Trial Outcomes & Findings for Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT01979952)
NCT ID: NCT01979952
Last Updated: 2018-04-17
Results Overview
Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
113 participants
Primary outcome timeframe
Baseline and 6 Months
Results posted on
2018-04-17
Participant Flow
Patients were randomized to receive nintedanib or placebo in 1:1 ratio. After Global Amendment 1, study design was changed to exploratory, and duration of double blind, placebo-controlled part of study was reduced from 12 months to 6 months, followed by conversion of all patients to open-label nintedanib treatment for a duration of up to 18 months.
Participant milestones
| Measure |
Nintedanib
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
57
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Nintedanib
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
5
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Other than specified above
|
1
|
0
|
Baseline Characteristics
Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
Baseline characteristics by cohort
| Measure |
Nintedanib
n=56 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=57 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
66.2 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
67.5 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Observed Cases (6 months) (OC6): The OC6 consisted of all patients in the TS (all patients who were randomized to a treatment group and received at least 1 dose of study drug) with observed data for the primary endpoint (relative change from baseline in HRCT QLF score at 6 months).
Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline.
Outcome measures
| Measure |
Nintedanib
n=42 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=45 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months
|
11.407 percent change
Standard Error 4.4819
|
14.583 percent change
Standard Error 4.3297
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: Observed Cases (12 months) (OC12): The OC12 consisted of all patients in OC6 with observed QLF data at 12 months.
Relative change from baseline in HRCT QLF score at 12 months was calculated as the ratio of the QLF score at 12 months to baseline. Greater values of the QLF score represented a worse health status and hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline. Note that due to the change in study design, patients randomized to the placebo group were treated with nintedanib after completion of the first 6-month treatment period. Therefore, this new endpoint was defined to address the effect of a 6-month delayed onset of nintedanib treatment.
Outcome measures
| Measure |
Nintedanib
n=30 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=31 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months
|
13.103 percent change
Standard Error 4.5454
|
15.622 percent change
Standard Error 4.4714
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Treated Set (TS) (Only patients with observed cases (OC) values were analysed)
Absolute change in Forced Vital Capacity (FVC) from baseline at 6 months is presented.
Outcome measures
| Measure |
Nintedanib
n=54 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=54 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months
|
-14.18 milliliter (mL)
Standard Error 31.050
|
-83.18 milliliter (mL)
Standard Error 28.067
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: TS (Only patients with observed cases (OC) values were analysed)
Relative change in FVC from baseline at 6 months is presented.
Outcome measures
| Measure |
Nintedanib
n=54 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=54 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Relative Change in FVC From Baseline at 6 Months
|
-0.67 percentage of change
Standard Error 1.05
|
-3.02 percentage of change
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: TS (Only patients with observed cases (OC) values were analysed)
Percentage of participants reporting categorical change in FVC from baseline at 6 months are presented.
Outcome measures
| Measure |
Nintedanib
n=46 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=46 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Categorical Change in FVC From Baseline at 6 Months
Decrease >10% or 200 mL
|
6.5 Percentage of participants
|
23.9 Percentage of participants
|
|
Categorical Change in FVC From Baseline at 6 Months
Change within ≤10% AND ≤200 mL
|
76.1 Percentage of participants
|
71.7 Percentage of participants
|
|
Categorical Change in FVC From Baseline at 6 Months
Increase >10% or 200 mL
|
17.4 Percentage of participants
|
4.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: TS (Only patients with observed cases (OC) values were analysed)
SGRQ total score change from baseline at 6 months is presented. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6).
Outcome measures
| Measure |
Nintedanib
n=55 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=53 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months
|
-2.24 Units on a scale
Standard Error 1.682
|
-2.19 Units on a scale
Standard Error 1.699
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: TS (Only patients with observed cases (OC) values were analysed)
Change in total distance covered in 6-minute walk test (6MWT) from baseline at 6 month is presented. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria.
Outcome measures
| Measure |
Nintedanib
n=55 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=52 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
6MWT Total Distance Walked Change From Baseline at 6 Months
|
4.93 meters
Standard Error 11.415
|
-13.00 meters
Standard Error 11.476
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: TS (Only patients with observed cases (OC) values were analysed)
University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline at 6 months is presented. Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6).
Outcome measures
| Measure |
Nintedanib
n=53 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=50 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months
|
3.42 Units on a scale
Standard Error 2.156
|
-1.46 Units on a scale
Standard Error 2.192
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: TS
Percentage of subjects died from all causes between 0 to 6 months are presented.
Outcome measures
| Measure |
Nintedanib
n=56 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=57 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
All-cause Mortality at 6 Months
|
0.0 Percentage of participants
|
5.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: TS
Percentage of subjects hospitalized due to respiratory problems between 0 to 6 months are presented.
Outcome measures
| Measure |
Nintedanib
n=56 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=57 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Respiratory Hospitalizations at 6 Months
|
0.0 Percentage of participants
|
7.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: TS
Percentage of subjects who died due to respiratory cause between 0 to 6 months are presented.
Outcome measures
| Measure |
Nintedanib
n=56 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=57 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Respiratory Mortality at 6 Months
|
0.0 Percentage of participants
|
3.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: TS
Percentage of subjects experienced first acute IPF exacerbations (based on Investigator reported adverse events) between 0 to 6 months are presented.
Outcome measures
| Measure |
Nintedanib
n=56 Participants
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=57 Participants
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months
|
1.8 Percentage of participants
|
1.8 Percentage of participants
|
Adverse Events
Nintedanib
Serious events: 11 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo
Serious events: 14 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nintedanib
n=56 participants at risk
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=57 participants at risk
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Cardiac disorders
Cardiogenic shock
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Eye disorders
Glaucoma
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Gastrointestinal disorders
Intestinal infarction
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Clostridium difficile infection
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Influenza
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Lyme disease
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Pneumonia
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
3.5%
2/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Sepsis
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Investigations
Liver function test increased
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Nervous system disorders
Ataxia
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Psychiatric disorders
Delirium
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.6%
2/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
Other adverse events
| Measure |
Nintedanib
n=56 participants at risk
Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months.
|
Placebo
n=57 participants at risk
Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization
|
|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
8.8%
5/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Gastrointestinal disorders
Constipation
|
3.6%
2/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
7.0%
4/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Gastrointestinal disorders
Diarrhoea
|
76.8%
43/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
70.2%
40/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
7.0%
4/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.9%
5/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
3.5%
2/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Gastrointestinal disorders
Nausea
|
28.6%
16/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
35.1%
20/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
10/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
15.8%
9/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
General disorders
Asthenia
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
General disorders
Fatigue
|
19.6%
11/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
15.8%
9/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Bronchitis
|
7.1%
4/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
12.3%
7/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Influenza
|
14.3%
8/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
10.5%
6/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Lower respiratory tract infection
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
0.00%
0/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Nasopharyngitis
|
8.9%
5/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
15.8%
9/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Respiratory tract infection
|
7.1%
4/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Sinusitis
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Tooth abscess
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
4/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
12.3%
7/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Infections and infestations
Urinary tract infection
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
8.8%
5/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
7.0%
4/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
7.0%
4/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Investigations
Eosinophil count increased
|
7.1%
4/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Investigations
International normalised ratio increased
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Investigations
Prothrombin time prolonged
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Investigations
Weight decreased
|
23.2%
13/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
7.0%
4/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.4%
12/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
10.5%
6/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
2/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
8.8%
5/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
2/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
7.0%
4/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Nervous system disorders
Dizziness
|
8.9%
5/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
7.0%
4/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Nervous system disorders
Headache
|
12.5%
7/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
15.8%
9/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Psychiatric disorders
Depression
|
3.6%
2/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.8%
1/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
9/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
26.3%
15/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
8/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
15.8%
9/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
8.9%
5/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
7.0%
4/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
1.8%
1/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
5.3%
3/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
3/56 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
7.0%
4/57 • From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
|
Additional Information
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Email: [email protected]
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