Trial Outcomes & Findings for Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia (NCT NCT01588522)

Last Updated: 2025-05-28

Results Overview

DLTs were graded according to the CTCAE v4.0. A DLT was defined as a clinically significant Grade 3 or 4 (severe or life-threatening, respectively) non-hematologic toxicity occurring during the first 28-day treatment cycle, and determined to be possibly, probably, or definitely related to BPM31543 and not the taxane-based regimen as best determined by investigators.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

28 days

Results posted on

2025-05-28

Participant Flow

Conducted at 2 US sites

Patients scheduled to receive follow up treatment with a taxane-based chemotherapy regimen

Participant milestones

Participant milestones
Measure	Compound 31543 Calcitriol - 5 μg/mL Compound 31543 Calcitriol (5 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 10 μg/mL Compound 31543 Calcitriol (10 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 20 μg/mL Compound 31543 Calcitriol (20 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 40 μg/mL Compound 31543 Calcitriol (40 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 60 μg/mL Compound 31543 Calcitriol (60 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 80 μg/mL Compound 31543 Calcitriol (80 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).
Overall Study STARTED	3	5	6	5	6	3
Overall Study Treated	3	3	6	4	4	3
Overall Study COMPLETED	1	0	2	2	2	3
Overall Study NOT COMPLETED	2	5	4	3	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Compound 31543 Calcitriol - 5 μg/mL Compound 31543 Calcitriol (5 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 10 μg/mL Compound 31543 Calcitriol (10 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 20 μg/mL Compound 31543 Calcitriol (20 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 40 μg/mL Compound 31543 Calcitriol (40 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 60 μg/mL Compound 31543 Calcitriol (60 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).
Overall Study Withdrawal by Subject	1	5	3	1	2
Overall Study Lack of Efficacy	0	0	0	0	1
Overall Study Adverse Event	0	0	0	1	0
Overall Study Grade 2 alopecia	1	0	0	0	0
Overall Study Severe toxicity of chemotherapy	0	0	1	0	0
Overall Study Taken off taxane-based regimen	0	0	0	1	0
Overall Study Did not initiate chemotherapy	0	0	0	0	1

Baseline Characteristics

Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Compound 31543 Calcitriol - 5 ug/mL n=3 Participants Compound 31543 Calcitriol (5 ug/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 10 ug/mL n=3 Participants Compound 31543 Calcitriol (10 ug/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 20 ug/mL n=6 Participants Compound 31543 Calcitriol (20 ug/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 40 ug/mL n=4 Participants Compound 31543 Calcitriol (40 ug/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 60 ug/mL n=4 Participants Compound 31543 Calcitriol (60 ug/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Compound 31543 Calcitriol - 80 ug/mL n=3 Participants Compound 31543 Calcitriol (80 ug/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).	Total n=23 Participants Total of all reporting groups
Age, Continuous	52.7 years STANDARD_DEVIATION 8.5 • n=5 Participants	47.0 years STANDARD_DEVIATION 6.08 • n=7 Participants	54.0 years STANDARD_DEVIATION 12.98 • n=5 Participants	51.0 years STANDARD_DEVIATION 17.83 • n=4 Participants	47.3 years STANDARD_DEVIATION 18.46 • n=21 Participants	58.0 years STANDARD_DEVIATION 12.17 • n=8 Participants	51.7 years STANDARD_DEVIATION 12.85 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	23 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	19 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	19 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Consisted of all patients who received at least one application of Compound 31543.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=6 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=4 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=4 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Dose-limiting Toxicities (DLT) of Topical Compound 31543	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: pre-dose on day 1 of Week 1

Pre-dose concentrations of Compound 31543 from serum samples collected on Week 1 Day 1.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=5 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Pre-dose Concentrations of Compound 31543	49.0 pg/mL Standard Deviation 5.8	43.2 pg/mL Standard Deviation 14.8	54.3 pg/mL Standard Deviation 31.5	58.4 pg/mL Standard Deviation 19.4	32.8 pg/mL Standard Deviation 5.2	37.8 pg/mL Standard Deviation 15.5

SECONDARY outcome

Timeframe: 8 hours

Population: Pharmacokinetic Parameters for Serum Calcitriol Concentrations on Week 1, Day 1 of BPM31543 Administration (PK Population) The pharmacokinetic evaluable population was intended to include all patients with concentration results for the four samples scheduled for Week 1 Day 1.

Cmax of Compound 31543 was calculated using serum samples collected on Week 1 Day 1 pre-dose and at 2 ± 0.5 hours, 4 ± 0.5 hours, and 8 ± 1 hours post-dose. The 8-hour Week 1 Day 1 sample was collected before the second of the daily doses.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=4 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Cmax of Compound 31543 on Week 1 Day 1	51.6 pg/mL Standard Deviation 6.9	47.2 pg/mL Standard Deviation 13.6	42.5 pg/mL Standard Deviation 8.5	81.0 pg/mL Standard Deviation 8.1	36.0 pg/mL Standard Deviation 9.8	53.5 pg/mL Standard Deviation 16.1

SECONDARY outcome

Timeframe: 8 hours

Area under the curve (AUC0-t) of Compound 31543 was calculated from serum samples collected on Week 1 Day 1 pre-dose and at 2 ± 0.5 hours, 4 ± 0.5 hours, and 8 ± 1 hours post-dose. The 8-hour Week 1 Day 1 sample was collected before the second of the daily doses.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
AUC0-t of Compound 31543 on Week 1 Day 1	346 pg•hour/mL Standard Deviation 10	334 pg•hour/mL Standard Deviation 163	259 pg•hour/mL Standard Deviation 60	530 pg•hour/mL Standard Deviation 165	230 pg•hour/mL Standard Deviation 87	370 pg•hour/mL Standard Deviation 99

SECONDARY outcome

Timeframe: 7 and 15 weeks

Population: Evaluable Population defined as all patients who completed at least one photographic assessment and diary completion through Week 7. Some patients discontinued treatment prior to week 15 and are therefore only analyzed at week 7.

Top of head/scalp view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=1 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Top View Photographic Review Score Week 7	-1 score on a scale Standard Deviation 0	-1.5 score on a scale Standard Deviation 0.71	-1 score on a scale	-3 score on a scale Standard Deviation 0	-1 score on a scale Standard Deviation 0	-2 score on a scale Standard Deviation 1
Top View Photographic Review Score Week 15	-2 score on a scale	—	-1 score on a scale	-3 score on a scale	-2 score on a scale Standard Deviation 1.41	-3 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 7 and 15 weeks

Right side of head/scalp view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=1 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Right Side Photographic Review Score Week 7	-1 score on a scale Standard Deviation 0	-2 score on a scale	-1 score on a scale Standard Deviation 0	-2.3 score on a scale Standard Deviation 1.15	-1 score on a scale Standard Deviation 0	-1.7 score on a scale Standard Deviation 0.58
Right Side Photographic Review Score Week 15	-2 score on a scale	—	-1.5 score on a scale Standard Deviation 0.71	-3 score on a scale	-2 score on a scale Standard Deviation 1.41	-2.5 score on a scale Standard Deviation .71

SECONDARY outcome

Timeframe: 7 and 15 weeks

Left side of head/scalp view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Left Side Photographic Review Score Week 15	-2 score on a scale	—	-1.5 score on a scale Standard Deviation 0.71	-3 score on a scale	-2 score on a scale Standard Deviation 1.41	-2.5 score on a scale Standard Deviation 0.71
Left Side Photographic Review Score Week 7	-0.5 score on a scale Standard Deviation 0.71	-1 score on a scale Standard Deviation 0	-1 score on a scale Standard Deviation 0	-2.3 score on a scale Standard Deviation 1.15	-1 score on a scale Standard Deviation 0	-1.7 score on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: 7 and 15 weeks

Front of head/face view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Front Photographic Review Score Week 7	-0.5 score on a scale Standard Deviation 0.71	-0.5 score on a scale Standard Deviation 0.71	-1 score on a scale Standard Deviation 0	-1.7 score on a scale Standard Deviation 0.58	-1 score on a scale Standard Deviation 0	-2.3 score on a scale Standard Deviation 0.58
Front Photographic Review Score Week 15	-2 score on a scale	—	-1.5 score on a scale Standard Deviation 0.71	-2 score on a scale	-2 score on a scale Standard Deviation 1.41	-2.5 score on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: 7 and 15 weeks

Back of head/face view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Back Photographic Review Score Week 7	-0.5 score on a scale Standard Deviation 0.71	-0.5 score on a scale Standard Deviation 0.71	-1 score on a scale Standard Deviation 0	-2 score on a scale Standard Deviation 1	-1 score on a scale Standard Deviation 0	-2 score on a scale Standard Deviation 1
Back Photographic Review Score Week 15	-2 score on a scale	—	-1 score on a scale Standard Deviation 0	-3 score on a scale	-2 score on a scale Standard Deviation 1.41	-2.5 score on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: 7 and 15 weeks

Mid-pattern of the scalp from a superior view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL n=1 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Superior (Mid Pattern) Photographic Review Score Week 7	-1 score on a scale	-1 score on a scale Standard Deviation 0	-1 score on a scale Standard Deviation 0	-1.7 score on a scale Standard Deviation 0.58	-0.5 score on a scale Standard Deviation 0.71	-1.7 score on a scale Standard Deviation 0.58
Superior (Mid Pattern) Photographic Review Score Week 15	—	—	-1 score on a scale Standard Deviation 0	-2 score on a scale	-2 score on a scale Standard Deviation 1.41	-2.5 score on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: 7 and 15 weeks

Population: Evaluable Population defined as all patients who completed at least one photographic assessment and diary completion through Week 7. Not all patients had this photograph taken. Some patients discontinued treatment prior to week 15 and are therefore only analyzed at week 7.

Vertex view with hair parted in the center at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = \>75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = \>75% greatly increased/hair gain.

Outcome measures

Outcome measures
Measure	Compound 31543 Calcitriol - 5 μg/mL Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=2 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 Participants Compound 31543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Vertex Photographic Review Score Week 7	—	—	-1 score on a scale Standard Deviation 0	-1.7 score on a scale Standard Deviation 0.58	-0.5 score on a scale Standard Deviation 0.71	-1.7 score on a scale Standard Deviation 0.58
Vertex Photographic Review Score Week 15	—	—	-1 score on a scale Standard Deviation 0	-2 score on a scale	-1.5 score on a scale Standard Deviation 2.12	-2.5 score on a scale Standard Deviation 0.71

Adverse Events

Compound 31543 Calcitriol - 5 μg/mL

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Compound 31543 Calcitriol - 10 μg/mL

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Compound 31543 Calcitriol - 20 μg/mL

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Compound 31543 Calcitriol - 40 μg/mL

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Compound 31543 Calcitriol - 60 μg/mL

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Compound 31543 Calcitriol - 80 μg/mL

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Compound 31543 Calcitriol - 5 μg/mL n=3 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=3 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=6 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=4 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=4 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Cardiac disorders Supraventicular Tachycardia	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
General disorders Pain	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Gastrointestinal disorders Nausea	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Gastrointestinal disorders Vomiting	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Metabolism and nutrition disorders Alkalosis	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
General disorders Pyrexia	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	50.0% 2/4 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Gastrointestinal disorders Constipation	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Gastrointestinal disorders Large Intestinal Obstruction	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Metabolism and nutrition disorders Dehyrdation	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Nervous system disorders Syncope	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Cardiac disorders Chest Pain	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
General disorders Fatigue	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Psychiatric disorders Insomnia	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Blood and lymphatic system disorders Vascular Pseudoaneurysm	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.

Other adverse events

Other adverse events
Measure	Compound 31543 Calcitriol - 5 μg/mL n=3 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 10 μg/mL n=3 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 20 μg/mL n=6 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 40 μg/mL n=4 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 60 μg/mL n=4 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications	Compound 31543 Calcitriol - 80 μg/mL n=3 participants at risk BPM1543 Calcitriol, Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications
Skin and subcutaneous tissue disorders Alopecia	100.0% 3/3 • Number of events 3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	100.0% 3/3 • Number of events 3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	50.0% 2/4 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	75.0% 3/4 • Number of events 3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	100.0% 3/3 • Number of events 3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Skin and subcutaneous tissue disorders Rash Maculo-papular	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Skin and subcutaneous tissue disorders Dry Skin	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 2/6 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Skin and subcutaneous tissue disorders Pain of Skin	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	75.0% 3/4 • Number of events 3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 2/6 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
General disorders Abdominal Pain	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	50.0% 2/4 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Gastrointestinal disorders Constipation	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	50.0% 2/4 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 2/6 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	50.0% 2/4 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	50.0% 2/4 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Gastrointestinal disorders Vomiting	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
General disorders Fatigue	100.0% 3/3 • Number of events 3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 2/6 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
General disorders Oedema Peripheral	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
General disorders Pain	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Investigations Blood Alkaline Phosphate Increased	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	50.0% 2/4 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Investigations Vitamin D Increased	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	50.0% 2/4 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	50.0% 2/4 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Psychiatric disorders Anxiety	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Psychiatric disorders Insomnia	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	16.7% 1/6 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	66.7% 2/3 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	50.0% 2/4 • Number of events 2 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	33.3% 1/3 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/6 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	25.0% 1/4 • Number of events 1 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/4 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.	0.00% 0/3 • 2 weeks (or 7 days ± 2 days if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily until termination of chemotherapy treatment (up to a maximum of 54 weeks) Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.

Additional Information

Bing Nie

BPGbio Inc.

Phone: 617-588-1002

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER