde partial pressure (PaCO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
OC-Randomised set
Posted
Mean
Standard Error
mmHg
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Absolute Change From Baseline in PaO2 by Categories
Absolute change from baseline in Arterial oxygen partial pressure (PaO2) by below mentioned categories:
Decrease > 4 mmHg
Change within +/- 4 mmHg
Increase > 4 mmHg
OC - Randomised set
Posted
Number
percentage of participants
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Absolute Change From Baseline in P(A-a) O2 by Categories
Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a) O2) by below mentioned categories:
Decrease > 4 mmHg
Change within +/- 4 mmHg
Increase > 4 mmHg
OC - Randomised set
Posted
Number
percentage of participants
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Absolute Change From Baseline in DLCO
Absolute change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
mmol.min^-1.kPa^-1
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Absolute Change From Baseline in DLCO by Categories
Absolute change from baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) by below mentioned categories:
Decrease > 15% or > 1
Change <= 15% or <= 1
Increase > 15% or > 1
LOCF Randomized set
Posted
Number
percentage of patients
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Absolute Change From Baseline in Distance Walk (6-MWT)
Absolute change from baseline in distance walk (6-MWT) at 52 weeks. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
Meter
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT)
Absolute change from baseline in Dyspnoea rating before exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :
0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).
The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
Units on a scale
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Secondary
Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT)
Change from baseline in Dyspnoea rating after exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :
0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).
The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
Units on a scale
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
Secondary
Absolute Change From Baseline in MRC Dyspnea Scale by Categories
Absolute change from baseline in Medical Research Council (MRC) dyspnea scale by below mentioned categories:
Decrease
No Change
Increase
LOCF- Randomised
Posted
Number
percentage of participants
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Absolute Change From Baseline in FEV1/FVC
Change from baseline of percentage of FVC expelled in the first second of a forced expiration (FEV1/FVC) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
percentage of FVC
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Change From Baseline in SGRQ Total Score
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score. Total score is defined as sum of the three domain scores symptoms, activities and impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
units on a scale
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Secondary
Change From Baseline in SGRQ Domain Score Symptoms
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score symptoms. Scores range from 0 to 100, with higher scores indicating more limitations.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
units on a scale
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Change From Baseline in SGRQ Domain Score Impacts
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF - Randomised set
Posted
Mean
Standard Error
units on a scale
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score activities. Scores range from 0 to 100, with higher scores indicating worst possible health status.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
units on a scale
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Secondary
St George's Respiratory Questionnaire (SGRQ) Responder
St George's Respiratory Questionnaire (SGRQ) responder (<= -4 points change) (%) at 52 weeks-worst case
Worst case - Randomised set
Posted
Number
percentage of participants
52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Change From Baseline in TLC
Change from Baseline in Total Lung Capacity (TLC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
Liters
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Change From Baseline in RV
Change from Baseline in Residual volume (RV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
Liters
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Change From Baseline in TGV
Change from Baseline in Thoracic gas volume (TGV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
Liters
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Change From Baseline in VC
Change from baseline in Vital capacity (VC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
Liters
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Change From Baseline in IC
Change from Baseline in Inspiratory Capacity (IC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
LOCF-Randomised set
Posted
Mean
Standard Error
Liters
Baseline and 52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Number of Patients With at Least One IPF Exacerbation
Number of patients with at least one Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks
OC-Randomised set
Posted
Number
participants
52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Occurrences of IPF Exacerbations Per Patient Per Year
Occurrences of Idiopathic Pulmonary Fibrosis (IPF) exacerbations per patient per year at 52 weeks
OC-Randomised set
Posted
Mean
Standard Deviation
Exacerbations Per Year
52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Time to First Occurrence of IPF Exacerbation
This endpoint is called time to first occurrence of IPF exacerbation however it was actually analysed as the proportion of patients having occurrence of Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks.
Failure means participants with event and Censored means participants with no event.
OC-Randomised set
Posted
Number
percentage of participants
52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Survival (Death Due to Respiratory Cause, and Lung-transplant Free)
Survival (death due to respiratory cause, and lung-transplant free) at 52 weeks.
Failure means participants with event and Censored means participants with no event.
OC-Randomised set
Posted
Number
percentage of participants
52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Secondary
Time to Progression
Time to progression. Progression was defined as at least one of the following: 5mmHg increase in the alveolo-arterial pressure difference in oxygen (P(A-a)O2), 10% decrease in FVC (FVC(baseline)-FVC(progression) >= 10%) or Death.
Failure means participants with event and Censored means participants with no event.
OC - Randomised set
Posted
Median
95% Confidence Interval
Days
52 weeks
ID
Title
Description
OG000
Placebo
Patients were treated with matching Placebo.
OG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Secondary
Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729).
Cpre,ss,729 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 729 and Cpre,ss,365 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 365. At day 365, values only for Nintedanib 50 qd group are presented as no values reported for other groups and at day 729, values are presented for all group except for Nintedanib 50 qd group as no values reported for it.
Randomised set
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
day 365 and day 729
ID
Title
Description
OG000
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
OG001
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
OG002
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
OG003
Nintedanib 150 Bid
Time Frame
First drug administration until 14 days after last drug administration
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Patients were treated with matching Placebo.
26
85
51
85
EG001
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
26
86
52
86
EG002
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
23
86
55
86
EG003
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
18
86
64
86
EG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
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
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D011658
Pulmonary Fibrosis
Ancestor Terms
ID
Term
D017563
Lung Diseases, Interstitial
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D005355
Fibrosis
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
27 subjects
0 subjects
4 subjects
1 subjects
65.1
± 8.63
BG00465.4± 7.82
BG00565.1± 8.56
24
BG00321
BG00420
BG005108
Male
BG00063
BG00165
BG00262
BG00365
BG00465
BG005320
85
OG00484
-0.162
± 0.035
OG004-0.060± 0.039
OG000
OG001
Mixed Models Analysis
MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.
0.7558
The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.
0.7920
The p-value presented is computed in the course of the closing testing procedure.
Mean Difference (Final Values)
-0.020
Standard Error of the Mean
0.051
2-Sided
95
-0.119
0.080
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.
0.6991
The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis
No
Superiority or Other
OG000
OG003
Mixed Models Analysis
MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.
0.8530
The p-value presented is computed in the course of the closing testing procedure.
Mean Difference (Final Values)
0.028
Standard Error of the Mean
0.051
2-Sided
95
-0.071
0.128
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
Mixed Models Analysis
MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.
0.5736
Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis
No
Superiority or Other
OG000
OG004
Mixed Models Analysis
MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.
0.0639
The p-value presented is computed in the course of the closing testing procedure.
Mean Difference (Final Values)
0.131
Standard Error of the Mean
0.053
2-Sided
95
0.027
0.235
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
Mixed Models Analysis
MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.
0.0136
Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis
No
Superiority or Other
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00084
OG00185
OG00286
OG00385
OG00484
Title
Denominators
Categories
Title
Measurements
OG000-6.00± 1.019
OG001-4.58± 1.029
OG002-4.90± 0.984
OG003-3.15± 1.004
OG004-1.04± 0.990
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.2774
Mean Difference (Final Values)
1.43
Standard Error of the Mean
1.312
2-Sided
95
-1.15
4.01
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.4014
Mean Difference (Final Values)
1.10
Standard Error of the Mean
1.312
2-Sided
95
-1.48
3.68
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0314
Mean Difference (Final Values)
2.86
Standard Error of the Mean
1.324
2-Sided
95
0.26
5.46
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0002
Mean Difference (Final Values)
4.97
Standard Error of the Mean
1.319
2-Sided
95
2.37
7.56
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00084
OG00185
OG00286
OG00385
OG00484
Title
Denominators
Categories
Title
Measurements
OG000-0.23± 0.036
OG001-0.18± 0.036
OG002-0.19± 0.035
OG003-0.13± 0.035
OG004-0.06± 0.035
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.3644
Mean Difference (Final Values)
0.04
Standard Error of the Mean
0.046
2-Sided
95
-0.05
0.13
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.4525
Mean Difference (Final Values)
0.03
Standard Error of the Mean
0.046
2-Sided
95
-0.06
0.13
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0471
Mean Difference (Final Values)
0.09
Standard Error of the Mean
0.046
2-Sided
95
0.00
0.18
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0004
Mean Difference (Final Values)
0.17
Standard Error of the Mean
0.046
2-Sided
95
0.08
0.26
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00084
OG00185
OG00286
OG00385
OG00484
Title
Denominators
Categories
Title
Measurements
OG000-7.28± 1.321
OG001-6.37± 1.334
OG002-6.42± 1.277
OG003-3.47± 1.302
OG004-1.81± 1.283
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.5920
Mean Difference (Final Values)
0.91
Standard Error of the Mean
1.702
2-Sided
95
-2.43
4.26
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.6155
Mean Difference (Final Values)
0.86
Standard Error of the Mean
1.702
2-Sided
95
-2.49
4.20
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0271
Mean Difference (Final Values)
3.81
Standard Error of the Mean
1.716
2-Sided
95
0.43
7.18
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0015
Mean Difference (Final Values)
5.47
Standard Error of the Mean
1.710
2-Sided
95
2.11
8.83
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00084
OG00185
OG00286
OG00385
OG00484
Title
Denominators
Categories
Title
Measurements
OG000-7.96± 1.314
OG001-6.98± 1.327
OG002-7.16± 1.272
OG003-4.13± 1.285
OG004-2.52± 1.277
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.5601
ANCOVA with fixed terms for treatment, baseline, region.
Mean Difference (Final Values)
0.99
Standard Error of the Mean
1.692
2-Sided
95
-2.34
4.31
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.6366
Mean Difference (Final Values)
0.80
Standard Error of the Mean
1.694
2-Sided
95
-2.53
4.13
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0246
Mean Difference (Final Values)
3.84
Standard Error of the Mean
1.702
2-Sided
95
0.49
7.18
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0015
Mean Difference (Final Values)
5.44
Standard Error of the Mean
1.700
2-Sided
95
2.10
8.78
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00084
OG00185
OG00286
OG00385
OG00484
Title
Denominators
Categories
Decrease > 10% or 200mL
Title
Measurements
OG00037
OG00135
OG00241
OG00330
OG00420
Change within <= 10% or <=200mL
Title
Measurements
OG00041
OG00144
OG00239
OG003
Increase > 10% or 200mL
Title
Measurements
OG0006
OG0016
OG0026
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.7543
Odds Ratio (OR)
0.911
2-Sided
95
0.506
1.637
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.6704
Odds Ratio (OR)
1.136
2-Sided
95
0.631
2.045
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.1649
Odds Ratio (OR)
0.657
2-Sided
95
0.363
1.189
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.0041
Odds Ratio (OR)
0.415
2-Sided
95
0.227
0.757
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Units
Counts
Participants
OG00087
OG00187
OG00286
OG00386
OG00486
Title
Denominators
Categories
Failure
Title
Measurements
OG0009
OG00111
OG0023
OG0034
OG0047
Censored
Title
Measurements
OG00078
OG00176
OG00283
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.5882
Hazard Ratio (HR)
1.278
2-Sided
95
0.526
3.102
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.0653
Hazard Ratio (HR)
0.290
2-Sided
95
0.078
1.081
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.0847
Hazard Ratio (HR)
0.350
2-Sided
95
0.106
1.154
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.5383
Hazard Ratio (HR)
0.732
2-Sided
95
0.271
1.977
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Units
Counts
Participants
OG00082
OG00182
OG00286
OG00384
OG00483
Title
Denominators
Categories
Title
Measurements
OG000-1.29± 0.373(-2.03 to -0.56)
OG001-0.86± 0.380(-1.60 to -0.11)
OG002-0.97± 0.357(-1.67 to -0.27)
OG0030.06± 0.363(-0.65 to 0.78)
OG004-0.18± 0.360(-0.89 to 0.53)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.3658
Mean Difference (Final Values)
0.44
Standard Error of the Mean
0.483
2-Sided
95
-0.51
1.39
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.4956
Mean Difference (Final Values)
0.33
Standard Error of the Mean
0.478
2-Sided
95
-0.61
1.27
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0051
Mean Difference (Final Values)
1.36
Standard Error of the Mean
0.482
2-Sided
95
0.41
2.31
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0211
Mean Difference (Final Values)
1.12
Standard Error of the Mean
0.483
2-Sided
95
0.17
2.07
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00082
OG00182
OG00286
OG00384
OG00483
Title
Denominators
Categories
Decrease > 4%
Title
Measurements
OG00011.0
OG0014.9
OG0028.1
OG0036.0
OG0043.6
Change within +/- 4%
Title
Measurements
OG00087.8
OG00190.2
OG00289.5
OG003
Increase > 4%
Title
Measurements
OG0001.2
OG0014.9
OG0022.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.1021
Odds Ratio (OR)
0.428
2-Sided
95
0.155
1.184
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.4318
Odds Ratio (OR)
0.682
2-Sided
95
0.262
1.773
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.0934
Odds Ratio (OR)
0.412
2-Sided
95
0.146
1.161
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.0317
Odds Ratio (OR)
0.313
2-Sided
95
0.108
0.903
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Units
Counts
Participants
OG00058
OG00156
OG00264
OG00368
OG00451
Title
Denominators
Categories
Title
Measurements
OG000-1.69± 1.790
OG001-2.77± 1.865
OG002-3.00± 1.686
OG003-1.46± 1.632
OG004-0.76± 1.854
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.6443
Mean Difference (Final Values)
-1.08
Standard Error of the Mean
2.330
2-Sided
95
-5.66
3.51
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.5656
Mean Difference (Final Values)
-1.31
Standard Error of the Mean
2.280
2-Sided
95
-5.80
3.18
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.9181
Mean Difference (Final Values)
0.23
Standard Error of the Mean
2.240
2-Sided
95
-4.18
4.64
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.6970
Mean Difference (Final Values)
0.93
Standard Error of the Mean
2.387
2-Sided
95
-3.77
5.63
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00056
OG00154
OG00264
OG00367
OG00451
Title
Denominators
Categories
Title
Measurements
OG0001.21± 1.898
OG0011.27± 1.984
OG0022.22± 1.773
OG0031.62± 1.723
OG0042.56± 1.944
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.9811
Mean Difference (Final Values)
0.06
Standard Error of the Mean
2.490
2-Sided
95
-4.84
4.96
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.6772
Mean Difference (Final Values)
1.01
Standard Error of the Mean
2.412
2-Sided
95
-3.74
5.75
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.8631
Mean Difference (Final Values)
0.41
Standard Error of the Mean
2.379
2-Sided
95
-4.27
5.09
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.5942
Mean Difference (Final Values)
1.35
Standard Error of the Mean
2.523
2-Sided
95
-3.62
6.31
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00058
OG00156
OG00264
OG00368
OG00451
Title
Denominators
Categories
Title
Measurements
OG000-0.63± 0.549
OG0010.16± 0.573
OG002-0.44± 0.517
OG003-0.74± 0.500
OG004-0.77± 0.569
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.2716
Mean Difference (Final Values)
0.79
Standard Error of the Mean
0.715
2-Sided
95
-0.62
2.19
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.7871
Mean Difference (Final Values)
0.19
Standard Error of the Mean
0.696
2-Sided
95
-1.18
1.56
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.8721
Mean Difference (Final Values)
-0.11
Standard Error of the Mean
0.685
2-Sided
95
-1.46
1.24
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.8523
Mean Difference (Final Values)
-0.14
Standard Error of the Mean
0.734
2-Sided
95
-1.58
1.31
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00058
OG00156
OG00264
OG00368
OG00451
Title
Denominators
Categories
Decrease > 4 mmHg
Title
Measurements
OG00034.5
OG00150.0
OG00242.2
OG00339.7
OG00429.4
Change within +/- 4 mmHg
Title
Measurements
OG00050.0
OG00121.4
OG00232.8
OG003
Increase > 4 mmHg
Title
Measurements
OG00015.5
OG00128.6
OG00225.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.7997
Odds Ratio (OR)
1.093
2-Sided
95
0.549
2.175
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.7989
Odds Ratio (OR)
0.916
2-Sided
95
0.467
1.797
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.4596
Odds Ratio (OR)
0.780
2-Sided
95
0.403
1.508
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.2548
Odds Ratio (OR)
0.665
2-Sided
95
0.330
1.341
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00056
OG00154
OG00264
OG00367
OG00451
Title
Denominators
Categories
Decrease > 4 mmHg
Title
Measurements
OG00025.0
OG00137.0
OG00231.3
OG00325.4
OG00417.6
Change within +/- 4 mmHg
Title
Measurements
OG00033.9
OG00114.8
OG00225.0
OG003
Increase > 4 mmHg
Title
Measurements
OG00041.1
OG00148.1
OG00243.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.8887
Odds Ratio (OR)
1.051
2-Sided
95
0.521
2.122
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.5758
Odds Ratio (OR)
1.216
2-Sided
95
0.613
2.410
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.9829
Odds Ratio (OR)
0.993
2-Sided
95
0.506
1.949
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Regression, Logistic
Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.9375
Odds Ratio (OR)
0.972
2-Sided
95
0.476
1.985
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00075
OG00168
OG00280
OG00381
OG00469
Title
Denominators
Categories
Title
Measurements
OG000-0.455± 0.1098
OG001-0.357± 0.1163
OG002-0.610± 0.1038
OG003-0.535± 0.1035
OG004-0.576± 0.1111
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.4998
Mean Difference (Final Values)
0.098
Standard Error of the Mean
0.1456
2-Sided
95
-0.188
0.385
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.2679
Mean Difference (Final Values)
-0.155
Standard Error of the Mean
0.1399
2-Sided
95
-0.430
0.120
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.5678
Mean Difference (Final Values)
-0.080
Standard Error of the Mean
0.1400
2-Sided
95
-0.355
0.195
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.4053
Mean Difference (Final Values)
-0.121
Standard Error of the Mean
0.1448
2-Sided
95
-0.406
0.164
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00075
OG00168
OG00280
OG00381
OG00469
Title
Denominators
Categories
Decrease > 15% or > 1
Title
Measurements
OG00037.3
OG00138.2
OG00243.8
OG00335.8
OG00450.7
Change <= 15% or <= 1
Title
Measurements
OG00058.7
OG00151.5
OG00251.3
OG003
Increase > 15% or > 1
Title
Measurements
OG0004.0
OG00110.3
OG0025.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.7307
Odds Ratio (OR)
0.892
2-Sided
95
0.465
1.710
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Regression, Logistic
An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.3869
Odds Ratio (OR)
1.317
2-Sided
95
0.706
2.458
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Regression, Logistic
An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.8237
Odds Ratio (OR)
0.931
2-Sided
95
0.498
1.741
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Regression, Logistic
An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.1177
Odds Ratio (OR)
1.676
2-Sided
95
0.878
3.202
Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00069
OG00161
OG00275
OG00372
OG00463
Title
Denominators
Categories
Title
Measurements
OG000-35.67± 12.732
OG001-46.91± 13.652
OG002-48.84± 11.974
OG003-36.80± 12.131
OG004-29.35± 12.957
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.5111
Median Difference (Final Values)
-11.24
Standard Error of the Mean
17.089
2-Sided
95
-44.86
22.37
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.4176
Mean Difference (Final Values)
-13.17
Standard Error of the Mean
16.234
2-Sided
95
-45.11
18.76
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.9454
Mean Difference (Final Values)
-1.13
Standard Error of the Mean
16.506
2-Sided
95
-33.60
31.34
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.7101
Mean Difference (Final Values)
6.32
Standard Error of the Mean
16.980
2-Sided
95
-27.08
39.72
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Patients were treated with 100mg nintedanib twice daily
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00069
OG00161
OG00275
OG00372
OG00463
Title
Denominators
Categories
Title
Measurements
OG0000.227± 0.1695
OG0010.282± 0.1817
OG0020.045± 0.1594
OG0030.260± 0.1612
OG0040.086± 0.1736
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.8090
Mean Difference (Final Values)
0.055
Standard Error of the Mean
0.2271
2-Sided
95
-0.392
0.502
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.3995
Mean Difference (Final Values)
-0.182
Standard Error of the Mean
0.2158
2-Sided
95
-0.606
0.242
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.8822
Mean Difference (Final Values)
0.033
Standard Error of the Mean
0.2193
2-Sided
95
-0.399
0.464
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.5338
Mean Difference (Final Values)
-0.141
Standard Error of the Mean
0.2257
2-Sided
95
-0.584
0.303
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG004
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00069
OG00161
OG00275
OG00372
OG00463
Title
Denominators
Categories
Title
Measurements
OG0000.527± 0.2439
OG0010.639± 0.2616
OG0020.449± 0.2295
OG0030.377± 0.2321
OG0040.194± 0.2492
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.7329
Mean Difference (Final Values)
0.112
Standard Error of the Mean
0.3272
2-Sided
95
-0.532
0.755
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.8009
Mean Difference (Final Values)
-0.078
Standard Error of the Mean
0.3109
2-Sided
95
-0.690
0.533
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.6358
Mean Difference (Final Values)
-0.150
Standard Error of the Mean
0.3159
2-Sided
95
-0.771
0.472
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.3064
Mean Difference (Final Values)
-0.333
Standard Error of the Mean
0.3252
2-Sided
95
-0.973
0.307
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00077
OG00175
OG00281
OG00382
OG00476
Title
Denominators
Categories
Decrease
Title
Measurements
OG0007.8
OG00113.3
OG0028.6
OG00314.6
OG00411.8
No Change
Title
Measurements
OG00051.9
OG00145.3
OG00253.1
OG003
Increase
Title
Measurements
OG00040.3
OG00141.3
OG00238.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.9646
Odds Ratio (OR)
1.014
2-Sided
95
0.540
1.906
Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
Regression, Logistic
An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.9850
Odds Ratio (OR)
0.994
2-Sided
95
0.536
1.844
Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
Regression, Logistic
An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.7136
Odds Ratio (OR)
1.123
2-Sided
95
0.604
2.089
Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
Regression, Logistic
An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.
0.1705
Odds Ratio (OR)
1.551
2-Sided
95
0.828
2.906
Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00084
OG00185
OG00286
OG00385
OG00484
Title
Denominators
Categories
Title
Measurements
OG0001.25± 0.529
OG001-0.10± 0.533
OG0020.00± 0.511
OG003-0.53± 0.516
OG004-0.42± 0.513
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0479
Mean Difference (Final Values)
-1.35
Standard Error of the Mean
0.680
2-Sided
95
-2.69
-0.01
Mean difference to placebo is calculated.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0685
Mean Difference (Final Values)
-1.24
Standard Error of the Mean
0.680
2-Sided
95
-2.58
0.09
Mean difference to placebo is calculated.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0099
Mean Difference (Final Values)
-1.77
Standard Error of the Mean
0.684
2-Sided
95
-3.12
-0.43
Mean difference to placebo is calculated.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0152
Mean Difference (Final Values)
-1.67
Standard Error of the Mean
0.683
2-Sided
95
-3.01
-0.32
Mean difference to placebo is calculated.
No
Superiority or Other
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00079
OG00176
OG00282
OG00382
OG00475
Title
Denominators
Categories
Title
Measurements
OG0005.46± 1.731
OG0014.67± 1.779
OG0022.18± 1.654
OG0031.48± 1.660
OG004-0.66± 1.712
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.7250
Mean Difference (Final Values)
-0.79
Standard Error of the Mean
2.253
2-Sided
95
-5.22
3.64
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.1389
Mean Difference (Final Values)
-3.28
Standard Error of the Mean
2.213
2-Sided
95
-7.63
1.07
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0741
Mean Difference (Final Values)
-3.98
Standard Error of the Mean
2.221
2-Sided
95
-8.35
0.39
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0071
Mean Difference (Final Values)
-6.12
Standard Error of the Mean
2.262
2-Sided
95
-10.57
-1.67
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00079
OG00176
OG00282
OG00382
OG00476
Title
Denominators
Categories
Title
Measurements
OG0006.45± 2.446
OG0013.39± 2.514
OG0022.11± 2.338
OG0032.33± 2.346
OG004-3.14± 2.403
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.3370
Mean Difference (Final Values)
-3.06
Standard Error of the Mean
3.183
2-Sided
95
-9.32
3.20
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.1659
Mean Difference (Final Values)
-4.34
Standard Error of the Mean
3.126
2-Sided
95
-10.49
1.81
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.1897
Mean Difference (Final Values)
-4.12
Standard Error of the Mean
3.138
2-Sided
95
-10.29
2.05
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0028
Mean Difference (Final Values)
-9.60
Standard Error of the Mean
3.184
2-Sided
95
-15.86
-3.34
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00079
OG00176
OG00282
OG00382
OG00475
Title
Denominators
Categories
Title
Measurements
OG0004.21± 1.986
OG0013.71± 2.040
OG0021.73± 1.897
OG0030.79± 1.906
OG004-0.14± 1.965
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.8458
Mean Difference (Final Values)
-0.50
Standard Error of the Mean
2.586
2-Sided
95
-5.59
4.58
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.3286
Mean Difference (Final Values)
-2.48
Standard Error of the Mean
2.540
2-Sided
95
-7.48
2.51
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.1799
Mean Difference (Final Values)
-3.42
Standard Error of the Mean
2.548
2-Sided
95
-8.43
1.59
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0948
Mean Difference (Final Values)
-4.35
Standard Error of the Mean
2.597
2-Sided
95
-9.46
0.76
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00079
OG00176
OG00282
OG00382
OG00475
Title
Denominators
Categories
Title
Measurements
OG0007.48± 1.910
OG0017.39± 1.962
OG0023.54± 1.824
OG0033.00± 1.832
OG0040.32± 1.887
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.9708
Mean Difference (Final Values)
-0.09
Standard Error of the Mean
2.484
2-Sided
95
-4.98
4.79
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.1069
Mean Difference (Final Values)
-3.94
Standard Error of the Mean
2.440
2-Sided
95
-8.74
0.85
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0682
Mean Difference (Final Values)
-4.49
Standard Error of the Mean
2.453
2-Sided
95
-9.31
0.34
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0043
Mean Difference (Final Values)
-7.16
Standard Error of the Mean
2.494
2-Sided
95
-12.06
-2.26
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00087
OG00187
OG00286
OG00386
OG00486
Title
Denominators
Categories
Title
Measurements
OG00016.1
OG00123.0
OG00226.7
OG00332.6
OG00429.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Based on an Cochran-Mantel-Haenszel test to adjust for region effect.
0.2698
Odds Ratio (OR)
1.54
2-Sided
95
0.72
3.31
In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
Based on an Cochran-Mantel-Haenszel test to adjust for region effect.
0.0891
Odds Ratio (OR)
1.90
2-Sided
95
0.90
4.01
In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Cochran-Mantel-Haenszel
Based on an Cochran-Mantel-Haenszel test to adjust for region effect.
0.0069
Odds Ratio (OR)
2.70
2-Sided
95
1.29
5.66
In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Cochran-Mantel-Haenszel
Based on an Cochran-Mantel-Haenszel test to adjust for region effect.
0.0341
Odds Ratio (OR)
2.20
2-Sided
95
1.05
4.61
In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Units
Counts
Participants
OG00075
OG00168
OG00280
OG00380
OG00469
Title
Denominators
Categories
Title
Measurements
OG000-0.240± 0.0765
OG001-0.218± 0.0809
OG002-0.100± 0.0725
OG003-0.082± 0.0723
OG0040.118± 0.0774
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.8288
Mean Difference (Final Values)
0.022
Standard Error of the Mean
0.1015
2-Sided
95
-0.178
0.222
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.1506
Mean Difference (Final Values)
0.140
Standard Error of the Mean
0.0974
2-Sided
95
-0.051
0.332
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.1059
Mean Difference (Final Values)
0.158
Standard Error of the Mean
0.0977
2-Sided
95
-0.034
0.351
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0004
Mean Difference (Final Values)
0.358
Standard Error of the Mean
0.1008
2-Sided
95
0.160
0.556
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00075
OG00168
OG00280
OG00380
OG00469
Title
Denominators
Categories
Title
Measurements
OG000-0.036± 0.0512
OG001-0.056± 0.0543
OG0020.029± 0.0484
OG003-0.012± 0.0484
OG0040.086± 0.0518
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.7789
Mean Difference (Final Values)
-0.019
Standard Error of the Mean
0.0680
2-Sided
95
-0.153
0.115
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.3149
Mean Difference (Final Values)
0.066
Standard Error of the Mean
0.0652
2-Sided
95
-0.063
0.194
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.7062
Mean Difference (Final Values)
0.025
Standard Error of the Mean
0.0654
2-Sided
95
-0.104
0.153
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0703
Mean Difference (Final Values)
0.123
Standard Error of the Mean
0.0675
2-Sided
95
-0.010
0.255
Mean difference to placebo is calculated. Positive change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00073
OG00164
OG00278
OG00378
OG00466
Title
Denominators
Categories
Title
Measurements
OG000-0.137± 0.0657
OG001-0.075± 0.0707
OG002-0.035± 0.0622
OG003-0.016± 0.0623
OG0040.200± 0.0668
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.4792
Mean Difference (Final Values)
0.063
Standard Error of the Mean
0.0884
2-Sided
95
-0.111
0.236
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.2221
Mean Difference (Final Values)
0.103
Standard Error of the Mean
0.0839
2-Sided
95
-0.062
0.268
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.1510
Mean Difference (Final Values)
0.121
Standard Error of the Mean
0.0843
2-Sided
95
-0.044
0.287
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0001
Mean Difference (Final Values)
0.337
Standard Error of the Mean
0.0874
2-Sided
95
0.165
0.509
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00074
OG00167
OG00280
OG00380
OG00469
Title
Denominators
Categories
Title
Measurements
OG000-0.191± 0.0458
OG001-0.095± 0.0485
OG002-0.107± 0.0433
OG003-0.082± 0.0432
OG0040.010± 0.0462
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.1129
Mean Difference (Final Values)
0.097
Standard Error of the Mean
0.0609
2-Sided
95
-0.023
0.217
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.1498
Mean Difference (Final Values)
0.084
Standard Error of the Mean
0.0584
2-Sided
95
-0.031
0.199
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0632
Mean Difference (Final Values)
0.109
Standard Error of the Mean
0.0585
2-Sided
95
-0.006
0.224
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.0009
Mean Difference (Final Values)
0.201
Standard Error of the Mean
0.0604
2-Sided
95
0.083
0.320
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00074
OG00167
OG00278
OG00380
OG00468
Title
Denominators
Categories
Title
Measurements
OG000-0.031± 0.0509
OG001-0.064± 0.0539
OG002-0.053± 0.0483
OG003-0.038± 0.0479
OG004-0.012± 0.0515
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.6306
Mean Difference (Final Values)
-0.033
Standard Error of the Mean
0.0676
2-Sided
95
-0.165
0.100
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.7426
Mean Difference (Final Values)
-0.021
Standard Error of the Mean
0.0650
2-Sided
95
-0.149
0.106
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.9209
Mean Difference (Final Values)
-0.006
Standard Error of the Mean
0.0651
2-Sided
95
-0.134
0.121
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA with fixed terms for treatment, baseline, region.
0.7701
Mean Difference (Final Values)
0.020
Standard Error of the Mean
0.0671
2-Sided
95
-0.112
0.152
Mean difference to placebo is calculated. Negative change indicates worsening.
No
Superiority or Other
Units
Counts
Participants
OG00087
OG00187
OG00286
OG00386
OG00486
Title
Denominators
Categories
Title
Measurements
OG00012
OG00110
OG00210
OG0036
OG0042
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Negative binomial model
Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.
0.6671
Based on the statistic of ln(risk ratio) having a normal distribution N[0,[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) ] ]
Risk Ratio (RR)
0.83
2-Sided
95
0.36
1.93
Risk ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Negative binomial model
Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.
0.5926
Based on the statistic of ln(risk ratio) having a normal distribution N[0,[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) ] ]
Risk Ratio (RR)
0.80
2-Sided
95
0.34
1.84
Risk ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Negative binomial model
Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.
0.1381
Based on the statistic of ln(risk ratio) having a normal distribution N[0,[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) ] ]
Risk Ratio (RR)
0.48
2-Sided
95
0.18
1.27
Risk ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Negative binomial model
Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.
0.0150
Based on the statistic of ln(risk ratio) having a normal distribution N[0,[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) ] ]
Risk Ratio (RR)
0.16
2-Sided
95
0.03
0.70
Risk ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Units
Counts
Participants
OG00087
OG00187
OG00286
OG00386
OG00486
Title
Denominators
Categories
Title
Measurements
OG0000.243± 0.8008
OG0010.243± 0.7884
OG0020.242± 0.9830
OG0030.256± 1.7315
OG0040.075± 0.5177
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Negative binomial model
0.8282
Risk Ratio (RR)
0.90
2-Sided
95
0.347
2.336
Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).
No
Superiority or Other
OG000
OG002
Negative Binomial model
0.5326
Risk Ratio (RR)
0.73
2-Sided
95
0.278
1.938
Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).
No
Superiority or Other
OG000
OG003
Negative Binomial model
0.1944
Risk Ratio (RR)
0.49
2-Sided
95
0.167
1.438
Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).
No
Superiority or Other
OG000
OG004
Negative Binomial model
0.0324
Risk Ratio (RR)
0.22
2-Sided
95
0.056
0.882
Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00087
OG00187
OG00286
OG00386
OG00486
Title
Denominators
Categories
Failure
Title
Measurements
OG00013.8
OG00111.5
OG00211.6
OG0037.0
OG0042.3
Censored
Title
Measurements
OG00086.2
OG00188.5
OG00288.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.5206
Hazard Ratio (HR)
0.758
2-Sided
95
0.326
1.765
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.6862
Hazard Ratio (HR)
0.841
2-Sided
95
0.362
1.952
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.1891
Hazard Ratio (HR)
0.517
2-Sided
95
0.193
1.384
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.0161
Hazard Ratio (HR)
0.158
2-Sided
95
0.035
0.711
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Units
Counts
Participants
OG00087
OG00187
OG00286
OG00386
OG00486
Title
Denominators
Categories
Failure
Title
Measurements
OG0009.2
OG00110.3
OG0023.5
OG0032.3
OG0042.3
Censored
Title
Measurements
OG00090.8
OG00189.7
OG00296.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.7449
Hazard Ratio (HR)
1.173
2-Sided
95
0.448
3.072
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.0925
Hazard Ratio (HR)
0.316
2-Sided
95
0.083
1.209
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.0379
Hazard Ratio (HR)
0.190
2-Sided
95
0.040
0.911
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.0600
Hazard Ratio (HR)
0.225
2-Sided
95
0.048
1.065
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily
Units
Counts
Participants
OG00087
OG00187
OG00286
OG00386
OG00486
Title
Denominators
Categories
Title
Measurements
OG000363(302 to 366)
OG001365(309 to 366)
OG002365(330 to 365)
OG003365(NA to NA)The 95% CI for the median could not be calculated due to computational reason as the number of participants with event was insufficient.
OG004365(NA to NA)The 95% CI for the median could not be calculated due to computational reason as the number of participants with event was insufficient.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.7883
Hazard Ratio (HR)
1.055
2-Sided
95
0.713
1.563
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG002
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.8293
Hazard Ratio (HR)
0.958
2-Sided
95
0.646
1.419
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG003
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.3030
Hazard Ratio (HR)
0.805
2-Sided
95
0.534
1.216
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
OG000
OG004
Regression, Cox
Cox regression model with fixed terms for treatment, gender, age, height, region.
0.6505
Hazard Ratio (HR)
0.910
2-Sided
95
0.605
1.369
Hazard ratio lower than 1 favours the treatment group over placebo.
No
Superiority or Other
Patients were treated with 150mg nintedanib twice daily