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f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Pathologically confirmed HER2-positive MBC Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Stable systemic disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: LVEF at least 50% Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Adequate hematologic, renal, and hepatic function Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Life expectancy more than 12 weeks Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Progression of systemic disease at Screening Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Leptomeningeal disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: History of intolerance or hypersensitivity to study drug Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Use of certain investigational therapies within 21 days prior to enrollment Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Current anthracycline use Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Active infection Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Pregnant or lactating women Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Significant history or risk of cardiac disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: Symptomatic intrinsic lung disease or lung involvement Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Currently disease free of breast cancer and other invasive malignancies at the time of registration secondary trial: History of other malignancy within the last 5 years Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Pathologically confirmed HER2-positive MBC Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Stable systemic disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: LVEF at least 50% Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Adequate hematologic, renal, and hepatic function Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Life expectancy more than 12 weeks Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Progression of systemic disease at Screening Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Leptomeningeal disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: History of intolerance or hypersensitivity to study drug Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Use of certain investigational therapies within 21 days prior to enrollment Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Current anthracycline use Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Active infection Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Pregnant or lactating women Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Significant history or risk of cardiac disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: Symptomatic intrinsic lung disease or lung involvement Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: No concurrent use of bisphosphonates secondary trial: History of other malignancy within the last 5 years Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Pathologically confirmed HER2-positive MBC Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Stable systemic disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: LVEF at least 50% Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Adequate hematologic, renal, and hepatic function Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Life expectancy more than 12 weeks Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Progression of systemic disease at Screening Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Leptomeningeal disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: History of intolerance or hypersensitivity to study drug Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Use of certain investigational therapies within 21 days prior to enrollment Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Current anthracycline use Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Active infection Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Pregnant or lactating women Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Significant history or risk of cardiac disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: Symptomatic intrinsic lung disease or lung involvement Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Metastatic disease secondary trial: History of other malignancy within the last 5 years Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | 1. Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | PFS was defined as the time from randomization to progressive disease, or death, whichever occurs first. Response was assessed according to RECIST 1.1 by BICR. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in weeks was reported for each treatment arm. Per protocol, participants remained on assigned treatment until disease progression. Participants who discontinued study treatment for reasons other than disease progression continued to be assessed by imaging until objective documentation of progression. All participants (including participants who discontinued study treatment) were followed for survival until investigator notification to discontinue. The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Time frame: From Day 1 through last post-study efficacy follow-up (up to ~19 months) The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Arm/Group Title: Ridaforolimus + Dalotuzumab + Exemestane The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Arm/Group Description: Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity. The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Overall Number of Participants Analyzed: 40 The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Median (95% Confidence Interval) The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Unit of Measure: Weeks 23.29 (8.71 to 38.43) The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Arm/Group Title: Ridaforolimus + Exemestane The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Arm/Group Description: Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity. The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Overall Number of Participants Analyzed: 40 The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Median (95% Confidence Interval) The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
4fef4cdf-53bf-4239-9d31-4710fd3edc6f | Unit of Measure: Weeks 31.86 (16.00 to 39.29) The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months. | 0 |
331affb2-f8e9-4a55-ac4c-62d2ecc4f80b | Prone The only difference between the interventions used in the primary trial is the patients position. | 1 |
331affb2-f8e9-4a55-ac4c-62d2ecc4f80b | Prone position The only difference between the interventions used in the primary trial is the patients position. | 1 |
331affb2-f8e9-4a55-ac4c-62d2ecc4f80b | Supine The only difference between the interventions used in the primary trial is the patients position. | 1 |
331affb2-f8e9-4a55-ac4c-62d2ecc4f80b | Supine position The only difference between the interventions used in the primary trial is the patients position. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Histologically confirmed breast cancer meeting 1 of the following criteria: Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Unresectable stage IIIB or IIIC disease Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Stage IV disease Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Must be negative for all of the following: Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Estrogen receptor (< 10%) Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Progesterone receptor (<10%) Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | HER-2 (negative FISH, IHC 0 - 1+, or IHC +2 with negative FISH) Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Measurable or evaluable disease Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | No symptomatic or progressive CNS (central nervous system) metastases Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Previously treated CNS metastases allowed provided all of the following criteria are met: Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | At least 8 weeks since prior radiation to brain or CNS metastases Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | No concurrent steroids Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | No leptomeningeal disease Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | PATIENT CHARACTERISTICS: Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Menopausal status not specified Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | ECOG (Eastern Cooperative Oncology Group) performance status 0-2 Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Life expectancy 6 months Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | WBC > 1,500/mm³ Patients must have a white blood cell count above 1,500/mm¬¨‚â• to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Platelet count > 100,000/mm³ Patients must have a white blood cell count above 1,500/mm¬¨‚â• to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Creatinine clearance > 40 mL/min Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Normal electrolytes (i.e., Na, K, and Ca normal; minor deviations are allowed if they do not impact on patient safety in the clinical judgment of the treating physician) Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Bilirubin 1.5 times upper limit of normal (ULN) Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | ALT and AST 2.5 times ULN ( 5 times ULN in the presence of documented liver metastases) Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Alkaline phosphatase 2.5 times ULN ( 5 times ULN in the presence of liver or bone metastases) Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Not pregnant or nursing Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |
a577e819-c928-4217-8743-f4809e852919 | Fertile patients must use effective barrier contraception Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial. | 1 |