Trial Outcomes & Findings for A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood (NCT NCT06070610)
NCT ID: NCT06070610
Last Updated: 2025-12-02
Results Overview
Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least squares mean (adjusted geometric mean) and the standard error (actually adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2)
Results posted on
2025-12-02
Participant Flow
This is an open-label, two-period, fixed-sequence crossover trial to investigate the effect of multiple oral doses of 18 mg nerandomilast on the pharmacokinetics of single oral doses of 100 mg nintedanib or 267 mg pirfenidone.
14 participants who met the inclusion and none of the exclusion criteria were included in the study. All 14 participants were treated in period 1. One of the 14 participants was discontinued after period 1 due to an adverse event. 13 participants were treated in period 2 and 1 of these subjects discontinue participation due to on-treatment adverse events. All 14 subjects completed the planned trial assessments. Participants were free to withdraw from the clinical trial at any time.
Participant milestones
| Measure |
Reference treatment/Test treatment
In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2.
In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast were administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2.
A washout period of at least 72 hours separated the last drug administration in the reference period from the first drug administration in the test period.
|
|---|---|
|
Period 1 (Reference treatment period)
STARTED
|
14
|
|
Period 1 (Reference treatment period)
COMPLETED
|
14
|
|
Period 1 (Reference treatment period)
NOT COMPLETED
|
0
|
|
Washout period
STARTED
|
14
|
|
Washout period
COMPLETED
|
13
|
|
Washout period
NOT COMPLETED
|
1
|
|
Period 2 (Test treatment period)
STARTED
|
13
|
|
Period 2 (Test treatment period)
COMPLETED
|
12
|
|
Period 2 (Test treatment period)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Reference treatment/Test treatment
In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2.
In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast were administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2.
A washout period of at least 72 hours separated the last drug administration in the reference period from the first drug administration in the test period.
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|---|---|
|
Washout period
Adverse Event
|
1
|
|
Period 2 (Test treatment period)
Adverse Event
|
1
|
Baseline Characteristics
A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood
Baseline characteristics by cohort
| Measure |
Reference Treatment/Test Treatment
n=14 Participants
In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2.
In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast were administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2.
A washout period of at least 72 hours separated the last drug administration in the reference period from the first drug administration in the test period.
|
|---|---|
|
Age, Continuous
|
36.3 Years
STANDARD_DEVIATION 10.9 • n=121 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=121 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
PRIMARY outcome
Timeframe: At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2)Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis.
Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least squares mean (adjusted geometric mean) and the standard error (actually adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.
Outcome measures
| Measure |
Pirfenidone/Nintedanib alone (Reference)
n=14 Participants
In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2.
|
Pirfenidone/Nintedanib in combination with Nerandomilast (Test)
n=13 Participants
In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast was administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Pirfenidone in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
9597.74 hour * nanogram / milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.10
|
9786.78 hour * nanogram / milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.10
|
PRIMARY outcome
Timeframe: At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2)Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis.
Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric least squares mean (adjusted geometric mean) and the standard error (actually adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.
Outcome measures
| Measure |
Pirfenidone/Nintedanib alone (Reference)
n=14 Participants
In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2.
|
Pirfenidone/Nintedanib in combination with Nerandomilast (Test)
n=13 Participants
In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast was administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2.
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|---|---|---|
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Area Under the Concentration-time Curve of Pirfenidone in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
10146.47 hour * nanogram / milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.09
|
10279.17 hour * nanogram / milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.10
|
PRIMARY outcome
Timeframe: At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2)Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis.
Maximum measured concentration of pirfenidone in plasma (Cmax). Geometric least squares mean (adjusted geometric mean) and the standard error (actually adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.
Outcome measures
| Measure |
Pirfenidone/Nintedanib alone (Reference)
n=14 Participants
In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2.
|
Pirfenidone/Nintedanib in combination with Nerandomilast (Test)
n=13 Participants
In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast was administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2.
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|---|---|---|
|
Maximum Measured Concentration of Pirfenidone in Plasma (Cmax)
|
2451.85 nanogram / milliliter (ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.08
|
2479.00 nanogram / milliliter (ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.08
|
PRIMARY outcome
Timeframe: At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2)Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis.
Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least squares mean (adjusted geometric mean) and the standard error (actually adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.
Outcome measures
| Measure |
Pirfenidone/Nintedanib alone (Reference)
n=14 Participants
In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2.
|
Pirfenidone/Nintedanib in combination with Nerandomilast (Test)
n=12 Participants
In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast was administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
137.88 hour * nanogram / milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.11
|
149.43 hour * nanogram / milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.11
|
PRIMARY outcome
Timeframe: At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2)Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis.
Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric least squares mean (adjusted geometric mean) and the standard error (actually adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.
Outcome measures
| Measure |
Pirfenidone/Nintedanib alone (Reference)
n=14 Participants
In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2.
|
Pirfenidone/Nintedanib in combination with Nerandomilast (Test)
n=11 Participants
In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast was administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
145.03 hour * nanogram / milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.11
|
157.82 hour * nanogram / milliliter (h*ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.11
|
PRIMARY outcome
Timeframe: At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2)Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis.
Maximum measured concentration of nintedanib in plasma (Cmax). Geometric least squares mean (adjusted geometric mean) and the standard error (actually adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.
Outcome measures
| Measure |
Pirfenidone/Nintedanib alone (Reference)
n=14 Participants
In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2.
|
Pirfenidone/Nintedanib in combination with Nerandomilast (Test)
n=12 Participants
In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast was administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2.
|
|---|---|---|
|
Maximum Measured Concentration of Nintedanib in Plasma (Cmax)
|
16.18 nanogram / milliliter (ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.12
|
14.12 nanogram / milliliter (ng/mL)
Standard Error NA
Adjusted geometric standard error = 1.13
|
Adverse Events
Pirfenidone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nintedanib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Nerandomilast
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Nerandomilast+pirfenidone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nerandomilast+nintedanib
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pirfenidone
n=14 participants at risk
A single dose of 267 mg film-coated tablet of pirfenidone was administered orally on Day 1 in the reference (R) treatment period 1.
|
Nintedanib
n=14 participants at risk
A single dose of 100 mg soft capsule of nintedanib was administered orally on Day 2 in the reference (R) treatment period 1.
|
Nerandomilast
n=13 participants at risk
One film-coated tablet of 18 mg nerandomilast (BI 1015550) was administered orally twice daily for 8 days (Day -6 to Day -1 and Day 3 to Day 4) in the test (T) treatment period 2.
|
Nerandomilast+pirfenidone
n=13 participants at risk
One film-coated tablet of 18 mg nerandomilast (BI 1015550) was administered orally twice daily together with a single dose of 267 mg pirfenidone on Day 1 in the test (T) treatment period 2.
|
Nerandomilast+nintedanib
n=13 participants at risk
One film-coated tablet of 18 mg nerandomilast (BI 1015550) was administered orally twice daily together with a single dose of 100 mg nintedanib on Day 2 in the test (T) treatment period 2.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.1%
1/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.1%
1/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
23.1%
3/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
14.3%
2/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
23.1%
3/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
15.4%
2/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.1%
1/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
14.3%
2/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
15.4%
2/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Injury, poisoning and procedural complications
Limb injury
|
7.1%
1/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/14 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
7.7%
1/13 • - For pirfenidone and for nerandomilast + pirfenidone: From administration of pirfenidone + Residual Effect Period (REP) of 12 hours, up to 1 day - For nintedanib and for nerandomilast + nintedanib: From administration of nintedanib + REP of 3 days, up to 3 days - For nerandomilast: up to 12 days - All cause-mortality: up to 25 days
Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug. The treated set was used for safety analyses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place