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The purpose of this study is to evaluate the safety and efficacy of pegylated liposomal doxorubicin (Caelyx) in elderly patients who are to receive first-line chemotherapy for metastatic or locally advanced breast cancer, not amenable to surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caelyx | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caelyx (pegylated liposomal doxorubicin; SCH 200746) | Drug | Caelyx will be administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug is diluted in 250 ml glucose 5% (500 ml for doses >=90 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors (RECIST) or World Health Organization (WHO) Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death). | Treatment failure was defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions. | Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Stable Disease (SD) as Best Response | Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used. RECIST response criteria for SD required steady state of response of at least 9 weeks duration. There may be no appearance of new lesions. WHO response criteria for SD required no significant change for at least 8 weeks. |
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Inclusion Criteria:
Patients meeting the following criteria will be eligible for enrollment.
Female patients with histologic or cytologic diagnosis of breast cancer that is locally advanced or metastatic, and not amenable to surgery.
Age >= 65 years.
World Health Organization (WHO) Performance Status 0 - 2
Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Patients with bone metastasis can also be included but will be evaluated according to WHO criteria. Patients with non-measurable disease can also be included.
Left ventricular ejection fraction (LVEF) >= 50% verified by ultrasound cardiography (UCG); no clinical signs of heart disease.
Normal organ function, except due to disease involvement, however maximum deviation:
Adequate bone marrow function, ie:
Life expectancy >= 12 weeks.
Patients having received oral and written information and having provided written informed consent.
Exclusion Criteria:
Patients will not be enrolled if any of the following conditions apply.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22056077 | Result | Green H, Stal O, Bachmeier K, Backlund LM, Carlsson L, Hansen J, Lagerlund M, Norberg B, Franzen A, Aleskog A, Malmstrom A. Pegylated liposomal doxorubicin as first-line monotherapy in elderly women with locally advanced or metastatic breast cancer: novel treatment predictive factors identified. Cancer Lett. 2011 Dec 27;313(2):145-53. doi: 10.1016/j.canlet.2011.07.017. Epub 2011 Aug 31. |
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28 patients were screened and 25 were enrolled. All 25 patients enrolled received >=1 cycle of treatment with Caelyx. Per protocol, treatment was to continue until progression, unacceptable toxicity, or other reason for discontinuation of treatment - all subjects eventually discontinued treatment but were considered to have completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caelyx | Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
| Number of Patients With Partial Response (PR) as Best Response | Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used. RECIST PR criteria required >=30% decrease in certain target lesions & no increase in size of non-target lesions or appearance of new lesions WHO PR criteria required partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for >=4 wks | Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
| Number of Patients With Progressive Disease (PD) as Best Response | Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used. RECIST PD criteria required >=20% increase in certain target lesions OR progression of non-target lesions, or appearance of new lesions WHO PD criteria required increase in size of existing lesions or appearance of new lesions. | Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
| Number of Patients Requiring Dose Reduction | The protocol contains instructions to reduce the Caelyx dose according to specific schedules, in cases necessary due to reasons such as hematological toxicity, non-hematological toxicity, cardiotoxicity, or other toxic side-effects of treatment reducing quality of life etc. | Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment). |
| Time to Response | Response can be partial (>=30% decrease in the sum of Longest Diameter of target lesions, determined by two observations not less than 4 weeks apart; no unequivocal increase in the size of non-target lesions or the appearance of new lesions may occur) or complete (disappearance of all clinical evidence of tumor determined by 2 observations not less than 4 weeks apart), whichever status is recorded first. | Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
| Duration of Response | Duration of response is defined as the time span from the first evaluation that shows response until the first evaluation that shows progression. Where patients did not show progress, duration of response was measured from the first evaluation that showed response until they discontinued the study. Response can be partial or complete (as previously defined), whichever status is recorded first. | Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
| Time to Progression | Progression is defined as the first evaluation that shows progression (either by RECIST or WHO criteria): Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions. | Time of treatment until progression, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
| Duration of Overall Survival | Patients were followed with regards to survival even after they left the trial (ie after End of Treatment visit). Deaths that occurred after patient participation ended were collected all the way through to the overall end of the trial which took place on Oct 31, 2009. These deaths were used to calculate overall survival. | Time of treatment until death, up to the time that all participants ended treatment |
| Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment | The cumulative sum of hospitalization days during the study, per patient. Some patients had multiple hospitalizations. | Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Caelyx | Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors (RECIST) or World Health Organization (WHO) Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death). | Treatment failure was defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions. | Posted | Median | 95% Confidence Interval | Months | Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
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| Secondary | Number of Patients With Stable Disease (SD) as Best Response | Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used. RECIST response criteria for SD required steady state of response of at least 9 weeks duration. There may be no appearance of new lesions. WHO response criteria for SD required no significant change for at least 8 weeks. | 10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis. | Posted | Number | participants | Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
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| Secondary | Number of Patients With Partial Response (PR) as Best Response | Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used. RECIST PR criteria required >=30% decrease in certain target lesions & no increase in size of non-target lesions or appearance of new lesions WHO PR criteria required partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for >=4 wks | 10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis. | Posted | Number | participants | Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
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| Secondary | Number of Patients With Progressive Disease (PD) as Best Response | Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used. RECIST PD criteria required >=20% increase in certain target lesions OR progression of non-target lesions, or appearance of new lesions WHO PD criteria required increase in size of existing lesions or appearance of new lesions. | 10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis. | Posted | Number | participants | Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
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| Secondary | Number of Patients Requiring Dose Reduction | The protocol contains instructions to reduce the Caelyx dose according to specific schedules, in cases necessary due to reasons such as hematological toxicity, non-hematological toxicity, cardiotoxicity, or other toxic side-effects of treatment reducing quality of life etc. | Posted | Number | participants | Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment). |
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| Secondary | Time to Response | Response can be partial (>=30% decrease in the sum of Longest Diameter of target lesions, determined by two observations not less than 4 weeks apart; no unequivocal increase in the size of non-target lesions or the appearance of new lesions may occur) or complete (disappearance of all clinical evidence of tumor determined by 2 observations not less than 4 weeks apart), whichever status is recorded first. | Only 3 patients had measureable time to response | Posted | Median | Full Range | Weeks | Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
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| Secondary | Duration of Response | Duration of response is defined as the time span from the first evaluation that shows response until the first evaluation that shows progression. Where patients did not show progress, duration of response was measured from the first evaluation that showed response until they discontinued the study. Response can be partial or complete (as previously defined), whichever status is recorded first. | Three patients showed Partial Response according to RECIST criteria. | Posted | Median | Full Range | weeks | Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
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| Secondary | Time to Progression | Progression is defined as the first evaluation that shows progression (either by RECIST or WHO criteria): Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions. | Of the 25 patients in the study 3 patients had non-measurable disease and could not be included in the progression analysis. | Posted | Median | 95% Confidence Interval | months | Time of treatment until progression, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment). |
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| Secondary | Duration of Overall Survival | Patients were followed with regards to survival even after they left the trial (ie after End of Treatment visit). Deaths that occurred after patient participation ended were collected all the way through to the overall end of the trial which took place on Oct 31, 2009. These deaths were used to calculate overall survival. | Posted | Median | 95% Confidence Interval | months | Time of treatment until death, up to the time that all participants ended treatment |
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| Secondary | Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment | The cumulative sum of hospitalization days during the study, per patient. Some patients had multiple hospitalizations. | Of the 25 total patients, 12 were hospitalized during the study. | Posted | Number | days | Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment). |
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Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caelyx | Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg). | 9 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
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| CENTRAL LINE INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| CYSTITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| DRY EYE | Eye disorders | MedDRA 12.1 | Systematic Assessment |
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| LACRIMATION INCREASED | Eye disorders | MedDRA 12.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| FLATULENCE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 12.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 12.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
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| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
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| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
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| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| BLISTER | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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If an investigator wishes to publish data from the study, a copy must be provided to the sponsor for review at least 60 days before submission for publication. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days. If issues arise regarding scientific integrity or regulatory compliance, the sponsor will review these issues with the investigator. The sponsor will not change scientific content or suppress information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
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