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| ID | Type | Description | Link |
|---|---|---|---|
| ET-C-002-07 | 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 evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).
This is a randomized (study drug assigned by chance), multicenter (when more than one hospital or medical school team work on a medical research study), Phase 3 trial to evaluate the efficacy and safety of trabectedin as compared to standard doxorubicin in participants with advanced TRS. Participants will be randomized in a 1:1 ratio to either of the 2 treatment groups, that is, trabectedin or doxorubicin plus ifosfamide group. Participants in trabectedin group will receive trabectedin 1.5 milligram per square meter (mg/m^2) given as a 24-hour continuous intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every 3 weeks and in doxorubicin plus ifosfamide group participants will receive doxorubicin 60 or 75 mg/m^2 intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks. Participants in either treatment arm will continue receiving therapy in the absence of progressive disease (PD) or intolerable side effects, until the participants' consent is withdrawn or the eligibility criteria for continuing treatment are no longer fulfilled, or when a concurrent condition precludes continuation of treatment. Efficacy will be assessed primarily by evaluating progression-free survival (PFS). Participants' safety will be monitored throughout the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabectedin | Experimental | Trabectedin 1.5 milligram per square meter (mg/m^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. |
|
| Doxorubicin plus Ifosfamide | Active Comparator | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabectedin | Drug | Trabectedin 1.5 milligram per square meter (mg/m^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression - Free Survival (PFS) | The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. | Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Progression - Free Survival | Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant. | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Monica | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24512981 | Derived | Blay JY, Leahy MG, Nguyen BB, Patel SR, Hohenberger P, Santoro A, Staddon AP, Penel N, Piperno-Neumann S, Hendifar A, Lardelli P, Nieto A, Alfaro V, Chawla SP. Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas. Eur J Cancer. 2014 Apr;50(6):1137-47. doi: 10.1016/j.ejca.2014.01.012. Epub 2014 Feb 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trabectedin | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. |
| FG001 | Doxorubicin Plus Ifosfamide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Doxorubicin | Drug | Doxorubicin 60 or 75 mg/m^2 will be given intravenously every 3 weeks until disease progression. |
|
| Ifosfamide | Drug | Ifosfamide 6 to 9 g/m^2 will be given intravenously every 3 weeks until disease progression. |
|
| Percentage of Participants With Objective Response | Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. | Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months |
| Overall Survival | Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date. | Baseline up to End of Study (an average of 4 years) |
| Duration of Response (DOR) | The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions. | Up to 20 months |
| Boston |
| Massachusetts |
| United States |
| Albuquerque | New Mexico | United States |
| Philadelphia | Pennsylvania | United States |
| Houston | Texas | United States |
| Salt Lake City | Utah | United States |
| Boreaux | France |
| Lille | France |
| Lyon | France |
| Paris | France |
| Villejuif | France |
| Bad Saarow | Germany |
| Cologne | Germany |
| Mannheim | Germany |
| Barcelona | Spain |
| Palma | Spain |
| Valencia | Spain |
| Edinburgh | United Kingdom |
| Glasgow | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trabectedin | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. |
| BG001 | Doxorubicin Plus Ifosfamide | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. |
| 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, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Progression - Free Survival (PFS) | The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. | Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of translocation-related sarcomas (TRS) | Posted | Median | 95% Confidence Interval | months | Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | 6-month Progression - Free Survival | Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant. | Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response | Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. | Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date. | Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. | Posted | Median | 95% Confidence Interval | months | Baseline up to End of Study (an average of 4 years) |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions. | Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Up to 20 months |
|
|
Not provided
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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 | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. | 24 | 61 | 55 | 61 | ||
| EG001 | Doxorubicin Plus Ifosfamide | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. | 16 | 57 | 52 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Injection site extravasation | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Infusion site infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Pneumococcal bacteremia | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Blood CPK increased | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Dyspraxia | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Mass | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphataseincreased | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Scar | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 11.0 | Non-systematic Assessment |
|
Before Investigators of this study publicly disclose information, PharmaMar must be provided with at least 60 days to review and approve disclosure in order to ensure that confidential and proprietary data are protected. If PharmaMar determines that patentable patient matter is disclosed in the proposed disclosure, the latter shall be withheld for period of time considered convenient.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Specialist, Clinical Oncology | PharmaMar SA Av de los Reyes 1, Poligono Industrial La Mina 28770 Colmenar Viejo, Madrid, Spain | +34 91 646-6087 |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077606 | Trabectedin |
| D004317 | Doxorubicin |
| D007069 | Ifosfamide |
| 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 |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| >=65 years |
|
| Male |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Participants |
|
|