Trial Outcomes & Findings for A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON) (NCT NCT05285982)
NCT ID: NCT05285982
Last Updated: 2026-03-04
Results Overview
Number of patients with treatment-emergent adverse events (AEs) over the whole trial.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
54 participants
Primary outcome timeframe
From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Results posted on
2026-03-04
Participant Flow
Pediatric patients with clinically significant fibrosing Interstitial Lung Disease who completed the parent trial 1199-0337 or new patients who were eligible to enter this trial.
Only subjects that met all study eligibility criteria were to be entered. They were free to withdraw at any time for any reason given. Close monitoring was adhered to throughout trial conduct.
Participant milestones
| Measure |
Nintedanib
Pediatric patients with clinically significant fibrosing intestitial lung disease (ILD) who either completed the parent trial 1199-0337 or were new patients received nintedanib soft gelatine capsules. Nintedanib doses ranged from 50 milligrams (mg) bid (13.5 to \< 23 kilograms (kg) bodyweight) to 150 mg bid (\>=57.5 kg bodyweight).
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Nintedanib
Pediatric patients with clinically significant fibrosing intestitial lung disease (ILD) who either completed the parent trial 1199-0337 or were new patients received nintedanib soft gelatine capsules. Nintedanib doses ranged from 50 milligrams (mg) bid (13.5 to \< 23 kilograms (kg) bodyweight) to 150 mg bid (\>=57.5 kg bodyweight).
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Burden of trial procedures
|
2
|
|
Overall Study
Other treatment option available
|
2
|
|
Overall Study
Perceived lack of efficacy
|
2
|
|
Overall Study
Change of residence
|
1
|
|
Overall Study
No reason provided
|
1
|
|
Overall Study
Other than listed
|
9
|
Baseline Characteristics
A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)
Baseline characteristics by cohort
| Measure |
Nintedanib
n=54 Participants
Pediatric patients with clinically significant fibrosing intestitial lung disease (ILD) who either completed the parent trial 1199-0337 or were new patients received nintedanib soft gelatine capsules. Nintedanib doses ranged from 50 milligrams (mg) bid (13.5 to \< 23 kilograms (kg) bodyweight) to 150 mg bid (\>=57.5 kg bodyweight).
|
|---|---|
|
Age, Continuous
|
13.6 years
STANDARD_DEVIATION 3.3 • n=41 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.Population: Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
Number of patients with treatment-emergent adverse events (AEs) over the whole trial.
Outcome measures
| Measure |
Nintedanib
n=54 Participants
Pediatric patients with clinically significant fibrosing intestitial lung disease (ILD) who either completed the parent trial 1199-0337 or were new patients received nintedanib soft gelatine capsules. Nintedanib doses ranged from 50 milligrams (mg) bid (13.5 to \< 23 kilograms (kg) bodyweight) to 150 mg bid (\>=57.5 kg bodyweight).
|
|---|---|
|
Number of Patients With Treatment-emergent Adverse Events (AEs) Over the Whole Trial
|
53 Participants
|
Adverse Events
Nintedanib
Serious events: 24 serious events
Other events: 53 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Nintedanib
n=54 participants at risk
Pediatric patients with clinically significant fibrosing intestitial lung disease (ILD) who either completed the parent trial 1199-0337 or were new patients received nintedanib soft gelatine capsules. Nintedanib doses ranged from 50 milligrams (mg) bid (13.5 to \< 23 kilograms (kg) bodyweight) to 150 mg bid (\>=57.5 kg bodyweight).
|
|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Cardiac disorders
Atrial thrombosis
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Cardiac disorders
Right ventricular failure
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Eye disorders
Optic atrophy
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Gastric fistula
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Oesophageal hypomotility
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Tooth development disorder
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Hepatobiliary disorders
Hepatitis
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Immune system disorders
Transplant rejection
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Infection
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Pelvic abscess
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Pneumonia bacterial
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Respiratory tract infection
|
3.7%
2/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Skin infection
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Subcutaneous abscess
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Nervous system disorders
Headache
|
3.7%
2/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Psychiatric disorders
Suicidal ideation
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
2/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
7.4%
4/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.7%
2/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.7%
2/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Vascular disorders
Hypertension
|
1.9%
1/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
Other adverse events
| Measure |
Nintedanib
n=54 participants at risk
Pediatric patients with clinically significant fibrosing intestitial lung disease (ILD) who either completed the parent trial 1199-0337 or were new patients received nintedanib soft gelatine capsules. Nintedanib doses ranged from 50 milligrams (mg) bid (13.5 to \< 23 kilograms (kg) bodyweight) to 150 mg bid (\>=57.5 kg bodyweight).
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.5%
10/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Constipation
|
7.4%
4/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Dental caries
|
29.6%
16/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
48.1%
26/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Nausea
|
31.5%
17/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
38.9%
21/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
General disorders
Chest pain
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
General disorders
Fatigue
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
General disorders
Pyrexia
|
13.0%
7/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Bronchitis
|
13.0%
7/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
COVID-19
|
13.0%
7/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Gastroenteritis
|
7.4%
4/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Gastroenteritis viral
|
7.4%
4/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Influenza
|
11.1%
6/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
20.4%
11/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Pneumonia
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Respiratory tract infection
|
16.7%
9/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Rhinitis
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
12/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Infections and infestations
Viral infection
|
7.4%
4/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Investigations
Hepatic enzyme increased
|
9.3%
5/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Investigations
Weight decreased
|
14.8%
8/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
4/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
4/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Nervous system disorders
Dizziness
|
7.4%
4/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Nervous system disorders
Headache
|
24.1%
13/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Psychiatric disorders
Anxiety
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.6%
16/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
4/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
11.1%
6/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.0%
7/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
6/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
3/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
4/54 • From first drug administration until end of residual effect period (REP) 28 days after the last dose of trial medication, up to 1127 days.
Treated Set (TS): The TS included all patients who were administered at least 1 dose of trial medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER