Trial Outcomes & Findings for BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I (NCT NCT00876460)
NCT ID: NCT00876460
Last Updated: 2016-11-17
Results Overview
Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel. Maximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) \<1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
During the first treatment course, up to 3 weeks
Results posted on
2016-11-17
Participant Flow
43 patients entered.1 patient was replaced because he did not take any nintedanib(Nin) due to new brain metastasis after completion of first administration of docetaxel. Accordingly,42 patients treated with at least 1 dose of Nin in combination with docetaxel.Patients started mono therapy phase after discontinued from combination therapy phase .
In case a patient had to discontinue docetaxel for reasons other than progression disease, the patient could continue therapy with nintedanib if the patient had been treated with combination therapy with docetaxel during at least 4 treatment courses.
Participant milestones
| Measure |
Nintedanib 100 mg + Docetaxel 60 mg/m2
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Combination Therapy Phase
STARTED
|
3
|
7
|
3
|
6
|
7
|
3
|
8
|
6
|
|
Combination Therapy Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Combination Therapy Phase
NOT COMPLETED
|
3
|
7
|
3
|
6
|
7
|
3
|
8
|
6
|
|
Mono Therapy Phase
STARTED
|
0
|
1
|
0
|
1
|
2
|
0
|
1
|
3
|
|
Mono Therapy Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Mono Therapy Phase
NOT COMPLETED
|
0
|
1
|
0
|
1
|
2
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
Nintedanib 100 mg + Docetaxel 60 mg/m2
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Combination Therapy Phase
Progressive disease
|
2
|
3
|
3
|
3
|
3
|
1
|
1
|
1
|
|
Combination Therapy Phase
Dose limiting toxicity
|
0
|
1
|
0
|
1
|
1
|
2
|
2
|
1
|
|
Combination Therapy Phase
Adverse Event
|
0
|
2
|
0
|
2
|
2
|
0
|
3
|
2
|
|
Combination Therapy Phase
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Combination Therapy Phase
Other reason not defined above
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Combination Therapy Phase
Not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Mono Therapy Phase
Progressive disease
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
3
|
|
Mono Therapy Phase
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Mono Therapy Phase
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I
Baseline characteristics by cohort
| Measure |
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=7 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=3 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
n=6 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=7 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=3 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=7 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
n=5 Participants
|
68.0 years
n=7 Participants
|
64.0 years
n=5 Participants
|
65.0 years
n=4 Participants
|
63.0 years
n=21 Participants
|
62.0 years
n=8 Participants
|
64.0 years
n=8 Participants
|
61.5 years
n=24 Participants
|
63.5 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: During the first treatment course, up to 3 weeksPopulation: Treated set (Patients eligible for DLT confirmation)
Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel. Maximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) \<1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT.
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=6 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=3 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
n=6 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=3 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=6 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 daysPopulation: Treated set
Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=7 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=3 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
n=6 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=7 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=3 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=7 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
Grade 4
|
6 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
|
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)Population: Patients who were treated with nintedanib and had both baseline and at least one post-treatment tumour measurement by computed tomography (CT) image
Number of participants with objective response defined as complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=9 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=12 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
n=8 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Objective Tumor Response
Yes
|
—
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Objective Tumor Response
No
|
—
|
3 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)Population: Patients who treated with nintedanib and had both baseline and at least one post-treated tumour measurement by computed tomography (CT) image
Number of participants with disease control, defined as complete response (CR) or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=9 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=12 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
n=8 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Disease Control
Yes
|
—
|
2 Participants
|
5 Participants
|
12 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Disease Control
No
|
—
|
1 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)Population: Treated set
For participants with known date of progression or death (of any cause): PFS \[days\] = earlier of date of progression or death - date the study treatment started + 1. For participants known to be alive without progression by the end of trial or follow-up visit: PFS (censored) \[days\] = date of last imaging when the participant is known to be progression-free and alive - date the study treatment started + 1. Progression is assessed according to RECIST version 1.0.
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=10 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=13 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
n=10 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
—
|
229.5 Days
Interval 200.0 to 259.0
|
117.0 Days
Interval 36.0 to 267.0
|
139.0 Days
Interval 87.0 to 262.0
|
351.0 Days
Interval 131.0 to 614.0
|
184.0 Days
Interval 68.0 to 884.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)Population: Treated set
For participants with known date of discontinuation of the study treatment (or progression \[not necessarily confirmed by tumour imaging; can also be based on any clinical sign of tumour progression\] or death): TTF \[days\] = earlier of date of discontinuation of the study treatment, progression, or death - date the study treatment started + 1. For participants known to be alive without progression by the end of trial or follow-up visit: TTF (censored) \[days\] = date when the patient is known to be progression-free and alive - date the study treatment started + 1. Progression is assessed according to RECIST version 1.0.
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=10 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=13 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
n=10 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Treatment Failure (TTF)
|
—
|
200.0 Days
Interval 54.0 to 259.0
|
83.5 Days
Interval 10.0 to 187.0
|
134.0 Days
Interval 75.0 to 178.0
|
87.0 Days
Interval 8.0 to 212.0
|
176.0 Days
Interval 52.0 to 884.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 daysPopulation: Treated set
Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=7 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=3 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
n=6 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=7 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=3 Participants
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=7 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Alanine aminotransferase increased
|
5 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Aspartate aminotransferase increased
|
5 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood alkaline phosphatase increased
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Gamma-glutamyltransferase increased
|
4 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
White blood cell count decreased
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood calcium decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood chloride decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood thyroid stimulating hormone increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood urea increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
C-reactive protein increased
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Haemoglobin decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Lymphocyte count decreased
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Neutrophil count decreased
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Prothrombin level decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood albumin decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood potassium decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood uric acid increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood urine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Blood urine present
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Gamma-glutamyltransferase
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Tri-iodothyronine free decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Relevant Abnormalities in Laboratory Parameters
Electrocardiogram QT prolonged
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: -0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1Population: Treated set (AUC0-inf could not be calculated in 5 patients because the elimination phase was not observed in plasma concentration-time profiles in these patients.)
AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of nintedanib in course 1
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=18 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=16 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-inf of Nintedanib in Course 1
|
—
|
169 ng*h/mL
Geometric Coefficient of Variation 56.1
|
260 ng*h/mL
Geometric Coefficient of Variation 50.1
|
349 ng*h/mL
Geometric Coefficient of Variation 25.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1Population: Treated set
Cmax (maximum measured plasma concentration) after the first administration of nintedanib in course 1
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=23 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=16 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of Nintedanib in Course 1
|
—
|
29.3 ng/mL
Geometric Coefficient of Variation 60.0
|
33.4 ng/mL
Geometric Coefficient of Variation 91.1
|
59.9 ng/mL
Geometric Coefficient of Variation 43.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administrationPopulation: Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. Pharmacokinetic (PK) sampling of docetaxel for this patient was done and included in PK analysis.)
AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 1
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=24 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=19 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-inf of Docetaxel in Course 1
|
—
|
3270 ng*h/mL
Geometric Coefficient of Variation 35.6
|
3810 ng*h/mL
Geometric Coefficient of Variation 22.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administrationPopulation: Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. PK sampling of docetaxel for this patient was done and included in PK analysis.)
Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 1
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=24 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=19 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of Docetaxel in Course 1
|
—
|
3150 ng/mL
Geometric Coefficient of Variation 42.8
|
3550 ng/mL
Geometric Coefficient of Variation 32.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administrationPopulation: Treated set (AUC0-inf could not be calculated in 1 patient because the elimination phase was not observed in plasma concentration-time profile in this patient.)
AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 2. Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol.
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=2 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=16 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=8 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-inf of Docetaxel in Course 2
|
—
|
2320 ng*h/mL
Geometric Coefficient of Variation 14.9
|
3750 ng*h/mL
Geometric Coefficient of Variation 31.1
|
4270 ng*h/mL
Geometric Coefficient of Variation 34.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administrationPopulation: Treated set
Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 2. Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol.
Outcome measures
| Measure |
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=2 Participants
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=16 Participants
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=9 Participants
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of Docetaxel in Course 2
|
—
|
1870 ng/mL
Geometric Coefficient of Variation 33.9
|
3740 ng/mL
Geometric Coefficient of Variation 33.7
|
4070 ng/mL
Geometric Coefficient of Variation 56.7
|
—
|
—
|
—
|
—
|
Adverse Events
Nintedanib 100 mg + Docetaxel 60 mg/m2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 participants at risk
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=7 participants at risk
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=3 participants at risk
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
n=6 participants at risk
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=7 participants at risk
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=3 participants at risk
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=7 participants at risk
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 participants at risk
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Death
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Infection
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
Other adverse events
| Measure |
Nintedanib 100 mg + Docetaxel 60 mg/m2
n=3 participants at risk
Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=7 participants at risk
Patients with body surface area (BSA) \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=3 participants at risk
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)
n=6 participants at risk
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=7 participants at risk
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)
n=3 participants at risk
Patients with body surface area \<1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)
n=7 participants at risk
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)
n=6 participants at risk
Patients with body surface area ≥1.5 m\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
83.3%
5/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
83.3%
5/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
83.3%
5/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
83.3%
5/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
4/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
7/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
85.7%
6/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
7/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
83.3%
5/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
7/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
6/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
7/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
7/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
83.3%
5/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Eye disorders
Diplopia
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Eye disorders
Eye discharge
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
85.7%
6/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
4/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Gingival pain
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
71.4%
5/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Stomatitis
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
71.4%
5/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Chest discomfort
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Chest pain
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Chills
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Fatigue
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
7/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
6/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
71.4%
5/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
6/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Malaise
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Oedema
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
General disorders
Pyrexia
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
4/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
4/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Eyelid infection
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Infection
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Oral infection
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Injury, poisoning and procedural complications
Excoriation
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
4/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood calcium decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood chloride decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood uric acid increased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood urine
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Blood urine present
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Gamma-glutamyltransferase
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
4/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
4/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Prothrombin level decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Tri-iodothyronine free decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Weight decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
Weight increased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
71.4%
5/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
6/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
85.7%
6/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
4/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
2/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
3/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
6/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
85.7%
6/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
57.1%
4/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
100.0%
6/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
28.6%
2/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
66.7%
4/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
42.9%
3/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
50.0%
3/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
33.3%
1/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
14.3%
1/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
16.7%
1/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/3 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/7 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
|
0.00%
0/6 • between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 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 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