ID

37940

Description

Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01299038

Link

https://clinicaltrials.gov/show/NCT01299038

Keywords

Versions (1)
  1. 9/1/19 9/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01299038

English

Eligibility Breast Cancer NCT01299038

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic adenocarcinoma of the breast (stage iv)
Description

Breast adenocarcinoma metastatic TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C1697918
UMLS CUI [1,2]
C0474926
actively receiving endocrine therapy for at least 6 weeks (with or without her2 therapy)
Description

Hormone Therapy | HER2 Targeted Therapy | HER2 Targeted Therapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C2985566
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C2985566
UMLS CUI [3,3]
C0332197
minimum age 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0, 1 or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
normal organ and marrow function as defined in the protocol
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants may not be receiving any other study agents
Description

Investigational New Drugs Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
actively receiving chemotherapy (exclusive of hormonal or her2 therapy ) within last 5 weeks
Description

Chemotherapy | Exclusion of Hormone Therapy | Exclusion of HER2 Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0279025
UMLS CUI [3,1]
C2828389
UMLS CUI [3,2]
C0069515
UMLS CUI [3,3]
C2985566
any statin therapy within the last 3 weeks
Description

Statin therapy

Data type

boolean

Alias
UMLS CUI [1]
C1278454
asian decent (including filipino, chinese, japanese, korean, vietnamese or asian-indian origin)
Description

Asians | Filipino | Chinese | Japanese | Korean | Vietnamese | Asian Indian

Data type

boolean

Alias
UMLS CUI [1]
C0078988
UMLS CUI [2]
C1556093
UMLS CUI [3]
C0152035
UMLS CUI [4]
C1556094
UMLS CUI [5]
C1556095
UMLS CUI [6]
C1561452
UMLS CUI [7]
C1524069
concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors
Description

Cyclosporine | Fibrates | Niacin | Gemfibrozil | Ketoconazole | Spironolactone | Cimetidine | Warfarin | Erythromycin | Protease Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2]
C1449704
UMLS CUI [3]
C0027996
UMLS CUI [4]
C0017245
UMLS CUI [5]
C0022625
UMLS CUI [6]
C0037982
UMLS CUI [7]
C0008783
UMLS CUI [8]
C0043031
UMLS CUI [9]
C0014806
UMLS CUI [10]
C0033607
conditions predisposing to renal failure secondary to rhabdomyolysis
Description

Condition predisposed Kidney Failure | Kidney Failure Secondary to Rhabdomyolysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0231203
UMLS CUI [1,3]
C0035078
UMLS CUI [2,1]
C0035078
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0035410
recent history of heavy alcohol use as judged by the treating physician
Description

Heavy alcohol use

Data type

boolean

Alias
UMLS CUI [1]
C0687132
known to be pregnant (testing not required) or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of rhabdomyolysis on statin therapy
Description

Rhabdomyolysis | Statin therapy

Data type

boolean

Alias
UMLS CUI [1]
C0035410
UMLS CUI [2]
C1278454
known history of hepatitis c or active hepatitis b infection (baseline testing not required)
Description

Hepatitis C | Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019163
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Description

Comorbidity Uncontrolled | Communicable Disease | Hepatitis | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0742758
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0003811
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0525058
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Similar models

Eligibility Breast Cancer NCT01299038

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma metastatic TNM Breast tumor staging
Item
metastatic adenocarcinoma of the breast (stage iv)
boolean
C1697918 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Hormone Therapy | HER2 Targeted Therapy | HER2 Targeted Therapy Absent
Item
actively receiving endocrine therapy for at least 6 weeks (with or without her2 therapy)
boolean
C0279025 (UMLS CUI [1])
C0069515 (UMLS CUI [2,1])
C2985566 (UMLS CUI [2,2])
C0069515 (UMLS CUI [3,1])
C2985566 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Age
Item
minimum age 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
normal organ and marrow function as defined in the protocol
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs Other
Item
participants may not be receiving any other study agents
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Chemotherapy | Exclusion of Hormone Therapy | Exclusion of HER2 Targeted Therapy
Item
actively receiving chemotherapy (exclusive of hormonal or her2 therapy ) within last 5 weeks
boolean
C0392920 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C2828389 (UMLS CUI [3,1])
C0069515 (UMLS CUI [3,2])
C2985566 (UMLS CUI [3,3])
Statin therapy
Item
any statin therapy within the last 3 weeks
boolean
C1278454 (UMLS CUI [1])
Asians | Filipino | Chinese | Japanese | Korean | Vietnamese | Asian Indian
Item
asian decent (including filipino, chinese, japanese, korean, vietnamese or asian-indian origin)
boolean
C0078988 (UMLS CUI [1])
C1556093 (UMLS CUI [2])
C0152035 (UMLS CUI [3])
C1556094 (UMLS CUI [4])
C1556095 (UMLS CUI [5])
C1561452 (UMLS CUI [6])
C1524069 (UMLS CUI [7])
Cyclosporine | Fibrates | Niacin | Gemfibrozil | Ketoconazole | Spironolactone | Cimetidine | Warfarin | Erythromycin | Protease Inhibitors
Item
concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors
boolean
C0010592 (UMLS CUI [1])
C1449704 (UMLS CUI [2])
C0027996 (UMLS CUI [3])
C0017245 (UMLS CUI [4])
C0022625 (UMLS CUI [5])
C0037982 (UMLS CUI [6])
C0008783 (UMLS CUI [7])
C0043031 (UMLS CUI [8])
C0014806 (UMLS CUI [9])
C0033607 (UMLS CUI [10])
Condition predisposed Kidney Failure | Kidney Failure Secondary to Rhabdomyolysis
Item
conditions predisposing to renal failure secondary to rhabdomyolysis
boolean
C0348080 (UMLS CUI [1,1])
C0231203 (UMLS CUI [1,2])
C0035078 (UMLS CUI [1,3])
C0035078 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0035410 (UMLS CUI [2,3])
Heavy alcohol use
Item
recent history of heavy alcohol use as judged by the treating physician
boolean
C0687132 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
known to be pregnant (testing not required) or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Rhabdomyolysis | Statin therapy
Item
history of rhabdomyolysis on statin therapy
boolean
C0035410 (UMLS CUI [1])
C1278454 (UMLS CUI [2])
Hepatitis C | Hepatitis B
Item
known history of hepatitis c or active hepatitis b infection (baseline testing not required)
boolean
C0019196 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Disease | Hepatitis | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
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