Trial Outcomes & Findings for A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis (NCT NCT05065190)
NCT ID: NCT05065190
Last Updated: 2025-05-20
Results Overview
Annual rate of decline in FVC over 52 weeks expressed in milliliter (mL). The main analysis used a restricted maximum likelihood (REML)-based approach with a random slope and intercept model. The analysis included the fixed, categorical effects of treatment, high resolution computed tomography (HRCT) pattern at baseline, fixed continuous effects of time and baseline FVC as well as the treatment-by-time and baseline-by-time interactions. Random effects were included for the patient response for both time and intercept. For patients who prematurely discontinued study treatment, data collected at follow-up visit and visits after treatment discontinuation was included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
81 participants
Primary outcome timeframe
From baseline up to Week 52.
Results posted on
2025-05-20
Participant Flow
A double blind, randomized, placebo-controlled trial to generate additional data on the efficacy of 150 mg bid nintedanib in Chinese patients with Chronic Fibrosing Interstitial Lung Disease (ILD) with a progressive phenotype compared with placebo over 52 weeks.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Placebo
A soft gelatin capsule of placebo matching in size, weight, colour and shape to 150 milligram (mg) or 100 mg soft gelatin capsule of Nintedanib, was administered orally twice daily (bid) in Chinese patients with chronic fibrosing Interstitial Lung Disease (ILD) with progressive phenotype with over 52 weeks.
|
150 mg Nintedanib
A soft gelatin capsule of 150 mg Nintedanib was administered orally twice daily (bid) in Chinese patients with chronic fibrosing ILD with progressive phenotype with over 52 weeks. Dose could be reduced to 100 mg bid to manage adverse events.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
54
|
|
Overall Study
COMPLETED
|
20
|
32
|
|
Overall Study
NOT COMPLETED
|
7
|
22
|
Reasons for withdrawal
| Measure |
Placebo
A soft gelatin capsule of placebo matching in size, weight, colour and shape to 150 milligram (mg) or 100 mg soft gelatin capsule of Nintedanib, was administered orally twice daily (bid) in Chinese patients with chronic fibrosing Interstitial Lung Disease (ILD) with progressive phenotype with over 52 weeks.
|
150 mg Nintedanib
A soft gelatin capsule of 150 mg Nintedanib was administered orally twice daily (bid) in Chinese patients with chronic fibrosing ILD with progressive phenotype with over 52 weeks. Dose could be reduced to 100 mg bid to manage adverse events.
|
|---|---|---|
|
Overall Study
Other than listed
|
2
|
12
|
|
Overall Study
Lack of Efficacy
|
4
|
0
|
|
Overall Study
Adverse Event
|
1
|
10
|
Baseline Characteristics
A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
A soft gelatin capsule of placebo matching in size, weight, colour and shape to 150 milligram (mg) or 100 mg soft gelatin capsule of Nintedanib, was administered orally twice daily (bid) in Chinese patients with chronic fibrosing Interstitial Lung Disease (ILD) with progressive phenotype with over 52 weeks.
|
150 mg Nintedanib
n=54 Participants
A soft gelatin capsule of 150 mg Nintedanib was administered orally twice daily (bid) in Chinese patients with chronic fibrosing ILD with progressive phenotype with over 52 weeks. Dose could be reduced to 100 mg bid to manage adverse events.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
64.5 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline up to Week 52.Population: Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
Annual rate of decline in FVC over 52 weeks expressed in milliliter (mL). The main analysis used a restricted maximum likelihood (REML)-based approach with a random slope and intercept model. The analysis included the fixed, categorical effects of treatment, high resolution computed tomography (HRCT) pattern at baseline, fixed continuous effects of time and baseline FVC as well as the treatment-by-time and baseline-by-time interactions. Random effects were included for the patient response for both time and intercept. For patients who prematurely discontinued study treatment, data collected at follow-up visit and visits after treatment discontinuation was included in the analysis.
Outcome measures
| Measure |
Placebo
n=27 Participants
A soft gelatin capsule of placebo matching in size, weight, colour and shape to 150 milligram (mg) or 100 mg soft gelatin capsule of Nintedanib, was administered orally twice daily (bid) in Chinese patients with chronic fibrosing Interstitial Lung Disease (ILD) with progressive phenotype with over 52 weeks.
|
150 mg Nintedanib
n=54 Participants
A soft gelatin capsule of 150 mg Nintedanib was administered orally twice daily (bid) in Chinese patients with chronic fibrosing ILD with progressive phenotype with over 52 weeks. Dose could be reduced to 100 mg bid to manage adverse events.
|
|---|---|---|
|
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks Expressed in Milliliter (mL)
|
-191.89 Milliliter/year
Interval -313.15 to -70.63
|
-85.32 Milliliter/year
Interval -176.4 to 5.76
|
Adverse Events
Placebo
Serious events: 12 serious events
Other events: 23 other events
Deaths: 3 deaths
150 mg Nintedanib
Serious events: 20 serious events
Other events: 51 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Placebo
n=27 participants at risk
A soft gelatin capsule of placebo matching in size, weight, colour and shape to 150 milligram (mg) or 100 mg soft gelatin capsule of Nintedanib, was administered orally twice daily (bid) in Chinese patients with chronic fibrosing Interstitial Lung Disease (ILD) with progressive phenotype with over 52 weeks.
|
150 mg Nintedanib
n=54 participants at risk
A soft gelatin capsule of 150 mg Nintedanib was administered orally twice daily (bid) in Chinese patients with chronic fibrosing ILD with progressive phenotype with over 52 weeks. Dose could be reduced to 100 mg bid to manage adverse events.
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
General disorders
Chest pain
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
COVID-19
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
COVID-19 pneumonia
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
3.7%
2/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
14.8%
4/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
9.3%
5/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Investigations
Myocardial necrosis marker increased
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
11.1%
3/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
3.7%
2/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=27 participants at risk
A soft gelatin capsule of placebo matching in size, weight, colour and shape to 150 milligram (mg) or 100 mg soft gelatin capsule of Nintedanib, was administered orally twice daily (bid) in Chinese patients with chronic fibrosing Interstitial Lung Disease (ILD) with progressive phenotype with over 52 weeks.
|
150 mg Nintedanib
n=54 participants at risk
A soft gelatin capsule of 150 mg Nintedanib was administered orally twice daily (bid) in Chinese patients with chronic fibrosing ILD with progressive phenotype with over 52 weeks. Dose could be reduced to 100 mg bid to manage adverse events.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
13.0%
7/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
7.4%
4/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
9.3%
5/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
5.6%
3/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
4/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
35.2%
19/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
7.4%
4/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
13.0%
7/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
General disorders
Chest pain
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
5.6%
3/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
General disorders
Fatigue
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
7.4%
4/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
7.4%
4/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
22.2%
12/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
5.6%
3/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
COVID-19
|
25.9%
7/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
25.9%
14/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
5.6%
3/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
11.1%
3/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
13.0%
7/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
3.7%
2/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
18.5%
10/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
14.8%
8/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
9.3%
5/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
9.3%
5/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
18.5%
10/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Investigations
Lymphocyte percentage decreased
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
5.6%
3/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
7.4%
4/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Investigations
Weight decreased
|
11.1%
3/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
13.0%
7/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
9.3%
5/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
0.00%
0/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
1.9%
1/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
2/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
11.1%
6/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
5.6%
3/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Renal and urinary disorders
Proteinuria
|
3.7%
1/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
7.4%
4/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.5%
5/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
11.1%
6/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
14.8%
4/27 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
9.3%
5/54 • All-cause mortality, serious and other adverse events: From first drug intake until end of trial visit, plus 7 days of residual effect period, up to 53 weeks.
Treated Set (TS): All patients who were randomized to a treatment group and received at least one dose of study medication.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER