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| ID | Type | Description | Link |
|---|---|---|---|
| ET743OVC1001 | 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 assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in participants with advanced solid tumor malignancies when administered at a therapeutic dose.
This is a single-blind (where the participant does not know the treatment he receives), multicenter (study conducted at multiple sites), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), sequential design (it is a design in a single group of Participants where one or more study medication is administered in a sequence) study to evaluate the potential effects of a single-dose administration of trabectedin on the QT intervals of the electrocardiogram (ECG). Initially, the study will consist of 2 phases: a screening phase (within 21 days before administration of the study medication), and a single-blind treatment phase (for 2 days). Participants who complete the single-blind treatment phase will be opted to take trabectedin in an open-label extension (for a minimum of 6 cycles), as long as they derive a clinical benefit (ie, until there is clear evidence of disease progression or unacceptable toxicity, as judged by the investigator). Participants will be assessed for ECG on predose before the single-blind treatment phase. During the single-blind treatment phase, a placebo control will be given on Day 1, and trabectedin (1.3 mg per square meter) will be administered on Day 2. Participants will be monitored until completion of the 24 hour pharmacokinetic blood sample collection. During the open-label extension (21 days after completion of the single-blind treatment phase), all Participants will receive trabectedin intravenously on Day 1 of each 17- to 49 day treatment cycle. The dose and schedule of trabectedin will be modified according to the type of malignancy being treated (ie, sarcoma, ovarian, or breast cancer). Safety evaluations will include assessment of adverse events, vital signs, physical examination, and clinical laboratory tests which will be performed throughout the study. The study duration for the open-label extension will vary by participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabectedin | Experimental | 3-hour placebo intravenous infusion on Day 1 and trabectedin 1.3 mg/m2 3-hour intravenous infusion on Day 2 (single-blind). Patients may continue treatment with trabectedin until clinical benefit or drug is commercially available (open-label). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabectedin | Drug | Trabectedin will be administered as 1.3 mg/m2 3-hour intravenous infusion on Day 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction | QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval. | Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2) |
| The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett's Correction | QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Bazett's Correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval. | Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration of Trabectedin (Cmax) | Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3). | |
| Time Taken to Acheive Maximum Plasma Concentration (Tmax) | Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3). |
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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 |
|---|---|---|---|---|---|---|
| Miami | Florida | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21739119 | Derived | Thertulien R, Manikhas GM, Dirix LY, Vermorken JB, Park K, Jain MM, Jiao JJ, Natarajan J, Parekh T, Zannikos P, Staddon AP. Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2012 Feb;69(2):341-50. doi: 10.1007/s00280-011-1697-6. Epub 2011 Jul 8. |
| Label | URL |
|---|---|
| A Placebo-Controlled Study Evaluating the Potential Effects of Trabectedin on the Heart in Patients with Advanced Cancer | View source |
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All enrolled participants (ie, 75 participants) received study medication. 26 participants completed the study.
This study was conducted in 7 countries: Belgium (3 sites), France (2 sites), India (2 sites), Republic of Korea (4 sites), Russia (4 sites), Spain (1 site), and the United States (4 sites). Total 75 participants were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trabectedin | 1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Participants will receive 3-hour placebo intravenous infusion on Day 1. |
|
| Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds | The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval. | Baseline (predose) to approximately 24 hour post dose |
| Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds | The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval. | Baseline (predose) to approximately 24 hour post dose |
| Number of Participants With QTc Interval Greater Than 450 Milli Seconds | The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval. | Baseline (predose) to approximately 24 hour post dose |
| Number of Participants With QTc Interval Greater Than 480 Milli Seconds | The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval. | Baseline (predose) to approximately 24 hour post dose |
| Number of Participants With QTc Interval Greater Than 500 Milli Seconds | The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval. | Baseline (predose) to approximately 24 hour post dose |
| Number of Participants With PR Interval Greater Than 200 Milli Seconds | PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization). | Baseline (predose) to approximately 24 hour post dose |
| Number of Participants With QRS Interval Greater Than 120 Milli Seconds | QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization. | Baseline (predose) to approximately 24 hour post dose |
| Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose | Baseline (predose on Day 1) to 24 hour post dose |
| Charlotte |
| North Carolina |
| United States |
| Philadelphia | Pennsylvania | United States |
| Tacoma | Washington | United States |
| Brussels | Belgium |
| Edegem | Belgium |
| Wilrijk | Belgium |
| Lyon | France |
| Marseille | France |
| Montpellier | France |
| Villejuif | France |
| Bengaluru | India |
| Pune | India |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Seoul | South Korea |
| PAU de Sanchinarro | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Trabectedin | 1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2 |
| 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 |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction | QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval. | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Mean | Standard Deviation | milli seconds | Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration of Trabectedin (Cmax) | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Mean | Standard Deviation | nanogram per milliliter | Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3). |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time Taken to Acheive Maximum Plasma Concentration (Tmax) | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Mean | Standard Deviation | hours | Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3). |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds | The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval. | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Number | participants | Baseline (predose) to approximately 24 hour post dose |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds | The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval. | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Number | participants | Baseline (predose) to approximately 24 hour post dose |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With QTc Interval Greater Than 450 Milli Seconds | The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval. | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Number | participants | Baseline (predose) to approximately 24 hour post dose |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With QTc Interval Greater Than 480 Milli Seconds | The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval. | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Number | participants | Baseline (predose) to approximately 24 hour post dose |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With QTc Interval Greater Than 500 Milli Seconds | The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval. | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Number | participants | Baseline (predose) to approximately 24 hour post dose |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With PR Interval Greater Than 200 Milli Seconds | PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization). | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Number | participants | Baseline (predose) to approximately 24 hour post dose |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With QRS Interval Greater Than 120 Milli Seconds | QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization. | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Number | participants | Baseline (predose) to approximately 24 hour post dose |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order was excluded from evaluations. 73 participants analyzed in trabectedin group to derive the mean. | Posted | Mean | Standard Deviation | beats per minute | Baseline (predose on Day 1) to 24 hour post dose |
|
| ||||||||||||||||||||||||||||||
| Primary | The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett's Correction | QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Bazett's Correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval. | All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations. | Posted | Mean | Standard Deviation | milli seconds | Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2) |
|
|
Until 30 days after the administration of the last dose of study medication
Adverse events were reported for overall study.
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 | 1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2 | 31 | 75 | 70 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Soft tissue haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Bone sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Oropharyngeal cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
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| Enzyme abnormality | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Director | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | 1 908 704-5779 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077606 | Trabectedin |
| 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 |
Not provided
Not provided
| Other |
|
| India |
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| Republic Of Korea |
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| Russia |
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| Spain |
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| United States Of America |
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