Trial Outcomes & Findings for Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer (NCT NCT01439282)

Last Updated: 2023-06-22

Results Overview

Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant's body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

21-Day Cycle 1 through 21-Day Cycle 4

Results posted on

2023-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Eribulin mesylate (1.4 mg/m\^2) was injected directly as an intravenous (IV) infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m\^2) was administered orally twice a day (BID) on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.	Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine Eribulin mesylate (E7389) (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Overall Study STARTED	67	10
Overall Study COMPLETED	59	9
Overall Study NOT COMPLETED	8	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Eribulin mesylate (1.4 mg/m\^2) was injected directly as an intravenous (IV) infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m\^2) was administered orally twice a day (BID) on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.	Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine Eribulin mesylate (E7389) (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Overall Study Adverse Event	5	0
Overall Study Withdrawal by Subject	2	0
Overall Study Other	1	1

Baseline Characteristics

Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine n=67 Participants Eribulin mesylate (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m\^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.	Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine n=10 Participants Eribulin mesylate (E7389) (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.	Total n=77 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=93 Participants	7 Participants n=4 Participants	53 Participants n=27 Participants
Age, Categorical >=65 years	21 Participants n=93 Participants	3 Participants n=4 Participants	24 Participants n=27 Participants
Sex: Female, Male Female	67 Participants n=93 Participants	10 Participants n=4 Participants	77 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 21-Day Cycle 1 through 21-Day Cycle 4

Population: Full analysis set included all participants who received at least one dose of eribulin mesylate plus capecitabine.

Outcome measures

Outcome measures
Measure	Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine n=67 Participants Eribulin mesylate (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m\^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.	Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine n=10 Participants Eribulin mesylate (E7389) (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%	77.6 Percentage of participants Interval 67.6 to 100.0	90.0 Percentage of participants Interval 60.6 to 99.5

SECONDARY outcome

Timeframe: On the day of study drug infusion treatments during Cycles 1 through 4

Population: Safety analysis set included all participants who received at least one dose of study treatments and had at least one postbaseline safety assessment.

Alopecia (hair loss) is a potential side effect of some chemotherapy agents. Chemotherapeutic drugs are toxic and could potentially harm the hair follicles (wear hair grows from) resulting in the hair falling out. It can occur in small patches on various parts of the body or all over the body and is usually temporary when related to cancer treatment. Cold cap therapy is one form of therapy for alopecia involving hair loss from the scalp. Wearing a cap or head covering with cold packs before, during, or after chemotherapy may help prevent hair loss as the cold narrows the blood vessels in the skin on your head which may lead to less of the drug reaching the hair follicles. Alopecia was one of the most common adverse events (AEs) related to eribulin only.

Outcome measures

Outcome measures
Measure	Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine n=67 Participants Eribulin mesylate (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m\^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.	Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine n=10 Participants Eribulin mesylate (E7389) (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Use of Cold Cap for Alopecia Participants with alopecia	52 Participants	9 Participants
Use of Cold Cap for Alopecia Participants who used a cold cap	3 Participants	0 Participants
Use of Cold Cap for Alopecia Participants who did not use a cold cap	49 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 1 through 30 days after last dose of study drugs (approximately up to 3 years)

Population: The safety analysis set was all participants who received at least 1 dose of study treatments and had at least 1 post treatment safety assessment.

Outcome measures

Outcome measures
Measure	Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine n=67 Participants Eribulin mesylate (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m\^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.	Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine n=10 Participants Eribulin mesylate (E7389) (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAE	67 participants	10 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAE	14 participants	1 participants

Adverse Events

Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine

Serious events: 14 serious events

Other events: 67 other events

Deaths: 0 deaths

Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: 1-888-274-2378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine n=67 participants at risk Eribulin mesylate (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m\^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.	Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine n=10 participants at risk Eribulin mesylate (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.5% 3/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Diarrhoea	3.0% 2/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Abdominal pain	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Abdominal pain upper	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Investigations Alanine aminotransferase increased	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Investigations Aspartate aminotransferase increased	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Investigations Blood alkaline phosphatase increased	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Vascular disorders Deep vein thrombosis	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Metabolism and nutrition disorders Diabetes mellitus	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Enteritis	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Blood and lymphatic system disorders Febrile neutropenia	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Gastritis	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Metabolism and nutrition disorders Hyperglycaemia	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Metabolism and nutrition disorders Hypophosphataemia	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Blood and lymphatic system disorders Leukopenia	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Eye disorders Macular hole	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Psychiatric disorders Mental status changes	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Muscular weakness	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Nausea	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Blood and lymphatic system disorders Neutropenia	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Infections and infestations Pneumonia	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Renal and urinary disorders Renal failure acute	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Vomiting	1.5% 1/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Psychiatric disorders Anxiety	0.00% 0/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.

Other adverse events
Measure	Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine n=67 participants at risk Eribulin mesylate (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m\^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.	Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine n=10 participants at risk Eribulin mesylate (1.4 mg/m\^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Blood and lymphatic system disorders Neutropenia	35.8% 24/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	20.0% 2/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Blood and lymphatic system disorders Anaemia	9.0% 6/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Blood and lymphatic system disorders Leukopenia	7.5% 5/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Eye disorders Lacrimation increased	13.4% 9/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Nausea	52.2% 35/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	40.0% 4/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Diarrhoea	40.3% 27/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	20.0% 2/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Constipation	34.3% 23/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	20.0% 2/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Vomiting	22.4% 15/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Dyspepsia	14.9% 10/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	30.0% 3/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Gastrooesophageal reflux disease	13.4% 9/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Stomatitis	13.4% 9/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Abdominal pain	11.9% 8/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	20.0% 2/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Dry mouth	11.9% 8/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Gastrointestinal disorders Haemorrhoids	6.0% 4/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
General disorders Fatigue	58.2% 39/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	60.0% 6/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
General disorders Oedema peripheral	14.9% 10/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
General disorders Pyrexia	14.9% 10/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
General disorders Mucosal inflammation	11.9% 8/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	20.0% 2/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
General disorders Pain	7.5% 5/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
General disorders Asthenia	9.0% 6/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Infections and infestations Urinary tract infection	9.0% 6/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Investigations Aspartate aminotransferase increased	14.9% 10/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Investigations Alanine aminotransferase increased	13.4% 9/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Investigations Blood bilirubin increased	7.5% 5/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Metabolism and nutrition disorders Hyperglycaemia	16.4% 11/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Metabolism and nutrition disorders Dehydration	14.9% 10/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Metabolism and nutrition disorders Hypokalaemia	11.9% 8/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Metabolism and nutrition disorders Decreased appetite	10.4% 7/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	30.0% 3/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Metabolism and nutrition disorders Hyponatraemia	6.0% 4/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Arthralgia	11.9% 8/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Pain in extremity	9.0% 6/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Nervous system disorders Headache	28.4% 19/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	40.0% 4/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Nervous system disorders Neuropathy peripheral	23.9% 16/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	30.0% 3/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Nervous system disorders Dysgeusia	11.9% 8/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	20.0% 2/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Nervous system disorders Dizziness	7.5% 5/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	20.0% 2/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Nervous system disorders Hypoaesthesia	7.5% 5/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Nervous system disorders Peripheral sensory neuropathy	6.0% 4/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Psychiatric disorders Insomnia	17.9% 12/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	0.00% 0/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Psychiatric disorders Anxiety	10.4% 7/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	10.0% 1/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	14.9% 10/67 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.	20.0% 2/10 • Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months. TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.