A Phase I/II Open Label Extension Study of BIBF 1120 Admi... | NCT00715403 | Trialant
NCT00715403
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Dec 2, 2014Estimated
Enrollment
41Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
BIBF 1120
Countries
France
Germany
Protocol Section
Identification Module
NCT ID
NCT00715403
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1199.16
Secondary IDs
Not provided
Brief Title
A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120
Official Title
Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Nov 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2004
Primary Completion Date
Sep 2009Actual
Completion Date
Not provided
First Submitted Date
Jul 11, 2008
First Submission Date that Met QC Criteria
Jul 14, 2008
First Posted Date
Jul 15, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 14, 2014
Results First Submitted that Met QC Criteria
Nov 24, 2014
Results First Posted Date
Dec 2, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 24, 2014
Last Update Posted Date
Dec 2, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.
Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
41Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BIBF 1120
Drug
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1
All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2
All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3
All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4
All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5
All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Secondary Outcomes
Measure
Description
Time Frame
Clinically Relevant Abnormalities for Vital Signs
Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
From baseline until final follow-up, up to 991 days
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female patients with advanced solid tumours who have completed a previous study with BIBF 1120. The patients should not have progression of their underlying tumour disease unless there is evidence for significant clinical benefit (e.g. symptom improvement) from treatment with BIBF 1120.
Age 18 years or older
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score <= 2
Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation)
Exclusion Criteria:
Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks
Presence of drug related toxicity > grade 2 CTC from previous therapy with BIBF 1120 or presence of drug related continuous toxicity of grade 2 for seven or more consecutive days which would preclude ongoing chronic therapy with BIBF 1120
Active ulcers (gastro-intestinal tract, skin)
Major injuries and surgery within the past three weeks with incomplete wound healing
Hypersensitivity to BIBF 1120 or the excipients of the trial drug
Known secondary malignancy requiring therapy
Active infectious disease
Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable angina pectoris, history of myocardial infarction, congestive heart failure > NYHA II)
Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
Brain metastases requiring therapy
Absolute neutrophil count less than 1,500/mm3
Platelet count less than 100,000/mm3
Bilirubin greater than 1.5 mg/dl (> 26 µmol/L)
Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
Serum creatinine greater than 2 mg/dl (> 176 µmol/L)
Concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug
Patients who are sexually active and unwilling to use a medically acceptable method of contraception
Pregnancy or lactation
Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy (visit 2) or concomitantly with this trial (except for a previous study with BIBF 1120)
Patients unable to comply with the protocol
Active alcohol or drug abuse
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
1199.16.3306A Boehringer Ingelheim Investigational Site
Bordeaux
France
1199.16.3311A Boehringer Ingelheim Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
This was a multinational, open-label, uncontrolled, extension trial with Nintedanib in patients who had experienced a clinical benefit with Nintedanib (objective tumour response or disease stabilisation and/or symptom improvement) in either one out of five phase I or phase I/IIA clinical trials for advanced solid tumours at study entry.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily (QD) in the morning.
FG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
No data available
No data is available for this block.
From signing the informed consent until final follow-up, up to 991 days
Difference From Baseline for Liver Enzymes
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Bilirubin, Creatinine and Glucose
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Haemoglobin
Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From baseline until end of treatment, up to 991 days
Difference From Baseline for Haematology and Differentials Parameters
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Coagulation Parameters
Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Electrolytes
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)
Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29
Just before drug administration every 28±7 days after day 29
Unconfirmed Best Overall Response
Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).
PD = Progressive disease.
Baseline until end of treatment, up to 991 days
Unconfirmed Best Objective Response
Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Baseline until end of treatment, up to 991 days
Clinical Benefit
Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).
Baseline until end of treatment, up to 991 days
Confirmed Objective Response
Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Baseline until end of treatment, up to 991 days
Progression Free Survival
Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.
PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.
Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first.
First drug administration (in previous trial) until end of treatment, up to 1230 days
Clichy
France
1199.16.3311B Boehringer Ingelheim Investigational Site
Clichy
France
1199.16.3302A Boehringer Ingelheim Investigational Site
Paris
France
1199.16.3312A Boehringer Ingelheim Investigational Site
Paris
France
1199.16.3313A Boehringer Ingelheim Investigational Site
Paris
France
1199.16.3313E Boehringer Ingelheim Investigational Site
Paris
France
1199.16.49001 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau
Germany
1199.16.49004 Boehringer Ingelheim Investigational Site
Großhansdorf
Germany
1199.16.49008 Boehringer Ingelheim Investigational Site
Tübingen
Germany
1199.16.49005 Boehringer Ingelheim Investigational Site
Wiesbaden
Germany
FG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily (BID).
FG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
FG004
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
FG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
FG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0039 subjects
FG0046 subjects
FG00519 subjects
FG0061 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0039 subjects
FG0046 subjects
FG00519 subjects
FG0061 subjects
Type
Comment
Reasons
Progressive disease
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0039 subjects
FG0045 subjects
FG00514 subjects
FG0061 subjects
Dose limiting Toxicity (DLT)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other Adverse Event than DLT
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other reason not defined above
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Treated set which comprised of all patients who received at least one dose of Nintedanib in both their previous Nintedanib trial and in this extension trial
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
BG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
BG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
BG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
BG004
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
BG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
BG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0024
BG0039
BG0046
BG00519
BG0061
BG00741
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00075.0(75 to 75)
BG00147.0(47 to 47)
BG00265.5(52 to 75)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1
All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Treated set
Posted
Number
percentage of participants
From signing the informed consent until final follow-up, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Dyspepsia
Title
Measurements
OG000100
OG0010
OG0020
OG003
Secondary
Clinically Relevant Abnormalities for Vital Signs
Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Treated set
Posted
Number
percentage of participants
From baseline until final follow-up, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Secondary
Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)
Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29
Treated set. No descriptive statistics could be calculated for the dosing groups 50 mg and 200 mg QD; 100 mg and 300 mg BID due to insufficient patients.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Just before drug administration every 28±7 days after day 29
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
Secondary
Unconfirmed Best Overall Response
Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).
PD = Progressive disease.
Treated set.
Posted
Number
percentage of participants
Baseline until end of treatment, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
Secondary
Unconfirmed Best Objective Response
Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Treated set.
Posted
Number
percentage of participants
Baseline until end of treatment, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
Secondary
Clinical Benefit
Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).
Treated set.
Posted
Number
percentage of participants
Baseline until end of treatment, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
Secondary
Confirmed Objective Response
Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Treated set.
Posted
Number
percentage of participants
Baseline until end of treatment, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
Secondary
Progression Free Survival
Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.
PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.
Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first.
Treated set. Data for category
Posted
Number
percentage of participants
First drug administration (in previous trial) until end of treatment, up to 1230 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Primary
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2
All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Treated set
Posted
Number
percentage of participants
From signing the informed consent until final follow-up, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Primary
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3
All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Treated set
Posted
Number
percentage of participants
From signing the informed consent until final follow-up, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Primary
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4
All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Treated set
Posted
Number
percentage of participants
From signing the informed consent until final follow-up, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Primary
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5
All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Treated set
Posted
Number
percentage of participants
From signing the informed consent until final follow-up, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Primary
Difference From Baseline for Liver Enzymes
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Treated set.
Posted
Median
Standard Error
U/L
From signing the informed consent until end of treatment, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Primary
Difference From Baseline for Bilirubin, Creatinine and Glucose
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Treated set.
Posted
Median
Standard Error
mg/dL
From signing the informed consent until end of treatment, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
Primary
Difference From Baseline for Haemoglobin
Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Treated set.
Posted
Median
Standard Error
g/dL
From baseline until end of treatment, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Primary
Difference From Baseline for Haematology and Differentials Parameters
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Treated set.
Posted
Median
Standard Error
10^9 /L
From signing the informed consent until end of treatment, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
Primary
Difference From Baseline for Coagulation Parameters
Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Treated set.
Posted
Median
Standard Error
sec
From signing the informed consent until end of treatment, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
Primary
Difference From Baseline for Electrolytes
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Treated set.
Posted
Median
Standard Error
mmol/L
From signing the informed consent until end of treatment, up to 991 days
ID
Title
Description
OG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
OG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
OG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Time Frame
From the first intake of trial medication until 28 days after last intake of medication, up to 1119 days
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
50mg QD
Patients were treated with 50 mg Nintedanib once daily in the morning.
0
1
1
1
EG001
200mg QD
Patients were treated with 200 mg Nintedanib once daily in the morning.
0
1
1
1
EG002
100mg BID
Patients were treated with 100 mg Nintedanib twice daily.
0
4
4
4
EG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
1
9
9
9
EG004
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
0
6
6
6
EG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
9
19
17
19
EG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
0
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG0030 affected9 at risk
EG0040 affected6 at risk
EG0052 affected19 at risk
EG0060 affected1 at risk
Ileus
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Subileus
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Osteolysis
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Convulsion
Nervous system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Sciatica
Nervous system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Renal failure
Renal and urinary disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG0030 affected9 at risk
EG0040 affected6 at risk
EG0051 affected19 at risk
EG0060 affected1 at risk
Lymphopenia
Blood and lymphatic system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Arrhythmia
Cardiac disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Vertigo
Ear and labyrinth disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Conjunctivitis
Eye disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Eye disorder
Eye disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Eye pain
Eye disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Eyelid oedema
Eye disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Visual impairment
Eye disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0021 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gastric disorder
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Tooth discolouration
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Adverse drug reaction
General disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Asthenia
General disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Chest pain
General disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Chills
General disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MEDDRA 12.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Oedema peripheral
General disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Xerosis
General disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypersensitivity
Immune system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Bronchitis
Infections and infestations
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Diarrhoea infectious
Infections and infestations
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Gastrointestinal infection
Infections and infestations
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MEDDRA 12.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Parotitis
Infections and infestations
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Viral infection
Infections and infestations
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MEDDRA 12.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Weight decreased
Investigations
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MEDDRA 12.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Balance disorder
Nervous system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dizziness
Nervous system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Sciatica
Nervous system disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Incontinence
Renal and urinary disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hot flush
Vascular disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Phlebitis superficial
Vascular disorders
MEDDRA 12.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C530716
nintedanib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
0 subjects
FG0052 subjects
FG0060 subjects
0 subjects
FG0051 subjects
FG0060 subjects
1 subjects
FG0051 subjects
FG0060 subjects
66.0
(52 to 78)
BG00463.5(45 to 74)
BG00566.0(41 to 80)
BG00667.0(67 to 67)
BG00766.0(41 to 80)
2
BG0032
BG0042
BG0051
BG0060
BG0078
Male
BG0001
BG0010
BG0022
BG0037
BG0044
BG00518
BG0061
BG00733
9
OG0046
OG00519
OG0061
11
OG0040
OG0050
OG0060
Fatigue
Title
Measurements
OG000100
OG0010
OG0020
OG00333
OG00417
OG0050
OG0060
Nasopharyngitis
Title
Measurements
OG000100
OG0010
OG0020
OG0030
OG00433
OG0055
OG0060
Anorexia
Title
Measurements
OG000100
OG0010
OG0020
OG00311
OG0040
OG00516
OG0060
Hyperhidrosis
Title
Measurements
OG000100
OG0010
OG0020
OG00311
OG0040
OG0055
OG0060
Diarrhoea
Title
Measurements
OG0000
OG001100
OG0020
OG00344
OG00450
OG00537
OG006100
Bronchitis
Title
Measurements
OG0000
OG001100
OG0020
OG0030
OG0040
OG0050
OG0060
Eye disorder
Title
Measurements
OG0000
OG0010
OG00225
OG0030
OG0040
OG0050
OG0060
Eyelid oedema
Title
Measurements
OG0000
OG0010
OG00225
OG0030
OG0040
OG0050
OG0060
Haemorrhoids
Title
Measurements
OG0000
OG0010
OG00225
OG0030
OG0040
OG0055
OG0060
Toothache
Title
Measurements
OG0000
OG0010
OG00225
OG0030
OG0040
OG0050
OG0060
Pyrexia
Title
Measurements
OG0000
OG0010
OG00225
OG00311
OG00417
OG0055
OG0060
Muscle spasms
Title
Measurements
OG0000
OG0010
OG00225
OG00311
OG0040
OG00511
OG0060
Neck pain
Title
Measurements
OG0000
OG0010
OG00225
OG0030
OG0040
OG0050
OG0060
Pain in extremity
Title
Measurements
OG0000
OG0010
OG00225
OG00311
OG00417
OG0055
OG0060
Vulvovaginal dryness
Title
Measurements
OG0000
OG0010
OG00225
OG0030
OG0040
OG0050
OG0060
Arrhythmia
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Nausea
Title
Measurements
OG0000
OG0010
OG0020
OG00333
OG00467
OG00521
OG0060
Vomiting
Title
Measurements
OG0000
OG0010
OG0020
OG00322
OG00433
OG0055
OG0060
Abdominal pain
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG00433
OG00511
OG0060
Gastrooesophageal reflux disease
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Tooth discolouration
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Asthenia
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG00433
OG0055
OG0060
Xerosis
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Gastrointestinal infection
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Bone pain
Title
Measurements
OG0000
OG0010
OG0020
OG00322
OG00417
OG0050
OG0060
Arthralgia
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG00450
OG0055
OG0060
Musculoskeletal chest pain
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Myalgia
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG006100
Dizziness
Title
Measurements
OG0000
OG0010
OG0020
OG00322
OG0040
OG0055
OG0060
Headache
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0055
OG0060
Anxiety
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Rales
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Nail disorder
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Rash
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Hot flush
Title
Measurements
OG0000
OG0010
OG0020
OG00311
OG0040
OG0050
OG0060
Vertigo
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG0050
OG0060
Constipation
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG00516
OG0060
Flatulence
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG00511
OG0060
Gastric disorder
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG0050
OG0060
Hypersensitivity
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG0050
OG0060
Viral infection
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG0050
OG0060
Musculoskeletal pain
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG0055
OG0060
Balance disorder
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG0050
OG0060
Carpal tunnel syndrome
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG0050
OG0060
Sciatica
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG0050
OG0060
Dysuria
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG0050
OG0060
Dyspnoea
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00433
OG0050
OG0060
Rash maculo-papular
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00417
OG0050
OG0060
Sinus tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Eye pain
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Visual impairment
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Abdominal distension
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Gastrointestinal haemorrhage
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Adverse drug reaction
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Chest pain
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Chills
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Hepatic pain
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Urinary tract infection
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Weight decreased
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG00511
OG0060
Hyperglycaemia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Muscular weakness
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG00511
OG0060
Back pain
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Joint swelling
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Dysgeusia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Peripheral sensory neuropathy
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Insomnia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG00511
OG0060
Haematuria
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Incontinence
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Cough
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Alopecia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Dry skin
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Pruritus
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Conjunctivitis
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG006100
Haemoptysis
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG006100
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
OG0050.0
OG0060.0
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0034
OG0042
OG0057
OG0060
Title
Denominators
Categories
Title
Measurements
OG0037.54± 48.3
OG00411.8± 33.5
OG00511.0± 48.5
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
Complete response
Title
Measurements
OG0000
OG001100
OG0020
OG0030
OG0040
OG0050
OG0060
Partial response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Stable disease
Title
Measurements
OG000100
OG0010
OG00275
OG003
Non-evaluable, clinically non-progressive disease
Title
Measurements
OG0000
OG0010
OG00225
OG003
PD or non-evaluable , clinically PD
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unknown
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
No
Title
Measurements
OG000100
OG0010
OG002100
OG00356
OG004100
OG00553
OG006100
Yes
Title
Measurements
OG0000
OG001100
OG0020
OG003
Unknown
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
No
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG00511
OG0060
Yes
Title
Measurements
OG000100
OG001100
OG002100
OG003
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
No
Title
Measurements
OG000100
OG0010
OG002100
OG00356
OG004100
OG00558
OG006100
Yes
Title
Measurements
OG0000
OG001100
OG0020
OG003
Unknown
Title
Measurements
OG0000
OG0010
OG0020
OG003
Patients were treated with 100 mg Nintedanib twice daily.
OG003
150mg BID
Patients were treated with 150 mg Nintedanib twice daily.
OG004
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
Progression (RECIST)
Title
Measurements
OG0000
OG001100
OG00225
OG00311
OG00433
OG00542
OG006100
Death
Title
Measurements
OG0000
OG0010
OG0020
OG003
No progressive disease (RECIST) or death
Title
Measurements
OG000100
OG0010
OG00275
OG003
Unknown
Title
Measurements
OG0000
OG0010
OG0020
OG003
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
Fatigue
Title
Measurements
OG0000
OG0010
OG0020
OG00322
OG0040
OG00511
OG0060
Anorexia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Diarrhoea
Title
Measurements
OG0000
OG0010
OG0020
OG003
Bronchitis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Nausea
Title
Measurements
OG0000
OG0010
OG0020
OG003
Vomiting
Title
Measurements
OG0000
OG0010
OG0020
OG003
Abdominal pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
Asthenia
Title
Measurements
OG0000
OG0010
OG00225
OG003
Gastrointestinal infection
Title
Measurements
OG0000
OG0010
OG0020
OG003
Bone pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
Arthralgia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Musculoskeletal chest pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
Headache
Title
Measurements
OG0000
OG0010
OG00225
OG003
Constipation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Flatulence
Title
Measurements
OG0000
OG0010
OG0020
OG003
Musculoskeletal pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sciatica
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dyspnoea
Title
Measurements
OG0000
OG0010
OG0020
OG003
Chest pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urinary tract infection
Title
Measurements
OG0000
OG0010
OG00225
OG003
Weight decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Back pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
Peripheral sensory neuropathy
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cough
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haemoptysis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Osteoarthritis
Title
Measurements
OG0000
OG0010
OG00225
OG003
Parotitis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Osteolysis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Abdominal pain upper
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gastrointestinal disorder
Title
Measurements
OG0000
OG0010
OG0020
OG003
Groin pain
Title
Measurements
OG0000
OG0010
OG0020
OG003
Anaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutropenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Oedema peripheral
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gamma-glutamyltransferase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dehydration
Title
Measurements
OG0000
OG0010
OG0020
OG003
Productive cough
Title
Measurements
OG0000
OG0010
OG0020
OG003
Deep vein thrombosis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Phlebitis superficial
Title
Measurements
OG0000
OG0010
OG0020
OG003
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
Gamma-glutamyltransferase increased
Title
Measurements
OG000100
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Diarrhoea
Title
Measurements
OG0000
OG0010
OG00225
OG003
Diarrhoea infectious
Title
Measurements
OG0000
OG0010
OG00225
OG003
Dyspnoea
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Constipation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haemorrhoids
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ileus
Title
Measurements
OG0000
OG0010
OG0020
OG003
Subileus
Title
Measurements
OG0000
OG0010
OG0020
OG003
Vomiting
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pneumonia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Convulsion
Title
Measurements
OG0000
OG0010
OG0020
OG003
Renal failure
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urinary tract obstruction
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pleural effusion
Title
Measurements
OG0000
OG0010
OG0020
OG003
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
Subdural Haematoma
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0060
Malignant neoplasm progression
Title
Measurements
OG0000
OG0010
OG0020
OG003
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00518
OG0061
Title
Denominators
Categories
Alkaline phosphatase
Title
Measurements
OG000127.0± 0.0
OG00111.9± 0.0
OG002-39.0± 70.5
OG003-21.2± 96.4
OG004-11.7± 81.0
OG00516.0± 180.9
OG0067.2± 0.0
Aspartate aminotransferase
Title
Measurements
OG00014.3± 0.0
OG00113.7± 0.0
OG0029.6± 18.0
OG003
Alanine aminotransferase
Title
Measurements
OG00010.6± 0.0
OG0016.6± 0.0
OG0020.6± 11.1
OG003
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00518
OG0061
Title
Denominators
Categories
Bilirubin (total)
Title
Measurements
OG0000.5± 0.0
OG0010.0± 0.0
OG0020.0± 0.2
OG0030.0± 0.3
OG0040.1± 0.1
OG0050.1± 0.3
OG0060.0± 0.0
Creatinine
Title
Measurements
OG000-0.1± 0.0
OG001-0.3± 0.0
OG0020.0± 0.2
OG003
Glucose (N=1,1,3,9,4,14,1)
Title
Measurements
OG000-60.0± 0.0
OG001-2.2± 0.0
OG00228.9± 126.1
OG003
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00518
OG0061
Title
Denominators
Categories
Title
Measurements
OG000-1.8± 0.0
OG0011.4± 0.0
OG0020.4± 2.3
OG0031.0± 1.3
OG0041.2± 0.7
OG005-0.2± 2.1
OG0061.1± 0.0
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00518
OG0061
Title
Denominators
Categories
Platelets
Title
Measurements
OG00042.2± 0.0
OG00111.1± 0.0
OG0021.0± 83.7
OG003-2.5± 25.2
OG004-38.1± 39.9
OG00511.2± 65.9
OG006-27.1± 0.0
White blood cell count
Title
Measurements
OG000-1.1± 0.0
OG001-0.7± 0.0
OG0020.2± 2.9
OG003
Lymphocytes (N=1,1,4,9,4,17,1)
Title
Measurements
OG000-0.6± 0.0
OG001-0.4± 0.0
OG002-0.1± 2.0
OG003
Neutrophils (N=1,1,4,9,6,17,1)
Title
Measurements
OG000-4.1± 0.0
OG001-4.7± 0.0
OG0020.9± 3.7
OG003
OG004
200mg BID
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0039
OG0046
OG00519
OG0061
Title
Denominators
Categories
PT-INR (N=1,1,3,7,5,14,1)
Title
Measurements
OG0000.1± 0.0
OG0010.1± 0.0
OG0020.3± 0.6
OG0030.1± 0.1
OG0040.2± 0.5
OG005-0.0± 0.1
OG0060.1± 0.0
Partial thromboplastin time (N=1,1,3,9,4,14,1)
Title
Measurements
OG0000.7± 0.0
OG0012.6± 0.0
OG002-3.6± 6.7
OG003
Patients were treated with 200 mg Nintedanib twice daily.
OG005
250mg BID
Patients were treated with 250 mg Nintedanib twice daily.
OG006
300mg BID
Patients were treated with 300 mg Nintedanib twice daily.