Trial Outcomes & Findings for An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer (NCT NCT00113607)

NCT ID: NCT00113607

Last Updated: 2014-06-27

Results Overview

PFS is defined as the time between randomization and disease progression or death.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 672 participants
• Primary outcome timeframe: From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years
• Results posted on: 2014-06-27

Participant Flow

This study was conducted in a total of 21 countries at 124 sites worldwide.

672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm) and out of which 9 participants were not treated. 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL.

Participant milestones

Measure	DOXIL 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks	Trabectedin/DOXIL 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
Overall Study STARTED	335	337
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	335	337

Reasons for withdrawal

Measure	DOXIL 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks	Trabectedin/DOXIL 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
Overall Study Adverse Event	40	71
Overall Study Death	8	8
Overall Study Withdrawal by Subject	50	58
Overall Study Lost to Follow-up	0	2
Overall Study Disease Progression	180	142
Overall Study Complete Response (Confirmed)	14	24
Overall Study Other	43	32

Baseline Characteristics

An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

Baseline characteristics by cohort

Measure	DOXIL n=335 Participants 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks	Trabectedin/DOXIL n=337 Participants 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks	Total n=672 Participants Total of all reporting groups
Age, Continuous	58.2 years STANDARD_DEVIATION 10.75 • n=5 Participants	56.8 years STANDARD_DEVIATION 10.48 • n=7 Participants	57.5 years STANDARD_DEVIATION 10.63 • n=5 Participants
Sex: Female, Male Female	335 Participants n=5 Participants	337 Participants n=7 Participants	672 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Argentina	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Australia	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Belgium-Luxemburg	12 participants n=5 Participants	13 participants n=7 Participants	25 participants n=5 Participants
Region of Enrollment Brazil	12 participants n=5 Participants	9 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment Canada	22 participants n=5 Participants	34 participants n=7 Participants	56 participants n=5 Participants
Region of Enrollment Chile	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment France	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Germany	6 participants n=5 Participants	13 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Hong Kong	10 participants n=5 Participants	15 participants n=7 Participants	25 participants n=5 Participants
Region of Enrollment Italy	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Netherlands	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment China	37 participants n=5 Participants	36 participants n=7 Participants	73 participants n=5 Participants
Region of Enrollment Poland	47 participants n=5 Participants	39 participants n=7 Participants	86 participants n=5 Participants
Region of Enrollment Republic Of Korea	17 participants n=5 Participants	11 participants n=7 Participants	28 participants n=5 Participants
Region of Enrollment Russia	52 participants n=5 Participants	56 participants n=7 Participants	108 participants n=5 Participants
Region of Enrollment Singapore	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Spain	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Sweden	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Taiwan	7 participants n=5 Participants	2 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment United Kingdom	18 participants n=5 Participants	20 participants n=7 Participants	38 participants n=5 Participants
Region of Enrollment United States Of America	63 participants n=5 Participants	58 participants n=7 Participants	121 participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years

Population: All Measurable Analysis Participants: All randomized participants who had measurable disease at baseline as assessed by the independent radiology review. Measurable disease is defined as having at least 1 lesion measured with a diameter of ≥20 mm using conventional techniques or of ≥10 mm using a spiral computerized tomography scan.

PFS is defined as the time between randomization and disease progression or death.

Outcome measures

Measure	DOXIL n=317 Participants 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks	Trabectedin/DOXIL n=328 Participants 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
Progression-Free Survival (PFS): Independent Radiologist Review	5.8 Months Interval 5.5 to 7.1	7.3 Months Interval 5.9 to 7.9

SECONDARY outcome

Timeframe: From the date of randomization until the date of death, as assessed for approximately 3 years

Population: All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not

Overall survival was defined as the time between the randomization and death

Outcome measures

Measure	DOXIL n=335 Participants 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks	Trabectedin/DOXIL n=337 Participants 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
Overall Survival	18.9 Months Interval 17.1 to 21.5	22.2 Months Interval 19.3 to 25.0

SECONDARY outcome

Timeframe: From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years

Population: All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not.

Percentage of participants who achieved complete response (CR) or partial response (PR) as best overall response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR)= greater than or equal to 30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.

Outcome measures

Measure	DOXIL n=335 Participants 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks	Trabectedin/DOXIL n=337 Participants 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
Objective Response Rate (ORR) - Independent Radiologist Review	18.8 Percentage of participants	27.6 Percentage of participants

SECONDARY outcome

Timeframe: From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years

Population: All Responders (CR/PR) Analysis Participants: all participants who achieved CR or PR as best overall response during the study.

Duration of response was defined only for participants who had complete response or partial response as best overall response. Duration of response was calculated from the date of first documentation of response (not the confirmation) to the date of disease progression or death due to progressive disease.

Outcome measures

Measure	DOXIL n=63 Participants 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks	Trabectedin/DOXIL n=93 Participants 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
Duration of Response: Independent Radiologist Review	7.7 Months Interval 6.5 to 9.0	7.9 Months Interval 7.4 to 9.2

SECONDARY outcome

Timeframe: Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2

Population: Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.

Median simulated area under the curve (AUC) of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil, calculated using the trapezoidal rule method. Simulations were based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (Participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.

Outcome measures

Measure	DOXIL n=86 Participants 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks	Trabectedin/DOXIL 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
Median Area Under Curve (AUC) of Trabectedin.	74.24 ng*h/mL	—

SECONDARY outcome

Timeframe: Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2

Population: Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.

Median simulated maximum plasma concentration (Cmax) at 3 hour of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil. The assessment of Cmax was based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.

Outcome measures

Measure	DOXIL n=86 Participants 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks	Trabectedin/DOXIL 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
Median Maximum Plasma Concentration (Cmax) of Trabectedin.	13394 pg/mL	—

Adverse Events

Trabectedin/DOXIL

Serious events: 133 serious events

Other events: 333 other events

Deaths: 0 deaths

DOXIL

Serious events: 102 serious events

Other events: 318 other events

Deaths: 0 deaths

Serious adverse events

Measure	Trabectedin/DOXIL n=333 participants at risk 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks	DOXIL n=330 participants at risk 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
Gastrointestinal disorders Gastrointestinal Disorder	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Gastrointestinal Obstruction	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Ileus	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	1.2% 4/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Catheter Site Cellulitis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Catheter Site Infection	1.2% 4/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Urticaria	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Renal and urinary disorders Renal Failure Acute	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Renal and urinary disorders Renal Impairment	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Arterial Insufficiency	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Reproductive system and breast disorders Oedema Genital	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	3.9% 13/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	1.8% 6/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Anaemia	5.1% 17/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	2.1% 7/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Bicytopenia	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Bone Marrow Failure	1.2% 4/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Febrile Neutropenia	5.4% 18/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	1.5% 5/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Granulocytopenia	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Leukopenia	4.8% 16/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Neutropenia	7.8% 26/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	2.1% 7/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Melanosis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Pancytopenia	1.8% 6/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Thrombocytopenia	6.3% 21/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Cardiac disorders Cardiac Arrest	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Cardiac disorders Cardiac Failure Congestive	0.60% 2/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Cardiac disorders Electromechanical Dissociation	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Cardiac disorders Palpitations	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Cardiac disorders Ventricular Tachycardia	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Congenital, familial and genetic disorders Adenomatous Polyposis Coli	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Abdominal Distension	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Abdominal Pain	1.8% 6/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	2.7% 9/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	1.2% 4/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Aphthous Stomatitis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Ascites	1.8% 6/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	2.1% 7/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Colonic Obstruction	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Constipation	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Diarrhoea	1.8% 6/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Enterocutaneous Fistula	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Erosive Oesophagitis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Intestinal Fistula	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Intestinal Obstruction	2.1% 7/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	3.3% 11/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Large Intestinal Obstruction	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Mechanical Ileus	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Nausea	4.2% 14/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	2.4% 8/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Oesophageal Ulcer	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Oesophagitis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Small Intestinal Obstruction	2.1% 7/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Stomatitis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Subileus	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Vomiting	4.5% 15/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	2.4% 8/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Adverse Drug Reaction	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Asthenia	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Catheter Related Complication	0.60% 2/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Catheter Site Phlebitis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Chest Discomfort	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Chills	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Condition Aggravated	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Extravasation	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Fatigue	2.4% 8/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders General Physical Health Deterioration	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Hernia Obstructive	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Hernia Pain	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Mucosal Inflammation	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Pruritus	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Non-Cardiac Chest Pain	0.60% 2/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Oedema Peripheral	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Pain	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Pyrexia	3.0% 10/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Sudden Death	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Hepatobiliary disorders Cholecystitis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Hepatobiliary disorders Cholelithiasis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Hepatobiliary disorders Hepatitis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Hepatobiliary disorders Hepatitis Cholestatic	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Hepatobiliary disorders Hepatitis Toxic	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Hepatobiliary disorders Hyperbilirubinaemia	0.60% 2/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Immune system disorders Anaphylactic Reaction	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Immune system disorders Drug Hypersensitivity	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Immune system disorders Hypersensitivity	0.60% 2/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.91% 3/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Abscess	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Bacteraemia	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Bacterial Sepsis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Bronchitis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Catheter Related Infection	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Catheter Sepsis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Cellulitis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Central Line Infection	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Clostridium Difficile Colitis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Enterocolitis Infectious	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Erysipeloid	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Helicobacter Gastritis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Herpes Oesophagitis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Infection	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Influenza	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Neutropenic Infection	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Neutropenic Sepsis	0.60% 2/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Rash	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Oesophageal Candidiasis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Perineal Abscess	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Pharyngitis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Pneumonia	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	1.2% 4/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Pyelonephritis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Respiratory Tract Infection Viral	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Sepsis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Septic Shock	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Staphylococcal Sepsis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Subcutaneous Abscess	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Urinary Tract Infection	0.60% 2/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Urinary Tract Infection Bacterial	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Urosepsis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Injury, poisoning and procedural complications Device Dislocation	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Injury, poisoning and procedural complications Medical Device Complication	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Injury, poisoning and procedural complications Postoperative Ileus	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Injury, poisoning and procedural complications Procedural Nausea	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Injury, poisoning and procedural complications Procedural Vomiting	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Injury, poisoning and procedural complications Wound Dehiscence	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Alanine Aminotransferase Increased	1.5% 5/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Aspartate Aminotransferase Increased	1.5% 5/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Blood Alkaline Phosphatase Increased	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Blood Creatine Phosphokinase Increased	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Blood Creatinine Increased	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Carbohydrate Antigen 125 Increased	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Electrocardiogram Change	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Gamma-Glutamyltransferase Increased	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Hepatic Enzyme Increased	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Liver Function Test Abnormal	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Transaminases Increased	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Anorexia	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	1.8% 6/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Dehydration	2.1% 7/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	1.2% 4/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Hypokalaemia	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Malnutrition	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Musculoskeletal and connective tissue disorders Bone Pain	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Central Nervous System	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Soft Tissue	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic Complication	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic Syndrome	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Cerebrovascular Accident	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Convulsion	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Dizziness	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Grand Mal Convulsion	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Headache	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Lethargy	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Loss of Consciousness	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Syncope	0.60% 2/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Syncope Vasovagal	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Psychiatric disorders Confusional State	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Renal and urinary disorders Haematuria	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Renal and urinary disorders Hydronephrosis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Renal and urinary disorders Nephrolithiasis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Renal and urinary disorders Obstructive Uropathy	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Axillary Vein Thrombosis	0.60% 2/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Deep Vein Thrombosis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.61% 2/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Haemorrhage	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Hypotension	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Jugular Vein Thrombosis	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Peripheral Ischaemia	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Subclavian Vein Thrombosis	0.60% 2/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Thrombosis	0.90% 3/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Vena Cava Thrombosis	0.00% 0/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.30% 1/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Vascular disorders Venous Occlusion	0.30% 1/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	0.00% 0/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.

Other adverse events

Measure	Trabectedin/DOXIL n=333 participants at risk 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks	DOXIL n=330 participants at risk 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
Blood and lymphatic system disorders Anaemia	48.0% 160/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	24.8% 82/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Leukopenia	49.2% 164/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	27.6% 91/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Neutropenia	76.9% 256/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	38.8% 128/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Blood and lymphatic system disorders Thrombocytopenia	34.5% 115/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	8.2% 27/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Abdominal Distension	5.4% 18/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	7.0% 23/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Abdominal Pain	21.0% 70/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	23.0% 76/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Abdominal Pain Upper	5.7% 19/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	7.6% 25/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Ascites	3.9% 13/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	5.5% 18/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Constipation	32.7% 109/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	27.9% 92/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Diarrhoea	25.2% 84/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	19.1% 63/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Dyspepsia	12.9% 43/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	10.6% 35/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Mouth Ulceration	3.3% 11/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	6.4% 21/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Nausea	75.4% 251/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	42.1% 139/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Stomatitis	20.1% 67/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	32.7% 108/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Gastrointestinal disorders Vomiting	56.5% 188/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	29.4% 97/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Asthenia	16.8% 56/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	11.5% 38/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Fatigue	45.9% 153/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	37.0% 122/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Mucosal Inflammation	12.6% 42/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	19.4% 64/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Oedema Peripheral	9.0% 30/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	8.5% 28/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Pain	5.4% 18/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	3.6% 12/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
General disorders Pyrexia	18.9% 63/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	13.3% 44/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Hepatobiliary disorders Hyperbilirubinaemia	15.3% 51/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	7.6% 25/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Infections and infestations Urinary Tract Infection	4.5% 15/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	5.8% 19/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Alanine Aminotransferase Increased	55.6% 185/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	10.0% 33/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Aspartate Aminotransferase Increased	41.7% 139/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	10.6% 35/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Blood Alkaline Phosphatase Increased	23.1% 77/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	8.8% 29/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Blood Creatine Phosphokinase Increased	6.9% 23/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	3.3% 11/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Investigations Blood Creatinine Increased	6.3% 21/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	6.1% 20/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Anorexia	32.7% 109/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	25.8% 85/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Hypoalbuminaemia	6.6% 22/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	5.8% 19/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Hypokalaemia	11.4% 38/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	7.9% 26/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Metabolism and nutrition disorders Hyponatraemia	5.7% 19/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	3.3% 11/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	6.3% 21/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	4.2% 14/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Musculoskeletal and connective tissue disorders Back Pain	9.0% 30/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	9.4% 31/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Musculoskeletal and connective tissue disorders Myalgia	5.4% 18/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	3.6% 12/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Musculoskeletal and connective tissue disorders Pain in Extremity	6.0% 20/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	5.5% 18/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Dizziness	9.9% 33/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	6.7% 22/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Dysgeusia	5.7% 19/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	3.0% 10/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Nervous system disorders Headache	16.5% 55/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	7.3% 24/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Psychiatric disorders Anxiety	6.9% 23/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	3.3% 11/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Psychiatric disorders Insomnia	10.2% 34/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	4.8% 16/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Respiratory, thoracic and mediastinal disorders Cough	12.3% 41/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	12.1% 40/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.6% 52/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	10.0% 33/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	5.1% 17/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	7.3% 24/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Alopecia	12.6% 42/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	14.5% 48/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Dry Skin	5.4% 18/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	3.0% 10/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Erythema	5.4% 18/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	5.8% 19/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	25.8% 86/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	54.2% 179/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Pruritus	3.3% 11/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	6.1% 20/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Rash	10.8% 36/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	17.9% 59/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	6.3% 21/333 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.	7.3% 24/330 • From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication. Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.

Additional Information

Director Clinical Research Medical Leader

Janssen R&D US

Phone: 908 704 5779

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60