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Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)

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ClinicalTrials.gov Identifier: NCT01170065
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Fibrosis
Intervention Drug: BIBF 1120
Enrollment 198
Recruitment Details Treatment groups are displayed according to dose at randomisation in 1199.30 (NCT00514683).
Pre-assignment Details Patients were not randomised to study medication in trial 1199.35 but were to receive open-label nintedanib, either at the dose received in period 2 of parent trial 1199.30 (NCT00514683) or they could increase their dose to nintedanib 150 mg twice daily (bid) after implementation of protocol amendment 1.
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Hide Arm/Group Description Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid) Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid. Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
Period Title: Overall Study
Started 37 126 35
Completed 9 [1] 34 [1] 9 [1]
Not Completed 28 92 26
Reason Not Completed
Adverse Event             17             50             10
Lost to Follow-up             1             4             1
Consent withdrawn, not due to AE             2             4             2
Reason other than specified             3             8             3
Ongoing after planned observation time             5             26             10
[1]
Planned observation time is from first trial drug intake to follow-up visit
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg Total
Hide Arm/Group Description Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid) Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid. Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial. Total of all reporting groups
Overall Number of Baseline Participants 37 126 35 198
Hide Baseline Analysis Population Description
Treated set (TS): The treated set which included all patients who received at least 1 dose of open-label study medication in trial 1199.35
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 126 participants 35 participants 198 participants
64.2  (7.3) 65.4  (8.6) 65.2  (7.2) 65.2  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 126 participants 35 participants 198 participants
Female
14
  37.8%
36
  28.6%
7
  20.0%
57
  28.8%
Male
23
  62.2%
90
  71.4%
28
  80.0%
141
  71.2%
1.Primary Outcome
Title Annual Rate of Decline in Forced Vital Capacity (FVC)
Hide Description

Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.

For this endpoint reported means represent the adjusted rate.

Time Frame From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS): which included all patients in the treated set who provided baseline data (for the first trial visit) for at least 1 endpoint in trial 1199.35
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Hide Arm/Group Description:
Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
Overall Number of Participants Analyzed 37 126 35
Mean (Standard Error)
Unit of Measure: milliliters per year (mL/ yr)
-129.0  (29.47) -137.5  (14.60) -132.9  (28.22)
2.Secondary Outcome
Title Overall Survival
Hide Description

Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death.

For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm.

Time Frame From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Hide Arm/Group Description:
Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
Overall Number of Participants Analyzed 37 126 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.4
(16.8 to 58.0)
46.8
(35.3 to 58.4)
66.2
(46.9 to 85.5)
3.Secondary Outcome
Title Progression-Free Survival
Hide Description

Progression-free survival was defined as the time from the first nintedanib intake in trial 1199.35 to disease progression.

For presentation of progression-free survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment progression-free survival is calculated within each treatment arm.

Time Frame From first trial drug intake in 1199.35 to disease progression; up to 61.8 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Hide Arm/Group Description:
Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
Overall Number of Participants Analyzed 37 126 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.6
(0.0 to 22.0)
3.5
(0.0 to 7.4)
12.2
(0.0 to 24.9)
4.Secondary Outcome
Title Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease
Hide Description

Haemoglobin corrected DLCO decrease was a secondary endpoint for the trial. It was considered important that all investigators used the same method of testing and recording data at each visit for each patient.

Haemoglobin corrected DLCO was calculated for each patient using the following formulae:

Males: Hb corrected DLCO = measured DLCO x (10.22 + Hb concentration) / (1.7 x Hb concentration) Females: Hb corrected DLCO = measured DLCO x (9.38 + Hb concentration) / (1.7 x Hb concentration). Annual rate of decline in haemoglobin corrected diffusing capacity of the lung for carbon monoxide (DLCO) decrease is presented.

Time Frame From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Hide Arm/Group Description:
Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
Overall Number of Participants Analyzed 37 126 35
Mean (Standard Error)
Unit of Measure: mmol/min/kPa/yr
-0.4  (0.08) -0.3  (0.04) -0.2  (0.07)
5.Secondary Outcome
Title Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Hide Description

Percentage of patients with at least one acute idiopathic pulmonary fibrosis (IPF) exacerbation are presented.

An exacerbation was defined as otherwise unexplained clinical features occurring within

1 month including all of the following:

  • Progression of dyspnoea over several days to 4 weeks
  • New diffuse pulmonary infiltrates on chest X-ray and/or high-resolution computerised tomography (HRCT) Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit
  • A decrease in arterial oxygen partial pressure (PaO2) of ≥10 mmHg or PaO2/fraction of inspired oxygen (FiO2) of <225 mmHg since the last visit
  • Exclusion of infection based on routine clinical practice and microbiological studies
  • Absence of other contributory causes such as congestive heart failure, pulmonary embolism, etc.
Time Frame From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Hide Arm/Group Description:
Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
Overall Number of Participants Analyzed 37 126 35
Measure Type: Number
Unit of Measure: Percentage of participants
13.5 19.8 20.0
6.Secondary Outcome
Title Incidence of Patients With at Least One Acute IPF Exacerbation Over Time
Hide Description Incidence rate = (Patients with at least one acute IPF exacerbation / Total number of years at risk) x 100
Time Frame From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Hide Arm/Group Description:
Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
Overall Number of Participants Analyzed 37 126 35
Measure Type: Number
Unit of Measure: Exacerbations Per Year
6.1 7.6 7.8
7.Secondary Outcome
Title Time to First Acute IPF Exacerbation
Hide Description Due to rare events, the median of time to event is not calculable, thus Kaplan-Meier estimates (providing the percentage of patients without acute IPF exacerbation for a certain amount of time after treatment) and confidence intervals (using Greenwood variance formula) are reported and presented within each treatment arm as secondary endpoint.
Time Frame From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Hide Arm/Group Description:
Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
Overall Number of Participants Analyzed 37 126 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.7
(39.4 to 95.9)
68.6
(56.8 to 80.4)
73.5
(55.9 to 91.1)
8.Secondary Outcome
Title Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs
Hide Description Percentage of patients with at least one Adverse events (AEs), with investigator defined drug-related AEs, AEs leading to discontinuation of trial drug, serious AEs are presented
Time Frame From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Hide Arm/Group Description:
Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
Overall Number of Participants Analyzed 37 126 35
Measure Type: Number
Unit of Measure: Percentage of participants
AEs 100.0 99.2 97.1
Investigator defined drug-related AEs 70.3 65.9 54.3
AEs leading to discontinuation of trial drug 48.6 41.3 34.3
Serious AE 67.6 74.6 62.9
Time Frame From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Hide Arm/Group Description Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid) Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid. Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
All-Cause Mortality
Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/37 (67.57%)   94/126 (74.60%)   22/35 (62.86%) 
Cardiac disorders       
Acute coronary syndrome  1  0/37 (0.00%)  1/126 (0.79%)  1/35 (2.86%) 
Acute myocardial infarction  1  0/37 (0.00%)  3/126 (2.38%)  0/35 (0.00%) 
Angina unstable  1  0/37 (0.00%)  3/126 (2.38%)  0/35 (0.00%) 
Arrhythmia  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Atrial fibrillation  1  1/37 (2.70%)  2/126 (1.59%)  0/35 (0.00%) 
Bradycardia  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Bundle branch block  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Cardiac arrest  1  2/37 (5.41%)  1/126 (0.79%)  0/35 (0.00%) 
Cardiac disorder  1  0/37 (0.00%)  0/126 (0.00%)  2/35 (5.71%) 
Cardiac failure  1  0/37 (0.00%)  5/126 (3.97%)  1/35 (2.86%) 
Cardiac failure acute  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Cardio-respiratory arrest  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Cardiopulmonary failure  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Coronary artery disease  1  1/37 (2.70%)  1/126 (0.79%)  0/35 (0.00%) 
Coronary artery stenosis  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Myocardial infarction  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Myocardial ischaemia  1  0/37 (0.00%)  2/126 (1.59%)  1/35 (2.86%) 
Right ventricular failure  1  0/37 (0.00%)  2/126 (1.59%)  0/35 (0.00%) 
Ventricular tachycardia  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Gastrointestinal disorders       
Anal haemorrhage  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Diarrhoea  1  3/37 (8.11%)  2/126 (1.59%)  1/35 (2.86%) 
Diverticulum intestinal  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Dysphagia  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Gastric ulcer  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Gastrointestinal disorder  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Haemorrhoids  1  2/37 (5.41%)  1/126 (0.79%)  0/35 (0.00%) 
Inguinal hernia  1  0/37 (0.00%)  1/126 (0.79%)  1/35 (2.86%) 
Intestinal obstruction  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Intestinal perforation  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Lower gastrointestinal haemorrhage  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Nausea  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Oesophageal ulcer  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Umbilical hernia  1  0/37 (0.00%)  2/126 (1.59%)  0/35 (0.00%) 
Volvulus  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Vomiting  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
General disorders       
Chest pain  1  1/37 (2.70%)  2/126 (1.59%)  1/35 (2.86%) 
Death  1  1/37 (2.70%)  1/126 (0.79%)  0/35 (0.00%) 
Disease progression  1  0/37 (0.00%)  2/126 (1.59%)  0/35 (0.00%) 
General physical health deterioration  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Impaired healing  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Multi-organ failure  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Pyrexia  1  1/37 (2.70%)  1/126 (0.79%)  0/35 (0.00%) 
Sudden death  1  0/37 (0.00%)  2/126 (1.59%)  0/35 (0.00%) 
Infections and infestations       
Bacterial infection  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Bronchitis  1  1/37 (2.70%)  3/126 (2.38%)  1/35 (2.86%) 
Bronchopneumonia  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Chlamydial infection  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Escherichia urinary tract infection  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Fungal infection  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Gastroenteritis  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Gastroenteritis clostridial  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Herpes zoster  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Influenza  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Lower respiratory tract infection  1  0/37 (0.00%)  4/126 (3.17%)  1/35 (2.86%) 
Lower respiratory tract infection bacterial  1  0/37 (0.00%)  1/126 (0.79%)  1/35 (2.86%) 
Lung infection  1  1/37 (2.70%)  5/126 (3.97%)  3/35 (8.57%) 
Pneumonia  1  3/37 (8.11%)  6/126 (4.76%)  2/35 (5.71%) 
Pneumonia escherichia  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Respiratory tract infection  1  1/37 (2.70%)  4/126 (3.17%)  1/35 (2.86%) 
Sepsis  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Septic shock  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Urinary tract infection  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Urosepsis  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Injury, poisoning and procedural complications       
Cervical vertebral fracture  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Contusion  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Fall  1  3/37 (8.11%)  2/126 (1.59%)  1/35 (2.86%) 
Gastrointestinal stoma complication  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Hip fracture  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Meniscus injury  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Overdose  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Rib fracture  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Toxicity to various agents  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Investigations       
Pancreatic enzymes increased  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Troponin I  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Weight decreased  1  1/37 (2.70%)  2/126 (1.59%)  0/35 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Diabetes mellitus  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Hypoglycaemia  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Hyponatraemia  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Musculoskeletal and connective tissue disorders       
Arthropathy  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Back pain  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Exostosis  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Foot deformity  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Groin pain  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma of colon  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Basal cell carcinoma  1  0/37 (0.00%)  2/126 (1.59%)  0/35 (0.00%) 
Colon cancer  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Lung neoplasm malignant  1  2/37 (5.41%)  2/126 (1.59%)  0/35 (0.00%) 
Malignant neoplasm progression  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Metastases to liver  1  1/37 (2.70%)  2/126 (1.59%)  0/35 (0.00%) 
Metastases to lung  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Metastases to spine  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Non-small cell lung cancer  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Pancreatic carcinoma  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Renal neoplasm  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Squamous cell carcinoma  1  0/37 (0.00%)  3/126 (2.38%)  0/35 (0.00%) 
Squamous cell carcinoma of skin  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Thyroid cancer  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Nervous system disorders       
Cerebral infarction  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Cerebrovascular accident  1  0/37 (0.00%)  1/126 (0.79%)  1/35 (2.86%) 
Coma  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Dizziness  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Epilepsy  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Hemiplegia  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Ischaemic stroke  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Loss of consciousness  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Syncope  1  0/37 (0.00%)  3/126 (2.38%)  0/35 (0.00%) 
Transient ischaemic attack  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Tremor  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Psychiatric disorders       
Depression  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Suicide attempt  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Renal and urinary disorders       
Acute kidney injury  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Haematuria  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Nephrolithiasis  1  0/37 (0.00%)  2/126 (1.59%)  0/35 (0.00%) 
Urinary bladder polyp  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Urinary tract obstruction  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Acute respiratory failure  1  1/37 (2.70%)  2/126 (1.59%)  0/35 (0.00%) 
Bronchial hyperreactivity  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Bronchiectasis  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Bronchostenosis  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Bullous lung disease  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Dyspnoea  1  2/37 (5.41%)  11/126 (8.73%)  0/35 (0.00%) 
Hypoventilation  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Hypoxia  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Idiopathic pulmonary fibrosis  1  11/37 (29.73%)  41/126 (32.54%)  10/35 (28.57%) 
Lung consolidation  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Lung disorder  1  0/37 (0.00%)  1/126 (0.79%)  1/35 (2.86%) 
Pneumomediastinum  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Pneumothorax spontaneous  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Pulmonary arterial hypertension  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Pulmonary congestion  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Pulmonary embolism  1  1/37 (2.70%)  6/126 (4.76%)  1/35 (2.86%) 
Pulmonary fibrosis  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Pulmonary hypertension  1  0/37 (0.00%)  5/126 (3.97%)  1/35 (2.86%) 
Respiratory disorder  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Respiratory failure  1  1/37 (2.70%)  7/126 (5.56%)  1/35 (2.86%) 
Skin and subcutaneous tissue disorders       
Erythema multiforme  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Granuloma skin  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Vascular disorders       
Aortic aneurysm  1  0/37 (0.00%)  0/126 (0.00%)  1/35 (2.86%) 
Deep vein thrombosis  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Hypertension  1  0/37 (0.00%)  1/126 (0.79%)  1/35 (2.86%) 
Hypotension  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Orthostatic hypotension  1  1/37 (2.70%)  0/126 (0.00%)  0/35 (0.00%) 
Peripheral artery aneurysm  1  0/37 (0.00%)  1/126 (0.79%)  0/35 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Nintedanib 50 mg- 100 mg Nintedanib 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/37 (91.89%)   111/126 (88.10%)   32/35 (91.43%) 
Blood and lymphatic system disorders       
Anaemia  1  2/37 (5.41%)  1/126 (0.79%)  2/35 (5.71%) 
Cardiac disorders       
Atrial fibrillation  1  0/37 (0.00%)  1/126 (0.79%)  2/35 (5.71%) 
Ear and labyrinth disorders       
Vertigo  1  2/37 (5.41%)  1/126 (0.79%)  0/35 (0.00%) 
Eye disorders       
Cataract  1  2/37 (5.41%)  9/126 (7.14%)  3/35 (8.57%) 
Glaucoma  1  0/37 (0.00%)  1/126 (0.79%)  2/35 (5.71%) 
Gastrointestinal disorders       
Abdominal pain  1  2/37 (5.41%)  9/126 (7.14%)  4/35 (11.43%) 
Abdominal pain upper  1  2/37 (5.41%)  4/126 (3.17%)  0/35 (0.00%) 
Constipation  1  2/37 (5.41%)  11/126 (8.73%)  1/35 (2.86%) 
Diarrhoea  1  19/37 (51.35%)  68/126 (53.97%)  22/35 (62.86%) 
Frequent bowel movements  1  1/37 (2.70%)  0/126 (0.00%)  2/35 (5.71%) 
Gastrooesophageal reflux disease  1  3/37 (8.11%)  4/126 (3.17%)  2/35 (5.71%) 
Nausea  1  9/37 (24.32%)  22/126 (17.46%)  2/35 (5.71%) 
Vomiting  1  7/37 (18.92%)  17/126 (13.49%)  3/35 (8.57%) 
General disorders       
Chest pain  1  2/37 (5.41%)  10/126 (7.94%)  1/35 (2.86%) 
Condition aggravated  1  2/37 (5.41%)  0/126 (0.00%)  1/35 (2.86%) 
Fatigue  1  2/37 (5.41%)  9/126 (7.14%)  4/35 (11.43%) 
Influenza like illness  1  0/37 (0.00%)  0/126 (0.00%)  2/35 (5.71%) 
Hepatobiliary disorders       
Hepatic function abnormal  1  1/37 (2.70%)  2/126 (1.59%)  2/35 (5.71%) 
Infections and infestations       
Bronchitis  1  12/37 (32.43%)  27/126 (21.43%)  6/35 (17.14%) 
Cystitis  1  2/37 (5.41%)  2/126 (1.59%)  1/35 (2.86%) 
Gastroenteritis  1  0/37 (0.00%)  8/126 (6.35%)  4/35 (11.43%) 
Influenza  1  1/37 (2.70%)  9/126 (7.14%)  6/35 (17.14%) 
Lower respiratory tract infection  1  4/37 (10.81%)  12/126 (9.52%)  1/35 (2.86%) 
Nasopharyngitis  1  8/37 (21.62%)  24/126 (19.05%)  6/35 (17.14%) 
Pneumonia  1  2/37 (5.41%)  3/126 (2.38%)  1/35 (2.86%) 
Respiratory tract infection  1  3/37 (8.11%)  8/126 (6.35%)  3/35 (8.57%) 
Sinusitis  1  0/37 (0.00%)  9/126 (7.14%)  0/35 (0.00%) 
Tinea pedis  1  0/37 (0.00%)  0/126 (0.00%)  2/35 (5.71%) 
Tooth abscess  1  2/37 (5.41%)  2/126 (1.59%)  0/35 (0.00%) 
Tracheobronchitis  1  2/37 (5.41%)  2/126 (1.59%)  2/35 (5.71%) 
Upper respiratory tract infection  1  1/37 (2.70%)  10/126 (7.94%)  1/35 (2.86%) 
Urinary tract infection  1  2/37 (5.41%)  11/126 (8.73%)  1/35 (2.86%) 
Investigations       
Gamma-glutamyltransferase increased  1  2/37 (5.41%)  6/126 (4.76%)  0/35 (0.00%) 
Hepatic enzyme increased  1  2/37 (5.41%)  3/126 (2.38%)  0/35 (0.00%) 
Weight decreased  1  10/37 (27.03%)  29/126 (23.02%)  7/35 (20.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  6/37 (16.22%)  17/126 (13.49%)  2/35 (5.71%) 
Hypokalaemia  1  1/37 (2.70%)  3/126 (2.38%)  2/35 (5.71%) 
Hyponatraemia  1  0/37 (0.00%)  0/126 (0.00%)  2/35 (5.71%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/37 (5.41%)  4/126 (3.17%)  1/35 (2.86%) 
Back pain  1  2/37 (5.41%)  10/126 (7.94%)  1/35 (2.86%) 
Muscle spasms  1  2/37 (5.41%)  2/126 (1.59%)  1/35 (2.86%) 
Osteoporosis  1  0/37 (0.00%)  1/126 (0.79%)  2/35 (5.71%) 
Nervous system disorders       
Dizziness  1  4/37 (10.81%)  11/126 (8.73%)  2/35 (5.71%) 
Paraesthesia  1  0/37 (0.00%)  1/126 (0.79%)  2/35 (5.71%) 
Sciatica  1  0/37 (0.00%)  1/126 (0.79%)  3/35 (8.57%) 
Psychiatric disorders       
Anxiety  1  0/37 (0.00%)  4/126 (3.17%)  3/35 (8.57%) 
Depression  1  2/37 (5.41%)  4/126 (3.17%)  1/35 (2.86%) 
Insomnia  1  0/37 (0.00%)  2/126 (1.59%)  2/35 (5.71%) 
Renal and urinary disorders       
Haematuria  1  0/37 (0.00%)  3/126 (2.38%)  2/35 (5.71%) 
Proteinuria  1  1/37 (2.70%)  2/126 (1.59%)  2/35 (5.71%) 
Urinary retention  1  0/37 (0.00%)  0/126 (0.00%)  2/35 (5.71%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/37 (8.11%)  27/126 (21.43%)  4/35 (11.43%) 
Dyspnoea  1  5/37 (13.51%)  19/126 (15.08%)  3/35 (8.57%) 
Epistaxis  1  2/37 (5.41%)  8/126 (6.35%)  1/35 (2.86%) 
Idiopathic pulmonary fibrosis  1  0/37 (0.00%)  22/126 (17.46%)  3/35 (8.57%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  1/37 (2.70%)  7/126 (5.56%)  2/35 (5.71%) 
Rash  1  2/37 (5.41%)  3/126 (2.38%)  0/35 (0.00%) 
Vascular disorders       
Hypertension  1  0/37 (0.00%)  7/126 (5.56%)  3/35 (8.57%) 
Hypotension  1  0/37 (0.00%)  3/126 (2.38%)  2/35 (5.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01170065    
Other Study ID Numbers: 1199.35
2009-013788-21 ( EudraCT Number )
First Submitted: July 6, 2010
First Posted: July 27, 2010
Results First Submitted: September 25, 2017
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019