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Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01619085
Recruitment Status : Active, not recruiting
First Posted : June 14, 2012
Results First Posted : July 25, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Intervention Drug: BIBF 1120
Enrollment 752
Recruitment Details This was a prospective, open-label extension trial in which patients with Idiopathic pulmonary fibrosis (IPF), who had completed 52 weeks of treatment and the follow-up period of the randomised, double-blind, placebo-controlled parent trials.
Pre-assignment Details Treatment received in parent trials was unknown until completed and databases had been locked and unblinded. Patients were to receive nintedanib 150 mg unless they had reduced the trial drug dose to 100 mg in the parent trials, patients receiving 100 mg trial drug at the end of the parent trials could receive either nintedanib 100 mg or 150 mg.
Arm/Group Title Nintedanib 100 mg/150 mg
Hide Arm/Group Description Patients were to receive soft gelatin capsules of nintedanib (orally) 150 mg twice daily (bid) unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or 150 mg bid . After unblinding of the parent trials, patients randomised to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid. The dose could also be increased to 150 mg at a later time point if medically justified.
Period Title: Overall Study
Started 735 [1]
Completed 366 [2]
Not Completed 369
Reason Not Completed
Adverse Event             212
Protocol Violation             10
Lost to Follow-up             10
Withdrawal by Subject             15
Other than specified             94
Not treated             1
Ongoing on trial             27
[1]
27 patients were ongoing on trial at database lock. 1 patient was not treated with trial drugs.
[2]
Total 341 patients did not complete the trial.
Arm/Group Title Nintedanib 100 mg/150 mg
Hide Arm/Group Description Patients were to receive soft gelatin capsules of nintedanib (orally) 150 mg twice daily (bid) unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or 150 mg bid . After unblinding of the parent trials, patients randomised to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid. The dose could also be increased to 150 mg at a later time point if medically justified.
Overall Number of Baseline Participants 734
Hide Baseline Analysis Population Description
Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose.
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 734 participants
67.2  (7.8)
[1]
Measure Description: Age of all patients included in the trial
[2]
Measure Analysis Population Description: Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose.
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 734 participants
Female
147
  20.0%
Male
587
  80.0%
[1]
Measure Description: Gender distribution of all patients included in the trial.
[2]
Measure Analysis Population Description: Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose.
Race (NIH/OMB)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 734 participants
American Indian or Alaska Native
1
   0.1%
Asian
214
  29.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   0.3%
White
431
  58.7%
More than one race
0
   0.0%
Unknown or Not Reported
86
  11.7%
[1]
Measure Description: Race of all patients included in the trial. Ethnicity data was not collected in the Case Report Form (CRF).
[2]
Measure Analysis Population Description: Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose
1.Primary Outcome
Title Incidence of Adverse Events (AE)
Hide Description This is the measure for percentage of patients with adverse events observed during the trial. The incidence of AEs (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.
Time Frame From first drug administration until treatment period, in total up to 56.3 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose.
Arm/Group Title Nintedanib 100 mg/150 mg
Hide Arm/Group Description:
Patients were to receive soft gelatin capsules of nintedanib (orally) 150 mg twice daily (bid) unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or 150 mg bid . After unblinding of the parent trials, patients randomised to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid. The dose could also be increased to 150 mg at a later time point if medically justified.
Overall Number of Participants Analyzed 734
Measure Type: Number
Unit of Measure: Percentage of patients (%)
Any AE 98.5
AE's leading to discontinuation of trial drug 42.6
Serious AEs 68.9
Fatal AEs 23.8
Time Frame From first drug administration until treatment period, in total up to 56.3 months.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with the treatment. Treated set was used for AE assessment.
 
Arm/Group Title Nintedanib 100 mg/150 mg
Hide Arm/Group Description Patients were to receive soft gelatin capsules of nintedanib (orally) 150 mg twice daily (bid) unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or 150 mg bid . After unblinding of the parent trials, patients randomised to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid. The dose could also be increased to 150 mg at a later time point if medically justified.
All-Cause Mortality
Nintedanib 100 mg/150 mg
Affected / at Risk (%)
Total   175/734 (23.84%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nintedanib 100 mg/150 mg
Affected / at Risk (%)
Total   506/734 (68.94%) 
Blood and lymphatic system disorders   
Anaemia  1  2/734 (0.27%) 
Disseminated intravascular coagulation  1  1/734 (0.14%) 
Febrile neutropenia  1  1/734 (0.14%) 
Haemorrhagic anaemia  1  1/734 (0.14%) 
Thrombocytopenia  1  2/734 (0.27%) 
Cardiac disorders   
Acute coronary syndrome  1  2/734 (0.27%) 
Acute myocardial infarction  1  6/734 (0.82%) 
Angina pectoris  1  5/734 (0.68%) 
Angina unstable  1  1/734 (0.14%) 
Arrhythmia  1  1/734 (0.14%) 
Arteriosclerosis coronary artery  1  1/734 (0.14%) 
Atrial fibrillation  1  9/734 (1.23%) 
Atrial flutter  1  1/734 (0.14%) 
Atrioventricular block complete  1  1/734 (0.14%) 
Bradycardia  1  3/734 (0.41%) 
Cardiac arrest  1  4/734 (0.54%) 
Cardiac failure  1  11/734 (1.50%) 
Cardiac failure acute  1  2/734 (0.27%) 
Cardiac failure congestive  1  7/734 (0.95%) 
Cardio-respiratory arrest  1  2/734 (0.27%) 
Cardiogenic shock  1  1/734 (0.14%) 
Cardiomyopathy  1  1/734 (0.14%) 
Conduction disorder  1  1/734 (0.14%) 
Cor pulmonale  1  8/734 (1.09%) 
Cor pulmonale chronic  1  1/734 (0.14%) 
Coronary artery disease  1  9/734 (1.23%) 
Coronary artery occlusion  1  1/734 (0.14%) 
Coronary artery stenosis  1  6/734 (0.82%) 
Cyanosis  1  1/734 (0.14%) 
Mitral valve incompetence  1  1/734 (0.14%) 
Myocardial infarction  1  4/734 (0.54%) 
Myocardial ischaemia  1  5/734 (0.68%) 
Myocarditis  1  1/734 (0.14%) 
Right ventricular failure  1  5/734 (0.68%) 
Tachycardia  1  3/734 (0.41%) 
Congenital, familial and genetic disorders   
Porokeratosis  1  1/734 (0.14%) 
Ear and labyrinth disorders   
Deafness  1  2/734 (0.27%) 
Deafness unilateral  1  1/734 (0.14%) 
Sudden hearing loss  1  1/734 (0.14%) 
Vestibular disorder  1  1/734 (0.14%) 
Endocrine disorders   
Thyroid mass  1  2/734 (0.27%) 
Eye disorders   
Amaurosis fugax  1  1/734 (0.14%) 
Blindness transient  1  1/734 (0.14%) 
Cataract  1  3/734 (0.41%) 
Dry age-related macular degeneration  1  1/734 (0.14%) 
Glaucoma  1  1/734 (0.14%) 
Optic ischaemic neuropathy  1  1/734 (0.14%) 
Panophthalmitis  1  1/734 (0.14%) 
Periorbital fat herniation  1  1/734 (0.14%) 
Posterior capsule opacification  1  1/734 (0.14%) 
Retinal artery occlusion  1  1/734 (0.14%) 
Retinal detachment  1  2/734 (0.27%) 
Retinal vein occlusion  1  1/734 (0.14%) 
Vision blurred  1  1/734 (0.14%) 
Gastrointestinal disorders   
Abdominal pain  1  3/734 (0.41%) 
Abdominal pain upper  1  2/734 (0.27%) 
Anal fistula  1  1/734 (0.14%) 
Anal haemorrhage  1  1/734 (0.14%) 
Ascites  1  1/734 (0.14%) 
Colitis  1  2/734 (0.27%) 
Constipation  1  2/734 (0.27%) 
Diarrhoea  1  10/734 (1.36%) 
Duodenal ulcer  1  2/734 (0.27%) 
Dyspepsia  1  1/734 (0.14%) 
Dysphagia  1  1/734 (0.14%) 
Enteritis  1  1/734 (0.14%) 
Enterocolitis  1  2/734 (0.27%) 
Erosive oesophagitis  1  1/734 (0.14%) 
Gastritis  1  1/734 (0.14%) 
Gastrointestinal haemorrhage  1  4/734 (0.54%) 
Haematochezia  1  1/734 (0.14%) 
Haemorrhoids  1  4/734 (0.54%) 
Ileus  1  2/734 (0.27%) 
Inguinal hernia  1  4/734 (0.54%) 
Inguinal hernia, obstructive  1  1/734 (0.14%) 
Intestinal obstruction  1  1/734 (0.14%) 
Large intestine perforation  1  1/734 (0.14%) 
Nausea  1  2/734 (0.27%) 
Obstruction gastric  1  1/734 (0.14%) 
Pancreatic pseudocyst  1  1/734 (0.14%) 
Pancreatitis  1  6/734 (0.82%) 
Pancreatitis acute  1  1/734 (0.14%) 
Pancreatitis necrotising  1  1/734 (0.14%) 
Protein-losing gastroenteropathy  1  1/734 (0.14%) 
Rectal haemorrhage  1  2/734 (0.27%) 
Small intestinal obstruction  1  1/734 (0.14%) 
Vomiting  1  2/734 (0.27%) 
General disorders   
Asthenia  1  2/734 (0.27%) 
Chest discomfort  1  1/734 (0.14%) 
Chest pain  1  11/734 (1.50%) 
Complication associated with device  1  1/734 (0.14%) 
Condition aggravated  1  3/734 (0.41%) 
Death  1  3/734 (0.41%) 
Disease progression  1  2/734 (0.27%) 
Gait disturbance  1  1/734 (0.14%) 
General physical health deterioration  1  2/734 (0.27%) 
Malaise  1  1/734 (0.14%) 
Multiple organ dysfunction syndrome  1  4/734 (0.54%) 
Oedema peripheral  1  1/734 (0.14%) 
Pyrexia  1  4/734 (0.54%) 
Sudden death  1  5/734 (0.68%) 
Vascular stent restenosis  1  1/734 (0.14%) 
Hepatobiliary disorders   
Bile duct stone  1  2/734 (0.27%) 
Biliary colic  1  1/734 (0.14%) 
Biliary dyskinesia  1  1/734 (0.14%) 
Cholangitis  1  1/734 (0.14%) 
Cholecystitis  1  3/734 (0.41%) 
Cholecystitis acute  1  6/734 (0.82%) 
Cholelithiasis  1  9/734 (1.23%) 
Drug-induced liver injury  1  1/734 (0.14%) 
Hepatic cirrhosis  1  2/734 (0.27%) 
Hepatic congestion  1  1/734 (0.14%) 
Hepatic function abnormal  1  2/734 (0.27%) 
Hepatitis  1  1/734 (0.14%) 
Hepatocellular injury  1  1/734 (0.14%) 
Liver disorder  1  2/734 (0.27%) 
Liver injury  1  2/734 (0.27%) 
Non-alcoholic steatohepatitis  1  1/734 (0.14%) 
Infections and infestations   
Bacteraemia  1  1/734 (0.14%) 
Biliary sepsis  1  1/734 (0.14%) 
Bronchitis  1  12/734 (1.63%) 
Bronchitis bacterial  1  1/734 (0.14%) 
Bronchopulmonary aspergillosis  1  1/734 (0.14%) 
Cellulitis  1  2/734 (0.27%) 
Cholecystitis infective  1  1/734 (0.14%) 
Diverticulitis  1  2/734 (0.27%) 
Enteritis infectious  1  1/734 (0.14%) 
Gastroenteritis  1  1/734 (0.14%) 
Gastroenteritis viral  1  2/734 (0.27%) 
Hepatitis A  1  1/734 (0.14%) 
Herpes simplex encephalitis  1  1/734 (0.14%) 
Herpes zoster  1  2/734 (0.27%) 
Infected cyst  1  1/734 (0.14%) 
Infectious colitis  1  1/734 (0.14%) 
Influenza  1  7/734 (0.95%) 
Intervertebral discitis  1  1/734 (0.14%) 
Lower respiratory tract infection  1  9/734 (1.23%) 
Lung infection  1  35/734 (4.77%) 
Oral fungal infection  1  1/734 (0.14%) 
Paraspinal abscess  1  1/734 (0.14%) 
Peritonitis  1  2/734 (0.27%) 
Pleural infection  1  1/734 (0.14%) 
Pneumocystis jirovecii pneumonia  1  2/734 (0.27%) 
Pneumonia  1  66/734 (8.99%) 
Pneumonia bacterial  1  5/734 (0.68%) 
Pneumonia influenzal  1  2/734 (0.27%) 
Postoperative abscess  1  2/734 (0.27%) 
Pulmonary mycosis  1  1/734 (0.14%) 
Pulmonary sepsis  1  1/734 (0.14%) 
Pulmonary tuberculosis  1  1/734 (0.14%) 
Pyelonephritis  1  2/734 (0.27%) 
Respiratory syncytial virus infection  1  1/734 (0.14%) 
Respiratory tract infection  1  13/734 (1.77%) 
Respiratory tract infection bacterial  1  1/734 (0.14%) 
Rhinovirus infection  1  1/734 (0.14%) 
Sepsis  1  8/734 (1.09%) 
Septic shock  1  3/734 (0.41%) 
Sinusitis  1  1/734 (0.14%) 
Spinal cord abscess  1  1/734 (0.14%) 
Subcutaneous abscess  1  1/734 (0.14%) 
Tinea capitis  1  1/734 (0.14%) 
Tuberculosis  1  1/734 (0.14%) 
Upper respiratory tract infection  1  7/734 (0.95%) 
Urinary tract infection  1  4/734 (0.54%) 
Urosepsis  1  1/734 (0.14%) 
Viral infection  1  1/734 (0.14%) 
Injury, poisoning and procedural complications   
Carbon monoxide poisoning  1  1/734 (0.14%) 
Cardiac valve replacement complication  1  1/734 (0.14%) 
Chest injury  1  1/734 (0.14%) 
Fall  1  6/734 (0.82%) 
Femoral neck fracture  1  1/734 (0.14%) 
Femur fracture  1  3/734 (0.41%) 
Head injury  1  1/734 (0.14%) 
Hip fracture  1  2/734 (0.27%) 
Hypobarism  1  1/734 (0.14%) 
Intentional overdose  1  1/734 (0.14%) 
Joint dislocation  1  1/734 (0.14%) 
Ligament rupture  1  1/734 (0.14%) 
Lumbar vertebral fracture  1  1/734 (0.14%) 
Post procedural haemorrhage  1  1/734 (0.14%) 
Postoperative delirium  1  1/734 (0.14%) 
Postoperative fever  1  1/734 (0.14%) 
Radiation pneumonitis  1  1/734 (0.14%) 
Rib fracture  1  4/734 (0.54%) 
Road traffic accident  1  3/734 (0.41%) 
Spinal compression fracture  1  1/734 (0.14%) 
Tendon rupture  1  2/734 (0.27%) 
Thoracic vertebral fracture  1  1/734 (0.14%) 
Traumatic haemothorax  1  1/734 (0.14%) 
Investigations   
Alanine aminotransferase increased  1  1/734 (0.14%) 
Aspartate aminotransferase increased  1  1/734 (0.14%) 
Blood alkaline phosphatase increased  1  1/734 (0.14%) 
Blood urea increased  1  1/734 (0.14%) 
Body temperature increased  1  2/734 (0.27%) 
C-reactive protein increased  1  2/734 (0.27%) 
Fibrin D dimer increased  1  1/734 (0.14%) 
Glycosylated haemoglobin increased  1  1/734 (0.14%) 
Hepatic enzyme increased  1  5/734 (0.68%) 
Transaminases increased  1  1/734 (0.14%) 
Weight decreased  1  2/734 (0.27%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/734 (0.14%) 
Dehydration  1  4/734 (0.54%) 
Diabetes mellitus  1  2/734 (0.27%) 
Diabetes mellitus inadequate control  1  1/734 (0.14%) 
Hyperglycaemia  1  1/734 (0.14%) 
Hyperkalaemia  1  1/734 (0.14%) 
Hypoglycaemia  1  2/734 (0.27%) 
Hyponatraemia  1  3/734 (0.41%) 
Hypophagia  1  1/734 (0.14%) 
Hypovolaemia  1  1/734 (0.14%) 
Malnutrition  1  2/734 (0.27%) 
Metabolic acidosis  1  1/734 (0.14%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/734 (0.14%) 
Arthritis  1  1/734 (0.14%) 
Back pain  1  2/734 (0.27%) 
Chondropathy  1  1/734 (0.14%) 
Exostosis  1  1/734 (0.14%) 
Groin pain  1  1/734 (0.14%) 
Intervertebral disc protrusion  1  3/734 (0.41%) 
Joint range of motion decreased  1  1/734 (0.14%) 
Osteoarthritis  1  3/734 (0.41%) 
Polymyalgia rheumatica  1  2/734 (0.27%) 
Rheumatoid arthritis  1  1/734 (0.14%) 
Spinal pain  1  1/734 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  8/734 (1.09%) 
Bladder cancer  1  1/734 (0.14%) 
Bladder cancer recurrent  1  1/734 (0.14%) 
Bladder neoplasm  1  1/734 (0.14%) 
Bowen's disease  1  3/734 (0.41%) 
Breast cancer  1  1/734 (0.14%) 
Cholangiocarcinoma  1  1/734 (0.14%) 
Hepatic neoplasm  1  2/734 (0.27%) 
Intraductal proliferative breast lesion  1  1/734 (0.14%) 
Lung adenocarcinoma  1  7/734 (0.95%) 
Lung cancer metastatic  1  1/734 (0.14%) 
Lung neoplasm  1  1/734 (0.14%) 
Lung neoplasm malignant  1  13/734 (1.77%) 
Malignant melanoma  1  1/734 (0.14%) 
Metastases to bone  1  3/734 (0.41%) 
Metastases to central nervous system  1  1/734 (0.14%) 
Metastases to eye  1  1/734 (0.14%) 
Metastases to liver  1  3/734 (0.41%) 
Metastatic squamous cell carcinoma  1  1/734 (0.14%) 
Mycosis fungoides  1  1/734 (0.14%) 
Myelodysplastic syndrome  1  2/734 (0.27%) 
Neuroendocrine carcinoma  1  1/734 (0.14%) 
Non-small cell lung cancer  1  3/734 (0.41%) 
Oesophageal carcinoma  1  1/734 (0.14%) 
Pleural neoplasm  1  1/734 (0.14%) 
Prostate cancer  1  5/734 (0.68%) 
Prostatic adenoma  1  1/734 (0.14%) 
Renal cancer  1  1/734 (0.14%) 
Sarcoma  1  1/734 (0.14%) 
Small cell lung cancer  1  6/734 (0.82%) 
Small intestine carcinoma  1  1/734 (0.14%) 
Squamous cell carcinoma  1  8/734 (1.09%) 
Squamous cell carcinoma of lung  1  2/734 (0.27%) 
Squamous cell carcinoma of skin  1  4/734 (0.54%) 
Tumour of ampulla of Vater  1  1/734 (0.14%) 
Nervous system disorders   
Balance disorder  1  1/734 (0.14%) 
Brain hypoxia  1  1/734 (0.14%) 
Carotid artery stenosis  1  2/734 (0.27%) 
Cerebral artery occlusion  1  1/734 (0.14%) 
Cerebral artery stenosis  1  1/734 (0.14%) 
Cerebral atrophy  1  1/734 (0.14%) 
Cerebral infarction  1  1/734 (0.14%) 
Cerebrovascular accident  1  3/734 (0.41%) 
Coma  1  1/734 (0.14%) 
Dizziness  1  2/734 (0.27%) 
Encephalopathy  1  1/734 (0.14%) 
Epilepsy  1  1/734 (0.14%) 
Hepatic encephalopathy  1  1/734 (0.14%) 
Ischaemic stroke  1  2/734 (0.27%) 
Lacunar infarction  1  1/734 (0.14%) 
Loss of consciousness  1  1/734 (0.14%) 
Neuropathy peripheral  1  1/734 (0.14%) 
Radiculopathy  1  1/734 (0.14%) 
Sciatica  1  1/734 (0.14%) 
Seizure  1  2/734 (0.27%) 
Syncope  1  9/734 (1.23%) 
Transient ischaemic attack  1  5/734 (0.68%) 
Psychiatric disorders   
Completed suicide  1  1/734 (0.14%) 
Confusional state  1  1/734 (0.14%) 
Delirium  1  2/734 (0.27%) 
Disorientation  1  2/734 (0.27%) 
Hallucination  1  1/734 (0.14%) 
Mental status changes  1  1/734 (0.14%) 
Suicide attempt  1  1/734 (0.14%) 
Renal and urinary disorders   
Acute kidney injury  1  7/734 (0.95%) 
Anuria  1  1/734 (0.14%) 
Azotaemia  1  1/734 (0.14%) 
Calculus urinary  1  1/734 (0.14%) 
Chronic kidney disease  1  1/734 (0.14%) 
Glomerulonephritis  1  1/734 (0.14%) 
Glomerulonephritis chronic  1  1/734 (0.14%) 
Haematuria  1  1/734 (0.14%) 
Lower urinary tract symptoms  1  1/734 (0.14%) 
Nephrolithiasis  1  1/734 (0.14%) 
Obstructive nephropathy  1  1/734 (0.14%) 
Prerenal failure  1  1/734 (0.14%) 
Renal colic  1  1/734 (0.14%) 
Renal failure  1  5/734 (0.68%) 
Ureterolithiasis  1  1/734 (0.14%) 
Urethral stenosis  1  1/734 (0.14%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  4/734 (0.54%) 
Genital prolapse  1  1/734 (0.14%) 
Ovarian cyst  1  1/734 (0.14%) 
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema  1  1/734 (0.14%) 
Acute respiratory distress syndrome  1  1/734 (0.14%) 
Acute respiratory failure  1  15/734 (2.04%) 
Bronchopleural fistula  1  1/734 (0.14%) 
Chronic obstructive pulmonary disease  1  2/734 (0.27%) 
Chronic respiratory failure  1  3/734 (0.41%) 
Cough  1  5/734 (0.68%) 
Dyspnoea  1  38/734 (5.18%) 
Dyspnoea exertional  1  3/734 (0.41%) 
Haemoptysis  1  4/734 (0.54%) 
Hypercapnia  1  2/734 (0.27%) 
Hypoxia  1  13/734 (1.77%) 
Idiopathic pulmonary fibrosis  1  152/734 (20.71%) 
Interstitial lung disease  1  8/734 (1.09%) 
Lung disorder  1  3/734 (0.41%) 
Nasal polyps  1  1/734 (0.14%) 
Pleurisy  1  2/734 (0.27%) 
Pneumomediastinum  1  2/734 (0.27%) 
Pneumonia aspiration  1  3/734 (0.41%) 
Pneumothorax  1  15/734 (2.04%) 
Pneumothorax spontaneous  1  1/734 (0.14%) 
Productive cough  1  1/734 (0.14%) 
Pulmonary arterial hypertension  1  11/734 (1.50%) 
Pulmonary congestion  1  2/734 (0.27%) 
Pulmonary embolism  1  17/734 (2.32%) 
Pulmonary fibrosis  1  11/734 (1.50%) 
Pulmonary granuloma  1  1/734 (0.14%) 
Pulmonary haemorrhage  1  1/734 (0.14%) 
Pulmonary hypertension  1  48/734 (6.54%) 
Pulmonary infarction  1  1/734 (0.14%) 
Pulmonary mass  1  2/734 (0.27%) 
Pulmonary oedema  1  4/734 (0.54%) 
Respiratory acidosis  1  1/734 (0.14%) 
Respiratory arrest  1  1/734 (0.14%) 
Respiratory distress  1  2/734 (0.27%) 
Respiratory failure  1  33/734 (4.50%) 
Respiratory tract haemorrhage  1  1/734 (0.14%) 
Skin and subcutaneous tissue disorders   
Dermatitis  1  1/734 (0.14%) 
Subcutaneous emphysema  1  1/734 (0.14%) 
Urticaria  1  1/734 (0.14%) 
Surgical and medical procedures   
Knee arthroplasty  1  1/734 (0.14%) 
Transurethral prostatectomy  1  1/734 (0.14%) 
Vascular disorders   
Aortic dissection  1  1/734 (0.14%) 
Aortic stenosis  1  3/734 (0.41%) 
Arterial thrombosis  1  1/734 (0.14%) 
Deep vein thrombosis  1  3/734 (0.41%) 
Hypotension  1  1/734 (0.14%) 
Orthostatic hypotension  1  2/734 (0.27%) 
Peripheral arterial occlusive disease  1  1/734 (0.14%) 
Peripheral artery occlusion  1  1/734 (0.14%) 
Peripheral ischaemia  1  1/734 (0.14%) 
Shock  1  2/734 (0.27%) 
Thrombosis  1  1/734 (0.14%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nintedanib 100 mg/150 mg
Affected / at Risk (%)
Total   669/734 (91.14%) 
Gastrointestinal disorders   
Abdominal pain  1  63/734 (8.58%) 
Abdominal pain upper  1  48/734 (6.54%) 
Constipation  1  57/734 (7.77%) 
Diarrhoea  1  514/734 (70.03%) 
Nausea  1  146/734 (19.89%) 
Vomiting  1  89/734 (12.13%) 
General disorders   
Asthenia  1  39/734 (5.31%) 
Chest pain  1  39/734 (5.31%) 
Fatigue  1  68/734 (9.26%) 
Oedema peripheral  1  50/734 (6.81%) 
Pyrexia  1  42/734 (5.72%) 
Infections and infestations   
Bronchitis  1  145/734 (19.75%) 
Lower respiratory tract infection  1  40/734 (5.45%) 
Respiratory tract infection  1  46/734 (6.27%) 
Rhinitis  1  39/734 (5.31%) 
Upper respiratory tract infection  1  108/734 (14.71%) 
Viral upper respiratory tract infection  1  146/734 (19.89%) 
Investigations   
Weight decreased  1  122/734 (16.62%) 
Metabolism and nutrition disorders   
Decreased appetite  1  103/734 (14.03%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  38/734 (5.18%) 
Back pain  1  57/734 (7.77%) 
Nervous system disorders   
Dizziness  1  48/734 (6.54%) 
Headache  1  42/734 (5.72%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  165/734 (22.48%) 
Dyspnoea  1  118/734 (16.08%) 
Idiopathic pulmonary fibrosis  1  80/734 (10.90%) 
Vascular disorders   
Hypertension  1  49/734 (6.68%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01619085     History of Changes
Other Study ID Numbers: 1199.33
2011-002766-21 ( EudraCT Number )
First Submitted: June 6, 2012
First Posted: June 14, 2012
Results First Submitted: July 2, 2018
Results First Posted: July 25, 2018
Last Update Posted: January 30, 2019