Trial Outcomes & Findings for Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis (NCT NCT00514683)
NCT ID: NCT00514683
Last Updated: 2015-01-06
Results Overview
Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment. The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
432 participants
Primary outcome timeframe
Baseline until 52 weeks
Results posted on
2015-01-06
Participant Flow
Participant milestones
| Measure |
Placebo
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
87
|
87
|
86
|
86
|
86
|
|
Overall Study
COMPLETED
|
61
|
62
|
68
|
72
|
53
|
|
Overall Study
NOT COMPLETED
|
26
|
25
|
18
|
14
|
33
|
Reasons for withdrawal
| Measure |
Placebo
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Overall Study
Not treated
|
2
|
1
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
21
|
20
|
15
|
13
|
27
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
0
|
4
|
|
Overall Study
Reason other than listed above
|
0
|
1
|
2
|
0
|
1
|
Baseline Characteristics
Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
Placebo
n=85 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=86 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=86 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=85 Participants
Patients were treated with 150mg nintedanib twice daily
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 8.57 • n=99 Participants
|
65.3 years
STANDARD_DEVIATION 9.42 • n=107 Participants
|
64.9 years
STANDARD_DEVIATION 8.48 • n=206 Participants
|
65.1 years
STANDARD_DEVIATION 8.63 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 7.82 • n=31 Participants
|
65.1 years
STANDARD_DEVIATION 8.56 • n=30 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
108 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
65 Participants
n=31 Participants
|
320 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline until 52 weeksPopulation: Observed Case (OC): This method was used for the replacement of missing values. Randomised set: This patient set includes all randomised patients whether treated or not.
Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment. The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.
Outcome measures
| Measure |
Placebo
n=83 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=85 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=85 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=84 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Rate of Decline in FVC
|
-0.190 Liters/year
Standard Error 0.036
|
-0.174 Liters/year
Standard Error 0.037
|
-0.210 Liters/year
Standard Error 0.035
|
-0.162 Liters/year
Standard Error 0.035
|
-0.060 Liters/year
Standard Error 0.039
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: Last Observation Carried Forward (LOCF): This method was used for the replacement of missing values. Randomised set: This patient set includes all randomised patients whether treated or not.
Change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
Outcome measures
| Measure |
Placebo
n=84 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=85 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=85 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=84 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in FVC%Pred
|
-6.00 percentage of predicted FVC
Standard Error 1.019
|
-4.58 percentage of predicted FVC
Standard Error 1.029
|
-4.90 percentage of predicted FVC
Standard Error 0.984
|
-3.15 percentage of predicted FVC
Standard Error 1.004
|
-1.04 percentage of predicted FVC
Standard Error 0.990
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from baseline in percentage of absolute Forced Vital Capacity (FVC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
Outcome measures
| Measure |
Placebo
n=84 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=85 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=85 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=84 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in FVC
|
-0.23 Liters
Standard Error 0.036
|
-0.18 Liters
Standard Error 0.036
|
-0.19 Liters
Standard Error 0.035
|
-0.13 Liters
Standard Error 0.035
|
-0.06 Liters
Standard Error 0.035
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Percent change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region.
Outcome measures
| Measure |
Placebo
n=84 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=85 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=85 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=84 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Relative Change From Baseline in FVC%Pred
|
-7.28 percentage of change
Standard Error 1.321
|
-6.37 percentage of change
Standard Error 1.334
|
-6.42 percentage of change
Standard Error 1.277
|
-3.47 percentage of change
Standard Error 1.302
|
-1.81 percentage of change
Standard Error 1.283
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Percent change from baseline in absolute Forced Vital Capacity (FVC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region
Outcome measures
| Measure |
Placebo
n=84 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=85 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=85 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=84 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Relative Change From Baseline in FVC
|
-7.96 percentage change
Standard Error 1.314
|
-6.98 percentage change
Standard Error 1.327
|
-7.16 percentage change
Standard Error 1.272
|
-4.13 percentage change
Standard Error 1.285
|
-2.52 percentage change
Standard Error 1.277
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from baseline in percentage of Forced Vital Capacity (FVC) at 52 weeks in below mentioned categories: 1. Decrease \> 10% or 200mL 2. Change within \<= 10% or \<=200 mL 3. Increase \> 10% or 200mL
Outcome measures
| Measure |
Placebo
n=84 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=85 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=85 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=84 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in FVC by Categories
Change within <= 10% or <=200mL
|
41 participants
|
44 participants
|
39 participants
|
46 participants
|
52 participants
|
|
Number of Participants With Change From Baseline in FVC by Categories
Increase > 10% or 200mL
|
6 participants
|
6 participants
|
6 participants
|
9 participants
|
12 participants
|
|
Number of Participants With Change From Baseline in FVC by Categories
Decrease > 10% or 200mL
|
37 participants
|
35 participants
|
41 participants
|
30 participants
|
20 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: OC-Randomised set
Survival (all causes of death and lung-transplant free) at 52 weeks, based on overall mortality and on-treatment survival. Failure means participants with event and Censored means participants with no event.
Outcome measures
| Measure |
Placebo
n=87 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=87 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=86 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=86 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Survival (All Causes of Death and Lung-transplant Free)
Failure
|
9 participants
|
11 participants
|
3 participants
|
4 participants
|
7 participants
|
|
Survival (All Causes of Death and Lung-transplant Free)
Censored
|
78 participants
|
76 participants
|
83 participants
|
82 participants
|
79 participants
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Absolute change from baseline in oxygen saturation (SpO2) at rest. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=82 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=82 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=84 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=83 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in SpO2 at Rest
|
-1.29 Percentage of SpO2
Standard Error 0.373 • Interval -2.03 to -0.56
|
-0.86 Percentage of SpO2
Standard Error 0.380 • Interval -1.6 to -0.11
|
-0.97 Percentage of SpO2
Standard Error 0.357 • Interval -1.67 to -0.27
|
0.06 Percentage of SpO2
Standard Error 0.363 • Interval -0.65 to 0.78
|
-0.18 Percentage of SpO2
Standard Error 0.360 • Interval -0.89 to 0.53
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Absolute change from baseline in oxygen saturation (SpO2) at rest by below mentioned categories: SpO2 (non-invasive) at 52 weeks: 1. Decrease \> 4% SpO2 2. Change within +/- 4% SpO2 3. Increase \> 4% SpO2
Outcome measures
| Measure |
Placebo
n=82 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=82 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=84 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=83 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in SpO2 at Rest by Categories
Decrease > 4%
|
11.0 percentage of participants
|
4.9 percentage of participants
|
8.1 percentage of participants
|
6.0 percentage of participants
|
3.6 percentage of participants
|
|
Absolute Change From Baseline in SpO2 at Rest by Categories
Change within +/- 4%
|
87.8 percentage of participants
|
90.2 percentage of participants
|
89.5 percentage of participants
|
89.3 percentage of participants
|
92.8 percentage of participants
|
|
Absolute Change From Baseline in SpO2 at Rest by Categories
Increase > 4%
|
1.2 percentage of participants
|
4.9 percentage of participants
|
2.3 percentage of participants
|
4.8 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: OC-Randomised set
Absolute change from baseline in Arterial oxygen partial pressure (PaO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=58 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=56 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=64 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=68 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=51 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in PaO2
|
-1.69 mmHg
Standard Error 1.790
|
-2.77 mmHg
Standard Error 1.865
|
-3.00 mmHg
Standard Error 1.686
|
-1.46 mmHg
Standard Error 1.632
|
-0.76 mmHg
Standard Error 1.854
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: OC-Randomised set
Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a)O2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=56 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=54 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=64 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=67 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=51 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in P(A-a)O2
|
1.21 mmHg
Standard Error 1.898
|
1.27 mmHg
Standard Error 1.984
|
2.22 mmHg
Standard Error 1.773
|
1.62 mmHg
Standard Error 1.723
|
2.56 mmHg
Standard Error 1.944
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: OC-Randomised set
Absolute change from baseline in Arterial carbon dioxyde partial pressure (PaCO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=58 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=56 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=64 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=68 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=51 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in PaCO2
|
-0.63 mmHg
Standard Error 0.549
|
0.16 mmHg
Standard Error 0.573
|
-0.44 mmHg
Standard Error 0.517
|
-0.74 mmHg
Standard Error 0.500
|
-0.77 mmHg
Standard Error 0.569
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: OC - Randomised set
Absolute change from baseline in Arterial oxygen partial pressure (PaO2) by below mentioned categories: 1. Decrease \> 4 mmHg 2. Change within +/- 4 mmHg 3. Increase \> 4 mmHg
Outcome measures
| Measure |
Placebo
n=58 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=56 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=64 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=68 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=51 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in PaO2 by Categories
Decrease > 4 mmHg
|
34.5 percentage of participants
|
50.0 percentage of participants
|
42.2 percentage of participants
|
39.7 percentage of participants
|
29.4 percentage of participants
|
|
Absolute Change From Baseline in PaO2 by Categories
Change within +/- 4 mmHg
|
50.0 percentage of participants
|
21.4 percentage of participants
|
32.8 percentage of participants
|
30.9 percentage of participants
|
43.1 percentage of participants
|
|
Absolute Change From Baseline in PaO2 by Categories
Increase > 4 mmHg
|
15.5 percentage of participants
|
28.6 percentage of participants
|
25.0 percentage of participants
|
29.4 percentage of participants
|
27.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: OC - Randomised set
Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a) O2) by below mentioned categories: 1. Decrease \> 4 mmHg 2. Change within +/- 4 mmHg 3. Increase \> 4 mmHg
Outcome measures
| Measure |
Placebo
n=56 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=54 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=64 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=67 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=51 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in P(A-a) O2 by Categories
Decrease > 4 mmHg
|
25.0 percentage of participants
|
37.0 percentage of participants
|
31.3 percentage of participants
|
25.4 percentage of participants
|
17.6 percentage of participants
|
|
Absolute Change From Baseline in P(A-a) O2 by Categories
Change within +/- 4 mmHg
|
33.9 percentage of participants
|
14.8 percentage of participants
|
25.0 percentage of participants
|
28.4 percentage of participants
|
45.1 percentage of participants
|
|
Absolute Change From Baseline in P(A-a) O2 by Categories
Increase > 4 mmHg
|
41.1 percentage of participants
|
48.1 percentage of participants
|
43.0 percentage of participants
|
46.3 percentage of participants
|
37.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Absolute change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=75 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=68 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=80 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=81 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=69 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in DLCO
|
-0.455 mmol.min^-1.kPa^-1
Standard Error 0.1098
|
-0.357 mmol.min^-1.kPa^-1
Standard Error 0.1163
|
-0.610 mmol.min^-1.kPa^-1
Standard Error 0.1038
|
-0.535 mmol.min^-1.kPa^-1
Standard Error 0.1035
|
-0.576 mmol.min^-1.kPa^-1
Standard Error 0.1111
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF Randomized set
Absolute change from baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) by below mentioned categories: 1. Decrease \> 15% or \> 1 2. Change \<= 15% or \<= 1 3. Increase \> 15% or \> 1
Outcome measures
| Measure |
Placebo
n=75 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=68 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=80 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=81 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=69 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in DLCO by Categories
Decrease > 15% or > 1
|
37.3 percentage of patients
|
38.2 percentage of patients
|
43.8 percentage of patients
|
35.8 percentage of patients
|
50.7 percentage of patients
|
|
Absolute Change From Baseline in DLCO by Categories
Change <= 15% or <= 1
|
58.7 percentage of patients
|
51.5 percentage of patients
|
51.3 percentage of patients
|
56.8 percentage of patients
|
44.9 percentage of patients
|
|
Absolute Change From Baseline in DLCO by Categories
Increase > 15% or > 1
|
4.0 percentage of patients
|
10.3 percentage of patients
|
5.0 percentage of patients
|
7.4 percentage of patients
|
4.3 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Absolute change from baseline in distance walk (6-MWT) at 52 weeks. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=69 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=61 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=75 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=72 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=63 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Distance Walk (6-MWT)
|
-35.67 Meter
Standard Error 12.732
|
-46.91 Meter
Standard Error 13.652
|
-48.84 Meter
Standard Error 11.974
|
-36.80 Meter
Standard Error 12.131
|
-29.35 Meter
Standard Error 12.957
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Absolute change from baseline in Dyspnoea rating before exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below : 0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal). The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=69 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=61 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=75 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=72 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=63 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT)
|
0.227 Units on a scale
Standard Error 0.1695
|
0.282 Units on a scale
Standard Error 0.1817
|
0.045 Units on a scale
Standard Error 0.1594
|
0.260 Units on a scale
Standard Error 0.1612
|
0.086 Units on a scale
Standard Error 0.1736
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from baseline in Dyspnoea rating after exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below : 0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal). The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=69 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=61 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=75 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=72 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=63 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT)
|
0.527 Units on a scale
Standard Error 0.2439
|
0.639 Units on a scale
Standard Error 0.2616
|
0.449 Units on a scale
Standard Error 0.2295
|
0.377 Units on a scale
Standard Error 0.2321
|
0.194 Units on a scale
Standard Error 0.2492
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF- Randomised
Absolute change from baseline in Medical Research Council (MRC) dyspnea scale by below mentioned categories: 1. Decrease 2. No Change 3. Increase
Outcome measures
| Measure |
Placebo
n=77 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=75 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=81 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=82 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=76 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in MRC Dyspnea Scale by Categories
Increase
|
40.3 percentage of participants
|
41.3 percentage of participants
|
38.3 percentage of participants
|
40.2 percentage of participants
|
34.2 percentage of participants
|
|
Absolute Change From Baseline in MRC Dyspnea Scale by Categories
Decrease
|
7.8 percentage of participants
|
13.3 percentage of participants
|
8.6 percentage of participants
|
14.6 percentage of participants
|
11.8 percentage of participants
|
|
Absolute Change From Baseline in MRC Dyspnea Scale by Categories
No Change
|
51.9 percentage of participants
|
45.3 percentage of participants
|
53.1 percentage of participants
|
45.1 percentage of participants
|
53.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from baseline of percentage of FVC expelled in the first second of a forced expiration (FEV1/FVC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=84 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=85 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=85 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=84 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in FEV1/FVC
|
1.25 percentage of FVC
Standard Error 0.529
|
-0.10 percentage of FVC
Standard Error 0.533
|
0.00 percentage of FVC
Standard Error 0.511
|
-0.53 percentage of FVC
Standard Error 0.516
|
-0.42 percentage of FVC
Standard Error 0.513
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score. Total score is defined as sum of the three domain scores symptoms, activities and impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=79 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=76 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=82 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=82 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=75 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Change From Baseline in SGRQ Total Score
|
5.46 units on a scale
Standard Error 1.731
|
4.67 units on a scale
Standard Error 1.779
|
2.18 units on a scale
Standard Error 1.654
|
1.48 units on a scale
Standard Error 1.660
|
-0.66 units on a scale
Standard Error 1.712
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score symptoms. Scores range from 0 to 100, with higher scores indicating more limitations. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=79 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=76 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=82 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=82 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=76 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Change From Baseline in SGRQ Domain Score Symptoms
|
6.45 units on a scale
Standard Error 2.446
|
3.39 units on a scale
Standard Error 2.514
|
2.11 units on a scale
Standard Error 2.338
|
2.33 units on a scale
Standard Error 2.346
|
-3.14 units on a scale
Standard Error 2.403
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF - Randomised set
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=79 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=76 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=82 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=82 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=75 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Change From Baseline in SGRQ Domain Score Impacts
|
4.21 units on a scale
Standard Error 1.986
|
3.71 units on a scale
Standard Error 2.040
|
1.73 units on a scale
Standard Error 1.897
|
0.79 units on a scale
Standard Error 1.906
|
-0.14 units on a scale
Standard Error 1.965
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score activities. Scores range from 0 to 100, with higher scores indicating worst possible health status. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=79 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=76 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=82 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=82 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=75 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities
|
7.48 units on a scale
Standard Error 1.910
|
7.39 units on a scale
Standard Error 1.962
|
3.54 units on a scale
Standard Error 1.824
|
3.00 units on a scale
Standard Error 1.832
|
0.32 units on a scale
Standard Error 1.887
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Worst case - Randomised set
St George's Respiratory Questionnaire (SGRQ) responder (\<= -4 points change) (%) at 52 weeks-worst case
Outcome measures
| Measure |
Placebo
n=87 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=87 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=86 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=86 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
St George's Respiratory Questionnaire (SGRQ) Responder
|
16.1 percentage of participants
|
23.0 percentage of participants
|
26.7 percentage of participants
|
32.6 percentage of participants
|
29.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from Baseline in Total Lung Capacity (TLC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=75 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=68 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=80 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=80 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=69 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Change From Baseline in TLC
|
-0.240 Liters
Standard Error 0.0765
|
-0.218 Liters
Standard Error 0.0809
|
-0.100 Liters
Standard Error 0.0725
|
-0.082 Liters
Standard Error 0.0723
|
0.118 Liters
Standard Error 0.0774
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from Baseline in Residual volume (RV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=75 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=68 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=80 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=80 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=69 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Change From Baseline in RV
|
-0.036 Liters
Standard Error 0.0512
|
-0.056 Liters
Standard Error 0.0543
|
0.029 Liters
Standard Error 0.0484
|
-0.012 Liters
Standard Error 0.0484
|
0.086 Liters
Standard Error 0.0518
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from Baseline in Thoracic gas volume (TGV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=73 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=64 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=78 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=78 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=66 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Change From Baseline in TGV
|
-0.137 Liters
Standard Error 0.0657
|
-0.075 Liters
Standard Error 0.0707
|
-0.035 Liters
Standard Error 0.0622
|
-0.016 Liters
Standard Error 0.0623
|
0.200 Liters
Standard Error 0.0668
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from baseline in Vital capacity (VC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=74 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=67 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=80 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=80 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=69 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Change From Baseline in VC
|
-0.191 Liters
Standard Error 0.0458
|
-0.095 Liters
Standard Error 0.0485
|
-0.107 Liters
Standard Error 0.0433
|
-0.082 Liters
Standard Error 0.0432
|
0.010 Liters
Standard Error 0.0462
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: LOCF-Randomised set
Change from Baseline in Inspiratory Capacity (IC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.
Outcome measures
| Measure |
Placebo
n=74 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=67 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=78 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=80 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=68 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Change From Baseline in IC
|
-0.031 Liters
Standard Error 0.0509
|
-0.064 Liters
Standard Error 0.0539
|
-0.053 Liters
Standard Error 0.0483
|
-0.038 Liters
Standard Error 0.0479
|
-0.012 Liters
Standard Error 0.0515
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: OC-Randomised set
Number of patients with at least one Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks
Outcome measures
| Measure |
Placebo
n=87 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=87 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=86 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=86 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Number of Patients With at Least One IPF Exacerbation
|
12 participants
|
10 participants
|
10 participants
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: OC-Randomised set
Occurrences of Idiopathic Pulmonary Fibrosis (IPF) exacerbations per patient per year at 52 weeks
Outcome measures
| Measure |
Placebo
n=87 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=87 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=86 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=86 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Occurrences of IPF Exacerbations Per Patient Per Year
|
0.243 Exacerbations Per Year
Standard Deviation 0.8008
|
0.243 Exacerbations Per Year
Standard Deviation 0.7884
|
0.242 Exacerbations Per Year
Standard Deviation 0.9830
|
0.256 Exacerbations Per Year
Standard Deviation 1.7315
|
0.075 Exacerbations Per Year
Standard Deviation 0.5177
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: OC-Randomised set
This endpoint is called time to first occurrence of IPF exacerbation however it was actually analysed as the proportion of patients having occurrence of Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks. Failure means participants with event and Censored means participants with no event.
Outcome measures
| Measure |
Placebo
n=87 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=87 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=86 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=86 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Time to First Occurrence of IPF Exacerbation
Failure
|
13.8 percentage of participants
|
11.5 percentage of participants
|
11.6 percentage of participants
|
7.0 percentage of participants
|
2.3 percentage of participants
|
|
Time to First Occurrence of IPF Exacerbation
Censored
|
86.2 percentage of participants
|
88.5 percentage of participants
|
88.4 percentage of participants
|
93.0 percentage of participants
|
97.7 percentage of participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: OC-Randomised set
Survival (death due to respiratory cause, and lung-transplant free) at 52 weeks. Failure means participants with event and Censored means participants with no event.
Outcome measures
| Measure |
Placebo
n=87 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=87 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=86 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=86 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Survival (Death Due to Respiratory Cause, and Lung-transplant Free)
Censored
|
90.8 percentage of participants
|
89.7 percentage of participants
|
96.5 percentage of participants
|
97.7 percentage of participants
|
97.7 percentage of participants
|
|
Survival (Death Due to Respiratory Cause, and Lung-transplant Free)
Failure
|
9.2 percentage of participants
|
10.3 percentage of participants
|
3.5 percentage of participants
|
2.3 percentage of participants
|
2.3 percentage of participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: OC - Randomised set
Time to progression. Progression was defined as at least one of the following: 5mmHg increase in the alveolo-arterial pressure difference in oxygen (P(A-a)O2), 10% decrease in FVC (FVC(baseline)-FVC(progression) \>= 10%) or Death. Failure means participants with event and Censored means participants with no event.
Outcome measures
| Measure |
Placebo
n=87 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=87 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=86 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=86 Participants
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Time to Progression
|
363 Days
Interval 302.0 to 366.0
|
365 Days
Interval 309.0 to 366.0
|
365 Days
Interval 330.0 to 365.0
|
365 Days
The 95% CI for the median could not be calculated due to computational reason as the number of participants with event was insufficient.
|
365 Days
The 95% CI for the median could not be calculated due to computational reason as the number of participants with event was insufficient.
|
SECONDARY outcome
Timeframe: day 365 and day 729Population: Randomised set
Cpre,ss,729 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 729 and Cpre,ss,365 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 365. At day 365, values only for Nintedanib 50 qd group are presented as no values reported for other groups and at day 729, values are presented for all group except for Nintedanib 50 qd group as no values reported for it.
Outcome measures
| Measure |
Placebo
n=35 Participants
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=52 Participants
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=53 Participants
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=33 Participants
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729).
|
1.07 ng/mL
Geometric Coefficient of Variation 41.6
|
2.12 ng/mL
Geometric Coefficient of Variation 91.1
|
4.20 ng/mL
Geometric Coefficient of Variation 69.0
|
6.66 ng/mL
Geometric Coefficient of Variation 94.0
|
—
|
Adverse Events
Placebo
Serious events: 26 serious events
Other events: 51 other events
Deaths: 0 deaths
Nintedanib 50 qd
Serious events: 26 serious events
Other events: 52 other events
Deaths: 0 deaths
Nintedanib 50 Bid
Serious events: 23 serious events
Other events: 55 other events
Deaths: 0 deaths
Nintedanib 100 Bid
Serious events: 18 serious events
Other events: 64 other events
Deaths: 0 deaths
Nintedanib 150 Bid
Serious events: 23 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=85 participants at risk
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=86 participants at risk
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 participants at risk
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=86 participants at risk
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=85 participants at risk
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Cardiac failure
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Cardiopulmonary failure
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Cardiac disorders
Right ventricular failure
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Eye disorders
Scleritis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
3.5%
3/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
General disorders
Chest pain
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
General disorders
Death
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
General disorders
Pyrexia
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Abscess limb
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Appendicitis
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Bronchitis
|
2.4%
2/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Eye infection fungal
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Lung infection
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Pneumonia
|
5.9%
5/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Respiratory tract infection
|
2.4%
2/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Sepsis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Viral infection
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Investigations
PO2 decreased
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Investigations
Pulmonary arterial pressure increased
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Investigations
Transplant evaluation
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Investigations
Weight decreased
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Nervous system disorders
Cerebral infarction
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Nervous system disorders
Cerebral ischaemia
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Nervous system disorders
Convulsion
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Psychiatric disorders
Depression
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Renal and urinary disorders
Nephritic syndrome
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Renal and urinary disorders
Renal failure chronic
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
3/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
3.5%
3/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
10.6%
9/85 • First drug administration until 14 days after last drug administration
|
5.8%
5/86 • First drug administration until 14 days after last drug administration
|
7.0%
6/86 • First drug administration until 14 days after last drug administration
|
4.7%
4/86 • First drug administration until 14 days after last drug administration
|
3.5%
3/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
5.8%
5/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Surgical and medical procedures
Lung transplant
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Surgical and medical procedures
Prosthesis implantation
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Vascular disorders
Hypotension
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
|
Vascular disorders
Varicose vein
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
Other adverse events
| Measure |
Placebo
n=85 participants at risk
Patients were treated with matching Placebo.
|
Nintedanib 50 qd
n=86 participants at risk
Patients were treated with 50mg nintedanib once daily
|
Nintedanib 50 Bid
n=86 participants at risk
Patients were treated with 50mg nintedanib twice daily
|
Nintedanib 100 Bid
n=86 participants at risk
Patients were treated with 100mg nintedanib twice daily
|
Nintedanib 150 Bid
n=85 participants at risk
Patients were treated with 150mg nintedanib twice daily
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
3.5%
3/86 • First drug administration until 14 days after last drug administration
|
3.5%
3/86 • First drug administration until 14 days after last drug administration
|
5.9%
5/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Abdominal pain
|
3.5%
3/85 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
5.8%
5/86 • First drug administration until 14 days after last drug administration
|
4.7%
4/86 • First drug administration until 14 days after last drug administration
|
7.1%
6/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.5%
3/85 • First drug administration until 14 days after last drug administration
|
7.0%
6/86 • First drug administration until 14 days after last drug administration
|
11.6%
10/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
11.8%
10/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Diarrhoea
|
15.3%
13/85 • First drug administration until 14 days after last drug administration
|
9.3%
8/86 • First drug administration until 14 days after last drug administration
|
18.6%
16/86 • First drug administration until 14 days after last drug administration
|
37.2%
32/86 • First drug administration until 14 days after last drug administration
|
51.8%
44/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Nausea
|
9.4%
8/85 • First drug administration until 14 days after last drug administration
|
10.5%
9/86 • First drug administration until 14 days after last drug administration
|
8.1%
7/86 • First drug administration until 14 days after last drug administration
|
19.8%
17/86 • First drug administration until 14 days after last drug administration
|
23.5%
20/85 • First drug administration until 14 days after last drug administration
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
4/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
4.7%
4/86 • First drug administration until 14 days after last drug administration
|
12.8%
11/86 • First drug administration until 14 days after last drug administration
|
12.9%
11/85 • First drug administration until 14 days after last drug administration
|
|
General disorders
Fatigue
|
8.2%
7/85 • First drug administration until 14 days after last drug administration
|
4.7%
4/86 • First drug administration until 14 days after last drug administration
|
5.8%
5/86 • First drug administration until 14 days after last drug administration
|
9.3%
8/86 • First drug administration until 14 days after last drug administration
|
10.6%
9/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Bronchitis
|
10.6%
9/85 • First drug administration until 14 days after last drug administration
|
11.6%
10/86 • First drug administration until 14 days after last drug administration
|
16.3%
14/86 • First drug administration until 14 days after last drug administration
|
7.0%
6/86 • First drug administration until 14 days after last drug administration
|
9.4%
8/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Influenza
|
4.7%
4/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
3.5%
3/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
7.1%
6/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Lower respiratory tract infection
|
7.1%
6/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
4.7%
4/86 • First drug administration until 14 days after last drug administration
|
7.0%
6/86 • First drug administration until 14 days after last drug administration
|
7.1%
6/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Nasopharyngitis
|
12.9%
11/85 • First drug administration until 14 days after last drug administration
|
12.8%
11/86 • First drug administration until 14 days after last drug administration
|
9.3%
8/86 • First drug administration until 14 days after last drug administration
|
17.4%
15/86 • First drug administration until 14 days after last drug administration
|
7.1%
6/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Sinusitis
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
8.1%
7/86 • First drug administration until 14 days after last drug administration
|
4.7%
4/86 • First drug administration until 14 days after last drug administration
|
2.4%
2/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Upper respiratory tract infection
|
14.1%
12/85 • First drug administration until 14 days after last drug administration
|
8.1%
7/86 • First drug administration until 14 days after last drug administration
|
11.6%
10/86 • First drug administration until 14 days after last drug administration
|
14.0%
12/86 • First drug administration until 14 days after last drug administration
|
8.2%
7/85 • First drug administration until 14 days after last drug administration
|
|
Infections and infestations
Urinary tract infection
|
3.5%
3/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
4.7%
4/86 • First drug administration until 14 days after last drug administration
|
5.8%
5/86 • First drug administration until 14 days after last drug administration
|
2.4%
2/85 • First drug administration until 14 days after last drug administration
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
7.1%
6/85 • First drug administration until 14 days after last drug administration
|
|
Investigations
Weight decreased
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
3.5%
3/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
3.5%
3/86 • First drug administration until 14 days after last drug administration
|
9.4%
8/85 • First drug administration until 14 days after last drug administration
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/85 • First drug administration until 14 days after last drug administration
|
3.5%
3/86 • First drug administration until 14 days after last drug administration
|
4.7%
4/86 • First drug administration until 14 days after last drug administration
|
4.7%
4/86 • First drug administration until 14 days after last drug administration
|
15.3%
13/85 • First drug administration until 14 days after last drug administration
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
4.7%
4/86 • First drug administration until 14 days after last drug administration
|
5.8%
5/86 • First drug administration until 14 days after last drug administration
|
5.9%
5/85 • First drug administration until 14 days after last drug administration
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
7/85 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
3.5%
3/86 • First drug administration until 14 days after last drug administration
|
7.1%
6/85 • First drug administration until 14 days after last drug administration
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.5%
3/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
5.8%
5/86 • First drug administration until 14 days after last drug administration
|
2.4%
2/85 • First drug administration until 14 days after last drug administration
|
|
Nervous system disorders
Dizziness
|
3.5%
3/85 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
7.0%
6/86 • First drug administration until 14 days after last drug administration
|
8.1%
7/86 • First drug administration until 14 days after last drug administration
|
7.1%
6/85 • First drug administration until 14 days after last drug administration
|
|
Nervous system disorders
Headache
|
5.9%
5/85 • First drug administration until 14 days after last drug administration
|
8.1%
7/86 • First drug administration until 14 days after last drug administration
|
10.5%
9/86 • First drug administration until 14 days after last drug administration
|
9.3%
8/86 • First drug administration until 14 days after last drug administration
|
12.9%
11/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
16/85 • First drug administration until 14 days after last drug administration
|
12.8%
11/86 • First drug administration until 14 days after last drug administration
|
19.8%
17/86 • First drug administration until 14 days after last drug administration
|
23.3%
20/86 • First drug administration until 14 days after last drug administration
|
9.4%
8/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
8/85 • First drug administration until 14 days after last drug administration
|
7.0%
6/86 • First drug administration until 14 days after last drug administration
|
12.8%
11/86 • First drug administration until 14 days after last drug administration
|
12.8%
11/86 • First drug administration until 14 days after last drug administration
|
5.9%
5/85 • First drug administration until 14 days after last drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
2.4%
2/85 • First drug administration until 14 days after last drug administration
|
7.0%
6/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/86 • First drug administration until 14 days after last drug administration
|
5.8%
5/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
7/85 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
0.00%
0/86 • First drug administration until 14 days after last drug administration
|
1.2%
1/85 • First drug administration until 14 days after last drug administration
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
4/85 • First drug administration until 14 days after last drug administration
|
2.3%
2/86 • First drug administration until 14 days after last drug administration
|
5.8%
5/86 • First drug administration until 14 days after last drug administration
|
5.8%
5/86 • First drug administration until 14 days after last drug administration
|
2.4%
2/85 • First drug administration until 14 days after last drug administration
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
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