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Trial record 1 of 1 for:    NCT01343277
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A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma

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ClinicalTrials.gov Identifier: NCT01343277
Recruitment Status : Completed
First Posted : April 28, 2011
Results First Posted : January 28, 2016
Last Update Posted : August 26, 2016
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Liposarcoma or Leiomyosarcoma
Interventions Drug: Trabectedin
Drug: Dacarbazine
Enrollment 579
Recruitment Details  
Pre-assignment Details Total enrolled participants were 577, but 2 participants were randomized twice, therefore counted twice in enrollment. Thus, enrolled participants are reported as 579.
Arm/Group Title Trabectedin Dacarbazine
Hide Arm/Group Description Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion. Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
Period Title: Overall Study
Started 384 193
Treated 378 172
Completed 0 0
Not Completed 384 193
Reason Not Completed
Other             3             3
Withdrawal by Subject             18             13
Physician Decision             1             2
Death             10             1
Adverse Event             67             13
Disease progression             270             138
Randomized not treated             6             21
Treatment ongoing             8             2
Subsequent anticancer therapy             1             0
Arm/Group Title Trabectedin Dacarbazine Total
Hide Arm/Group Description Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion. Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion. Total of all reporting groups
Overall Number of Baseline Participants 384 193 577
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 384 participants 193 participants 577 participants
56.5  (11.04) 54.1  (11.92) 55.7  (11.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 384 participants 193 participants 577 participants
Female
262
  68.2%
140
  72.5%
402
  69.7%
Male
122
  31.8%
53
  27.5%
175
  30.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 384 participants 193 participants 577 participants
AUS 15 8 23
BRA 10 2 12
NZL 3 0 3
USA 356 183 539
1.Primary Outcome
Title Overall Survival (OS)
Hide Description The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
Time Frame approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the randomized participants up to up to final analysis cut-off date (05 January 2015).
Arm/Group Title Trabectedin Dacarbazine
Hide Arm/Group Description:
Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
Overall Number of Participants Analyzed 384 193
Median (95% Confidence Interval)
Unit of Measure: Months
13.73
(12.16 to 16.00)
13.14
(9.10 to 16.23)
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
Time Frame approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Trabectedin Dacarbazine
Hide Arm/Group Description:
Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
Overall Number of Participants Analyzed 345 173
Median (95% Confidence Interval)
Unit of Measure: Months
4.21
(2.99 to 4.83)
1.54
(1.48 to 2.60)
3.Secondary Outcome
Title Time to Progression
Hide Description

Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.

Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.

Time Frame approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Trabectedin Dacarbazine
Hide Arm/Group Description:
Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
Overall Number of Participants Analyzed 345 173
Median (95% Confidence Interval)
Unit of Measure: Months
4.24
(3.22 to 4.93)
1.54
(1.48 to 2.60)
4.Secondary Outcome
Title Objective Response Rate
Hide Description The objective response rate (ORR) is defined as the percentage of participants who achieved a Complete response (CR) or partial response (PR) as best responses. according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
Time Frame approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Trabectedin Dacarbazine
Hide Arm/Group Description:
Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
Overall Number of Participants Analyzed 345 173
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
9.9
(6.9 to 13.5)
6.9
(3.6 to 11.8)
5.Secondary Outcome
Title Duration of Response
Hide Description

Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.

Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.

Time Frame approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Trabectedin Dacarbazine
Hide Arm/Group Description:
Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
Overall Number of Participants Analyzed 34 12
Median (95% Confidence Interval)
Unit of Measure: Months
6.47
(3.58 to 7.62)
4.17 [1] 
(2.14 to NA)
[1]
Insufficient participants reached the median percentile to calculate the upper limits of confidence interval.
6.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the treated participants.
Arm/Group Title Trabectedin Dacarbazine
Hide Arm/Group Description:
Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
Overall Number of Participants Analyzed 378 172
Measure Type: Number
Unit of Measure: Participants
Serious Adverse Events (SAEs) 155 52
Adverse Events (AEs) 375 166
Time Frame approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]
Adverse Event Reporting Description Safety population included all the treated participants.
 
Arm/Group Title Trabectedin Dacarbazine
Hide Arm/Group Description Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion. Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
All-Cause Mortality
Trabectedin Dacarbazine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Trabectedin Dacarbazine
Affected / at Risk (%) Affected / at Risk (%)
Total   155/378 (41.01%)   52/172 (30.23%) 
Blood and lymphatic system disorders     
Anaemia * 1  15/378 (3.97%)  4/172 (2.33%) 
Febrile Neutropenia * 1  12/378 (3.17%)  2/172 (1.16%) 
Leukocytosis * 1  3/378 (0.79%)  0/172 (0.00%) 
Leukopenia * 1  4/378 (1.06%)  3/172 (1.74%) 
Microangiopathic Haemolytic Anaemia * 1  1/378 (0.26%)  0/172 (0.00%) 
Neutropenia * 1  9/378 (2.38%)  1/172 (0.58%) 
Thrombocytopenia * 1  7/378 (1.85%)  3/172 (1.74%) 
Cardiac disorders     
Atrial Fibrillation * 1  2/378 (0.53%)  1/172 (0.58%) 
Atrial Flutter * 1  1/378 (0.26%)  0/172 (0.00%) 
Cardiac Arrest * 1  3/378 (0.79%)  0/172 (0.00%) 
Cardiac Disorder * 1  1/378 (0.26%)  0/172 (0.00%) 
Cardiac Failure * 1  3/378 (0.79%)  0/172 (0.00%) 
Cardiac Failure Acute * 1  1/378 (0.26%)  0/172 (0.00%) 
Cardiac Failure Congestive * 1  7/378 (1.85%)  0/172 (0.00%) 
Cardiomyopathy * 1  2/378 (0.53%)  0/172 (0.00%) 
Left Ventricular Dysfunction * 1  1/378 (0.26%)  0/172 (0.00%) 
Palpitations * 1  1/378 (0.26%)  0/172 (0.00%) 
Right Ventricular Dysfunction * 1  1/378 (0.26%)  0/172 (0.00%) 
Sinus Tachycardia * 1  1/378 (0.26%)  0/172 (0.00%) 
Tachycardia * 1  1/378 (0.26%)  1/172 (0.58%) 
Ear and labyrinth disorders     
Vertigo * 1  1/378 (0.26%)  0/172 (0.00%) 
Eye disorders     
Visual Impairment * 1  1/378 (0.26%)  0/172 (0.00%) 
Gastrointestinal disorders     
Abdominal Distension * 1  0/378 (0.00%)  1/172 (0.58%) 
Abdominal Hernia * 1  1/378 (0.26%)  0/172 (0.00%) 
Abdominal Pain * 1  13/378 (3.44%)  8/172 (4.65%) 
Abdominal Pain Lower * 1  2/378 (0.53%)  1/172 (0.58%) 
Abdominal Pain Upper * 1  1/378 (0.26%)  0/172 (0.00%) 
Ascites * 1  2/378 (0.53%)  0/172 (0.00%) 
Colitis * 1  2/378 (0.53%)  0/172 (0.00%) 
Constipation * 1  2/378 (0.53%)  1/172 (0.58%) 
Diarrhoea * 1  4/378 (1.06%)  0/172 (0.00%) 
Duodenal Obstruction * 1  1/378 (0.26%)  2/172 (1.16%) 
Dysphagia * 1  2/378 (0.53%)  0/172 (0.00%) 
Gastrointestinal Haemorrhage * 1  2/378 (0.53%)  0/172 (0.00%) 
Intestinal Obstruction * 1  3/378 (0.79%)  0/172 (0.00%) 
Intestinal Ulcer * 1  0/378 (0.00%)  1/172 (0.58%) 
Intra-Abdominal Haemorrhage * 1  1/378 (0.26%)  0/172 (0.00%) 
Large Intestinal Obstruction * 1  0/378 (0.00%)  1/172 (0.58%) 
Large Intestine Perforation * 1  1/378 (0.26%)  0/172 (0.00%) 
Lower Gastrointestinal Haemorrhage * 1  1/378 (0.26%)  0/172 (0.00%) 
Nausea * 1  15/378 (3.97%)  3/172 (1.74%) 
Obstruction Gastric * 1  1/378 (0.26%)  1/172 (0.58%) 
Oesophageal Obstruction * 1  1/378 (0.26%)  0/172 (0.00%) 
Oesophageal Pain * 1  1/378 (0.26%)  0/172 (0.00%) 
Pancreatitis * 1  3/378 (0.79%)  0/172 (0.00%) 
Rectal Haemorrhage * 1  1/378 (0.26%)  0/172 (0.00%) 
Small Intestinal Obstruction * 1  9/378 (2.38%)  3/172 (1.74%) 
Upper Gastrointestinal Haemorrhage * 1  1/378 (0.26%)  0/172 (0.00%) 
Vomiting * 1  15/378 (3.97%)  3/172 (1.74%) 
General disorders     
Asthenia * 1  5/378 (1.32%)  0/172 (0.00%) 
Catheter Site Inflammation * 1  1/378 (0.26%)  0/172 (0.00%) 
Chest Discomfort * 1  1/378 (0.26%)  0/172 (0.00%) 
Chest Pain * 1  1/378 (0.26%)  0/172 (0.00%) 
Death * 1  5/378 (1.32%)  3/172 (1.74%) 
Device Breakage * 1  1/378 (0.26%)  0/172 (0.00%) 
Device Failure * 1  1/378 (0.26%)  0/172 (0.00%) 
Fatigue * 1  4/378 (1.06%)  1/172 (0.58%) 
Gait Disturbance * 1  1/378 (0.26%)  0/172 (0.00%) 
Generalised Oedema * 1  1/378 (0.26%)  0/172 (0.00%) 
Infusion Site Extravasation * 1  2/378 (0.53%)  0/172 (0.00%) 
Malaise * 1  1/378 (0.26%)  0/172 (0.00%) 
Multi-Organ Failure * 1  1/378 (0.26%)  0/172 (0.00%) 
Necrosis * 1  1/378 (0.26%)  0/172 (0.00%) 
Non-Cardiac Chest Pain * 1  0/378 (0.00%)  1/172 (0.58%) 
Oedema Peripheral * 1  2/378 (0.53%)  1/172 (0.58%) 
Pain * 1  1/378 (0.26%)  1/172 (0.58%) 
Pyrexia * 1  12/378 (3.17%)  2/172 (1.16%) 
Thrombosis in Device * 1  1/378 (0.26%)  0/172 (0.00%) 
Hepatobiliary disorders     
Hepatotoxicity * 1  1/378 (0.26%)  0/172 (0.00%) 
Portal Vein Thrombosis * 1  1/378 (0.26%)  0/172 (0.00%) 
Immune system disorders     
Drug Hypersensitivity * 1  0/378 (0.00%)  1/172 (0.58%) 
Infections and infestations     
Appendicitis * 1  0/378 (0.00%)  1/172 (0.58%) 
Bacteraemia * 1  2/378 (0.53%)  0/172 (0.00%) 
Catheter Site Infection * 1  8/378 (2.12%)  1/172 (0.58%) 
Cellulitis * 1  2/378 (0.53%)  0/172 (0.00%) 
Clostridium Difficile Colitis * 1  1/378 (0.26%)  0/172 (0.00%) 
Clostridium Difficile Infection * 1  1/378 (0.26%)  0/172 (0.00%) 
Clostridium Difficile Sepsis * 1  1/378 (0.26%)  0/172 (0.00%) 
Enterococcal Bacteraemia * 1  1/378 (0.26%)  0/172 (0.00%) 
Kidney Infection * 1  1/378 (0.26%)  0/172 (0.00%) 
Lobar Pneumonia * 1  1/378 (0.26%)  0/172 (0.00%) 
Lung Infection * 1  2/378 (0.53%)  0/172 (0.00%) 
Osteomyelitis * 1  0/378 (0.00%)  1/172 (0.58%) 
Peritonitis * 1  0/378 (0.00%)  1/172 (0.58%) 
Pneumonia * 1  6/378 (1.59%)  0/172 (0.00%) 
Respiratory Tract Infection * 1  1/378 (0.26%)  0/172 (0.00%) 
Sepsis * 1  8/378 (2.12%)  0/172 (0.00%) 
Septic Shock * 1  2/378 (0.53%)  0/172 (0.00%) 
Staphylococcal Bacteraemia * 1  1/378 (0.26%)  0/172 (0.00%) 
Urinary Tract Infection * 1  7/378 (1.85%)  2/172 (1.16%) 
Urinary Tract Infection Staphylococcal * 1  1/378 (0.26%)  0/172 (0.00%) 
Vaginal Infection * 1  1/378 (0.26%)  0/172 (0.00%) 
Wound Abscess * 1  1/378 (0.26%)  0/172 (0.00%) 
Injury, poisoning and procedural complications     
Ankle Fracture * 1  1/378 (0.26%)  0/172 (0.00%) 
Fall * 1  2/378 (0.53%)  0/172 (0.00%) 
Post Procedural Haemorrhage * 1  1/378 (0.26%)  0/172 (0.00%) 
Vascular Access Complication * 1  1/378 (0.26%)  0/172 (0.00%) 
Wound * 1  1/378 (0.26%)  0/172 (0.00%) 
Investigations     
Alanine Aminotransferase Increased * 1  2/378 (0.53%)  0/172 (0.00%) 
Aspartate Aminotransferase Increased * 1  3/378 (0.79%)  0/172 (0.00%) 
Blood Bilirubin Increased * 1  0/378 (0.00%)  1/172 (0.58%) 
Blood Creatine Phosphokinase Increased * 1  4/378 (1.06%)  0/172 (0.00%) 
Blood Creatinine Increased * 1  4/378 (1.06%)  0/172 (0.00%) 
Blood Lactic Acid Increased * 1  0/378 (0.00%)  1/172 (0.58%) 
Ejection Fraction Decreased * 1  5/378 (1.32%)  0/172 (0.00%) 
International Normalised Ratio Increased * 1  2/378 (0.53%)  0/172 (0.00%) 
Liver Function Test Abnormal * 1  2/378 (0.53%)  0/172 (0.00%) 
Myoglobin Blood Increased * 1  1/378 (0.26%)  0/172 (0.00%) 
Neutrophil Count Decreased * 1  4/378 (1.06%)  1/172 (0.58%) 
Platelet Count Decreased * 1  4/378 (1.06%)  2/172 (1.16%) 
Transaminases Increased * 1  2/378 (0.53%)  0/172 (0.00%) 
Troponin I Increased * 1  2/378 (0.53%)  0/172 (0.00%) 
White Blood Cell Count Decreased * 1  2/378 (0.53%)  0/172 (0.00%) 
Metabolism and nutrition disorders     
Acidosis * 1  1/378 (0.26%)  0/172 (0.00%) 
Decreased Appetite * 1  3/378 (0.79%)  1/172 (0.58%) 
Dehydration * 1  15/378 (3.97%)  3/172 (1.74%) 
Failure to Thrive * 1  2/378 (0.53%)  0/172 (0.00%) 
Fluid Overload * 1  1/378 (0.26%)  0/172 (0.00%) 
Fluid Retention * 1  1/378 (0.26%)  1/172 (0.58%) 
Hyperglycaemia * 1  0/378 (0.00%)  1/172 (0.58%) 
Hyperkalaemia * 1  2/378 (0.53%)  0/172 (0.00%) 
Hyperlipasaemia * 1  1/378 (0.26%)  0/172 (0.00%) 
Hypomagnesaemia * 1  1/378 (0.26%)  0/172 (0.00%) 
Hyponatraemia * 1  1/378 (0.26%)  1/172 (0.58%) 
Malnutrition * 1  1/378 (0.26%)  0/172 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/378 (0.26%)  0/172 (0.00%) 
Back Pain * 1  3/378 (0.79%)  2/172 (1.16%) 
Bone Pain * 1  1/378 (0.26%)  0/172 (0.00%) 
Flank Pain * 1  0/378 (0.00%)  1/172 (0.58%) 
Joint Range of Motion Decreased * 1  1/378 (0.26%)  0/172 (0.00%) 
Joint Swelling * 1  1/378 (0.26%)  0/172 (0.00%) 
Neck Pain * 1  1/378 (0.26%)  0/172 (0.00%) 
Pain in Extremity * 1  2/378 (0.53%)  2/172 (1.16%) 
Rhabdomyolysis * 1  4/378 (1.06%)  0/172 (0.00%) 
Soft Tissue Necrosis * 1  1/378 (0.26%)  0/172 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer Pain * 1  1/378 (0.26%)  1/172 (0.58%) 
Malignant Ascites * 1  0/378 (0.00%)  1/172 (0.58%) 
Tumour Pain * 1  1/378 (0.26%)  3/172 (1.74%) 
Nervous system disorders     
Cerebrovascular Accident * 1  2/378 (0.53%)  0/172 (0.00%) 
Dizziness * 1  1/378 (0.26%)  0/172 (0.00%) 
Haemorrhage Intracranial * 1  1/378 (0.26%)  0/172 (0.00%) 
Headache * 1  1/378 (0.26%)  0/172 (0.00%) 
Neuralgia * 1  0/378 (0.00%)  2/172 (1.16%) 
Pyramidal Tract Syndrome * 1  0/378 (0.00%)  1/172 (0.58%) 
Spinal Cord Compression * 1  1/378 (0.26%)  2/172 (1.16%) 
Syncope * 1  3/378 (0.79%)  2/172 (1.16%) 
Psychiatric disorders     
Confusional State * 1  3/378 (0.79%)  0/172 (0.00%) 
Mental Status Changes * 1  1/378 (0.26%)  0/172 (0.00%) 
Renal and urinary disorders     
Haematuria * 1  1/378 (0.26%)  0/172 (0.00%) 
Hydronephrosis * 1  1/378 (0.26%)  1/172 (0.58%) 
Obstructive Uropathy * 1  1/378 (0.26%)  0/172 (0.00%) 
Renal Failure * 1  1/378 (0.26%)  0/172 (0.00%) 
Renal Failure Acute * 1  12/378 (3.17%)  1/172 (0.58%) 
Renal Tubular Necrosis * 1  1/378 (0.26%)  0/172 (0.00%) 
Urinary Retention * 1  2/378 (0.53%)  0/172 (0.00%) 
Urinary Tract Obstruction * 1  1/378 (0.26%)  0/172 (0.00%) 
Reproductive system and breast disorders     
Pelvic Pain * 1  2/378 (0.53%)  0/172 (0.00%) 
Perineal Fistula * 1  1/378 (0.26%)  0/172 (0.00%) 
Vaginal Haemorrhage * 1  0/378 (0.00%)  1/172 (0.58%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure * 1  1/378 (0.26%)  0/172 (0.00%) 
Bronchial Obstruction * 1  1/378 (0.26%)  0/172 (0.00%) 
Cough * 1  1/378 (0.26%)  0/172 (0.00%) 
Dyspnoea * 1  13/378 (3.44%)  2/172 (1.16%) 
Dyspnoea Exertional * 1  1/378 (0.26%)  0/172 (0.00%) 
Haemoptysis * 1  2/378 (0.53%)  0/172 (0.00%) 
Hypoxia * 1  2/378 (0.53%)  0/172 (0.00%) 
Pleural Effusion * 1  5/378 (1.32%)  3/172 (1.74%) 
Pleuritic Pain * 1  1/378 (0.26%)  0/172 (0.00%) 
Pneumonitis * 1  0/378 (0.00%)  1/172 (0.58%) 
Pneumothorax * 1  1/378 (0.26%)  0/172 (0.00%) 
Pulmonary Embolism * 1  6/378 (1.59%)  1/172 (0.58%) 
Pulmonary Hypertension * 1  2/378 (0.53%)  0/172 (0.00%) 
Pulmonary Oedema * 1  3/378 (0.79%)  0/172 (0.00%) 
Respiratory Arrest * 1  1/378 (0.26%)  0/172 (0.00%) 
Respiratory Distress * 1  1/378 (0.26%)  0/172 (0.00%) 
Respiratory Failure * 1  6/378 (1.59%)  1/172 (0.58%) 
Tachypnoea * 1  1/378 (0.26%)  0/172 (0.00%) 
Wheezing * 1  1/378 (0.26%)  0/172 (0.00%) 
Surgical and medical procedures     
Hip Surgery * 1  1/378 (0.26%)  0/172 (0.00%) 
Vascular disorders     
Circulatory Collapse * 1  0/378 (0.00%)  1/172 (0.58%) 
Deep Vein Thrombosis * 1  3/378 (0.79%)  1/172 (0.58%) 
Embolism * 1  1/378 (0.26%)  0/172 (0.00%) 
Embolism Venous * 1  1/378 (0.26%)  0/172 (0.00%) 
Hypotension * 1  4/378 (1.06%)  1/172 (0.58%) 
Jugular Vein Thrombosis * 1  1/378 (0.26%)  0/172 (0.00%) 
Temporal Arteritis * 1  0/378 (0.00%)  1/172 (0.58%) 
Venous Thrombosis * 1  1/378 (0.26%)  0/172 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trabectedin Dacarbazine
Affected / at Risk (%) Affected / at Risk (%)
Total   375/378 (99.21%)   166/172 (96.51%) 
Blood and lymphatic system disorders     
Anaemia * 1  149/378 (39.42%)  48/172 (27.91%) 
Leukopenia * 1  43/378 (11.38%)  11/172 (6.40%) 
Neutropenia * 1  111/378 (29.37%)  31/172 (18.02%) 
Thrombocytopenia * 1  70/378 (18.52%)  33/172 (19.19%) 
Gastrointestinal disorders     
Abdominal Distension * 1  30/378 (7.94%)  16/172 (9.30%) 
Abdominal Pain * 1  58/378 (15.34%)  29/172 (16.86%) 
Abdominal Pain Upper * 1  19/378 (5.03%)  8/172 (4.65%) 
Constipation * 1  140/378 (37.04%)  52/172 (30.23%) 
Diarrhoea * 1  130/378 (34.39%)  40/172 (23.26%) 
Dry Mouth * 1  22/378 (5.82%)  13/172 (7.56%) 
Dyspepsia * 1  30/378 (7.94%)  12/172 (6.98%) 
Gastrooesophageal Reflux Disease * 1  12/378 (3.17%)  11/172 (6.40%) 
Nausea * 1  282/378 (74.60%)  85/172 (49.42%) 
Stomatitis * 1  21/378 (5.56%)  6/172 (3.49%) 
Vomiting * 1  167/378 (44.18%)  35/172 (20.35%) 
General disorders     
Catheter Site Pain * 1  19/378 (5.03%)  1/172 (0.58%) 
Chest Pain * 1  19/378 (5.03%)  6/172 (3.49%) 
Chills * 1  34/378 (8.99%)  11/172 (6.40%) 
Fatigue * 1  260/378 (68.78%)  90/172 (52.33%) 
Influenza Like Illness * 1  19/378 (5.03%)  6/172 (3.49%) 
Oedema Peripheral * 1  107/378 (28.31%)  21/172 (12.21%) 
Pain * 1  18/378 (4.76%)  9/172 (5.23%) 
Pyrexia * 1  64/378 (16.93%)  27/172 (15.70%) 
Infections and infestations     
Upper Respiratory Tract Infection * 1  24/378 (6.35%)  10/172 (5.81%) 
Urinary Tract Infection * 1  29/378 (7.67%)  8/172 (4.65%) 
Investigations     
Alanine Aminotransferase Increased * 1  186/378 (49.21%)  12/172 (6.98%) 
Aspartate Aminotransferase Increased * 1  141/378 (37.30%)  10/172 (5.81%) 
Blood Alkaline Phosphatase Increased * 1  87/378 (23.02%)  16/172 (9.30%) 
Blood Bilirubin Increased * 1  34/378 (8.99%)  5/172 (2.91%) 
Blood Creatine Phosphokinase Increased * 1  54/378 (14.29%)  2/172 (1.16%) 
Blood Creatinine Increased * 1  47/378 (12.43%)  3/172 (1.74%) 
Lymphocyte Count Decreased * 1  21/378 (5.56%)  4/172 (2.33%) 
Neutrophil Count Decreased * 1  93/378 (24.60%)  24/172 (13.95%) 
Platelet Count Decreased * 1  61/378 (16.14%)  29/172 (16.86%) 
Weight Decreased * 1  27/378 (7.14%)  5/172 (2.91%) 
White Blood Cell Count Decreased * 1  96/378 (25.40%)  20/172 (11.63%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  138/378 (36.51%)  36/172 (20.93%) 
Dehydration * 1  43/378 (11.38%)  17/172 (9.88%) 
Hyperglycaemia * 1  30/378 (7.94%)  5/172 (2.91%) 
Hypoalbuminaemia * 1  32/378 (8.47%)  7/172 (4.07%) 
Hypocalcaemia * 1  27/378 (7.14%)  3/172 (1.74%) 
Hypokalaemia * 1  53/378 (14.02%)  22/172 (12.79%) 
Hyponatraemia * 1  26/378 (6.88%)  7/172 (4.07%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  57/378 (15.08%)  15/172 (8.72%) 
Back Pain * 1  65/378 (17.20%)  28/172 (16.28%) 
Bone Pain * 1  20/378 (5.29%)  12/172 (6.98%) 
Muscular Weakness * 1  25/378 (6.61%)  4/172 (2.33%) 
Musculoskeletal Pain * 1  29/378 (7.67%)  14/172 (8.14%) 
Myalgia * 1  47/378 (12.43%)  11/172 (6.40%) 
Pain in Extremity * 1  47/378 (12.43%)  15/172 (8.72%) 
Nervous system disorders     
Dizziness * 1  46/378 (12.17%)  21/172 (12.21%) 
Dysgeusia * 1  34/378 (8.99%)  11/172 (6.40%) 
Headache * 1  94/378 (24.87%)  33/172 (19.19%) 
Hypoaesthesia * 1  22/378 (5.82%)  3/172 (1.74%) 
Paraesthesia * 1  22/378 (5.82%)  9/172 (5.23%) 
Psychiatric disorders     
Anxiety * 1  40/378 (10.58%)  13/172 (7.56%) 
Depression * 1  30/378 (7.94%)  7/172 (4.07%) 
Insomnia * 1  55/378 (14.55%)  16/172 (9.30%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  85/378 (22.49%)  36/172 (20.93%) 
Dyspnoea * 1  91/378 (24.07%)  33/172 (19.19%) 
Dyspnoea Exertional * 1  26/378 (6.88%)  4/172 (2.33%) 
Nasal Congestion * 1  23/378 (6.08%)  6/172 (3.49%) 
Oropharyngeal Pain * 1  19/378 (5.03%)  4/172 (2.33%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  13/378 (3.44%)  9/172 (5.23%) 
Vascular disorders     
Flushing * 1  19/378 (5.03%)  9/172 (5.23%) 
Hot Flush * 1  13/378 (3.44%)  10/172 (5.81%) 
Hypertension * 1  22/378 (5.82%)  2/172 (1.16%) 
Hypotension * 1  19/378 (5.03%)  7/172 (4.07%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01343277    
Other Study ID Numbers: CR018004
ET743SAR3007 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: April 26, 2011
First Posted: April 28, 2011
Results First Submitted: December 22, 2015
Results First Posted: January 28, 2016
Last Update Posted: August 26, 2016