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| ID | Type | Description | Link |
|---|---|---|---|
| ET743-STS-201 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
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| Name | Class |
|---|---|
| PharmaMar | INDUSTRY |
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The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.
This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yondelis weekly schedule | Experimental | Yondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion. |
|
| Yondelis once every 3 weeks schedule | Experimental | Yondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yondelis | Drug | 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression- Independent Review | Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease. | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Objective Response - Independent Review | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
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| Label | URL |
|---|---|
| Demetri GD et al. J Clin Oncol. 2009;27(25):4188-96. | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trabectedin 1.5 mg/m2 | 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. |
| FG001 | Trabectedin 0.58 mg/m2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Yondelis | Drug | 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle. |
|
| Dexamethasone | Drug | Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle. |
|
| Dexamethasone | Drug | Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion. |
|
| From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years |
| Duration of Response - Independent Review | 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. | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years |
| Progression-Free Survival - Independent Review | The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years |
| Overall Survival | The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years |
| Aurora |
| Colorado |
| United States |
| Coeur d'Alene | Idaho | United States |
| Park Ridge | Illinois | United States |
| Indianapolis | Indiana | United States |
| Louisville | Kentucky | United States |
| Boston | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Rochester | Minnesota | United States |
| Newark | New Jersey | United States |
| New York | New York | United States |
| Cleveland | Ohio | United States |
| Portland | Oregon | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| Salt Lake City | Utah | United States |
| Seattle | Washington | United States |
| Milwaukee | Wisconsin | United States |
| East Melbourne | Australia |
| Newcastle | Australia |
| Perth | Australia |
| Woodville | Australia |
| Leuven | Belgium |
| Calgary | Alberta | Canada |
| London | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Edmonton | Canada |
| Lyon | France |
| Villejuif | France |
| Düsseldorf | Germany |
| Moscow | Russia |
| Obninsk | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Barcelona | Spain |
| Valencia | Spain |
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 |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trabectedin 1.5 mg/m2 | 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. |
| BG001 | Trabectedin 0.58 mg/m2 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Progression- Independent Review | Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease. | All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. | Posted | Median | 95% Confidence Interval | months | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Objective Response - Independent Review | 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. | All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response - Independent Review | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival - Independent Review | The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. | All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. | Posted | Median | 95% Confidence Interval | months | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. | All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. | Posted | Median | 95% Confidence Interval | months | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years |
|
|
5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trabectedin 1.5 mg/m2 | 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. | 48 | 130 | 129 | 130 | ||
| EG001 | Trabectedin 0.58 mg/m2 | 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 | 41 | 130 | 128 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Extravasation | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Organ Failure | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Arthritis Bacterial | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Catheter Related Infection | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Perineal Abscess | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Radiation Pneumonitis | Injury, poisoning and procedural complications | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Blood Urea Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Mediastinoscopy | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Liposarcoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Tumour Associated Fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Tumour Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Depressed Level of Consciousness | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Nerve Compression | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Non-Cardiogenic Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Abdominal Operation | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Bladder Catheterisation | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hepatectomy | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hepatic Embolisation | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Laparotomy | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Lung Operation | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Mass Excision | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Sarcoma Excision | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Spinal Laminectomy | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Therapeutic Embolisation | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Tumour Excision | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Vitrectomy | Surgical and medical procedures | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Thrombophlebitis Superficial | Vascular disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 8.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Chest Wall Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 8.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 8.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Janssen R&D US | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| D007890 | Leiomyosarcoma |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D012509 | Sarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077606 | Trabectedin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
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| Canada |
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| France |
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| Germany |
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| Italy |
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| Russia |
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| Spain |
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| United States Of America |
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