Trial Outcomes & Findings for Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer (NCT NCT01605916)
NCT ID: NCT01605916
Last Updated: 2016-10-21
Results Overview
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Results posted on
2016-10-21
Participant Flow
First patient enrolled on 01 June 2012. Last subject last visit on 30 March 2015.
Out of 33 enrolled subjects, 25 subjects were assigned to selumetinib (AZD6244, ARRY-142886), and 8 subjects were not assigned. The reasons of no assignment were 'Screen failure' (7 subjects) and 'Withdrawal by subject' (1 subject).
Participant milestones
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
6
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
6
|
6
|
Reasons for withdrawal
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
3
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
2
|
Baseline Characteristics
Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=7 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.5 Years
STANDARD_DEVIATION 17.33 • n=99 Participants
|
58.8 Years
STANDARD_DEVIATION 8.50 • n=107 Participants
|
60.0 Years
STANDARD_DEVIATION 12.36 • n=206 Participants
|
60.0 Years
STANDARD_DEVIATION 11.75 • n=7 Participants
|
66.7 Years
STANDARD_DEVIATION 12.22 • n=31 Participants
|
61.0 Years
STANDARD_DEVIATION 12.15 • n=30 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=7 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Cmax of Selumetinib After Single Dose
|
2534 ng/mL
Geometric Coefficient of Variation 40.45
|
1073 ng/mL
Geometric Coefficient of Variation 35.18
|
370.3 ng/mL
Geometric Coefficient of Variation 96.87
|
897.1 ng/mL
Geometric Coefficient of Variation 69.34
|
2084 ng/mL
Geometric Coefficient of Variation 50.85
|
PRIMARY outcome
Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=7 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Tmax of Selumetinib After Single Dose
|
1.49 hour
Full Range 40.45 • Interval 0.97 to 2.0
|
1.00 hour
Full Range 35.18 • Interval 0.98 to 1.5
|
1.74 hour
Interval 0.47 to 4.05
|
1.51 hour
Interval 0.93 to 4.12
|
0.98 hour
Interval 0.93 to 2.0
|
PRIMARY outcome
Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=7 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
AUC(0-12) of Selumetinib After Single Dose
|
6784 ng*h/mL
Geometric Coefficient of Variation 26.63
|
1599 ng*h/mL
Geometric Coefficient of Variation 35.48
|
1021 ng*h/mL
Geometric Coefficient of Variation 30.62
|
2723 ng*h/mL
Geometric Coefficient of Variation 33.24
|
5578 ng*h/mL
Geometric Coefficient of Variation 35.77
|
PRIMARY outcome
Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=7 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Cmax of N-desmethyl Selumetinib After Single Dose
|
130.8 ng/mL
Geometric Coefficient of Variation 63.44
|
68.61 ng/mL
Geometric Coefficient of Variation 15.10
|
27.50 ng/mL
Geometric Coefficient of Variation 41.42
|
46.55 ng/mL
Geometric Coefficient of Variation 57.74
|
136.6 ng/mL
Geometric Coefficient of Variation 29.28
|
PRIMARY outcome
Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=7 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Tmax of N-desmethyl Selumetinib After Single Dose
|
1.75 hour
Full Range 40.45 • Interval 1.47 to 2.0
|
1.00 hour
Full Range 35.18 • Interval 0.98 to 1.5
|
1.74 hour
Interval 0.47 to 4.05
|
1.75 hour
Interval 0.93 to 4.12
|
1.47 hour
Interval 0.93 to 2.0
|
PRIMARY outcome
Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=7 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
AUC(0-12) of N-desmethyl Selumetinib After Single Dose
|
409.6 ng*h/mL
Geometric Coefficient of Variation 32.29
|
159.6 ng*h/mL
Geometric Coefficient of Variation 33.22
|
88.79 ng*h/mL
Geometric Coefficient of Variation 7.700
|
182.6 ng*h/mL
Geometric Coefficient of Variation 48.45
|
495.4 ng*h/mL
Geometric Coefficient of Variation 17.99
|
PRIMARY outcome
Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=3 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=6 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib
|
2437 ng/mL
Geometric Coefficient of Variation 64.93
|
662.3 ng/mL
Geometric Coefficient of Variation 31.07
|
623.4 ng/mL
Geometric Coefficient of Variation 46.09
|
1012 ng/mL
Geometric Coefficient of Variation 47.08
|
2178 ng/mL
Geometric Coefficient of Variation 79.67
|
PRIMARY outcome
Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=3 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=6 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib
|
3.97 hour
Full Range 40.45 • Interval 1.48 to 4.02
|
1.25 hour
Full Range 35.18 • Interval 1.0 to 12.0
|
1.23 hour
Interval 0.5 to 2.07
|
1.96 hour
Interval 1.0 to 4.03
|
1.50 hour
Interval 0.95 to 2.0
|
PRIMARY outcome
Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=3 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=6 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib
|
13050 ng*h/mL
Geometric Coefficient of Variation 12.86
|
2334 ng*h/mL
Geometric Coefficient of Variation 42.31
|
2130 ng*h/mL
Geometric Coefficient of Variation 20.09
|
4818 ng*h/mL
Geometric Coefficient of Variation 20.07
|
8734 ng*h/mL
Geometric Coefficient of Variation 55.99
|
PRIMARY outcome
Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=3 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=6 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
|
38.91 ng/mL
Geometric Coefficient of Variation 133.7
|
34.46 ng/mL
Geometric Coefficient of Variation 35.21
|
36.16 ng/mL
Geometric Coefficient of Variation 31.26
|
42.18 ng/mL
Geometric Coefficient of Variation 56.89
|
84.56 ng/mL
Geometric Coefficient of Variation 74.73
|
PRIMARY outcome
Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=3 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=6 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
|
3.97 hour
Full Range 40.45 • Interval 1.48 to 4.02
|
1.25 hour
Full Range 35.18 • Interval 1.0 to 1.97
|
1.25 hour
Interval 0.95 to 2.07
|
1.96 hour
Interval 1.48 to 4.03
|
1.74 hour
Interval 0.98 to 4.0
|
PRIMARY outcome
Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=3 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 Participants
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 Participants
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=6 Participants
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
|
241.5 ng*h/mL
Geometric Coefficient of Variation 115.7
|
150.4 ng*h/mL
Geometric Coefficient of Variation 44.08
|
146.3 ng*h/mL
Geometric Coefficient of Variation 29.77
|
251.3 ng*h/mL
Geometric Coefficient of Variation 39.33
|
445.0 ng*h/mL
Geometric Coefficient of Variation 61.88
|
SECONDARY outcome
Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
|
2329 ng/mL
Geometric Coefficient of Variation 9.805
|
2726 ng/mL
Geometric Coefficient of Variation 27.92
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
|
0.99 hour
Full Range 9.805 • Interval 0.5 to 1.05
|
0.99 hour
Full Range 27.92 • Interval 0.93 to 1.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dosePopulation: Pharmacokinetic Analysis Set
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Outcome measures
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 Participants
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
|
2422 ng*h/mL
Geometric Coefficient of Variation 13.72
|
3056 ng*h/mL
Geometric Coefficient of Variation 28.64
|
—
|
—
|
—
|
Adverse Events
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Monotherapy Cohort 1 Selumetinib 25 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Monotherapy Cohort 2 Selumetinib 50 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Monotherapy Cohort 3 Selumetinib 75 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 participants at risk
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 participants at risk
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 participants at risk
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 participants at risk
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=7 participants at risk
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
Other adverse events
| Measure |
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce
n=4 participants at risk
Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce
n=4 participants at risk
Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
|
Monotherapy Cohort 1 Selumetinib 25 mg
n=4 participants at risk
Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 2 Selumetinib 50 mg
n=6 participants at risk
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
|
Monotherapy Cohort 3 Selumetinib 75 mg
n=7 participants at risk
Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
|
|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Nail infection
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Pharyngitis
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Immune system disorders
Food allergy
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Psychiatric disorders
Delusion
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Nervous system disorders
Presyncope
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Eye disorders
Eye oedema
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
33.3%
2/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Eye disorders
Visual impairment
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Eye disorders
Xanthopsia
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Cardiac disorders
Bradycardia
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Vascular disorders
Vascular pain
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
33.3%
2/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
33.3%
2/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
71.4%
5/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Gastritis
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
33.3%
2/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Stomatitis
|
100.0%
4/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Toothache
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
66.7%
4/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
50.0%
3/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
57.1%
4/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
General disorders
Face oedema
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
General disorders
Malaise
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
50.0%
3/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
28.6%
2/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
General disorders
Oedema
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
42.9%
3/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
Alanine aminotransferase increased
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
4/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
33.3%
2/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
42.9%
3/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
Blood alkaline phosphatase increased
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
Blood urea increased
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
Gamma-glutamyltransferase increased
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
25.0%
1/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Investigations
White blood cell count decreased
|
50.0%
2/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
75.0%
3/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
16.7%
1/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/4 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
0.00%
0/6 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
14.3%
1/7 • Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
|
Additional Information
Masahiro Nii
Biometrics Department, Science Affairs Division, R&D, Astrazeneca Japan
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
- Publication restrictions are in place
Restriction type: OTHER