ID

38462

Beskrivning

Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis; ODM derived from: https://clinicaltrials.gov/show/NCT01281696

Länk

https://clinicaltrials.gov/show/NCT01281696

Nyckelord

Versioner (1)
  1. 2019-10-20 2019-10-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01281696

Engelsk

Eligibility Breast Neoplasms NCT01281696

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. a histological confirmed invasive breast cancer
Beskrivning

Invasive carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0853879
2. patient with at least one measurable brain metastatic tumor (≧10mm on t1-weighted gadolinium enhanced mri or contrast-enhanced ct) or leptomeningeal metastasis with positive csf cytology study.
Beskrivning

Metastatic malignant neoplasm to brain Measurable Quantity | Tumor size T1 Nuclear magnetic resonance imaging gadolinium-enhanced | Metastatic malignant neoplasm to brain Measurable CT scan contrast | Metastatic Malignant Neoplasm to the Leptomeninges Cerebrospinal Fluid Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C2697938
UMLS CUI [2,3]
C0855566
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C1513040
UMLS CUI [3,3]
C0742919
UMLS CUI [4,1]
C1704231
UMLS CUI [4,2]
C0007806
UMLS CUI [4,3]
C1514241
3. patient whose brain parenchymal metastatic tumors either progress after wbrt, develop new lesions after wbrt, or cns metastatic tumor do not response to wbrt according to image study 3 months after treatment. patients with leptomeningeal metastasis does not necessarily need whole brain radiotherapy before enrollment.
Beskrivning

Metastatic malignant neoplasm to brain Parenchymal | Disease Progression | Status post Whole brain radiation therapy | New Lesion Identification | CNS metastases Unresponsive to Whole brain radiation therapy | Imaging study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C4277702
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1520143
UMLS CUI [4]
C2986548
UMLS CUI [5,1]
C0686377
UMLS CUI [5,2]
C0205269
UMLS CUI [5,3]
C1520143
UMLS CUI [6]
C1881134
4. patients with her2/neu overexpression or amplification will be allowed but will be informed about other available treatment options such as lapatinib plus capecitabine.
Beskrivning

HER2 Protein Overexpression | HER2 gene amplification | Treatment option | Lapatinib plus Capecitabine

Datatyp

boolean

Alias
UMLS CUI [1]
C1515560
UMLS CUI [2]
C1512127
UMLS CUI [3]
C0683525
UMLS CUI [4,1]
C1506770
UMLS CUI [4,2]
C0332287
UMLS CUI [4,3]
C0671970
5. patients must have adequate organ and marrow reserve measured within 14 days prior to randomization as defined below:
Beskrivning

Organ function Total | Bone Marrow Mature Neutrophils Present

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0439810
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C1708947
absolute neutrophil count ≧1,000/mcl
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≧75,000/mcl
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin ≦ 1.5 x upper normal limit
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
ast(sgot)/alt(sgpt) ≦ 2.5 x upper normal limit; for patients with liver metastases ast(sgot)/alt(sgpt) ≦ 5 x is allowed
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0494165
serum creatinine ≦ upper normal limit or creatinine clearance ≧50ml/min
Beskrivning

Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
hemoglobin≧8.0 gm/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
ptt ≦ upper normal limit; inr ≦ 1.5
Beskrivning

Activated Partial Thromboplastin Time measurement | International Normalized Ratio

Datatyp

boolean

Alias
UMLS CUI [1]
C0030605
UMLS CUI [2]
C0525032
proteinuria ≤ 1+, if > 1+, urine protein must be ≦ 1 g/24 hours
Beskrivning

Proteinuria | Urine protein test g/24h

Datatyp

boolean

Alias
UMLS CUI [1]
C0033687
UMLS CUI [2,1]
C0262923
UMLS CUI [2,2]
C0439417
6. patient age 18 to 75 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
7. patient's life expectancy is more than 2 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
8. eastern cooperative oncology group performance status (ecog ps) of 0, 1, 2 or 3
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
9. all women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy
Beskrivning

Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
10. patients with reproductive potential must use effective contraception (hormone or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months after the completion of therapy
Beskrivning

Females & males of reproductive potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C2985296
UMLS CUI [3]
C0004764
UMLS CUI [4]
C0036899
11. patients (or a surrogate) must be able to comply with study procedures and sign informed consent
Beskrivning

Protocol Compliance | Informed Consent | Protocol Compliance Patient Representative | Informed Consent Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0030701
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior therapy with bevacizumab, sorafenib, sunitinib, or other vegf pathway-targeted therapy
Beskrivning

bevacizumab | sorafenib | sunitinib | Targeted Therapy VEGF Signaling Pathway

Datatyp

boolean

Alias
UMLS CUI [1]
C0796392
UMLS CUI [2]
C1516119
UMLS CUI [3]
C1176020
UMLS CUI [4,1]
C2985566
UMLS CUI [4,2]
C2984329
2. patients whose cns metastasis progressed or developed during prior cisplatin treatment
Beskrivning

CNS metastases | Disease Progression | Cisplatin

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0242656
UMLS CUI [3]
C0008838
3. history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
Beskrivning

Congenital bleeding diathesis | Blood Coagulation Disorder with Bleeding risk

Datatyp

boolean

Alias
UMLS CUI [1]
C1856452
UMLS CUI [2,1]
C0005779
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C3251812
4. history of thrombotic disorders
Beskrivning

Thrombosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0040053
5. active gastrointestinal bleeding
Beskrivning

Gastrointestinal Hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C0017181
6. patients with a history of self-reported intra-cranial hemorrhage
Beskrivning

Intracranial Hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C0151699
7. patients with clinical signs or symptoms of gastrointestinal obstruction and who require parenteral hydration and/or nutrition because of obstruction
Beskrivning

Clinical signs Gastrointestinal obstruction | Symptoms Gastrointestinal obstruction | Obstruction Requirement Parenteral fluids for hydration | Obstruction Requirement Parenteral Nutrition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0236124
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0236124
UMLS CUI [3,1]
C0028778
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C2034480
UMLS CUI [4,1]
C0028778
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0030547
8. history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of first dose of bevacizumab
Beskrivning

Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess

Datatyp

boolean

Alias
UMLS CUI [1]
C1879311
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0243001
9. clinically significant peripheral artery disease
Beskrivning

Peripheral Arterial Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1704436
10. arterial thromboembolic event within the past 6 months, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction
Beskrivning

Thromboembolic event Arterial | Transient Ischemic Attack | Cerebrovascular accident | Angina, Unstable | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040038
UMLS CUI [1,2]
C0221464
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0027051
11. history of gross hemoptysis (i.e. ≥ 1 teaspoon of bright red blood)
Beskrivning

Hemoptysis Gross

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019079
UMLS CUI [1,2]
C0439806
12. other malignancy within 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Beskrivning

Cancer Other | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Carcinoma in situ of uterine cervix Cured

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1880198
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1880198
13. psychiatric illness or social situation that would preclude study compliance
Beskrivning

Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
14. serious non-healing wound, ulcer, or bone fracture
Beskrivning

Non healing wound Serious | Ulcer | Bone fracture

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0041582
UMLS CUI [3]
C0016658
15. major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment
Beskrivning

Major surgery | Incisional biopsy | Traumatic injury

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
16. prior minor surgery or needle biopsies within 7 days
Beskrivning

Minor Surgical Procedures | Needle biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0038904
UMLS CUI [2]
C0005560
17. concurrent chronic daily aspirin (> 325 mg/day), dipyridamole, ticlopidine, clopidogrel, cilostazol, non-steroidal anti-inflammatory agents known to inhibit platelet function
Beskrivning

Aspirin chronic Daily Dose | Dipyridamole | Ticlopidine | clopidogrel | cilostazol | Non-Steroidal Anti-Inflammatory Agents Inhibiting Platelet function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C2348070
UMLS CUI [2]
C0012582
UMLS CUI [3]
C0040207
UMLS CUI [4]
C0070166
UMLS CUI [5]
C0055729
UMLS CUI [6,1]
C0003211
UMLS CUI [6,2]
C3463820
UMLS CUI [6,3]
C1254881
18. concurrent therapeutic anticoagulation, but prophylactic anti-coagulation of venous access devices is allowed
Beskrivning

Anticoagulation Therapy | Prophylactic anticoagulation Venous access allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2,1]
C4304154
UMLS CUI [2,2]
C0750164
UMLS CUI [2,3]
C0683607
19. history of allergic reaction to compounds of similar chemical composition to the study drugs
Beskrivning

Allergic Reaction Compound Investigational New Drug Similar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205198
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C2348205
20. pregnancy or lactation
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Tillbaka till toppen

Similar models

Eligibility Breast Neoplasms NCT01281696

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
1. a histological confirmed invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Measurable Quantity | Tumor size T1 Nuclear magnetic resonance imaging gadolinium-enhanced | Metastatic malignant neoplasm to brain Measurable CT scan contrast | Metastatic Malignant Neoplasm to the Leptomeninges Cerebrospinal Fluid Positive
Item
2. patient with at least one measurable brain metastatic tumor (≧10mm on t1-weighted gadolinium enhanced mri or contrast-enhanced ct) or leptomeningeal metastasis with positive csf cytology study.
boolean
C0220650 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0475440 (UMLS CUI [2,1])
C2697938 (UMLS CUI [2,2])
C0855566 (UMLS CUI [2,3])
C0220650 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0742919 (UMLS CUI [3,3])
C1704231 (UMLS CUI [4,1])
C0007806 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
Metastatic malignant neoplasm to brain Parenchymal | Disease Progression | Status post Whole brain radiation therapy | New Lesion Identification | CNS metastases Unresponsive to Whole brain radiation therapy | Imaging study
Item
3. patient whose brain parenchymal metastatic tumors either progress after wbrt, develop new lesions after wbrt, or cns metastatic tumor do not response to wbrt according to image study 3 months after treatment. patients with leptomeningeal metastasis does not necessarily need whole brain radiotherapy before enrollment.
boolean
C0220650 (UMLS CUI [1,1])
C4277702 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1520143 (UMLS CUI [3,2])
C2986548 (UMLS CUI [4])
C0686377 (UMLS CUI [5,1])
C0205269 (UMLS CUI [5,2])
C1520143 (UMLS CUI [5,3])
C1881134 (UMLS CUI [6])
HER2 Protein Overexpression | HER2 gene amplification | Treatment option | Lapatinib plus Capecitabine
Item
4. patients with her2/neu overexpression or amplification will be allowed but will be informed about other available treatment options such as lapatinib plus capecitabine.
boolean
C1515560 (UMLS CUI [1])
C1512127 (UMLS CUI [2])
C0683525 (UMLS CUI [3])
C1506770 (UMLS CUI [4,1])
C0332287 (UMLS CUI [4,2])
C0671970 (UMLS CUI [4,3])
Organ function Total | Bone Marrow Mature Neutrophils Present
Item
5. patients must have adequate organ and marrow reserve measured within 14 days prior to randomization as defined below:
boolean
C0678852 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C1708947 (UMLS CUI [2,2])
Absolute neutrophil count
Item
absolute neutrophil count ≧1,000/mcl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≧75,000/mcl
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≦ 1.5 x upper normal limit
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
ast(sgot)/alt(sgpt) ≦ 2.5 x upper normal limit; for patients with liver metastases ast(sgot)/alt(sgpt) ≦ 5 x is allowed
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Creatinine measurement, serum | Creatinine clearance measurement
Item
serum creatinine ≦ upper normal limit or creatinine clearance ≧50ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Hemoglobin measurement
Item
hemoglobin≧8.0 gm/dl
boolean
C0518015 (UMLS CUI [1])
Activated Partial Thromboplastin Time measurement | International Normalized Ratio
Item
ptt ≦ upper normal limit; inr ≦ 1.5
boolean
C0030605 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Proteinuria | Urine protein test g/24h
Item
proteinuria ≤ 1+, if > 1+, urine protein must be ≦ 1 g/24 hours
boolean
C0033687 (UMLS CUI [1])
C0262923 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Age
Item
6. patient age 18 to 75 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
7. patient's life expectancy is more than 2 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
8. eastern cooperative oncology group performance status (ecog ps) of 0, 1, 2 or 3
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
9. all women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Females & males of reproductive potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
10. patients with reproductive potential must use effective contraception (hormone or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months after the completion of therapy
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0004764 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
Protocol Compliance | Informed Consent | Protocol Compliance Patient Representative | Informed Consent Patient Representative
Item
11. patients (or a surrogate) must be able to comply with study procedures and sign informed consent
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3,1])
C0030701 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
bevacizumab | sorafenib | sunitinib | Targeted Therapy VEGF Signaling Pathway
Item
1. prior therapy with bevacizumab, sorafenib, sunitinib, or other vegf pathway-targeted therapy
boolean
C0796392 (UMLS CUI [1])
C1516119 (UMLS CUI [2])
C1176020 (UMLS CUI [3])
C2985566 (UMLS CUI [4,1])
C2984329 (UMLS CUI [4,2])
CNS metastases | Disease Progression | Cisplatin
Item
2. patients whose cns metastasis progressed or developed during prior cisplatin treatment
boolean
C0686377 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0008838 (UMLS CUI [3])
Congenital bleeding diathesis | Blood Coagulation Disorder with Bleeding risk
Item
3. history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
boolean
C1856452 (UMLS CUI [1])
C0005779 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C3251812 (UMLS CUI [2,3])
Thrombosis
Item
4. history of thrombotic disorders
boolean
C0040053 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
5. active gastrointestinal bleeding
boolean
C0017181 (UMLS CUI [1])
Intracranial Hemorrhage
Item
6. patients with a history of self-reported intra-cranial hemorrhage
boolean
C0151699 (UMLS CUI [1])
Clinical signs Gastrointestinal obstruction | Symptoms Gastrointestinal obstruction | Obstruction Requirement Parenteral fluids for hydration | Obstruction Requirement Parenteral Nutrition
Item
7. patients with clinical signs or symptoms of gastrointestinal obstruction and who require parenteral hydration and/or nutrition because of obstruction
boolean
C3540840 (UMLS CUI [1,1])
C0236124 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0236124 (UMLS CUI [2,2])
C0028778 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C2034480 (UMLS CUI [3,3])
C0028778 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0030547 (UMLS CUI [4,3])
Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess
Item
8. history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of first dose of bevacizumab
boolean
C1879311 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])
Peripheral Arterial Disease
Item
9. clinically significant peripheral artery disease
boolean
C1704436 (UMLS CUI [1])
Thromboembolic event Arterial | Transient Ischemic Attack | Cerebrovascular accident | Angina, Unstable | Myocardial Infarction
Item
10. arterial thromboembolic event within the past 6 months, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction
boolean
C0040038 (UMLS CUI [1,1])
C0221464 (UMLS CUI [1,2])
C0007787 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Hemoptysis Gross
Item
11. history of gross hemoptysis (i.e. ≥ 1 teaspoon of bright red blood)
boolean
C0019079 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Carcinoma in situ of uterine cervix Cured
Item
12. other malignancy within 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1880198 (UMLS CUI [4,3])
Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance
Item
13. psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Non healing wound Serious | Ulcer | Bone fracture
Item
14. serious non-healing wound, ulcer, or bone fracture
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Major surgery | Incisional biopsy | Traumatic injury
Item
15. major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
Minor Surgical Procedures | Needle biopsy
Item
16. prior minor surgery or needle biopsies within 7 days
boolean
C0038904 (UMLS CUI [1])
C0005560 (UMLS CUI [2])
Aspirin chronic Daily Dose | Dipyridamole | Ticlopidine | clopidogrel | cilostazol | Non-Steroidal Anti-Inflammatory Agents Inhibiting Platelet function
Item
17. concurrent chronic daily aspirin (> 325 mg/day), dipyridamole, ticlopidine, clopidogrel, cilostazol, non-steroidal anti-inflammatory agents known to inhibit platelet function
boolean
C0004057 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0012582 (UMLS CUI [2])
C0040207 (UMLS CUI [3])
C0070166 (UMLS CUI [4])
C0055729 (UMLS CUI [5])
C0003211 (UMLS CUI [6,1])
C3463820 (UMLS CUI [6,2])
C1254881 (UMLS CUI [6,3])
Anticoagulation Therapy | Prophylactic anticoagulation Venous access allowed
Item
18. concurrent therapeutic anticoagulation, but prophylactic anti-coagulation of venous access devices is allowed
boolean
C0003281 (UMLS CUI [1])
C4304154 (UMLS CUI [2,1])
C0750164 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Allergic Reaction Compound Investigational New Drug Similar
Item
19. history of allergic reaction to compounds of similar chemical composition to the study drugs
boolean
C1527304 (UMLS CUI [1,1])
C0205198 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
20. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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