Trial Outcomes & Findings for Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy (NCT NCT02300298)
NCT ID: NCT02300298
Last Updated: 2025-02-11
Results Overview
DLT was defined as any of the following study drug related adverse events (AEs): * Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 non-haematological toxicity except transient electrolyte abnormality and isolated increase of gamma-glutamyltransferase (GGT); gastrointestinal toxicity, despite adequate supportive care * CTCAE grade 4 haematological toxicity; Neutrophil count decreased or white blood cell count (not associated with fever) for \>7 days despite adequate supportive treatment * CTCAE grade 4 febrile neutropenia with fever ≥38.5 degrees * CTCAE grade ≥2 alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increase in conjunction with CTCAE grade ≥2 total bilirubin increase * Inability to resume nintedanib dosing within 14 days after stopping Investigators judged clinically as DLT after dose reduction and severity medically notable (CTCAE, version 3). Sponsor with safety review committee was allowed to confirm the adequacy of this judgment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Cycle 1, from first administration of study medication up to 21 days thereafter.
Results posted on
2025-02-11
Participant Flow
This is a single arm study but it was allowed to discontinue the docetaxel treatment and continue the nintedanib treatment.
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that they (the patient) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
Participant milestones
| Measure |
Nintedanib Plus Docetaxel (Patient Disposition for Nintedanib)
The patient received 2\*100 milligram (mg) twice daily (b.i.d.) of nintedanib. Nintedanib was administered orally in a soft gelatine capsule. It was allowed to reduce the daily dose to 150 mg b.i.d. or 100 mg b.i.d. No dose increase was allowed after a dose reduction.
Once every 21 days 75 milligram (mg)/ square meters (m²) of docetaxel was administered intravenous (over one hour). It was also allowed to reduce the dose of this intravenous infusion to 60 mg/m² or 50 mg/m². Thereafter it was not allowed to increase the dose again.
|
Nintedanib Plus Docetaxel (Patient Disposition for Docetaxel)
The patient received 2\*100 milligram (mg) b.i.d. of nintedanib. Nintedanib was administered orally in a soft gelatine capsule. It was allowed to reduce the daily dose to 150 mg b.i.d. or 100 mg b.i.d. No dose increase was allowed after a dose reduction.
Once every 21 days 75 milligram (mg)/ square meters (m²) of docetaxel was administered intravenous (over one hour). It was also allowed to reduce the dose of this intravenous infusion to 60 mg/m² or 50 mg/m². Thereafter it was not allowed to increase the dose again.
|
|---|---|---|
|
Disposition for Nintedanib
STARTED
|
10
|
0
|
|
Disposition for Nintedanib
COMPLETED
|
0
|
0
|
|
Disposition for Nintedanib
NOT COMPLETED
|
10
|
0
|
|
Disposition for Docetaxel
STARTED
|
0
|
10
|
|
Disposition for Docetaxel
COMPLETED
|
0
|
0
|
|
Disposition for Docetaxel
NOT COMPLETED
|
0
|
10
|
Reasons for withdrawal
| Measure |
Nintedanib Plus Docetaxel (Patient Disposition for Nintedanib)
The patient received 2\*100 milligram (mg) twice daily (b.i.d.) of nintedanib. Nintedanib was administered orally in a soft gelatine capsule. It was allowed to reduce the daily dose to 150 mg b.i.d. or 100 mg b.i.d. No dose increase was allowed after a dose reduction.
Once every 21 days 75 milligram (mg)/ square meters (m²) of docetaxel was administered intravenous (over one hour). It was also allowed to reduce the dose of this intravenous infusion to 60 mg/m² or 50 mg/m². Thereafter it was not allowed to increase the dose again.
|
Nintedanib Plus Docetaxel (Patient Disposition for Docetaxel)
The patient received 2\*100 milligram (mg) b.i.d. of nintedanib. Nintedanib was administered orally in a soft gelatine capsule. It was allowed to reduce the daily dose to 150 mg b.i.d. or 100 mg b.i.d. No dose increase was allowed after a dose reduction.
Once every 21 days 75 milligram (mg)/ square meters (m²) of docetaxel was administered intravenous (over one hour). It was also allowed to reduce the dose of this intravenous infusion to 60 mg/m² or 50 mg/m². Thereafter it was not allowed to increase the dose again.
|
|---|---|---|
|
Disposition for Nintedanib
Progressive disease
|
10
|
0
|
|
Disposition for Docetaxel
Progressive disease
|
0
|
6
|
|
Disposition for Docetaxel
other adverse event
|
0
|
4
|
Baseline Characteristics
Treated Set
Baseline characteristics by cohort
| Measure |
Nintedanib Plus Docetaxel
n=10 Participants
The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
|
|---|---|
|
Age, Continuous
|
67.30 Years
STANDARD_DEVIATION 6.98 • n=99 Participants • Treated Set
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants • Treated Set
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants • Treated Set
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants • Treated Set
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants • Treated Set
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • Treated Set
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • Treated Set
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=99 Participants • Treated Set
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • Treated Set
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants • Treated Set
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants • Treated Set
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • Treated Set
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • Treated Set
|
PRIMARY outcome
Timeframe: Cycle 1, from first administration of study medication up to 21 days thereafter.Population: Treated set 2 included all patients who were dispensed study medication and were documented to have taken at least one dose of study treatment, except replaced patients according to the trial clinical protocol.
DLT was defined as any of the following study drug related adverse events (AEs): * Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 non-haematological toxicity except transient electrolyte abnormality and isolated increase of gamma-glutamyltransferase (GGT); gastrointestinal toxicity, despite adequate supportive care * CTCAE grade 4 haematological toxicity; Neutrophil count decreased or white blood cell count (not associated with fever) for \>7 days despite adequate supportive treatment * CTCAE grade 4 febrile neutropenia with fever ≥38.5 degrees * CTCAE grade ≥2 alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increase in conjunction with CTCAE grade ≥2 total bilirubin increase * Inability to resume nintedanib dosing within 14 days after stopping Investigators judged clinically as DLT after dose reduction and severity medically notable (CTCAE, version 3). Sponsor with safety review committee was allowed to confirm the adequacy of this judgment.
Outcome measures
| Measure |
Nintedanib Plus Docetaxel
n=10 Participants
The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
|
|---|---|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Total with DLTs - all grades
|
2 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Total with DLTs - grade 1/2
|
0 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Total with DLTs - grade 3/4/5
|
2 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Hepatobiliary disorders (hep. dis.) - all grades
|
1 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Hep. dis. - grade 1/2
|
1 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Hep. dis. - grade 3/4/5
|
0 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Hep. dis. - hyperbilirubinaemia - all grades
|
1 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Hep. dis. - hyperbilirubinaemia - grade 1/2
|
1 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Hep. dis. - hyperbilirubinaemia - grades 3/4/5
|
0 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Investigations (inv.) - all grades
|
2 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Inv. - grade 1/2
|
0 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Inv. - grade 3/4/5
|
2 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Inv. - ALT increased - all grades
|
2 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Inv. - ALT increased - grades 1/2
|
0 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Inv. - ALT increased - grades 3/4/5
|
2 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Inv. - AST increased - all grades
|
2 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Inv. - AST increased - grades 1/2
|
0 Participants
|
|
Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1
Inv. - AST increased - grades 3/4/5
|
2 Participants
|
SECONDARY outcome
Timeframe: At 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 h after first drug administration of docetaxel in cycle 1.Population: Pharmacokinetic set (PKS) included all patients in treated set who had at least one valid drug plasma concentration available. This patient set was used for the analysis of pharmacokinetics.
This outcome measure presents the maximum measured concentration (Cmax) of nintedanib in plasma in cycle 1.
Outcome measures
| Measure |
Nintedanib Plus Docetaxel
n=9 Participants
The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
|
|---|---|
|
Maximum Measured Concentration (Cmax) of Nintedanib
|
65.1 nanogram (ng)/ millilitre (mL)
Geometric Coefficient of Variation 86.6
|
SECONDARY outcome
Timeframe: just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)Population: PKS
This outcome measure presents the Cmax of docetaxel in plasma in cycles 1 and 2.
Outcome measures
| Measure |
Nintedanib Plus Docetaxel
n=10 Participants
The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
|
|---|---|
|
Cmax of Docetaxel
Cycle 1
|
2710 nanogram (ng)/ millilitre (mL)
Geometric Coefficient of Variation 37.6
|
|
Cmax of Docetaxel
Cycle 2
|
2680 nanogram (ng)/ millilitre (mL)
Geometric Coefficient of Variation 49.6
|
SECONDARY outcome
Timeframe: At 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 after first drug administration of docetaxel in cycle 1.Population: PKS
This outcome measure presents the area under the concentration-time curve of nintedanib over the time interval from 0 to time of the last quantifiable concentration in plasma (AUC0-tz) in cycle 1.
Outcome measures
| Measure |
Nintedanib Plus Docetaxel
n=9 Participants
The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
|
|---|---|
|
Area Under the Concentration-time Curve of Nintedanib Over the Time Interval From 0 to Time of the Last Quantifiable Concentration (AUC0-tz)
|
342 ng*h/mL
Geometric Coefficient of Variation 59.8
|
SECONDARY outcome
Timeframe: just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)Population: PKS
This outcome measure presents AUC0-tz of docetaxel in plasma in cycles 1 and 2.
Outcome measures
| Measure |
Nintedanib Plus Docetaxel
n=10 Participants
The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
|
|---|---|
|
AUC0-tz of Docetaxel
Cycle 2
|
3320 ng*h/mL
Geometric Coefficient of Variation 29.8
|
|
AUC0-tz of Docetaxel
Cycle 1
|
3080 ng*h/mL
Geometric Coefficient of Variation 27.4
|
SECONDARY outcome
Timeframe: at 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 h after first drug administration of docetaxel in cycle 1.Population: PKS
This outcome measure presents the Area under the concentration-time curve of nintedanib over the time interval from 0 extrapolated to infinity in plasma (AUC0-infinity) in cycle 1.
Outcome measures
| Measure |
Nintedanib Plus Docetaxel
n=8 Participants
The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
|
|---|---|
|
Area Under the Concentration-time Curve of Nintedanib Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
|
381 ng*h/mL
Geometric Coefficient of Variation 62.7
|
SECONDARY outcome
Timeframe: just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)Population: PKS
This outcome measure presents the AUC0-infinity of docetaxel in plasma in cycles 1 and 2.
Outcome measures
| Measure |
Nintedanib Plus Docetaxel
n=10 Participants
The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
|
|---|---|
|
AUC0-infinity of Docetaxel
Cycle 1
|
3320 ng*h/mL
Geometric Coefficient of Variation 26.2
|
|
AUC0-infinity of Docetaxel
Cycle 2
|
3590 ng*h/mL
Geometric Coefficient of Variation 26.6
|
Adverse Events
Nintedanib Plus Docetaxel
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nintedanib Plus Docetaxel
n=10 participants at risk
The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
|
|---|---|
|
General disorders
Fatigue
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Respiratory, thoracic and mediastinal disorders
Paraneoplastic pleural effusion
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
Other adverse events
| Measure |
Nintedanib Plus Docetaxel
n=10 participants at risk
The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Eye disorders
Eyelid ptosis
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Eye disorders
Lacrimation increased
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Eye disorders
Ocular hyperaemia
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Gastrointestinal disorders
Constipation
|
50.0%
5/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
5/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
General disorders
Face oedema
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
General disorders
Fatigue
|
40.0%
4/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
General disorders
Malaise
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
General disorders
Medical device site pain
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
General disorders
Mucosal inflammation
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
General disorders
Oedema peripheral
|
30.0%
3/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
General disorders
Pyrexia
|
30.0%
3/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Infections and infestations
Cystitis
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Infections and infestations
Gingivitis
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
Alanine aminotransferase increased
|
80.0%
8/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
Aspartate aminotransferase increased
|
70.0%
7/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
Blood creatinine increased
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
Blood sodium decreased
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
40.0%
4/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
Haemoglobin decreased
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
Lymphocyte count decreased
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
Neutrophil count decreased
|
100.0%
10/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Investigations
White blood cell count decreased
|
100.0%
10/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
4/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Nervous system disorders
Dysgeusia
|
30.0%
3/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.0%
4/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Psychiatric disorders
Insomnia
|
30.0%
3/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
90.0%
9/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Vascular disorders
Embolism
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Vascular disorders
Flushing
|
20.0%
2/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Vascular disorders
Vasculitis
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Ear and labyrinth disorders
Hypoacusis
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Gastrointestinal disorders
Chronic gastritis
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Nervous system disorders
Hypoaesthesia
|
40.0%
4/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
10.0%
1/10 • From the first administration of docetaxel up to 28 days after the day of the last administration of study medication (docetaxel and/or nintedanib) up to 1002 days
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER