Trial Outcomes & Findings for Trabectedin for Recurrent Grade II/III Meningioma (NCT NCT02234050)

NCT ID: NCT02234050

Last Updated: 2025-07-10

Results Overview

Progression (PD) was measured according to the Macdonald response criteria as at least a 25% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) AND an absolute increase of ≥ 5 mm. Appearance of new lesions will also constitute PD (including lesions in previously unassessed areas). Progression Free Survival (PFS) was measured from the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first. Patients without evidence of progression was censored at the last follow-up visit date. If a patient received a second anti-tumoral therapy without prior documentation of disease progression, the patient was censored at the date of starting new anti-tumoral therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first up.PFS was assessed by its median the point time at which 50% of the patients have experienced disease progression or death.
• Results posted on: 2025-07-10

Participant Flow

Patient randomization was only accepted from authorized investigators. Patients were randomized directly on the EORTC online randomization system (ORTA = online randomized trials access), accessible 24 hours a day, 7 days a week, through the internet. A patient could only be randomized after verification of eligibility. Both the eligibility check and randomization Case Report Forms had to be done before the start of the protocol treatment.

Participant milestones

Measure	Trabectedin Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.	Local Standard of Care Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator. In some countries no treatment is administered to the patient instead an active surveillance or wait and see approach is applied. This was also considered a valid local standard of care in this study.
Overall Study STARTED	61	29
Overall Study COMPLETED	0	4
Overall Study NOT COMPLETED	61	25

Reasons for withdrawal

Measure	Trabectedin Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.	Local Standard of Care Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator. In some countries no treatment is administered to the patient instead an active surveillance or wait and see approach is applied. This was also considered a valid local standard of care in this study.
Overall Study Lack of Efficacy	38	22
Overall Study Adverse Event	13	1
Overall Study Withdrawal by Subject	4	2
Overall Study Sponsor's decision	6	0

Baseline Characteristics

Trabectedin for Recurrent Grade II/III Meningioma

Baseline characteristics by cohort

Measure	Local Standard of Care n=29 Participants Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator	Trabectedin n=61 Participants Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	29 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	32 Participants n=7 Participants	45 Participants n=5 Participants
Age, Continuous	63 years n=5 Participants	62 years n=7 Participants	62.2 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	31 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	30 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	29 Participants n=5 Participants	61 Participants n=7 Participants	90 Participants n=5 Participants
Region of Enrollment Austria	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Netherlands	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Belgium	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Norway	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Italy	5 participants n=5 Participants	14 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment United Kingdom	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment France	9 participants n=5 Participants	14 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Germany	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants
World Health Organization (WHO) performance status PS 0	7 participants n=5 Participants	15 participants n=7 Participants	22 participants n=5 Participants
World Health Organization (WHO) performance status PS 1	13 participants n=5 Participants	34 participants n=7 Participants	47 participants n=5 Participants
World Health Organization (WHO) performance status PS 2	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants
World Health Organization (WHO) performance status PS 3	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Histology grade WHO Grade II	19 participants n=5 Participants	36 participants n=7 Participants	55 participants n=5 Participants
Histology grade WHO Grade III	10 participants n=5 Participants	25 participants n=7 Participants	35 participants n=5 Participants
Corticosteroids intake No	20 participants n=5 Participants	39 participants n=7 Participants	59 participants n=5 Participants
Corticosteroids intake Yes	9 participants n=5 Participants	21 participants n=7 Participants	30 participants n=5 Participants
Corticosteroids intake Not completed	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Largest diameter of initial target lesions (mm)	36 mm n=5 Participants	44 mm n=7 Participants	43.5 mm n=5 Participants

PRIMARY outcome

Timeframe: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first up.PFS was assessed by its median the point time at which 50% of the patients have experienced disease progression or death.

Population: Per protocol population was defined as all patients who were eligible and had started their allocated treatment (at least one dose of Trabectedin or start of local standard of care therapy)

Progression (PD) was measured according to the Macdonald response criteria as at least a 25% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) AND an absolute increase of ≥ 5 mm. Appearance of new lesions will also constitute PD (including lesions in previously unassessed areas). Progression Free Survival (PFS) was measured from the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first. Patients without evidence of progression was censored at the last follow-up visit date. If a patient received a second anti-tumoral therapy without prior documentation of disease progression, the patient was censored at the date of starting new anti-tumoral therapy.

Outcome measures

Measure	Local Standard of Care n=22 Participants Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator	Trabectedin n=57 Participants Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.
Progression Free Survival (PFS)	4.17 Months Interval 2.0 to 5.95	2.43 Months Interval 2.07 to 3.32

SECONDARY outcome

Timeframe: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first. PFS at 6 months,the proportion of patients who have not experienced disease progression or death by 6 months is presented

Population: Per protocol population: all patients who were eligible and had started their allocated treatment (at least one dose of Trabectedin or start of local standard of care therapy)

The PFS probability at 6 months (PFS-6) was extracted from the Kaplan-Meyer PFS curve. 95% confidence intervals were computed based on the Greenwood's formula.

Outcome measures

Measure	Local Standard of Care n=22 Participants Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator	Trabectedin n=57 Participants Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.
Progression Free Survival at 6 Months (PFS-6)	29.1 percentage of participants Interval 11.9 to 48.8	21.1 percentage of participants Interval 11.3 to 32.9

SECONDARY outcome

Timeframe: From the date of randomization until disease progression or death, up to 24 months from date of randomization.It was assessed every 9 or 12 weeks (see measure description for details).The response rate presented is based on the best response observed.

Population: Per protocol population: all patients who were eligible and had started their allocated treatment (at least one dose of Trabectedin or start of local standard of care therapy)

Tumor response was measured according to the Macdonald response criteria as Complete Response (CR): disappearance of all target and non-target lesions. Residual lesions (other than nodes < 10 mm) thought to be non-malignant should be further investigated before CR can be accepted. Clinical evaluation must be stable or improving. No steroids should be needed.

Partial Response (PR): at least a 50% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non target lesions must be non-PD. Clinical evaluation must be stable or improving. Steroid dose must be stable or diminishing. Objective response was defined as both CR and PR. It was scheduled every 9 weeks from randomization until progression and after discontinuation of treatment without progression, every 9 weeks for the first year from randomization and every 12 weeks thereafter.

Outcome measures

Measure	Local Standard of Care n=22 Participants Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator	Trabectedin n=57 Participants Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.
Objective Response (CR/PR)	0 percentage of participants	1.8 percentage of participants

SECONDARY outcome

Timeframe: From the date of randomization up to the date of death. OS was assessed by its median the point time at which 50% of the patients have experienced death.

Population: Per protocol population: all patients who were eligible and had started their allocated treatment (at least one dose of Trabectedin or start of local standard of care therapy)

Overall Survival (OS) was calculated from the date of randomization up to the date of death (any cause). For patients still alive or lost to follow-up at the time of analysis, survival will be censored at last follow-up visit date.

Outcome measures

Measure	Local Standard of Care n=22 Participants Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator	Trabectedin n=57 Participants Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.
Overall Survival (OS)	10.61 Months Interval 5.91 to 13.54	11.37 Months Interval 8.15 to 16.89

SECONDARY outcome

Timeframe: Baseline measurements were collected before or on the day of the start of protocol treatment, but no earlier than 28 days before. The median baseline Global health status / QoL scores per treatment arm is reported.

Population: Safety population: all patients who had started their allocated treatment (at least one dose of Trabectedin or start of local standard of care therapy). Additionally per protocol windows were used to allocate the Qol assessments to the baseline timepoint.

Due to the small sample size and low compliance in the Standard of Care (SoC) arm, the analysis of Quality of Life (QoL) was restricted to describing The Global health status / QoL scores at baseline. The Global health status / QoL scores are part of the EORTC QLQ-C30, which is a core questionnaire designed to assess the quality of life of cancer patients. These scores are derived from a specific scale within the EORTC Quality of Life Questionnaire (QLQ-C30) that evaluates the overall health status and quality of life of the patient. The scoring for the Global health status / QoL scale involves a linear transformation of the raw score to a standardized score ranging from 0 to 100. This scale is revised in version 3.0 of the QLQ-C30 and includes two items with a range of 6, specifically items 29 (Global health status)and 30 (QoL scale). Higher score values represent a better outcome i.e. a higher quality of life.

Outcome measures

Measure	Local Standard of Care n=24 Participants Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator	Trabectedin n=55 Participants Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.
Health-related Quality of Life (HRQol)	54.2 score on a scale Interval 16.7 to 83.3	58.3 score on a scale Interval 0.0 to 100.0

Adverse Events

Trabectedin

Serious events: 26 serious events

Other events: 58 other events

Deaths: 40 deaths

Local Standard of Care

Serious events: 4 serious events

Other events: 25 other events

Deaths: 17 deaths

Serious adverse events

Measure	Trabectedin n=61 participants at risk Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.	Local Standard of Care n=27 participants at risk Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator
Blood and lymphatic system disorders Anemia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Blood and lymphatic system disorders Febrile Neutropenia	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Blood and lymphatic system disorders Other AE	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Cardiac disorders Myocarditis	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Ear and labyrinth disorders Other AE	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Diarrhea	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Nausea	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Vomiting	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Other AE	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Fatigue	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Sudden Death Nos	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Hepatobiliary disorders Other AE	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Catheter Related Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Lung Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Meningitis	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Mucosal Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Otitis Externa	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Sepsis	6.6% 4/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Upper Respiratory Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Urinary Tract Infection	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Wound Infection	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Injury, poisoning and procedural complications Fall	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Alanine Aminotransferase Increased	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Aspartate Aminotransferase Increased	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Cpk Increased	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Ggt Increased	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Neutrophil Count Decreased	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Anorexia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Dehydration	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Hyponatremia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Myalgia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Dizziness	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Hydrocephalus	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Intracranial Hemorrhage	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Ischemia Cerebrovascular	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Lethargy	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Seizure	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Somnolence	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Other AE	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Respiratory, thoracic and mediastinal disorders Other AE	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Vascular disorders Hypotension	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Vascular disorders Thromboembolic Event	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.

Other adverse events

Measure	Trabectedin n=61 participants at risk Patient will be treated with trabectedin Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.	Local Standard of Care n=27 participants at risk Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Local standard of care: Left to the discretion of the investigator
Blood and lymphatic system disorders Anemia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Blood and lymphatic system disorders Febrile Neutropenia	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Blood and lymphatic system disorders Other AE	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Cardiac disorders Myocarditis	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Cardiac disorders Sinus Tachycardia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Ear and labyrinth disorders Ear Pain	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Ear and labyrinth disorders Vertigo	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Ear and labyrinth disorders Vestibular Disorder	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Ear and labyrinth disorders Other AE	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Endocrine disorders Cushingoid	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Endocrine disorders Hypothyroidism	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Eye disorders Blurred Vision	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Eye disorders Eyelid Function Disorder	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Eye disorders Watering Eyes	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Abdominal Pain	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Constipation	24.6% 15/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Diarrhea	14.8% 9/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Dysphagia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Esophageal Pain	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Fecal Incontinence	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Gastritis	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Gastroesophageal Reflux Disease	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Gastrointestinal Pain	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Mucositis Oral	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Nausea	47.5% 29/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	18.5% 5/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Periodontal Disease	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Stomach Pain	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Toothache	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Vomiting	36.1% 22/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Gastrointestinal disorders Other AE	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Chills	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Edema Limbs	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Fatigue	42.6% 26/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	40.7% 11/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Fever	9.8% 6/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Flu Like Symptoms	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Gait Disturbance	6.6% 4/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Localized Edema	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Malaise	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Pain	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
General disorders Sudden Death Nos	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Hepatobiliary disorders Other AE	8.2% 5/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Bladder Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Bronchial Infection	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Catheter Related Infection	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Device Related Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Enterocolitis Infectious	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Eye Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Gum Infection	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Lung Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Meningitis	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Mucosal Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Otitis Externa	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Paronychia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Sepsis	6.6% 4/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Skin Infection	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Upper Respiratory Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Urinary Tract Infection	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Wound Infection	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Infections and infestations Other AE	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Injury, poisoning and procedural complications Fall	9.8% 6/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Injury, poisoning and procedural complications Fracture	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Alanine Aminotransferase Increased	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Aspartate Aminotransferase Increased	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Cpk Increased	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Ggt Increased	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Neutrophil Count Decreased	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Serum Amylase Increased	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Weight Gain	9.8% 6/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations Weight Loss	14.8% 9/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Investigations White Blood Cell Decreased	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Anorexia	18.0% 11/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Dehydration	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Hyperglycemia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Hyperuricemia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Hypomagnesemia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Hyponatremia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Hypophosphatemia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Metabolism and nutrition disorders Other AE	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Arthralgia	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Back Pain	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Bone Pain	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Muscle Weakness Left-Sided	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Muscle Weakness Right-Sided	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Muscle Weakness Upper Limb	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Myalgia	11.5% 7/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	11.1% 3/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Myositis	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Pain In Extremity	6.6% 4/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Musculoskeletal and connective tissue disorders Other AE	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Ataxia	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Cerebrospinal Fluid Leakage	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Cognitive Disturbance	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Concentration Impairment	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Depressed Level Of Consciousness	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Dizziness	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Dysgeusia	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Dysphasia	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Edema Cerebral	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Headache	16.4% 10/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	25.9% 7/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Hydrocephalus	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Hypersomnia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Intracranial Hemorrhage	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Ischemia Cerebrovascular	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Ivth Nerve Disorder	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Lethargy	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Memory Impairment	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Paresthesia	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Peripheral Motor Neuropathy	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Pyramidal Tract Syndrome	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Seizure	9.8% 6/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	14.8% 4/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Somnolence	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Stroke	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Tremor	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Trigeminal Nerve Disorder	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Nervous system disorders Other AE	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Psychiatric disorders Anxiety	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Psychiatric disorders Confusion	6.6% 4/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Psychiatric disorders Depression	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Psychiatric disorders Insomnia	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Psychiatric disorders Other AE	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Renal and urinary disorders Acute Kidney Injury	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Renal and urinary disorders Proteinuria	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Renal and urinary disorders Urinary Frequency	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Renal and urinary disorders Urinary Incontinence	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Reproductive system and breast disorders Genital Edema	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Reproductive system and breast disorders Testicular Disorder	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.8% 6/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Respiratory, thoracic and mediastinal disorders Hiccups	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Respiratory, thoracic and mediastinal disorders Sore Throat	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Respiratory, thoracic and mediastinal disorders Other AE	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Skin and subcutaneous tissue disorders Dry Skin	3.3% 2/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Skin and subcutaneous tissue disorders Skin Ulceration	0.00% 0/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	7.4% 2/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Skin and subcutaneous tissue disorders Other AE	1.6% 1/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	3.7% 1/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Vascular disorders Hypertension	14.8% 9/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	40.7% 11/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Vascular disorders Hypotension	4.9% 3/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.
Vascular disorders Thromboembolic Event	8.2% 5/61 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.	0.00% 0/27 • Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. SAEs and all AEs were reported in the safety population defined as the randomized patients who have started their allocated treatments. All-cause mortality was also reported in the safety population.

Additional Information

Dr. Thierry Gorlia

EORTC

Phone: 027741652

Email: thierry.gorlia@eortc.org

Results disclosure agreements

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