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A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT00060944
Recruitment Status : Completed
First Posted : May 19, 2003
Results First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Liposarcoma
Leiomyosarcoma
Interventions Drug: Yondelis
Drug: Dexamethasone
Enrollment 271
Recruitment Details This study evaluated the efficacy and safety of of trabectedin in participants with locally advanced or metastatic L-sarcoma whose disease had relapsed or become refractory after treatment with an anthracycline and ifosfamide. The study was conducted between 12 May 2003 and 23 April 2008 and recruited participants from 9 countries worldwide.
Pre-assignment Details In this study 271 participants were enrolled of which 270 participants (134 in the Trabectedin 1.5 mg/m2 group and 136 in the Trabectedin 0.58 mg/m2 group) were randomized as 1 participant was enrolled twice. Of these, 260 participants were treated with trabectedin including 130 participants in each treatment group.
Arm/Group Title Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2
Hide Arm/Group Description Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion. Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
Period Title: Overall Study
Started 136 134
Treated 130 130
Completed 0 0
Not Completed 136 134
Reason Not Completed
Adverse Event             12             10
Death             2             3
Withdrawal by Subject             18             5
Disease Progression             93             94
Lost to Follow-up             1             0
Subject Ineligible To Continue             2             1
Treatment Switch             0             13
Other             2             4
randomized but not treated             6             4
Arm/Group Title Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2 Total
Hide Arm/Group Description Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion. Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion Total of all reporting groups
Overall Number of Baseline Participants 136 134 270
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants 134 participants 270 participants
52.8  (9.95) 53.4  (10.7) 53.1  (10.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 134 participants 270 participants
Female
92
  67.6%
78
  58.2%
170
  63.0%
Male
44
  32.4%
56
  41.8%
100
  37.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 136 participants 134 participants 270 participants
Australia 3 1 4
Belgium 1 2 3
Canada 13 11 24
France 5 12 17
Germany 2 0 2
Italy 5 3 8
Russia 15 13 28
Spain 3 0 3
United States Of America 89 92 181
1.Primary Outcome
Title Time to Progression- Independent Review
Hide Description Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
Time Frame From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.
Arm/Group Title Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2
Hide Arm/Group Description:
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
Overall Number of Participants Analyzed 136 134
Median (95% Confidence Interval)
Unit of Measure: months
3.7
(2.1 to 5.4)
2.3
(2.0 to 3.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trabectedin 1.5 mg/m2, Trabectedin 0.58 mg/m2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0302
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.734
Confidence Interval (2-Sided) 95%
0.554 to 0.974
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Objective Response - Independent Review
Hide Description Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
Time Frame From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.
Arm/Group Title Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2
Hide Arm/Group Description:
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
Overall Number of Participants Analyzed 136 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
5.1
(2.1 to 10.3)
1.5
(0.2 to 5.3)
3.Secondary Outcome
Title Duration of Response - Independent Review
Hide Description Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.
Time Frame From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. Participants with confirmed response only were analyzed.
Arm/Group Title Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2
Hide Arm/Group Description:
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
Overall Number of Participants Analyzed 7 2
Median (95% Confidence Interval)
Unit of Measure: Months
7.5
(6.1 to 7.8)
NA [1] 
(3.4 to NA)
[1]
Median was not estimable as data was available for only 1 participant and second participant was censored.
4.Secondary Outcome
Title Progression-Free Survival - Independent Review
Hide Description The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
Time Frame From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.
Arm/Group Title Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2
Hide Arm/Group Description:
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
Overall Number of Participants Analyzed 136 134
Median (95% Confidence Interval)
Unit of Measure: months
3.3
(2.1 to 4.6)
2.3
(2.0 to 3.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trabectedin 1.5 mg/m2, Trabectedin 0.58 mg/m2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0418
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.755
Confidence Interval (2-Sided) 95%
0.574 to 0.992
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival
Hide Description The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
Time Frame From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.
Arm/Group Title Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2
Hide Arm/Group Description:
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
Overall Number of Participants Analyzed 136 134
Median (95% Confidence Interval)
Unit of Measure: months
13.9
(12.5 to 18.6)
11.8
(9.9 to 14.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trabectedin 1.5 mg/m2, Trabectedin 0.58 mg/m2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1920
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.843
Confidence Interval (2-Sided) 95%
0.653 to 1.090
Estimation Comments [Not Specified]
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2
Hide Arm/Group Description Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion. Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
All-Cause Mortality
Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2
Affected / at Risk (%) Affected / at Risk (%)
Total   48/130 (36.92%)   41/130 (31.54%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/130 (0.00%)  1/130 (0.77%) 
Febrile Neutropenia * 1  0/130 (0.00%)  1/130 (0.77%) 
Haemolytic Anaemia * 1  0/130 (0.00%)  1/130 (0.77%) 
Neutropenia * 1  0/130 (0.00%)  1/130 (0.77%) 
Thrombocytopenia * 1  1/130 (0.77%)  0/130 (0.00%) 
Cardiac disorders     
Acute Myocardial Infarction * 1  0/130 (0.00%)  1/130 (0.77%) 
Atrial Fibrillation * 1  2/130 (1.54%)  0/130 (0.00%) 
Cardiac Arrest * 1  0/130 (0.00%)  1/130 (0.77%) 
Cardiac Failure Congestive * 1  1/130 (0.77%)  3/130 (2.31%) 
Cardio-Respiratory Arrest * 1  0/130 (0.00%)  1/130 (0.77%) 
Cardiomyopathy * 1  1/130 (0.77%)  0/130 (0.00%) 
Mitral Valve Incompetence * 1  1/130 (0.77%)  0/130 (0.00%) 
Myocardial Infarction * 1  0/130 (0.00%)  1/130 (0.77%) 
Tachycardia * 1  1/130 (0.77%)  0/130 (0.00%) 
Ventricular Tachycardia * 1  1/130 (0.77%)  0/130 (0.00%) 
Gastrointestinal disorders     
Abdominal Distension * 1  0/130 (0.00%)  1/130 (0.77%) 
Abdominal Pain * 1  7/130 (5.38%)  3/130 (2.31%) 
Abdominal Pain Upper * 1  0/130 (0.00%)  1/130 (0.77%) 
Ascites * 1  1/130 (0.77%)  0/130 (0.00%) 
Constipation * 1  1/130 (0.77%)  1/130 (0.77%) 
Diarrhoea * 1  2/130 (1.54%)  0/130 (0.00%) 
Flatulence * 1  0/130 (0.00%)  1/130 (0.77%) 
Gastrointestinal Haemorrhage * 1  0/130 (0.00%)  1/130 (0.77%) 
Ileus * 1  1/130 (0.77%)  0/130 (0.00%) 
Intestinal Obstruction * 1  3/130 (2.31%)  3/130 (2.31%) 
Nausea * 1  1/130 (0.77%)  2/130 (1.54%) 
Small Intestinal Obstruction * 1  3/130 (2.31%)  2/130 (1.54%) 
Vomiting * 1  3/130 (2.31%)  2/130 (1.54%) 
General disorders     
Chest Discomfort * 1  1/130 (0.77%)  0/130 (0.00%) 
Chest Pain * 1  1/130 (0.77%)  0/130 (0.00%) 
Extravasation * 1  1/130 (0.77%)  0/130 (0.00%) 
Fatigue * 1  0/130 (0.00%)  1/130 (0.77%) 
Oedema * 1  1/130 (0.77%)  0/130 (0.00%) 
Oedema Peripheral * 1  0/130 (0.00%)  1/130 (0.77%) 
Organ Failure * 1  0/130 (0.00%)  1/130 (0.77%) 
Pain * 1  3/130 (2.31%)  2/130 (1.54%) 
Pyrexia * 1  5/130 (3.85%)  5/130 (3.85%) 
Infections and infestations     
Arthritis Bacterial * 1  0/130 (0.00%)  1/130 (0.77%) 
Bacteraemia * 1  1/130 (0.77%)  0/130 (0.00%) 
Bronchopneumonia * 1  0/130 (0.00%)  1/130 (0.77%) 
Catheter Related Infection * 1  2/130 (1.54%)  0/130 (0.00%) 
Empyema * 1  1/130 (0.77%)  0/130 (0.00%) 
Infection * 1  1/130 (0.77%)  0/130 (0.00%) 
Perineal Abscess * 1  0/130 (0.00%)  1/130 (0.77%) 
Pneumonia * 1  6/130 (4.62%)  2/130 (1.54%) 
Sepsis * 1  1/130 (0.77%)  2/130 (1.54%) 
Septic Shock * 1  1/130 (0.77%)  0/130 (0.00%) 
Urosepsis * 1  1/130 (0.77%)  0/130 (0.00%) 
Wound Infection * 1  0/130 (0.00%)  1/130 (0.77%) 
Injury, poisoning and procedural complications     
Patella Fracture * 1  0/130 (0.00%)  1/130 (0.77%) 
Radiation Pneumonitis * 1  0/130 (0.00%)  1/130 (0.77%) 
Investigations     
Alanine Aminotransferase Increased * 1  1/130 (0.77%)  0/130 (0.00%) 
Aspartate Aminotransferase Increased * 1  1/130 (0.77%)  0/130 (0.00%) 
Blood Alkaline Phosphatase Increased * 1  1/130 (0.77%)  0/130 (0.00%) 
Blood Bilirubin Increased * 1  1/130 (0.77%)  0/130 (0.00%) 
Blood Creatinine Increased * 1  2/130 (1.54%)  0/130 (0.00%) 
Blood Urea Increased * 1  1/130 (0.77%)  0/130 (0.00%) 
Mediastinoscopy * 1  0/130 (0.00%)  1/130 (0.77%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/130 (0.77%)  3/130 (2.31%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  3/130 (2.31%)  0/130 (0.00%) 
Pain in Extremity * 1  1/130 (0.77%)  2/130 (1.54%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Liposarcoma Metastatic * 1  0/130 (0.00%)  1/130 (0.77%) 
Tumour Associated Fever * 1  0/130 (0.00%)  1/130 (0.77%) 
Tumour Haemorrhage * 1  1/130 (0.77%)  0/130 (0.00%) 
Nervous system disorders     
Cerebral Haemorrhage * 1  1/130 (0.77%)  0/130 (0.00%) 
Depressed Level of Consciousness * 1  0/130 (0.00%)  1/130 (0.77%) 
Nerve Compression * 1  0/130 (0.00%)  1/130 (0.77%) 
Neuropathy * 1  0/130 (0.00%)  1/130 (0.77%) 
Paresis * 1  0/130 (0.00%)  1/130 (0.77%) 
Spinal Cord Compression * 1  0/130 (0.00%)  3/130 (2.31%) 
Transient Ischaemic Attack * 1  0/130 (0.00%)  1/130 (0.77%) 
Psychiatric disorders     
Suicide Attempt * 1  1/130 (0.77%)  0/130 (0.00%) 
Renal and urinary disorders     
Renal Failure * 1  0/130 (0.00%)  1/130 (0.77%) 
Renal Failure Acute * 1  2/130 (1.54%)  0/130 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/130 (0.00%)  1/130 (0.77%) 
Dyspnoea * 1  2/130 (1.54%)  3/130 (2.31%) 
Hypoxia * 1  2/130 (1.54%)  0/130 (0.00%) 
Non-Cardiogenic Pulmonary Oedema * 1  1/130 (0.77%)  0/130 (0.00%) 
Pleural Effusion * 1  1/130 (0.77%)  2/130 (1.54%) 
Pneumothorax * 1  3/130 (2.31%)  0/130 (0.00%) 
Pulmonary Embolism * 1  1/130 (0.77%)  2/130 (1.54%) 
Pulmonary Hypertension * 1  2/130 (1.54%)  0/130 (0.00%) 
Pulmonary Oedema * 1  0/130 (0.00%)  1/130 (0.77%) 
Respiratory Failure * 1  1/130 (0.77%)  0/130 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin Ulcer * 1  1/130 (0.77%)  0/130 (0.00%) 
Surgical and medical procedures     
Abdominal Operation * 1  1/130 (0.77%)  0/130 (0.00%) 
Bladder Catheterisation * 1  1/130 (0.77%)  0/130 (0.00%) 
Cholecystectomy * 1  1/130 (0.77%)  0/130 (0.00%) 
Hepatectomy * 1  0/130 (0.00%)  1/130 (0.77%) 
Hepatic Embolisation * 1  1/130 (0.77%)  0/130 (0.00%) 
Laparotomy * 1  0/130 (0.00%)  1/130 (0.77%) 
Lung Operation * 1  0/130 (0.00%)  1/130 (0.77%) 
Mass Excision * 1  0/130 (0.00%)  1/130 (0.77%) 
Sarcoma Excision * 1  2/130 (1.54%)  0/130 (0.00%) 
Spinal Laminectomy * 1  1/130 (0.77%)  0/130 (0.00%) 
Therapeutic Embolisation * 1  1/130 (0.77%)  0/130 (0.00%) 
Tumour Excision * 1  1/130 (0.77%)  0/130 (0.00%) 
Vitrectomy * 1  0/130 (0.00%)  1/130 (0.77%) 
Vascular disorders     
Deep Vein Thrombosis * 1  5/130 (3.85%)  0/130 (0.00%) 
Embolism * 1  1/130 (0.77%)  0/130 (0.00%) 
Hypertension * 1  1/130 (0.77%)  0/130 (0.00%) 
Hypotension * 1  1/130 (0.77%)  1/130 (0.77%) 
Shock * 1  1/130 (0.77%)  0/130 (0.00%) 
Thrombophlebitis Superficial * 1  0/130 (0.00%)  1/130 (0.77%) 
Thrombosis * 1  2/130 (1.54%)  0/130 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 8.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trabectedin 1.5 mg/m2 Trabectedin 0.58 mg/m2
Affected / at Risk (%) Affected / at Risk (%)
Total   129/130 (99.23%)   128/130 (98.46%) 
Blood and lymphatic system disorders     
Anaemia * 1  42/130 (32.31%)  40/130 (30.77%) 
Leukopenia * 1  16/130 (12.31%)  9/130 (6.92%) 
Neutropenia * 1  64/130 (49.23%)  36/130 (27.69%) 
Thrombocytopenia * 1  25/130 (19.23%)  10/130 (7.69%) 
Gastrointestinal disorders     
Abdominal Distension * 1  8/130 (6.15%)  10/130 (7.69%) 
Abdominal Pain * 1  17/130 (13.08%)  26/130 (20.00%) 
Abdominal Pain Upper * 1  8/130 (6.15%)  4/130 (3.08%) 
Constipation * 1  45/130 (34.62%)  45/130 (34.62%) 
Diarrhoea * 1  30/130 (23.08%)  28/130 (21.54%) 
Dyspepsia * 1  8/130 (6.15%)  12/130 (9.23%) 
Nausea * 1  97/130 (74.62%)  71/130 (54.62%) 
Vomiting * 1  56/130 (43.08%)  34/130 (26.15%) 
General disorders     
Asthenia * 1  26/130 (20.00%)  26/130 (20.00%) 
Chest Pain * 1  6/130 (4.62%)  15/130 (11.54%) 
Chills * 1  8/130 (6.15%)  5/130 (3.85%) 
Fatigue * 1  76/130 (58.46%)  72/130 (55.38%) 
Oedema * 1  4/130 (3.08%)  7/130 (5.38%) 
Oedema Peripheral * 1  17/130 (13.08%)  19/130 (14.62%) 
Pain * 1  8/130 (6.15%)  11/130 (8.46%) 
Pyrexia * 1  31/130 (23.85%)  18/130 (13.85%) 
Infections and infestations     
Upper Respiratory Tract Infection * 1  16/130 (12.31%)  11/130 (8.46%) 
Investigations     
Alanine Aminotransferase Increased * 1  71/130 (54.62%)  54/130 (41.54%) 
Aspartate Aminotransferase Increased * 1  62/130 (47.69%)  38/130 (29.23%) 
Blood Alkaline Phosphatase Increased * 1  39/130 (30.00%)  37/130 (28.46%) 
Blood Bilirubin Increased * 1  14/130 (10.77%)  7/130 (5.38%) 
Blood Creatine Phosphokinase Increased * 1  14/130 (10.77%)  19/130 (14.62%) 
Blood Creatinine Increased * 1  9/130 (6.92%)  6/130 (4.62%) 
Haemoglobin Decreased * 1  9/130 (6.92%)  8/130 (6.15%) 
Neutrophil Count Decreased * 1  16/130 (12.31%)  5/130 (3.85%) 
Platelet Count Decreased * 1  7/130 (5.38%)  4/130 (3.08%) 
Transaminases Increased * 1  7/130 (5.38%)  2/130 (1.54%) 
Weight Decreased * 1  6/130 (4.62%)  8/130 (6.15%) 
White Blood Cell Count Decreased * 1  11/130 (8.46%)  8/130 (6.15%) 
Metabolism and nutrition disorders     
Anorexia * 1  29/130 (22.31%)  21/130 (16.15%) 
Decreased Appetite * 1  11/130 (8.46%)  9/130 (6.92%) 
Dehydration * 1  9/130 (6.92%)  7/130 (5.38%) 
Hyperglycaemia * 1  7/130 (5.38%)  3/130 (2.31%) 
Hypoalbuminaemia * 1  6/130 (4.62%)  9/130 (6.92%) 
Hypocalcaemia * 1  11/130 (8.46%)  3/130 (2.31%) 
Hypokalaemia * 1  13/130 (10.00%)  7/130 (5.38%) 
Hyponatraemia * 1  5/130 (3.85%)  8/130 (6.15%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  17/130 (13.08%)  16/130 (12.31%) 
Back Pain * 1  18/130 (13.85%)  25/130 (19.23%) 
Chest Wall Pain * 1  6/130 (4.62%)  8/130 (6.15%) 
Myalgia * 1  17/130 (13.08%)  15/130 (11.54%) 
Pain in Extremity * 1  13/130 (10.00%)  15/130 (11.54%) 
Nervous system disorders     
Dizziness * 1  18/130 (13.85%)  14/130 (10.77%) 
Dysgeusia * 1  13/130 (10.00%)  8/130 (6.15%) 
Headache * 1  37/130 (28.46%)  35/130 (26.92%) 
Hypoaesthesia * 1  8/130 (6.15%)  6/130 (4.62%) 
Paraesthesia * 1  9/130 (6.92%)  6/130 (4.62%) 
Psychiatric disorders     
Anxiety * 1  11/130 (8.46%)  9/130 (6.92%) 
Depression * 1  9/130 (6.92%)  9/130 (6.92%) 
Insomnia * 1  20/130 (15.38%)  17/130 (13.08%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  23/130 (17.69%)  22/130 (16.92%) 
Dyspnoea * 1  21/130 (16.15%)  34/130 (26.15%) 
Dyspnoea Exertional * 1  7/130 (5.38%)  6/130 (4.62%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  4/130 (3.08%)  7/130 (5.38%) 
Pruritus * 1  9/130 (6.92%)  3/130 (2.31%) 
Rash * 1  7/130 (5.38%)  3/130 (2.31%) 
Vascular disorders     
Hypotension * 1  13/130 (10.00%)  2/130 (1.54%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 8.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen R&D US
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00060944    
Other Study ID Numbers: CR004336
ET743-STS-201 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Submitted: May 16, 2003
First Posted: May 19, 2003
Results First Submitted: January 14, 2014
Results First Posted: September 8, 2014
Last Update Posted: September 8, 2014