Trial Outcomes & Findings for The Efficacy and Safety of Pegylated Liposomal Doxorubicin Compared With Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (P04445/MK-2746-071) (NCT NCT00266799)

NCT ID: NCT00266799

Last Updated: 2017-06-08

Results Overview

TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ \& \>20 mm by clinical imaging (\>=10 mm with spiral CT scan). Non-target lesions were all other lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 210 participants
• Primary outcome timeframe: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death
• Results posted on: 2017-06-08

Participant Flow

210 participants were enrolled with 105 participants randomized for treatment with PLD and 105 participants randomized for treatment with Capecitabine, of which 7 participants in the PLD group and 3 participants in the Capecitabine group were not treated.

Participant milestones

Measure	Pegylated Liposomal Doxorubicin (PLD) PLD 50 mg/m\^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.	Capecitabine Capecitabine 1250 mg/m\^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
Overall Study STARTED	98	102
Overall Study COMPLETED	62	68
Overall Study NOT COMPLETED	36	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Efficacy and Safety of Pegylated Liposomal Doxorubicin Compared With Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (P04445/MK-2746-071)

Baseline characteristics by cohort

Measure	Pegylated Liposomal Doxorubicin (PLD) n=105 Participants PLD 50 mg/m\^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.	Capecitabine n=105 Participants Capecitabine 1250 mg/m\^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.	Total n=210 Participants Total of all reporting groups
Age, Continuous	61.4 years STANDARD_DEVIATION 10.66 • n=5 Participants	61.5 years STANDARD_DEVIATION 10.59 • n=7 Participants	61.5 years STANDARD_DEVIATION 10.60 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	105 Participants n=7 Participants	210 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death

Population: Intent-to-treat (ITT): 7 in PLD group \& 3 participants in Capecitabine group were missing response assessments. TTP Population: included participants in view of major protocol violations/deviations, i.e. tumor-relevant inclusion/exclusion criteria, treatment compliance, tumor assessments by RECIST with maximum 4 month interval between assessments.

TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin (PLD) n=98 Participants PLD 50 mg/m\^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.	Capecitabine n=102 Participants Capecitabine 1250 mg/m\^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST) By RECIST Criteria (TTP N = 63, N = 59)	6.02 Months Interval 4.37 to 7.86	6.05 Months Interval 4.08 to 9.27
Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST) By Investigator Assessment (ITT)	6.02 Months Interval 5.1 to 8.19	6.05 Months Interval 4.27 to 9.07
Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST) By RECIST Criteria (ITT)	6.58 Months Interval 5.29 to 8.19	7.10 Months Interval 4.77 to 9.53
Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST) By Investigator Assessment (TTP N = 63, N = 59)	5.85 Months Interval 4.37 to 7.86	5.88 Months Interval 2.99 to 8.98

SECONDARY outcome

Timeframe: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death

Population: Intent-to-treat (ITT) population included all randomized participants.

Overall responses by investigator assessment/RECIST criteria of participant responses; CR=disappearance of target/nontarget lesions + PR=30% decrease in longest diameter sum (noting baseline sum) of target lesions. RECIST used changes in the largest diameter of target/non-target lesions. Target lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions. Evaluation of progress was repeated every 3 months (+/-7 days) post first date of lesion measurements, in detection absence until the participant´s death.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin (PLD) n=105 Participants PLD 50 mg/m\^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.	Capecitabine n=105 Participants Capecitabine 1250 mg/m\^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups By Investigator Assessment - CR	1 Participants	0 Participants
Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups By Investigator Assessment - PR	5 Participants	12 Participants
Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups By Investigator Assessment Overall Response	6 Participants	12 Participants
Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups By RECIST Criteria - CR	1 Participants	0 Participants
Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups By RECIST Criteria - PR	8 Participants	11 Participants
Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups By RECIST Criteria Overall Response	9 Participants	11 Participants

SECONDARY outcome

Timeframe: From Day 1 (Cycle 1) until Death

Population: ITT: 7 in PLD group and 3 participants in Capecitabine group were missing response assessments and therefore were not included in the analysis.

Survival time was defined as duration time from onset of treatment with the study drug until death.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin (PLD) n=98 Participants PLD 50 mg/m\^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.	Capecitabine n=102 Participants Capecitabine 1250 mg/m\^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
Overall Survival Time in the PLD and Capecitabine Treatment Groups	23.31 Months Interval 21.44 to 27.52	26.79 Months Interval 18.67 to 32.28

SECONDARY outcome

Timeframe: From Day 1 (Cycle 1) until End of Treatment

Population: ITT: 7 in PLD group and 3 participants in Capecitabine group were missing response assessments and therefore were not included in the analysis.

Time to treatment failure was defined as the duration of time from the date of the first administration of the study drug to the date of discontinuation of the study drug for any reason.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin (PLD) n=98 Participants PLD 50 mg/m\^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.	Capecitabine n=102 Participants Capecitabine 1250 mg/m\^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups	4.60 Months Interval 3.35 to 4.93	3.68 Months Interval 2.93 to 5.85

SECONDARY outcome

Timeframe: From Screening to Day 1 of every Treatment Cycle up to 12 Cycles

Population: ITT: included all randomized participants. There were only a few participants who completed more than 12 cycles due to the longer duration of each cycle.

QoL questionnaire was an EORTC QLQ-C30 & SSQ integration. Scores on the SSQ scale ranged from 1 (very much worse) - 7 (very much better). SSQ consisted of 4 items which corresponded to core domains in the 30 Item EORTC QLQ-C30, such as improvement/deterioration in physical functioning, emotional functioning, social functioning, global QoL. Percentages were based on number of participants at each cycle & rounded to the nearest whole number. Early Withdrawal Questionnaires were obtained in 7-14 days of study drug final dose.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin (PLD) n=105 Participants PLD 50 mg/m\^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.	Capecitabine n=105 Participants Capecitabine 1250 mg/m\^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Screening - About the Same	67 Percentage of Participants	41 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Screening - A Little Better	4 Percentage of Participants	0 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Screening - Moderately Better	2 Percentage of Participants	0 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Screening - Very Much Better	2 Percentage of Participants	7 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 1 - Very Much Worse	0 Percentage of Participants	9 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 1 - Moderately Worse	10 Percentage of Participants	9 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 1 - A Little Worse	22 Percentage of Participants	9 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 1 - About the Same	63 Percentage of Participants	65 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 2 - Very Much Worse	3 Percentage of Participants	11 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 2 - About the Same	51 Percentage of Participants	50 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 2 - A Little Better	9 Percentage of Participants	9 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 2 - Moderately Better	1 Percentage of Participants	5 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 2 - Very Much Better	1 Percentage of Participants	3 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 3 - About the Same	58 Percentage of Participants	48 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 3 - A Little Better	8 Percentage of Participants	10 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 3 - Moderately Better	4 Percentage of Participants	2 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 3 - Very Much Better	0 Percentage of Participants	0 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 4 - Moderately Worse	11 Percentage of Participants	12 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 4 - A Little Worse	26 Percentage of Participants	22 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 4 - About the Same	47 Percentage of Participants	55 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 4 - A Little Better	9 Percentage of Participants	2 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 4 - Moderately Better	2 Percentage of Participants	4 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 5 - A Little Worse	21 Percentage of Participants	19 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 6 - Moderately Worse	7 Percentage of Participants	6 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 6 - A Little Worse	9 Percentage of Participants	11 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 6 - About the Same	58 Percentage of Participants	60 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 6 - A Little Better	14 Percentage of Participants	14 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 7 - Very Much Worse	0 Percentage of Participants	3 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 7 - A Little Worse	17 Percentage of Participants	23 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 7 - About the Same	52 Percentage of Participants	42 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 7 - A Little Better	13 Percentage of Participants	6 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 7 - Moderately Better	13 Percentage of Participants	16 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 8 - A Little Worse	17 Percentage of Participants	16 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 8 - About the Same	57 Percentage of Participants	61 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 8 - A Little Better	9 Percentage of Participants	6 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 8 - Moderately Better	0 Percentage of Participants	6 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 8 - Very Much Better	4 Percentage of Participants	0 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 9 - Moderately Worse	0 Percentage of Participants	3 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 9 - A Little Worse	25 Percentage of Participants	21 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 9 - A Little Better	6 Percentage of Participants	10 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 9 - Moderately Better	6 Percentage of Participants	3 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 10 - Very Much Better	0 Percentage of Participants	8 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 11 - A Little Worse	0 Percentage of Participants	13 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 11 - Moderately Better	11 Percentage of Participants	9 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 11 - Very Much Better	0 Percentage of Participants	17 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 12 - Very Much Worse	0 Percentage of Participants	4 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 12 - A Little Worse	11 Percentage of Participants	13 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 12 - About the Same	78 Percentage of Participants	50 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 1 - A Little Better	5 Percentage of Participants	2 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 1 - Moderately Better	0 Percentage of Participants	5 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 1 - Very Much Better	0 Percentage of Participants	0 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 5 - Moderately Worse	0 Percentage of Participants	2 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 2 - Moderately Worse	9 Percentage of Participants	8 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 2 - A Little Worse	25 Percentage of Participants	15 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Screening - Very Much Worse	4 Percentage of Participants	14 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Screening - Moderately Worse	8 Percentage of Participants	14 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 3 - Very Much Worse	4 Percentage of Participants	3 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 3 - Moderately Worse	13 Percentage of Participants	13 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 3 - A Little Worse	13 Percentage of Participants	23 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Screening - A Little Worse	12 Percentage of Participants	24 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 4 - Very Much Worse	4 Percentage of Participants	6 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 4 - Very Much Better	0 Percentage of Participants	0 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 5 - Very Much Worse	5 Percentage of Participants	0 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 5 - About the Same	40 Percentage of Participants	62 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 5 - A Little Better	19 Percentage of Participants	14 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 5 - Moderately Better	10 Percentage of Participants	2 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 5 - Very Much Better	5 Percentage of Participants	0 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 6 - Very Much Worse	5 Percentage of Participants	3 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 6 - Moderately Better	5 Percentage of Participants	3 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 6 - Very Much Better	2 Percentage of Participants	3 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 8 - Very Much Worse	0 Percentage of Participants	3 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 8 - Moderately Worse	13 Percentage of Participants	6 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 7 - Moderately Worse	4 Percentage of Participants	3 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 7 - Very Much Better	0 Percentage of Participants	6 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 12 - Moderately Better	0 Percentage of Participants	8 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 9 - Very Much Worse	6 Percentage of Participants	0 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 9 - About the Same	50 Percentage of Participants	55 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 9 - Very Much Better	6 Percentage of Participants	7 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 10 - Very Much Worse	0 Percentage of Participants	4 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 10 - Moderately Worse	8 Percentage of Participants	8 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 10 - A Little Worse	17 Percentage of Participants	13 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 10 - About the Same	67 Percentage of Participants	50 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 10 - A Little Better	8 Percentage of Participants	13 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 10 - Moderately Better	0 Percentage of Participants	4 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 11 - Very Much Worse	0 Percentage of Participants	0 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 11 - Moderately Worse	11 Percentage of Participants	9 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 11 - About the Same	67 Percentage of Participants	39 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 11 - A Little Better	11 Percentage of Participants	13 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 12 - Moderately Worse	0 Percentage of Participants	8 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 12 - A Little Better	11 Percentage of Participants	13 Percentage of Participants
Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) Cycle 12 - Very Much Better	0 Percentage of Participants	4 Percentage of Participants

Adverse Events

Pegylated Liposomal Doxorubicin (PLD)

Serious events: 30 serious events

Other events: 96 other events

Deaths: 0 deaths

Capecitabine

Serious events: 46 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pegylated Liposomal Doxorubicin (PLD) n=98 participants at risk PLD 50 mg/m\^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.	Capecitabine n=102 participants at risk Capecitabine 1250 mg/m\^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
Blood and lymphatic system disorders NEUTROPENIA	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Cardiac disorders ATRIAL FIBRILLATION	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Cardiac disorders CARDIAC FAILURE	1.0% 1/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Cardiac disorders TACHYCARDIA	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Ear and labyrinth disorders ACUTE VESTIBULAR SYNDROME	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Ear and labyrinth disorders VERTIGO	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders COLITIS	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders DIARRHOEA	2.0% 2/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	7.8% 8/102 • Number of events 8 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders FEMORAL HERNIA	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders HAEMATEMESIS	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders ILEUS	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders NAUSEA	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders STOMATITIS	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders VOMITING	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders ASTHENIA	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders CATHETER THROMBOSIS	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders CONDITION AGGRAVATED	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders DEATH	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders DISEASE PROGRESSION	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.9% 3/102 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders FATIGUE	2.0% 2/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.9% 3/102 • Number of events 4 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	4.1% 4/98 • Number of events 4 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders PYREXIA	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.9% 3/102 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Hepatobiliary disorders HEPATIC FAILURE	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Hepatobiliary disorders SUBACUTE HEPATIC FAILURE	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Immune system disorders HYPERSENSITIVITY	2.0% 2/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations CATHETER SITE INFECTION	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations FOLLICULITIS	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations HERPES ZOSTER	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations LARYNGITIS	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations PNEUMONIA	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations PSEUDOMONAS INFECTION	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations PYELONEPHRITIS	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations SEPSIS	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations UROSEPSIS	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations WOUND INFECTION	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations WOUND INFECTION BACTERIAL	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Injury, poisoning and procedural complications FOOT FRACTURE	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Injury, poisoning and procedural complications FRACTURE	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Injury, poisoning and procedural complications TRACHEAL OBSTRUCTION	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Injury, poisoning and procedural complications VASCULAR ACCESS COMPLICATION	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations BLOOD POTASSIUM DECREASED	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations BLOOD POTASSIUM INCREASED	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations EAR, NOSE AND THROAT EXAMINATION ABNORMAL	2.0% 2/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations HAEMOGLOBIN DECREASED	1.0% 1/98 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	3.9% 4/102 • Number of events 4 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations NEUTROPHIL COUNT DECREASED	2.0% 2/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations WHITE BLOOD CELL COUNT DECREASED	2.0% 2/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Musculoskeletal and connective tissue disorders BONE PAIN	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Musculoskeletal and connective tissue disorders PATHOLOGICAL FRACTURE	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CONTRALATERAL BREAST CANCER	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PLEURAL EFFUSION	2.0% 2/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.9% 3/102 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO ABDOMINAL WALL	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LYMPH NODES	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO MENINGES	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO THORAX	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PERICARDIAL EFFUSION MALIGNANT	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR PAIN	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders DIZZINESS	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders ENCEPHALOPATHY	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders FACIAL PALSY	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders HEADACHE	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders SYNCOPE	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders VERTIGO CNS ORIGIN	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders VITH NERVE PARALYSIS	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Renal and urinary disorders RENAL FAILURE	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.9% 3/102 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Reproductive system and breast disorders BREAST PAIN	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Respiratory, thoracic and mediastinal disorders ACQUIRED TRACHEO-OESOPHAGEAL FISTULA	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	2.0% 2/98 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	4.9% 5/102 • Number of events 7 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	2.0% 2/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	5.9% 6/102 • Number of events 6 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	3.9% 4/102 • Number of events 4 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Vascular disorders THROMBOSIS	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.9% 3/102 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.

Other adverse events

Measure	Pegylated Liposomal Doxorubicin (PLD) n=98 participants at risk PLD 50 mg/m\^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.	Capecitabine n=102 participants at risk Capecitabine 1250 mg/m\^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
Ear and labyrinth disorders VERTIGO	5.1% 5/98 • Number of events 6 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Eye disorders LACRIMATION INCREASED	0.00% 0/98 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	6.9% 7/102 • Number of events 7 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders ABDOMINAL PAIN	1.0% 1/98 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	10.8% 11/102 • Number of events 14 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	5.1% 5/98 • Number of events 5 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	8.8% 9/102 • Number of events 11 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders CONSTIPATION	25.5% 25/98 • Number of events 43 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	9.8% 10/102 • Number of events 11 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders DIARRHOEA	14.3% 14/98 • Number of events 18 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	41.2% 42/102 • Number of events 82 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders DYSPEPSIA	7.1% 7/98 • Number of events 7 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	8.8% 9/102 • Number of events 13 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders DYSPHAGIA	7.1% 7/98 • Number of events 8 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders NAUSEA	41.8% 41/98 • Number of events 58 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	40.2% 41/102 • Number of events 57 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders OESOPHAGITIS	5.1% 5/98 • Number of events 6 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.00% 0/102 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders STOMATITIS	39.8% 39/98 • Number of events 53 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	16.7% 17/102 • Number of events 22 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Gastrointestinal disorders VOMITING	18.4% 18/98 • Number of events 24 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	27.5% 28/102 • Number of events 41 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders FATIGUE	54.1% 53/98 • Number of events 81 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	52.9% 54/102 • Number of events 89 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders OEDEMA PERIPHERAL	7.1% 7/98 • Number of events 7 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	11.8% 12/102 • Number of events 12 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
General disorders PYREXIA	5.1% 5/98 • Number of events 5 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	5.9% 6/102 • Number of events 9 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Immune system disorders HYPERSENSITIVITY	10.2% 10/98 • Number of events 12 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	0.98% 1/102 • Number of events 1 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Infections and infestations NASOPHARYNGITIS	4.1% 4/98 • Number of events 5 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	7.8% 8/102 • Number of events 11 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations ALANINE AMINOTRANSFERASE INCREASED	10.2% 10/98 • Number of events 12 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	14.7% 15/102 • Number of events 23 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	11.2% 11/98 • Number of events 14 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	11.8% 12/102 • Number of events 22 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	8.2% 8/98 • Number of events 10 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	5.9% 6/102 • Number of events 9 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations BLOOD BILIRUBIN INCREASED	2.0% 2/98 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	12.7% 13/102 • Number of events 38 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations BLOOD CREATININE INCREASED	3.1% 3/98 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	7.8% 8/102 • Number of events 11 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations EAR, NOSE AND THROAT EXAMINATION ABNORMAL	42.9% 42/98 • Number of events 57 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	16.7% 17/102 • Number of events 21 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	8.2% 8/98 • Number of events 11 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations HAEMOGLOBIN DECREASED	25.5% 25/98 • Number of events 50 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	18.6% 19/102 • Number of events 41 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations NEUTROPHIL COUNT DECREASED	18.4% 18/98 • Number of events 55 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	8.8% 9/102 • Number of events 20 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations PLATELET COUNT DECREASED	6.1% 6/98 • Number of events 10 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	6.9% 7/102 • Number of events 12 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations WEIGHT DECREASED	5.1% 5/98 • Number of events 7 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	6.9% 7/102 • Number of events 8 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Investigations WHITE BLOOD CELL COUNT DECREASED	37.8% 37/98 • Number of events 106 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	15.7% 16/102 • Number of events 37 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Metabolism and nutrition disorders ANOREXIA	12.2% 12/98 • Number of events 13 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	14.7% 15/102 • Number of events 18 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Musculoskeletal and connective tissue disorders BACK PAIN	13.3% 13/98 • Number of events 18 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	9.8% 10/102 • Number of events 10 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Musculoskeletal and connective tissue disorders BONE PAIN	9.2% 9/98 • Number of events 13 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	14.7% 15/102 • Number of events 18 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	8.2% 8/98 • Number of events 11 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.9% 3/102 • Number of events 12 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR PAIN	6.1% 6/98 • Number of events 8 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 4 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders DIZZINESS	3.1% 3/98 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	9.8% 10/102 • Number of events 15 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders DYSGEUSIA	2.0% 2/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	7.8% 8/102 • Number of events 10 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders HEADACHE	6.1% 6/98 • Number of events 6 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	4.9% 5/102 • Number of events 5 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	17.3% 17/98 • Number of events 23 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	24.5% 25/102 • Number of events 29 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Psychiatric disorders DEPRESSION	2.0% 2/98 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	7.8% 8/102 • Number of events 9 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Psychiatric disorders INSOMNIA	9.2% 9/98 • Number of events 10 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	6.9% 7/102 • Number of events 9 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Respiratory, thoracic and mediastinal disorders COUGH	5.1% 5/98 • Number of events 5 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	10.8% 11/102 • Number of events 12 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	14.3% 14/98 • Number of events 19 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	21.6% 22/102 • Number of events 26 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Skin and subcutaneous tissue disorders ALOPECIA	27.6% 27/98 • Number of events 27 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	9.8% 10/102 • Number of events 11 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Skin and subcutaneous tissue disorders DRY SKIN	10.2% 10/98 • Number of events 11 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	5.9% 6/102 • Number of events 6 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Skin and subcutaneous tissue disorders EXFOLIATIVE RASH	7.1% 7/98 • Number of events 8 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	6.9% 7/102 • Number of events 8 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	8.2% 8/98 • Number of events 12 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.9% 3/102 • Number of events 4 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Skin and subcutaneous tissue disorders NAIL DISORDER	9.2% 9/98 • Number of events 12 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	11.8% 12/102 • Number of events 16 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	66.3% 65/98 • Number of events 227 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	66.7% 68/102 • Number of events 248 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Skin and subcutaneous tissue disorders PRURITUS	8.2% 8/98 • Number of events 11 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 2 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	6.1% 6/98 • Number of events 9 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.9% 3/102 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.
Vascular disorders FLUSHING	6.1% 6/98 • Number of events 7 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.	2.0% 2/102 • Number of events 3 Due to the specification of no reason for the 2 deaths on the Capecitabine arm, these 2 events were coded as 'Death'.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee If investigator wishes to publish study information, a copy of the manuscript must be provided to sponsor for review at least 60 days before submission of publication/presentation. In the event issues arise regarding scientific integrity/regulatory compliance, sponsor will review these issues with investigator. Investigator will not publish data derived from the individual site until 12 months after conclusion/abandonment/termination of study at all sites.
• Publication restrictions are in place

Restriction type: OTHER