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=5 Participants	58.8 Years STANDARD_DEVIATION 8.50 • n=7 Participants	60.0 Years STANDARD_DEVIATION 12.36 • n=5 Participants	60.0 Years STANDARD_DEVIATION 11.75 • n=4 Participants	66.7 Years STANDARD_DEVIATION 12.22 • n=21 Participants	61.0 Years STANDARD_DEVIATION 12.15 • n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	9 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	16 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

Population: Pharmacokinetic Analysis Set

Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib

Outcome measures

Measure	Monotherapy Cohort 3 Selumetinib 75 mg n=7 Participants Monotherapy of Selumetinib 75 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	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
Cmax of Selumetinib After Single Dose	2084 ng/mL Geometric Coefficient of Variation 50.85	897.1 ng/mL Geometric Coefficient of Variation 69.34	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

PRIMARY outcome

Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

Population: Pharmacokinetic Analysis Set

Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib

Outcome measures

Measure	Monotherapy Cohort 3 Selumetinib 75 mg n=7 Participants Monotherapy of Selumetinib 75 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	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
Tmax of Selumetinib After Single Dose	0.98 hour Interval 0.93 to 2.0	1.51 hour Interval 0.93 to 4.12	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

PRIMARY outcome

Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Population: 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	Monotherapy Cohort 3 Selumetinib 75 mg n=7 Participants Monotherapy of Selumetinib 75 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	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
AUC(0-12) of Selumetinib After Single Dose	5578 ng*h/mL Geometric Coefficient of Variation 35.77	2723 ng*h/mL Geometric Coefficient of Variation 33.24	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

PRIMARY outcome

Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

Population: Pharmacokinetic Analysis Set

Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib

Outcome measures

Measure	Monotherapy Cohort 3 Selumetinib 75 mg n=7 Participants Monotherapy of Selumetinib 75 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	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
Cmax of N-desmethyl Selumetinib After Single Dose	136.6 ng/mL Geometric Coefficient of Variation 29.28	46.55 ng/mL Geometric Coefficient of Variation 57.74	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

PRIMARY outcome

Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

Population: 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	Monotherapy Cohort 3 Selumetinib 75 mg n=7 Participants Monotherapy of Selumetinib 75 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	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
Tmax of N-desmethyl Selumetinib After Single Dose	1.47 hour Interval 0.93 to 2.0	1.75 hour Interval 0.93 to 4.12	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

PRIMARY outcome

Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Population: 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	Monotherapy Cohort 3 Selumetinib 75 mg n=7 Participants Monotherapy of Selumetinib 75 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	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
AUC(0-12) of N-desmethyl Selumetinib After Single Dose	495.4 ng*h/mL Geometric Coefficient of Variation 17.99	182.6 ng*h/mL Geometric Coefficient of Variation 48.45	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

PRIMARY outcome

Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Population: Pharmacokinetic Analysis Set

Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib

Outcome measures

Measure	Monotherapy Cohort 3 Selumetinib 75 mg n=6 Participants Monotherapy of Selumetinib 75 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	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
Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib	2178 ng/mL Geometric Coefficient of Variation 79.67	1012 ng/mL Geometric Coefficient of Variation 47.08	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

PRIMARY outcome

Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Population: 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	Monotherapy Cohort 3 Selumetinib 75 mg n=6 Participants Monotherapy of Selumetinib 75 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	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
Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib	1.50 hour Interval 0.95 to 2.0	1.96 hour Interval 1.0 to 4.03	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

PRIMARY outcome

Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Population: 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	Monotherapy Cohort 3 Selumetinib 75 mg n=6 Participants Monotherapy of Selumetinib 75 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	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
AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib	8734 ng*h/mL Geometric Coefficient of Variation 55.99	4818 ng*h/mL Geometric Coefficient of Variation 20.07	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

PRIMARY outcome

Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Population: Pharmacokinetic Analysis Set

Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib

Outcome measures

Measure	Monotherapy Cohort 3 Selumetinib 75 mg n=6 Participants Monotherapy of Selumetinib 75 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	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
Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib	84.56 ng/mL Geometric Coefficient of Variation 74.73	42.18 ng/mL Geometric Coefficient of Variation 56.89	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

PRIMARY outcome

Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Population: 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	Monotherapy Cohort 3 Selumetinib 75 mg n=6 Participants Monotherapy of Selumetinib 75 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	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
Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib	1.74 hour Interval 0.98 to 4.0	1.96 hour Interval 1.48 to 4.03	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

PRIMARY outcome

Timeframe: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Population: 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	Monotherapy Cohort 3 Selumetinib 75 mg n=6 Participants Monotherapy of Selumetinib 75 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	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
AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib	445.0 ng*h/mL Geometric Coefficient of Variation 61.88	251.3 ng*h/mL Geometric Coefficient of Variation 39.33	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

SECONDARY outcome

Timeframe: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Population: 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	Monotherapy Cohort 3 Selumetinib 75 mg Monotherapy of Selumetinib 75 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	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
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-dose

Population: 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	Monotherapy Cohort 3 Selumetinib 75 mg Monotherapy of Selumetinib 75 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	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
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-dose

Population: 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	Monotherapy Cohort 3 Selumetinib 75 mg Monotherapy of Selumetinib 75 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	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
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: Masahiro.Nii@astrazeneca.com

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