Trial Outcomes & Findings for A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD) (NCT NCT04093024)

Last Updated: 2024-07-09

Results Overview

Area under the plasma concentration-time curve at steady state (AUCt,ss) based on sampling at steady state (at Week 2 and Week 26) after multiple oral administration of Nintedanib by age group over all treatments. Values of samples taken at Week 2 (for randomised Nintedanib participants) and at Week 26 (for randomised placebo participants) were used. Missing values at Week 2 of randomised Nintedanib participants were replaced with values taken at Week 26.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

39 participants

Primary outcome timeframe

At Week 2 and at Week 26: at 5 minutes before and at 0, 1, 2, 3, 4, 6, and 8 hours post administration of the morning dose

Results posted on

2024-07-09

Participant Flow

This was a multicenter, multinational, prospective clinical trial to evaluate the dose-exposure and safety of Nintedanib on top of standard of care (SOC) in children and adolescents (6 to 17 years old) with clinically significant fibrosing Interstitial Lung Disease (ILD) in two parts. A randomised, placebo-controlled, double-blind treatment period of 24 weeks (double-blind period (DBP)) was followed by an open-label Nintedanib period (OLNP)) of variable duration.

Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All participants were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all participants was adhered to throughout the trial conduct. Treatment interruption and dose reduction were allowed as medically indicated.

Participant milestones

Participant milestones
Measure	DBP+OLNP: Randomised to Placebo This arm shows placebo randomised participants treated orally with a Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Participants who continued with the open-label Nintedanib period (OLNP) after the DBP switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo first (DBP) and then Nintedanib (OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.
Double-blind Period STARTED	13	26
Double-blind Period COMPLETED	11	21
Double-blind Period NOT COMPLETED	2	5
Open-label Nintedanib Period (OLNP) STARTED	11	21
Open-label Nintedanib Period (OLNP) COMPLETED	11	20
Open-label Nintedanib Period (OLNP) NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	DBP+OLNP: Randomised to Placebo This arm shows placebo randomised participants treated orally with a Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Participants who continued with the open-label Nintedanib period (OLNP) after the DBP switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo first (DBP) and then Nintedanib (OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.
Double-blind Period Completed prematurely due to administrative end of trial and did not continue with OLNP	2	2
Double-blind Period Discontinued treatment due to adverse event	0	2
Double-blind Period Discontinued treatment due to other reason	0	1
Open-label Nintedanib Period (OLNP) Discontinuation of trial medication due to other reason	0	1

Baseline Characteristics

A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DBP+OLNP: Randomised to Placebo n=13 Participants This arm shows placebo randomised participants treated orally with a Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Participants who continued with the open-label Nintedanib period (OLNP) after the DBP switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo first (DBP) and then Nintedanib (OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib n=26 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	Total n=39 Participants Total of all reporting groups
Age, Continuous	12.9 Years STANDARD_DEVIATION 2.8 • n=5 Participants	12.5 Years STANDARD_DEVIATION 3.6 • n=7 Participants	12.6 Years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	18 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 2 and at Week 26: at 5 minutes before and at 0, 1, 2, 3, 4, 6, and 8 hours post administration of the morning dose

Population: Pharmacokinetic parameter analysis set (PKS): This set includes all patients in the treated set (TS) who provide at least one pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=23 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=10 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Area Under the Plasma Concentration-time Curve at Steady State (AUCτ,ss) Based on Sampling at Steady State (at Week 2 and Week 26)	167 Hours times nanogram per mililiter Geometric Coefficient of Variation 83.6	175 Hours times nanogram per mililiter Geometric Coefficient of Variation 85.1	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From first drug administration until the earlier of (i) first intake of open-label nintedanib (exclusive) and (ii) last drug intake, up to 28 weeks

Population: Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.

Treatment-emergent was defined as: Adverse events with onset or worsening on or after date of treatment start until end of double-blind period (defined as the day before first intake of open-label nintedanib or last double-blind drug intake + residual effect period, whichever is earlier) were considered as treatment-emergent and were included in the analysis. Adverse events were counted under the treatment as randomized for the double-blind period.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Number of Participants With Treatment-emergent Adverse Events During the Double-blind Period	22 Participants	11 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24 (included values at Week 12 and Week 24); Up to Week 52 (included values at Week 12, 24, 36 and 52)

Population: Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.

Number of participants with at least one treatment-emergent pathological finding of the epiphyseal growth plate imaging (Magnetic Resonance Imaging (MRI)s/x-rays) were analyzed cumulatively and based on central review.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Number of Participants With at Least One Treatment-emergent Pathological Finding of Epiphyseal Growth Plate on Imaging up to Week 24, and Week 52 At Week 24	2 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With at Least One Treatment-emergent Pathological Finding of Epiphyseal Growth Plate on Imaging up to Week 24, and Week 52 At Week 52	3 Participants	2 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Dental examination: at Week 12 and Week 24; Dental imaging: at Week 24

Population: Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.

Number of participants with treatment-emergent pathological findings on dental examination (clinical examination) based on dentist assessment or imaging (panoramic x-ray) based on central review were analyzed. Number of participants with treatment-emergent pathological findings on dental imaging were analyzed cumulatively.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Number of Participants With Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 24 Dental imaging: Accelerated growth of dental root	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 24 Dental imaging: extra / supernumerary teeth	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 24 Dental imaging: Impacted permanent teeth	4 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 24 Dental imaging: Additional findings	5 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 24 Dental imaging: Other findings	1 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 24 Dental examination: Pathological findings up to week 24	5 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 24 Dental imaging: Stunted growth of dental root	6 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Dental examination: at Week 12, 24, 34, and Week 52; Dental imaging: at Week 24 and at Week 52.

Population: Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Number of Participants With at Least One Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 52 Dental examination: Pathological findings up to week 52	7 Participants	3 Participants	—	—	—	—	—	—
Number of Participants With at Least One Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 52 Dental imaging: Stunted growth of dental root	6 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With at Least One Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 52 Dental imaging: Accelerated growth of dental root	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With at Least One Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 52 Dental imaging: extra / supernumerary teeth	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With at Least One Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 52 Dental imaging: Impacted permanent teeth	5 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With at Least One Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 52 Dental imaging: Additional findings	6 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With at Least One Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 52 Dental imaging: Other findings	2 Participants	3 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first drug administration until the last drug intake, up to 92 weeks

Population: Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.

Treatment-emergent was defined as: Adverse events with onset or worsening on or after date of treatment start until last drug intake + residual effect period was considered as treatment-emergent and was included in the analysis. Adverse events were counted under the treatment as randomized for the double-blind period.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=11 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib n=26 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Number of Participants With Treatment-emergent Adverse Events Over the Whole Trial	11 Participants	11 Participants	26 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements pre-administration at -4 weeks and at 0, 12, 24, 36, 52, 64, 76, and 88 weeks after first drug administration. MMRM values at Week 24 are reported in the table below

Population: Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication. Only participants with correctly measured baseline and at least one post-baseline measurement were included in the analysis.

Absolute change from baseline in height at Week 24 was measured with a stadiometer 3 times at each time point. The average of these 3 measurements was taken per time point. Absolute change from baseline in height at Week 24 in the treated set (TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=25 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Height at Week 24	1.3 Centimeter Interval 0.8 to 1.8	1.3 Centimeter Interval 0.6 to 1.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements pre-administration at -4 weeks and at 0, 12, 24, 36, 52, 64, 76, and 88 weeks after first drug administration. MMRM values at Week 52 are reported in the table below

Absolute change from baseline in height at Week 52 was measured with a stadiometer 3 times at each time point. The average of these 3 measurements was taken per time point. Absolute change from baseline in height at Week 52 in the treated set (TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=25 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Height at Week 52	2.8 Centimeter Interval 1.8 to 3.8	2.8 Centimeter Interval 1.5 to 4.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measurements were assessed at Week 0 and at Week 76

Absolute change from baseline in height at Week 76 was measured with a stadiometer 3 times at each time point. The average of these 3 measurements was taken per time point. MMRM has been calculated but did not provide estimates for this time point due to low sample size. Thus, change in height from baseline to Week 76 was analyzed descriptively only.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=4 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=3 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Height at Week 76 At Baseline	162.5 Centimeter Standard Deviation 15.8	143.7 Centimeter Standard Deviation 11.2	—	—	—	—	—	—
Absolute Change From Baseline in Height at Week 76 At Week 76	165.5 Centimeter Standard Deviation 13.0	150.0 Centimeter Standard Deviation 15.7	—	—	—	—	—	—

SECONDARY outcome

Absolute change from baseline in sitting height at Week 24 was measured with a stadiometer 3 times at each time point. The average of these 3 measurements was taken per time point. Absolute change from baseline in sitting height at Week 24 in the treated set (TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=15 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=6 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Sitting Height at Week 24	2.1 Centimeters Interval 0.6 to 3.6	1.0 Centimeters Interval -1.3 to 3.4	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measurements were assessed at Week 0 and at Week 52

Absolute change from baseline in sitting height at Week 52 was measured with a stadiometer 3 times at each time point. The average of these 3 measurements was taken per time point. MMRM has been calculated but did not provide estimates for this time point due to low sample size. Thus, change in sitting height from baseline to Week 52 was analyzed descriptively only.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=7 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=3 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Sitting Height at Week 52 At Baseline	77.6 Centimeters Standard Deviation 9.4	78.7 Centimeters Standard Deviation 11.8	—	—	—	—	—	—
Absolute Change From Baseline in Sitting Height at Week 52 At Week 52	79.3 Centimeters Standard Deviation 8.6	79.0 Centimeters Standard Deviation 12.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Measurements were assessed at Week 0 and at Week 76

Absolute change from baseline in sitting height at Week 76 was measured with a stadiometer 3 times at each time point. The average of these 3 measurements was take per time point. MMRM has been calculated but did not provide estimates for this time point due to low sample size. Thus, change in sitting height from baseline to Week 76 was analyzed descriptively only.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=2 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=1 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Sitting Height at Week 76 At Baseline	83.0 Centimeters Standard Deviation 4.2	65.0 Centimeters Standard Deviation NA One participant is not sufficient to calculate a standard deviation.	—	—	—	—	—	—
Absolute Change From Baseline in Sitting Height at Week 76 At Week 76	84.5 Centimeters Standard Deviation 3.5	65.0 Centimeters Standard Deviation NA One participant is not sufficient to calculate a standard deviation.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 12, 24, 36, 52, 64, and 76 weeks after first drug administration. MMRM values at Week 24 are reported in the table below

Absolute change from baseline in left leg length at Week 24 was assessed by measuring the distance between the anterior iliac spine and the medial malleolus 3 times at each leg and each time point. The average of these 3 measurements was taken per time point. Absolute change from baseline in left leg length at Week 24 in the treated set (TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=23 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Leg Length at Week 24 - Left	1.7 Centimeters Interval 0.8 to 2.7	1.6 Centimeters Interval 0.3 to 2.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 12, 24, 36, 52, 64, and 76 weeks after first drug administration. MMRM values at Week 52 are reported in the table below

Absolute change from baseline in left leg length at Week 52 was assessed by measuring the distance between the anterior iliac spine and the medial malleolus 3 times at each leg and each time point. The average of these 3 measurements was taken per time point. Absolute change from baseline in left leg length at Week 52 in the treated set (TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=23 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Leg Length at Week 52 - Left	2.9 Centimeter Interval 0.9 to 4.9	2.8 Centimeter Interval 0.3 to 5.4	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 12, 24, 36, 52, 64, and 76 weeks after first drug administration. MMRM values at Week 76 are reported in the table below

Absolute change from baseline in left leg length at Week 76 was assessed by measuring the distance between the anterior iliac spine and the medial malleolus 3 times at each leg and each time point. The average of these 3 measurements was taken per time point. Absolute change from baseline in left leg length at Week 76 in the treated set (TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=23 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Leg Length at Week 76 - Left	2.6 Centimeter Interval -1.5 to 6.7	5.2 Centimeter Interval 0.0 to 10.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 12, 24, 36, 52, 64, and 76 weeks after first drug administration. MMRM values at Week 24 are reported in the table below

Absolute change from baseline in right leg length at Week 24 was assessed by measuring the distance between the anterior iliac spine and the medial malleolus 3 times at each leg and each time point. The average of these 3 measurements was taken per time point. Absolute change from baseline in right leg length at Week 24 in the treated set (TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=23 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Leg Length at Week 24 - Right	1.6 Centimeters Interval 0.6 to 2.6	1.6 Centimeters Interval 0.3 to 2.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 12, 24, 36, 52, 64, and 76 weeks after first drug administration. MMRM values at Week 52 are reported in the table below

Absolute change from baseline in right leg length at Week 52 was assessed by measuring the distance between the anterior iliac spine and the medial malleolus 3 times at each leg and each time point. The average of these 3 measurements was taken per time point. Absolute change from baseline in right leg length at Week 52 in the treated set (TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=23 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Leg Length at Week 52 - Right	3.4 Centimeter Interval 1.6 to 5.2	2.8 Centimeter Interval 0.4 to 5.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 12, 24, 36, 52, 64, and 76 weeks after first drug administration. MMRM values at Week 76 are reported in the table below

Absolute change from baseline in right leg length at Week 76 was assessed by measuring the distance between the anterior iliac spine and the medial malleolus 3 times at each leg and each time point. The average of these 3 measurements was taken per time point. Absolute change from baseline in right leg length at Week 76 in the treated set (TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=23 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Leg Length at Week 76 - Right	4.3 Centimeter Interval 0.8 to 7.7	3.9 Centimeter Interval -0.5 to 8.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements pre-administration at -4 weeks and at 0, 2, 6, 12, 24, 26, 36, and 52 weeks after first drug administration. MMRM values at Week 24 are reported in the table below

Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. The predicted values were calculated according to the Global Lungs Initiative (GLI) 2012 equations. Absolute change from baseline in Forced Vital Capacity (FVC) % predicted at Week 24 in the treated set(TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Forced Vital Capacity (FVC) % Predicted at Week 24	0.3112 Percentage of predicted FVC Interval -2.3595 to 2.982	-0.8939 Percentage of predicted FVC Interval -4.609 to 2.8211	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements pre-administration at -4 weeks and at 0, 2, 6, 12, 24, 26, 36, and 52 weeks after first drug administration. MMRM values at Week 52 are reported in the table below

Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. The predicted values were calculated according to the Global Lungs Initiative (GLI) 2012 equations. Absolute change from baseline in Forced Vital Capacity (FVC) % predicted at Week 52 in the treated set(TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Forced Vital Capacity (FVC) % Predicted at Week 52	0.7906 Percentage of predicted FVC Interval -2.9464 to 4.5277	-0.9827 Percentage of predicted FVC Interval -6.2611 to 4.2958	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 24 are reported in the table below

The PedsQL™ questionnaires consists of 23 items (i) and 4 dimensions: physical (8i), emotional (5i), social (5i) and school (5i) functioning. A 5-point Likert response scale (0 = never (worst outcome) to 4=almost always (best outcome)) was used except for the Young Child Report, where a 3-point scale (0=not at all (worst outcome) to 4=a lot (best outcome)) was used. Items were reverse-scored and linearly transformed to a 0-100 scale (0 = 100 to 4 = 0). Higher scores indicated better health-related quality of life. To create total scores, the mean was computed. Absolute change from baseline in PedsQL™ reported by parents was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=21 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=11 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Pediatric Quality of Life Questionnaire™(PedsQL™) at Week 24 - Parent Report	5.481 Unit on scale Interval 0.384 to 10.578	5.615 Unit on scale Interval -1.506 to 12.736	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 52 are reported in the table below

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=21 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=11 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Pediatric Quality of Life Questionnaire™(PedsQL™) at Week 52 - Parent Report	7.830 Unit on scale Interval 1.799 to 13.862	4.377 Unit on scale Interval -4.403 to 13.157	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 24 are reported in the table below

The PedsQL™ questionnaires consists of 23 items (i) and 4 dimensions: physical (8i), emotional (5i), social (5i) and school (5i) functioning. A 5-point Likert response scale (0 = never (worst outcome) to 4=almost always (best outcome)) was used except for the Young Child Report, where a 3-point scale (0=not at all (worst outcome) to 4=a lot (best outcome)) was used. Items were reverse-scored and linearly transformed to a 0-100 scale (0 = 100 to 4 = 0). Higher scores indicated better health-related quality of life. To create total scores, the mean was computed. Absolute change from baseline in PedsQL™ was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=21 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=11 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Pediatric Quality of Life Questionnaire™(PedsQL™) at Week 24 - Participant Report	6.514 Unit on scale Interval 2.531 to 10.497	5.484 Unit on scale Interval -0.051 to 11.018	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 52 are reported in the table below

The PedsQL™ questionnaires consists of 23 items (i) and 4 dimensions: physical (8i), emotional (5i), social (5i) and school (5i) functioning. A 5-point Likert response scale (0 = never (worst outcome) to 4=almost always (best outcome)) was used except for the Young Child Report, where a 3-point scale (0=not at all (worst outcome) to 4=a lot (best outcome)) was used. Items were reverse-scored and linearly transformed to a 0-100 scale (0 = 100 to 4 = 0). Higher scores indicated better health-related quality of life. To create total scores, the mean was computed. Absolute change from baseline in PedsQL™ was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=21 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=11 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Pediatric Quality of Life Questionnaire™(PedsQL™) at Week 52 - Participant Report	1.243 Unit on scale Interval -4.598 to 7.083	0.902 Unit on scale Interval -7.616 to 9.42	—	—	—	—	—	—

SECONDARY outcome

Oxygen saturation (SpO₂) was measured after minimum 5 minutes on room air by standard pulse oximetry at rest. Absolute change from baseline in SpO₂ at Week 24 in the treated set(TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Oxygen Saturation (SpO₂) on Room Air at Rest at Week 24	0.07 Percentage of SpO₂ Interval -1.49 to 1.63	-2.25 Percentage of SpO₂ Interval -4.45 to -0.04	—	—	—	—	—	—

SECONDARY outcome

Oxygen saturation (SpO₂) was measured after minimum 5 minutes on room air by standard pulse oximetry at rest. Absolute change from baseline in SpO₂ at Week 52 in the treated set(TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in Oxygen Saturation (SpO₂) on Room Air at Rest at Week 52	-0.32 Percentage of SpO₂ Interval -2.03 to 1.4	-2.60 Percentage of SpO₂ Interval -5.02 to -0.18	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 24 are reported in the table below

Absolute change from baseline in 6 minutes (min) walk distance at Week 24 in the treated set (TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=21 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=11 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in 6 Minutes (Min) Walk Distance at Week 24	17.6 Meter Interval -16.2 to 51.5	10.5 Meter Interval -36.4 to 57.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 52 are reported in the table below

Absolute change from baseline in 6 minutes (min) walk distance at Week 52 in the treated set(TS) was based on a Mixed Model Repeated Measures (MMRM), with fixed categorical effects of (randomised) treatment at each visit, age-group and the fixed continuous effects of baseline at each visit, and random effect for participant. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-participant measurements.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=21 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=11 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Absolute Change From Baseline in 6 Minutes (Min) Walk Distance at Week 52	-4.9 Meter (m) Interval -44.5 to 34.7	28.1 Meter (m) Interval -29.4 to 85.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Acceptability was assessed at Week 24

Acceptability is defined as the overall ability and willingness of the participant to use the medicinal product as intended. Acceptability based on the capsule size was assessed by a acceptability questionnaire (1 item with 3 categories as shown below) for participants. In case the participant was considered not old enough as per investigator judgment the caregiver could assist with the completion. In addition to the commercially available 100 milligram (mg) soft capsules (oblong shape, 6 millimeter (mm) diameter and 16 mm length) and 150 mg soft capsules (oblong shape, 7 mm diameter and 18 mm length), 25 mg Nintedanib soft capsules of smaller size (oval shape, 5 mm diameter and 8 mm length) were provided in this trial for participants who were assigned to a dose smaller than 100 mg or were unable to swallow the larger 100 mg or 150 mg capsules.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=6 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=4 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib n=4 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule n=14 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule n=3 Participants This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule n=2 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Participants Acceptability Based on the Size of Capsules at Week 24 - Patient Question OK	6 Participants	4 Participants	4 Participants	14 Participants	3 Participants	2 Participants	—	—
Participants Acceptability Based on the Size of Capsules at Week 24 - Patient Question Large	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Participants Acceptability Based on the Size of Capsules at Week 24 - Patient Question Very Large	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Acceptability was assessed at Week 24

Population: Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.

Acceptability is defined as the overall ability and willingness of the participant to use the medicinal product as intended. Acceptability based on the capsule size was assessed by a acceptability questionnaire (1 item with 3 categories as shown below) for investigators. In addition to the commercially available 100 milligram (mg) soft capsules (oblong shape, 6 millimeter (mm) diameter and 16 mm length) and 150 mg soft capsules (oblong shape, 7 mm diameter and 18 mm length), 25 mg Nintedanib soft capsules of smaller size (oval shape, 5 mm diameter and 8 mm length) were provided in this trial for participants who were assigned to a dose smaller than 100 mg or were unable to swallow the larger 100 mg or 150 mg capsules.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=6 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=4 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib n=4 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule n=14 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule n=3 Participants This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule n=2 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Participants Acceptability Based on the Size of Capsules at Week 24 - Investigator Question No	2 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants	—	—
Participants Acceptability Based on the Size of Capsules at Week 24 - Investigator Question Yes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Participants Acceptability Based on the Size of Capsules at Week 24 - Investigator Question Missing	4 Participants	3 Participants	3 Participants	12 Participants	3 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Acceptability was assessed at Week 24

Acceptability is defined as the overall ability and willingness of the participant to use the medicinal product as intended. Acceptability based on the number of capsule was assessed by a acceptability questionnaire (1 item with 3 categories as shown below) for participants. In case the participant was considered not old enough as per investigator judgment the caregiver could assist with the completion. In addition to the commercially available 100 milligram (mg) soft capsules (oblong shape, 6 millimeter (mm) diameter and 16 mm length) and 150 mg soft capsules (oblong shape, 7 mm diameter and 18 mm length), 25 mg Nintedanib soft capsules of smaller size (oval shape, 5 mm diameter and 8 mm length) were provided in this trial for participants who were assigned to a dose smaller than 100 mg or were unable to swallow the larger 100 mg or 150 mg capsules. Medication dosage was based on the participant's body weight and number of capsules per administration ranged from 2 to \>6 capsules.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=16 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=7 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib n=2 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule n=3 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule n=1 Participants This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule n=3 Participants This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules n=1 Participants This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Participants Acceptability Based on the Number of Capsules at Week 24 - Patient Question I had no problem swallowing them	16 Participants	7 Participants	2 Participants	3 Participants	1 Participants	3 Participants	1 Participants	0 Participants
Participants Acceptability Based on the Number of Capsules at Week 24 - Patient Question I swallowed them but it was difficult	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Participants Acceptability Based on the Number of Capsules at Week 24 - Patient Question I could not swallow them sometimes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first drug administration until the last drug intake + 28 days residual effect period (REP), up to 92.6 weeks

Population: Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.

Number of participants with occurrence of first respiratory-related hospitalization over the whole trial. The number of participants with first respiratory-related hospitalization is reported instead of a metric summarizing the time-to-event data with unit of time, as the numbers resulting from the Kaplan-Meier-analysis were even below the first quartile.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Number of Participants With Occurrence of First Respiratory-related Hospitalization Over the Whole Trial	3 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first drug administration until the last drug intake + 28 days REP, up to 92.6 weeks

Population: Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.

Number of participants with occurrence of first acute Interstitial Lung Disease (ILD) exacerbation or death over the whole trial. The number of participants with first acute ILD exacerbation is reported instead of a metric summarizing the time-to-event data with unit of time, as the numbers resulting from the Kaplan-Meier-analysis were even below the first quartile.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Number of Participants With Occurrence of First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over the Whole Trial	2 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first drug administration until the last drug intake + 28 days REP, up to 92.6 weeks

Population: Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.

Number of participants with occurrence of death over the whole trial over the whole trial was computed. The number of participants with occurrence of death is reported instead of a metric summarizing the time-to-event data with unit of time, as the numbers resulting from the Kaplan-Meier-analysis were even below the first quartile.

Outcome measures

Outcome measures
Measure	OLNP: Randomised to Placebo and Switched to Nintedanib n=26 Participants This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: 6 to < 12 Years - Exposed to Nintedanib n=13 Participants This arm shows participants aged 6 to \< 12 years old who were exposed to Nintedanib only, either randomised placebo (treated with Nintedanib in the OLNP only) and randomised Nintedanib (treated with Nintedanib in both, DBP and OLNP). The 6 to \< 12 years old participant were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP or DBP+OLNP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participants in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP: Randomised to Nintedanib - Capsule Size of 100 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 100 mg with a capsule size of 6 mm diameter and 16 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 100 mg \[1 capsules with strength 100 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - Capsule Size of 150 mg Capsule This arm shows placebo randomised participants treated orally with placebo soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - Capsule Size of 150 mg Capsule This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 150 mg with a capsule size of 7 mm diameter and 18 mm length, oblong shaped, twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage per administration was 150 mg \[1 capsules with strength 150 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Placebo - >6 Capsules This arm shows placebo randomised participants treated orally with \>3 Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	DBP: Randomised to Nintedanib - >6 Capsules This arm shows Nintedanib randomised participants treated orally with \>3 Nintedanib soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 100 mg \[4 capsules with strength 25 mg\] or 150 mg \[6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). In this arm participants received Nintedanib only (DBP). Participants in this arm do not entail participants from the 'randomised to placebo' arm. DBP: Planned was from first randomised trial drug intake to last blinded drug intake.
Number of Participants With Occurrence of Death Over the Whole Trial	0 Participants	0 Participants	—	—	—	—	—	—

Adverse Events

DBP: Randomised to Placebo

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

OLNP: Randomised to Placebo and Switched to Nintedanib

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

DBP+OLNP: Randomised to Nintedanib (Nintedanib Exposure Period)

Serious events: 5 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DBP: Randomised to Placebo n=13 participants at risk This arm shows placebo randomised participants treated orally with a Nintedanib matching placebo soft capsule twice daily with a dose interval of approximately 12 hours from one dose to the next dose in the double-blind period (DBP). Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake.	OLNP: Randomised to Placebo and Switched to Nintedanib n=11 participants at risk This arm shows participants who continued with the open-label Nintedanib period (OLNP) after the DBP, switched to active Nintedanib treatment in the OLNP and were treated orally with Nintedanib twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib only (OLNP). OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.	DBP+OLNP: Randomised to Nintedanib (Nintedanib Exposure Period) n=26 participants at risk This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP and OLNP twice daily with a dose interval of approximately 12 hours from one dose to the next dose. Medication dosage was per administration 50 milligram (mg) \[2 capsules with strength 25 mg\],75 mg \[3 capsules with strength 25 mg\], 100 mg \[1 capsule with strength 100 mg or 4 capsules with strength 25 mg\] or 150 mg \[1 capsule with strength 150 mg or 6 capsules with strength 25 mg\] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. In this arm participants received Nintedanib in both periods (DBP + OLNP). Participation in this arm do not entail participants from the 'randomised to placebo' arms. DBP: Planned was from first randomised trial drug intake to last blinded drug intake. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake.
Gastrointestinal disorders Tooth development disorder	0.00% 0/13 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	0.00% 0/11 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	3.8% 1/26 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/13 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	9.1% 1/11 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	0.00% 0/26 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.
Hepatobiliary disorders Liver injury	0.00% 0/13 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	0.00% 0/11 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	3.8% 1/26 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.
Infections and infestations COVID-19	0.00% 0/13 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	0.00% 0/11 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	7.7% 2/26 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.
Investigations Carbon dioxide increased	0.00% 0/13 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	0.00% 0/11 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	3.8% 1/26 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.
Nervous system disorders Frontal lobe epilepsy	7.7% 1/13 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	0.00% 0/11 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	0.00% 0/26 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/13 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	0.00% 0/11 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	3.8% 1/26 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/13 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	0.00% 0/11 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	3.8% 1/26 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.
Vascular disorders Neurogenic shock	0.00% 0/13 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	9.1% 1/11 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.	0.00% 0/26 • Placebo-randomised DBP: From treatment start till end of DBP (defined as the day before first intake of open-label nintedanib (NIN) or last double-blind drug intake, up to 24.4 weeks + 28 days (REP), whichever is earlier) Placebo-randomised OLNP: From first intake of NIN till last intake of the OLNP, up to 64.6 weeks + 28 days (REP). Nintedanib-randomised DBP+OLNP: From first intake of NIN (DBP / OLNP) till last intake of NIN (DBP or OLNP), up to 85.1 weeks + 28 days (REP). Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.

Other adverse events

Additional Information

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