Trial Outcomes & Findings for A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) (NCT NCT03820726)
NCT ID: NCT03820726
Last Updated: 2023-09-13
Results Overview
Number of participants with adverse events over the course of the extension trial, AEs defined as any untoward medical occurrence in a patient administered with the investigational product and which does not necessarily have to have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
435 participants
Primary outcome timeframe
From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Results posted on
2023-09-13
Participant Flow
A phase III, open label, extension trial. The study aimed to evaluate the long-term tolerability and safety of oral nintedanib treatment in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have completed (and did not prematurely discontinue trial medication in) the phase III parent trial, 1199.247 (INBUILD®) NCT02999178.
Only patients with PF-ILD who completed the parent trial (INBUILD®) on treatment (i.e., did not discontinue treatment early) were eligible and were included in this trial if they fulfilled all the inclusion criteria and did not present any of the exclusion criteria.
Participant milestones
| Measure |
Nintedanib
Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (\~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
|
|---|---|
|
Overall Study
STARTED
|
435
|
|
Overall Study
Treated
|
434
|
|
Overall Study
COMPLETED
|
224
|
|
Overall Study
NOT COMPLETED
|
211
|
Reasons for withdrawal
| Measure |
Nintedanib
Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (\~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
|
|---|---|
|
Overall Study
Other than listed
|
23
|
|
Overall Study
Withdrawal by Subject
|
37
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Protocol deviation
|
1
|
|
Overall Study
Adverse Event
|
146
|
|
Overall Study
Not treated
|
1
|
Baseline Characteristics
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Baseline characteristics by cohort
| Measure |
Nintedanib
n=434 Participants
Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (\~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
|
|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
223 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
328 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
279 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.Population: Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
Number of participants with adverse events over the course of the extension trial, AEs defined as any untoward medical occurrence in a patient administered with the investigational product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Nintedanib
n=434 Participants
Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (\~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
|
|---|---|
|
Number of Participants With Any Adverse Events
|
417 Participants
|
Adverse Events
Nintedanib
Serious events: 234 serious events
Other events: 371 other events
Deaths: 83 deaths
Serious adverse events
| Measure |
Nintedanib
n=434 participants at risk
Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (\~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Vascular disorders
Air embolism
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Vascular disorders
Aortic stenosis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Vascular disorders
Deep vein thrombosis
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Vascular disorders
Extremity necrosis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Vascular disorders
Neurogenic shock
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Vascular disorders
Peripheral ischaemia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Vascular disorders
Vein disorder
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Angina pectoris
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
7/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Atrial flutter
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Bradycardia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Cardiac arrest
|
0.92%
4/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Cardiac failure
|
1.6%
7/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Cardiac failure acute
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.2%
5/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Myocardial infarction
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Pericarditis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Prinzmetal angina
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Right ventricular failure
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Sinus arrest
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Eye disorders
Age-related macular degeneration
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Eye disorders
Cataract
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Eye disorders
Diplopia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Eye disorders
Glaucoma
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Eye disorders
Normal tension glaucoma
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Colitis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
5/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Faecaloma
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Ileus
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Melaena
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
General disorders
Asthenia
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
General disorders
Chest pain
|
0.92%
4/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
General disorders
Death
|
0.92%
4/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
General disorders
Disease progression
|
1.2%
5/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
General disorders
General physical health deterioration
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
General disorders
Impaired healing
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
General disorders
Pyrexia
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
General disorders
Sudden death
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Hepatobiliary disorders
Biliary colic
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Hepatobiliary disorders
Liver injury
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Abscess limb
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Anal abscess
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Appendicitis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Appendicitis perforated
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Atypical mycobacterial pneumonia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Bacterial infection
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Bronchitis
|
0.92%
4/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
COVID-19
|
2.8%
12/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
COVID-19 pneumonia
|
1.6%
7/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Chronic tonsillitis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Coronavirus infection
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Device related infection
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Diverticulitis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Enterococcal sepsis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Escherichia bacteraemia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Gastroenteritis
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Herpes zoster
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Infection
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Influenza
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Localised infection
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Peritonitis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Pneumonia
|
8.3%
36/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Pneumonia aspiration
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Pneumonia bacterial
|
0.92%
4/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
5/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Sepsis
|
0.92%
4/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Septic shock
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Urinary tract infection
|
0.92%
4/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Fall
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Injury
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Investigations
Alanine aminotransferase increased
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Investigations
Aspartate aminotransferase increased
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Investigations
Liver function test increased
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Investigations
Oxygen consumption increased
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Investigations
Platelet count decreased
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Investigations
Weight decreased
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Musculoskeletal and connective tissue disorders
Systemic scleroderma
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Nervous system disorders
Cerebral infarction
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
5/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Nervous system disorders
Ischaemic stroke
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Nervous system disorders
Lacunar infarction
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Nervous system disorders
Mental impairment
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Nervous system disorders
Vascular parkinsonism
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Psychiatric disorders
Confusional state
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Psychiatric disorders
Delirium
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Psychiatric disorders
Depression
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Renal and urinary disorders
Calculus urinary
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Renal and urinary disorders
IgA nephropathy
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Renal and urinary disorders
Pulmonary renal syndrome
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Renal and urinary disorders
Renal failure
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.5%
15/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
12/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity pneumonitis
|
1.4%
6/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic interstitial pneumonia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
8.1%
35/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.1%
9/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.69%
3/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
4.6%
20/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.2%
14/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.46%
2/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.9%
17/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.23%
1/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
Other adverse events
| Measure |
Nintedanib
n=434 participants at risk
Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (\~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
29/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.1%
22/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Constipation
|
5.3%
23/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Diarrhoea
|
59.0%
256/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Nausea
|
17.3%
75/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Gastrointestinal disorders
Vomiting
|
12.4%
54/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Bronchitis
|
11.1%
48/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
COVID-19
|
5.1%
22/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
38/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Respiratory tract infection
|
5.8%
25/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Infections and infestations
Urinary tract infection
|
6.5%
28/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Investigations
Alanine aminotransferase increased
|
9.9%
43/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Investigations
Aspartate aminotransferase increased
|
8.5%
37/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.1%
31/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Investigations
Weight decreased
|
15.9%
69/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.4%
45/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
24/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
30/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Nervous system disorders
Headache
|
7.1%
31/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.8%
73/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.1%
61/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.8%
25/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
|
Vascular disorders
Hypertension
|
6.2%
27/434 • From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER