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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004530-14 | EudraCT Number |
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The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind period (DBP) + open-label Nintedanib period (OLNP): Randomised Nintedanib | Experimental | 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. |
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| DBP+OLNP: Randomised placebo | Placebo Comparator | Placebo randomised participants were treated orally with a Nintedanib matching placebo soft capsule twice daily 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. Medication dosage was per administration 50 milligram (mg) [2 25 mg capsules (cap)],75 mg [3 25 mg cap], 100 mg [1 100 mg or 4 25 mg cap] or 150 mg [1 150 mg or 6 25 mg cap] based on the participant's weight at baseline (= 0 weeks). The dosage was adjusted at subsequent visits if the participant's weight had changed. The dose interval was approximately 12 hours between one and the next dose. Here participants received placebo first (DBP) and then Nintedanib (OLNP). DBP: Planned was from first to last randomised blinded drug intake. OLNP: Planned was from first to last open-label Nintedanib intake. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve at Steady State (AUCÏ„,ss) Based on Sampling at Steady State (at Week 2 and Week 26) | 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. | 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 |
| Number of Participants With Treatment-emergent Adverse Events During the Double-blind Period | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Treatment-emergent Pathological Finding of Epiphyseal Growth Plate on Imaging up to Week 24, and Week 52 | 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. | 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) |
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Inclusion Criteria:
Children and adolescents 6 to 17 years old at Visit 2.
Signed and dated written informed consent and assent, where applicable, in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Male or female patients. Female of childbearing potential (WOCBP) must confirm that sexual abstinence is standard practice and will be continued until 3 months after last drug intake, or be ready and able to use a highly effective method of birth control per International Conference on Harmonisation (ICH) M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly, in combination with one barrier method, from 28 days prior to initiation of study treatment, during treatment and until 3 months after last drug intake. Sexual abstinence is defined as abstinence from any sexual act that may result in pregnancy. A list of contraception methods meeting these criteria is provided in the parental information.
Patients with evidence of fibrosing Interstitial Lung Disease (ILD) on High-Resolution Computed Tomography (HRCT) within 12 months of Visit 1 as assessed by the investigator and confirmed by central review.
Patients with Forced Vital Capacity (FVC)% predicted ≥25% at Visit 2. [Note: Predicted normal values will be calculated according to GLI (Global Lung Initiative)]
Patients with clinically significant disease at Visit 2, as assessed by the investigator based on any of the following:
Fan score ≥3, or
Documented evidence of clinical progression over time based on either
Exclusion Criteria:
Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT)>1.5 x Upper Level of Normal (ULN) at Visit 1.
Bilirubin >1.5 x ULN at Visit 1.
Creatinine clearance <30 mL/min calculated by Schwartz formula at Visit 1. [Note: Laboratory parameters from Visit 1 have to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results will be available only after randomization. In case at Visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the patient remains on study drug. The justification for decision needs to be documented. Laboratory parameters that are found to be abnormal at Visit 1 are allowed to be re-tested (once) if it is thought to be a measurement error (i.e. there was no abnormal result of this test in the recent history of the patient and there is no related clinical sign) or the result of a temporary and reversible medical condition, once that condition is resolved.]
Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment) at Visit 1.
Previous treatment with nintedanib.
Other investigational therapy received within 1 month or 5 half-lives (whichever is shorter but ≥1 week) prior to Visit 2.
Significant pulmonary arterial hypertension (PAH) defined by any of the following:
In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
Cardiovascular diseases, any of the following:
Severe hypertension, uncontrolled under treatment, within 6 months of Visit 1. Uncontrolled hypertension is defined as
Myocardial infarction within 6 months of Visit 1
Unstable cardiac angina within 6 months of Visit 1
Bleeding risk, any of the following:
Known genetic predisposition to bleeding
Patients who require
History of haemorrhagic central nervous system (CNS) event within 12 months of Visit 1
Any of the following within 3 months of Visit 1:
Any of the following coagulation parameters at Visit 1:
History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Visit 1.
Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
Patients with documented allergy to peanut or soya.
Other disease that may interfere with testing procedures or in the judgment of the investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
Life expectancy for any concomitant disease other than Interstitial Lung Disease (ILD)<2.5 years (investigator assessment).
Female patients who are pregnant, nursing, or who plan to become pregnant while in the trial.
Patients not able or willing to adhere to trial procedures, including intake of study medication.
Patients with any diagnosed growth disorder such as growth hormone deficiency or any genetic disorder that is associated with short stature (e.g. Turner Syndrome, Noonan Syndrome, Russell-Silver Syndrome) and/or treatment with growth hormone therapy within 6 months before Visit 2. Patients with short stature considered by the investigator to be due to glucocorticoid therapy may be included.
Patients <13.5 kg of weight at Visit 1 (same threshold to be used for male and female patients).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Children's Hospital Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36041751 | Derived | Deterding R, Young LR, DeBoer EM, Warburton D, Cunningham S, Schwerk N, Flaherty KR, Brown KK, Dumistracel M, Erhardt E, Bertulis J, Gahlemann M, Stowasser S, Griese M; InPedILD trial investigators. Nintedanib in children and adolescents with fibrosing interstitial lung diseases. Eur Respir J. 2023 Feb 2;61(2):2201512. doi: 10.1183/13993003.01512-2022. Print 2023 Feb. | |
| 34164554 |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2021 | Jan 11, 2023 |
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| Placebo | Drug | Capsule |
|
| Number of Participants With Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 24 | 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. | Dental examination: at Week 12 and Week 24; Dental imaging: at Week 24 |
| Number of Participants With at Least One Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 52 | 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. | Dental examination: at Week 12, 24, 34, and Week 52; Dental imaging: at Week 24 and at Week 52. |
| Number of Participants With Treatment-emergent Adverse Events Over the Whole Trial | 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. | From first drug administration until the last drug intake, up to 92 weeks |
| Absolute Change From Baseline in Height at Week 24 | 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. | 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 |
| Absolute Change From Baseline in Height at Week 52 | 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. | 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 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. | Measurements were assessed at Week 0 and at Week 76 |
| Absolute Change From Baseline in Sitting Height at Week 24 | 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. | 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. |
| Absolute Change From Baseline in Sitting Height 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. | Measurements were assessed at Week 0 and at Week 52 |
| Absolute Change From Baseline in Sitting Height 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. | Measurements were assessed at Week 0 and at Week 76 |
| Absolute Change From Baseline in Leg Length at Week 24 - Left | 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. | 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 Leg Length at Week 52 - Left | 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. | 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 Leg Length at Week 76 - Left | 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. | 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 Leg Length at Week 24 - Right | 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. | 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 Leg Length at Week 52 - Right | 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. | 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 Leg Length at Week 76 - Right | 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. | 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 Forced Vital Capacity (FVC) % Predicted at Week 24 | 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. | 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 |
| Absolute Change From Baseline in Forced Vital Capacity (FVC) % Predicted at Week 52 | 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. | 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 |
| Absolute Change From Baseline in Pediatric Quality of Life Questionnaireâ„¢(PedsQLâ„¢) at Week 24 - Parent Report | The PedsQLâ„¢ 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 PedsQLâ„¢ 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. | 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 Pediatric Quality of Life Questionnaireâ„¢(PedsQLâ„¢) at Week 52 - Parent Report | The PedsQLâ„¢ 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 PedsQLâ„¢ 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. | 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 Pediatric Quality of Life Questionnaireâ„¢(PedsQLâ„¢) at Week 24 - Participant Report | The PedsQLâ„¢ 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 PedsQLâ„¢ 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. | 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 Pediatric Quality of Life Questionnaireâ„¢(PedsQLâ„¢) at Week 52 - Participant Report | The PedsQLâ„¢ 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 PedsQLâ„¢ 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. | 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 Oxygen Saturation (SpOâ‚‚) on Room Air at Rest at Week 24 | Oxygen saturation (SpOâ‚‚) was measured after minimum 5 minutes on room air by standard pulse oximetry at rest. Absolute change from baseline in SpOâ‚‚ 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. | 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 |
| Absolute Change From Baseline in Oxygen Saturation (SpOâ‚‚) on Room Air at Rest at Week 52 | Oxygen saturation (SpOâ‚‚) was measured after minimum 5 minutes on room air by standard pulse oximetry at rest. Absolute change from baseline in SpOâ‚‚ 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. | 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 |
| Absolute Change From Baseline in 6 Minutes (Min) Walk Distance at Week 24 | 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. | 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 52 | 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. | MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 52 are reported in the table below |
| Participants Acceptability Based on the Size of Capsules at Week 24 - Patient Question | 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. | Acceptability was assessed at Week 24 |
| Participants Acceptability Based on the Size of Capsules at Week 24 - Investigator Question | 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. | Acceptability was assessed at Week 24 |
| Participants Acceptability Based on the Number of Capsules at Week 24 - Patient Question | 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. | Acceptability was assessed at Week 24 |
| Number of Participants With Occurrence of First Respiratory-related Hospitalization Over the Whole Trial | 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. | From first drug administration until the last drug intake + 28 days residual effect period (REP), up to 92.6 weeks |
| Number of Participants With Occurrence of First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over the Whole Trial | 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. | From first drug administration until the last drug intake + 28 days REP, up to 92.6 weeks |
| Number of Participants With Occurrence of Death Over the Whole Trial | 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. | From first drug administration until the last drug intake + 28 days REP, up to 92.6 weeks |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Hospital de PediatrÃa " Prof. Dr. Juan P. Garrahan" | CABA | C1245AAM | Argentina |
| Hospital de Niños Dr. Ricardo Gutierrez | CABA | C1425EFD | Argentina |
| INSARES | Mendoza | M5500CCG | Argentina |
| Women's and Children's Hospital | North Adelaide | South Australia | 5006 | Australia |
| Brussels - UNIV HUDERF | Brussels | 1020 | Belgium |
| Serviços Medicos Respirar Sul Fluminense | Barra Mansa | 27323240 | Brazil |
| Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP | São Paulo | 5403-900 | Brazil |
| BC Children's Hospital | Vancouver | British Columbia | V6H 3N1 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Teaching Hospital Motol, Oncology Clinic | Prague | 150 06 | Czechia |
| Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| Tampere University Hospital | Tampere | 33520 | Finland |
| HOP Intercommunal | Créteil | 94010 | France |
| HOP Armand-Trousseau | Paris | 75571 | France |
| General Hospital of Thessaloniki "Ippokrateio" | Thessaloniki | 54642 | Greece |
| Semmelweis University | Budapest | 1122 | Hungary |
| Azienda Ospedaliera Meyer | Florence | 50139 | Italy |
| Azienda Ospedaliera Universitaria di Padova | Padova | 35128 | Italy |
| Osp. Pediatrico Bambin Gesù | Roma | 00165 | Italy |
| Clinical Research Institute S.C. | Tlalnepantla | 54055 | Mexico |
| Oslo Universitetssykehus HF, Rikshospitalet | Oslo | N-0372 | Norway |
| Independent Public Teaching Children's Hospital | Warsaw | 02091 | Poland |
| CHULC, EPE - Hospital Dona Estefânia | Lisbon | 1169-045 | Portugal |
| Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria | Lisbon | 1649-035 | Portugal |
| Children's Hematology,Oncology&Immunology na Rogachev,Moscow | Moscow | 117198 | Russia |
| State Novosibirsk Regional Clinical Hospital | Novosibirsk | 630087 | Russia |
| St. Petersburg State Pediatric University | Saint Petersburg | 194100 | Russia |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Virgen del RocÃo | Seville | 41013 | Spain |
| Regional Children Clinical Hospital, Pulmonology, Kharkiv | Kharkiv | 61093 | Ukraine |
| Institute of Phthisiology and Pulmonology n. a. F.G.Yanovsky | Kyiv | 03680 | Ukraine |
| Regional clinical children hospital, Zaporizhya | Zaporizhya | 69063 | Ukraine |
| Birmingham Children's Hospital | Birmingham | B4 6NH | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Deterding R, Griese M, Deutsch G, Warburton D, DeBoer EM, Cunningham S, Clement A, Schwerk N, Flaherty KR, Brown KK, Voss F, Schmid U, Schlenker-Herceg R, Verri D, Dumistracel M, Schiwek M, Stowasser S, Tetzlaff K, Clerisme-Beaty E, Young LR. Study design of a randomised, placebo-controlled trial of nintedanib in children and adolescents with fibrosing interstitial lung disease. ERJ Open Res. 2021 Jun 21;7(2):00805-2020. doi: 10.1183/23120541.00805-2020. eCollection 2021 Apr. |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
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| Open-label Nintedanib Period (OLNP) |
|
|
Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve at Steady State (AUCÏ„,ss) Based on Sampling at Steady State (at Week 2 and Week 26) | 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. | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours times nanogram per mililiter | 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 |
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| Primary | Number of Participants With Treatment-emergent Adverse Events During the Double-blind Period | 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. | Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants With at Least One Treatment-emergent Pathological Finding of Epiphyseal Growth Plate on Imaging up to Week 24, and Week 52 | 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. | Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication. | Posted | Count of Participants | Participants | 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) |
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| Secondary | Number of Participants With Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 24 | 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. | Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication. | Posted | Count of Participants | Participants | Dental examination: at Week 12 and Week 24; Dental imaging: at Week 24 |
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| Secondary | Number of Participants With at Least One Treatment-emergent Pathological Findings on Dental Examination or Imaging up to Week 52 | 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. | Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication. | Posted | Count of Participants | Participants | Dental examination: at Week 12, 24, 34, and Week 52; Dental imaging: at Week 24 and at Week 52. |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events Over the Whole Trial | 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. | Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication. | Posted | Count of Participants | Participants | From first drug administration until the last drug intake, up to 92 weeks |
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| Secondary | Absolute Change From Baseline in Height at Week 24 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Centimeter | 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 |
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| Secondary | Absolute Change From Baseline in Height at Week 52 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Centimeter | 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 |
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| Secondary | Absolute Change From Baseline in Height 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. | 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. | Posted | Mean | Standard Deviation | Centimeter | Measurements were assessed at Week 0 and at Week 76 |
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| Secondary | Absolute Change From Baseline in Sitting Height at Week 24 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Centimeters | 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. |
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| Secondary | Absolute Change From Baseline in Sitting Height 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. | 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 non-missing results were included in the analysis. | Posted | Mean | Standard Deviation | Centimeters | Measurements were assessed at Week 0 and at Week 52 |
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| Secondary | Absolute Change From Baseline in Sitting Height 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. | 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 non-missing results were included in the analysis. | Posted | Mean | Standard Deviation | Centimeters | Measurements were assessed at Week 0 and at Week 76 |
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| Secondary | Absolute Change From Baseline in Leg Length at Week 24 - Left | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Centimeters | 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 |
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| Secondary | Absolute Change From Baseline in Leg Length at Week 52 - Left | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Centimeter | 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 |
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| Secondary | Absolute Change From Baseline in Leg Length at Week 76 - Left | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Centimeter | 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 |
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| Secondary | Absolute Change From Baseline in Leg Length at Week 24 - Right | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Centimeters | 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 |
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| Secondary | Absolute Change From Baseline in Leg Length at Week 52 - Right | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Centimeter | 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 |
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| Secondary | Absolute Change From Baseline in Leg Length at Week 76 - Right | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Centimeter | 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 |
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| Secondary | Absolute Change From Baseline in Forced Vital Capacity (FVC) % Predicted at Week 24 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of predicted FVC | 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 |
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| Secondary | Absolute Change From Baseline in Forced Vital Capacity (FVC) % Predicted at Week 52 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of predicted FVC | 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 |
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| Secondary | Absolute Change From Baseline in Pediatric Quality of Life Questionnaireâ„¢(PedsQLâ„¢) at Week 24 - Parent Report | The PedsQLâ„¢ 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 PedsQLâ„¢ 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 24 are reported in the table below |
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| Secondary | Absolute Change From Baseline in Pediatric Quality of Life Questionnaireâ„¢(PedsQLâ„¢) at Week 52 - Parent Report | The PedsQLâ„¢ 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 PedsQLâ„¢ 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 52 are reported in the table below |
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| Secondary | Absolute Change From Baseline in Pediatric Quality of Life Questionnaireâ„¢(PedsQLâ„¢) at Week 24 - Participant Report | The PedsQLâ„¢ 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 PedsQLâ„¢ 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 24 are reported in the table below |
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| Secondary | Absolute Change From Baseline in Pediatric Quality of Life Questionnaireâ„¢(PedsQLâ„¢) at Week 52 - Participant Report | The PedsQLâ„¢ 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 PedsQLâ„¢ 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 52 are reported in the table below |
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| Secondary | Absolute Change From Baseline in Oxygen Saturation (SpOâ‚‚) on Room Air at Rest at Week 24 | Oxygen saturation (SpOâ‚‚) was measured after minimum 5 minutes on room air by standard pulse oximetry at rest. Absolute change from baseline in SpOâ‚‚ 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of SpOâ‚‚ | 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 |
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| Secondary | Absolute Change From Baseline in Oxygen Saturation (SpOâ‚‚) on Room Air at Rest at Week 52 | Oxygen saturation (SpOâ‚‚) was measured after minimum 5 minutes on room air by standard pulse oximetry at rest. Absolute change from baseline in SpOâ‚‚ 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of SpOâ‚‚ | 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 |
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| Secondary | Absolute Change From Baseline in 6 Minutes (Min) Walk Distance at Week 24 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Meter | MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 24 are reported in the table below |
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| Secondary | Absolute Change From Baseline in 6 Minutes (Min) Walk Distance at Week 52 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Meter (m) | MMRM included measurements at 0, 24, and 52 weeks after first drug administration. MMRM values at Week 52 are reported in the table below |
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| Secondary | Participants Acceptability Based on the Size of Capsules at Week 24 - Patient Question | 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. | 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 non-missing results were included in the analysis. | Posted | Count of Participants | Participants | Acceptability was assessed at Week 24 |
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| Secondary | Participants Acceptability Based on the Size of Capsules at Week 24 - Investigator Question | 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. | Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication. | Posted | Count of Participants | Participants | Acceptability was assessed at Week 24 |
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| Secondary | Participants Acceptability Based on the Number of Capsules at Week 24 - Patient Question | 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. | 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 non-missing results were included in the analysis. | Posted | Count of Participants | Participants | Acceptability was assessed at Week 24 |
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| Secondary | Number of Participants With Occurrence of First Respiratory-related Hospitalization Over the Whole Trial | 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. | Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication. | Posted | Count of Participants | Participants | From first drug administration until the last drug intake + 28 days residual effect period (REP), up to 92.6 weeks |
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| Secondary | Number of Participants With Occurrence of First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over the Whole Trial | 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. | Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication. | Posted | Count of Participants | Participants | From first drug administration until the last drug intake + 28 days REP, up to 92.6 weeks |
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| Secondary | Number of Participants With Occurrence of Death Over the Whole Trial | 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. | Treated set (TS): The TS consisted of participants who were randomised to a treatment group and received at least one dose of study medication. | Posted | Count of Participants | Participants | From first drug administration until the last drug intake + 28 days REP, up to 92.6 weeks |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DBP: 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). 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. | 0 | 13 | 1 | 13 | 11 | 13 |
| EG001 | OLNP: Randomised to Placebo and Switched to Nintedanib | 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. | 0 | 11 | 2 | 11 | 11 | 11 |
| EG002 | DBP+OLNP: Randomised to Nintedanib (Nintedanib Exposure Period) | 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. | 0 | 26 | 5 | 26 | 26 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth development disorder | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Carbon dioxide increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Frontal lobe epilepsy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neurogenic shock | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right atrial hypertrophy | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Supernumerary teeth | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dental cyst | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malpositioned teeth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth deposit | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth development disorder | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Multiple allergies | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal bacterial overgrowth | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| X-ray limb abnormal | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bruxism | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Menstruation delayed | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Melanosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
In the protocol it was planned to communicate the end of trial (EoT) once 30 participants had completed pharmacokinetic (PK) sampling at Week 26 or prematurely discontinued the trial and PK data was confirmed as adequate.
When the EoT was communicated, no participant had reached Week 100 yet, thus Week 100 time points were not assessable and the trial was completed as per protocol.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2022 | Nov 14, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| OG001 | DBP: Randomised to Nintedanib | This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP 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 (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. |
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| OG001 | 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. |
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| DBP: Randomised to Nintedanib |
This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP 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 (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. |
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| OG001 | 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. |
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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. |
| OG002 | 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. |
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| OG001 | DBP: Randomised to Nintedanib | This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP 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 (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. |
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| OG001 | 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 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. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake. |
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| OG001 | 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. |
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| OG001 | DBP: Randomised to Nintedanib | This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP 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 (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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | DBP: Randomised to Nintedanib | This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP 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 (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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | DBP: Randomised to Nintedanib | This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP 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 (DBP). 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | DBP: 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 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. |
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| OG001 | 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. |
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| OG001 | DBP: Randomised to Nintedanib | This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP 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 (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. |
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| OG001 | 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. |
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| OG001 | DBP: Randomised to Nintedanib | This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP 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 (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. |
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| OG001 | 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. |
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| OG001 | DBP: Randomised to Nintedanib | This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP 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 (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. |
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| OG001 | 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. |
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| OG001 | DBP: Randomised to Nintedanib | This arm shows Nintedanib randomised participants treated orally with Nintedanib in the DBP 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 (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. |
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| OG001 | DBP+OLNP: Randomised 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). DBP: Planned was from first randomised trial drug intake to last blinded drug intake, up to 24 weeks. OLNP: Planned was from first open-label Nintedanib intake to last open-label Nintedanib intake. |
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| OG001 | DBP: Randomised to Nintedanib - Capsule Size of 25 mg Capsule | This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 25 milligram (mg) with a capsule size of 5 millimeter (mm) diameter and 8 mm length, oval 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 50 milligram (mg) [2 capsules with strength 25 mg], 75 mg [3 capsules with strength 25 mg], 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. |
| OG002 | DBP: Randomised to Placebo - Capsule Size of 100 mg Capsule | This arm shows placebo randomised participants treated orally with placebo 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 placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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| OG001 | DBP: Randomised to Nintedanib - Capsule Size of 25 mg Capsule | This arm shows Nintedanib randomised participants treated orally with Nintedanib soft capsules of 25 milligram (mg) with a capsule size of 5 millimeter (mm) diameter and 8 mm length, oval 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 50 milligram (mg) [2 capsules with strength 25 mg], 75 mg [3 capsules with strength 25 mg], 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. |
| OG002 | DBP: Randomised to Placebo - Capsule Size of 100 mg Capsule | This arm shows placebo randomised participants treated orally with placebo 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 placebo only (DBP). DBP: Planned was from first randomised trial drug intake to last blinded drug intake. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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| OG001 | DBP: Randomised to Nintedanib - 2 Capsules | This arm shows Nintedanib randomised participants treated orally with 1 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 [1 capsule with strength 100 mg] or 150 mg [1 capsule 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. |
| OG002 | DBP: Randomised to Placebo - 4 Capsules | This arm shows placebo randomised participants treated orally with 2 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], based on the participant's weight at baseline (= 0 weeks). 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. |
| OG003 | DBP: Randomised to Nintedanib - 4 Capsules | This arm shows Nintedanib randomised participants treated orally with 2 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 50 milligram (mg) [2 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. |
| OG004 | 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 75 mg [3 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. |
| OG005 | 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 75 mg [3 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 (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. |
| OG006 | 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. |
| OG007 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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