ID

37750

Description

Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02511639

Link

https://clinicaltrials.gov/show/NCT02511639

Keywords

  1. 8/21/19 8/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 21, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer Metastatic NCT02511639

Eligibility Breast Cancer Metastatic NCT02511639

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. >18 years old women with metastatic breast cancer
Description

Age | Gender | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0346993
2. histological confirmation of hormone-receptor positive (defined as at least 10% of estrogen receptor (er) and/or progesterone receptor (pgr) positivity) and human epidermal growth factor receptor 2 (her2) negative (score 0-1+ in immunohistochemistry or fish negativity) breast cancer
Description

Hormone receptor positive malignant neoplasm of breast | Estrogen receptor positive Percentage | Progesterone receptor positive Percentage | HER2 Negative Immunohistochemistry | HER2 Negative FISH

Data type

boolean

Alias
UMLS CUI [1]
C1562029
UMLS CUI [2,1]
C0279754
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C0279759
UMLS CUI [3,2]
C0439165
UMLS CUI [4,1]
C2348908
UMLS CUI [4,2]
C0021044
UMLS CUI [5,1]
C2348908
UMLS CUI [5,2]
C0162789
3. postmenopausal status
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
4. one line of chemotherapy for metastatic disease; patients must have received a minimum of 6 cycles of chemotherapy in order to be eligible, and must have obtained disease control (cr or pr od sd)
Description

Line of Chemotherapy Quantity Neoplasm Metastasis | Chemotherapy cycle Quantity Minimum | Disease Controlled | In complete remission | Partial response | Stable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C4524693
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0027627
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1524031
UMLS CUI [3]
C2911690
UMLS CUI [4]
C0677874
UMLS CUI [5]
C1521726
UMLS CUI [6]
C0677946
5. eastern cooperative oncology group (ecog) performance status < 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate bone marrow and coagulation function
Description

Bone Marrow Function | Blood coagulation Function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2,1]
C0005778
UMLS CUI [2,2]
C0031843
7. adequate liver function
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
8. adequate renal function
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
9. fasting serum cholesterol ≤ 300 mg/dl or 7.75 mmol/l and fasting triglycerides ≤ 2.5
Description

Fasting cholesterol level | Serum fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C1282513
UMLS CUI [2]
C0582824
× upper limit of normal (uln). in case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy or other lipid lowering drugs (eg fibrates), and when the above mentioned values have been achieved
Description

Upper Limit of Normal Out of range Statin therapy | Upper Limit of Normal Out of range Hypolipidemic Agents | Fibrates

Data type

boolean

Alias
UMLS CUI [1,1]
C1519815
UMLS CUI [1,2]
C3845292
UMLS CUI [1,3]
C1278454
UMLS CUI [2,1]
C1519815
UMLS CUI [2,2]
C3845292
UMLS CUI [2,3]
C0086440
UMLS CUI [3]
C1449704
10. fasting glucose < 1.5 × uln
Description

Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1]
C0202045
11. written informed consent obtained before any screening procedure and according to local guidelines.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. her2-overexpressing patients by local laboratory testing (immunohistochemistry 3+
Description

HER2 Protein Overexpression Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C1515560
UMLS CUI [1,2]
C0021044
staining or in situ hybridization positive)
Description

HER2 Protein Overexpression Staining | HER2 Protein Overexpression In Situ Hybridization

Data type

boolean

Alias
UMLS CUI [1,1]
C1515560
UMLS CUI [1,2]
C0487602
UMLS CUI [2,1]
C1515560
UMLS CUI [2,2]
C0162788
2. previous treatment with mammalian target of rapamycin (mtor) inhibitors
Description

mTOR Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1515672
3. known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin)
Description

Hypersensitivity mTOR Inhibitors | Hypersensitivity Sirolimus

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1515672
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0072980
4. more than one chemotherapy line for metastatic disease
Description

Line of Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C4524693
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0027627
5. treatment with angiogenetic compounds as maintenance therapy (eg. bevacizumab)
Description

Compound Angiogenic Maintenance therapy | bevacizumab

Data type

boolean

Alias
UMLS CUI [1,1]
C1706082
UMLS CUI [1,2]
C0302600
UMLS CUI [1,3]
C0677908
UMLS CUI [2]
C0796392
6. radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. patients must have recovered from radiotherapy toxicities prior to enrollment
Description

Therapeutic radiology procedure | Toxicity due to radiotherapy Patient recovered

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1302210
UMLS CUI [2,2]
C1115804
7. symptomatic central nervous system metastases
Description

CNS metastases Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
8. patients with a known history of hiv positivity
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
9. active, bleeding diathesis, or on oral anti-vitamin k medication (except low dose warfarin and acetylsalicylic acid or equivalent, as long as the international normalized ratio (inr) is ≤ 2.0)
Description

Bleeding tendency | Vitamin K Antagonist Oral | Exception Warfarin Low dose | Exception Aspirin Low Dose | Exception Equivalent | Relationship International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2,1]
C2267235
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0043031
UMLS CUI [3,3]
C0445550
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2608320
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0205163
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C0525032
10. any severe and / or uncontrolled medical conditions such as:
Description

Medical condition Severe | Medical condition Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to enrollment, serious uncontrolled cardiac arrhythmia
Description

Angina, Unstable | Symptomatic congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0742758
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
uncontrolled diabetes as defined by fasting serum glucose > 1.5 × uln
Description

DIABETES MELLITUS UNCONTROLLED | Serum fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0743131
UMLS CUI [2]
C0583334
acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
Description

Communicable Diseases | Chronic infectious disease | Illness Non-Malignant Uncontrolled | Complications Due to Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C1518371
UMLS CUI [3,3]
C0205318
UMLS CUI [4,1]
C0009566
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0949266
impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
Description

Abnormal digestive tract function | Gastrointestinal Disease Changing Absorption Investigational New Drugs | Ulcer | Nausea Uncontrolled | Vomiting | Diarrhea | Malabsorption Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0232459
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
UMLS CUI [3]
C0041582
UMLS CUI [4,1]
C0027497
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C0042963
UMLS CUI [6]
C0011991
UMLS CUI [7]
C0024523
significant symptomatic deterioration of lung function. if clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusion capacity of lung for carbon monoxide (dlco) and o2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.
Description

Deterioration of lung function Symptomatic | Indication Pulmonary function tests | Indication Lung Volume Measurements predicted | Carbon Monoxide Diffusing Capability Test | Oxygen saturation measurement At rest On room air | Restrictive pulmonary disease Excluded | Pneumonitis Excluded | Pulmonary Infiltrates Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C4014536
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0024119
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0024129
UMLS CUI [3,3]
C0681842
UMLS CUI [4]
C1516251
UMLS CUI [5,1]
C0523807
UMLS CUI [5,2]
C0443144
UMLS CUI [5,3]
C2709070
UMLS CUI [6,1]
C0877013
UMLS CUI [6,2]
C0332196
UMLS CUI [7,1]
C3714636
UMLS CUI [7,2]
C0332196
UMLS CUI [8,1]
C0235896
UMLS CUI [8,2]
C0332196
11. patients who test positive for hepatitis b or c (patients who test negative for hepatitis b virus (hbv)-dna, hbsag, and hbcab but positive for hbsab with prior history of vaccination against hepatitis b will be eligible)
Description

Hepatitis B positive | Hepatitis C positive

Data type

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
12. patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cytochrome p3a (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) within the last 5 days prior to enrollment
Description

CYP3A Inhibitors Strong | CYP3A Inducers Strong | Rifabutin | Rifampin | Clarithromycin | Ketoconazole | Itraconazole | voriconazole | Ritonavir | telithromycin

Data type

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850044
UMLS CUI [2,2]
C0442821
UMLS CUI [3]
C0140575
UMLS CUI [4]
C0035608
UMLS CUI [5]
C0055856
UMLS CUI [6]
C0022625
UMLS CUI [7]
C0064113
UMLS CUI [8]
C0393080
UMLS CUI [9]
C0292818
UMLS CUI [10]
C0907410
13. history of non-compliance to medical regimens
Description

Compliance Lacking Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0087111
14. patients unwilling to or unable to comply with the protocol
Description

Protocol Compliance Unwilling | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582

Similar models

Eligibility Breast Cancer Metastatic NCT02511639

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender | Secondary malignant neoplasm of female breast
Item
1. >18 years old women with metastatic breast cancer
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0346993 (UMLS CUI [3])
Hormone receptor positive malignant neoplasm of breast | Estrogen receptor positive Percentage | Progesterone receptor positive Percentage | HER2 Negative Immunohistochemistry | HER2 Negative FISH
Item
2. histological confirmation of hormone-receptor positive (defined as at least 10% of estrogen receptor (er) and/or progesterone receptor (pgr) positivity) and human epidermal growth factor receptor 2 (her2) negative (score 0-1+ in immunohistochemistry or fish negativity) breast cancer
boolean
C1562029 (UMLS CUI [1])
C0279754 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0279759 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C2348908 (UMLS CUI [4,1])
C0021044 (UMLS CUI [4,2])
C2348908 (UMLS CUI [5,1])
C0162789 (UMLS CUI [5,2])
Postmenopausal state
Item
3. postmenopausal status
boolean
C0232970 (UMLS CUI [1])
Line of Chemotherapy Quantity Neoplasm Metastasis | Chemotherapy cycle Quantity Minimum | Disease Controlled | In complete remission | Partial response | Stable Disease
Item
4. one line of chemotherapy for metastatic disease; patients must have received a minimum of 6 cycles of chemotherapy in order to be eligible, and must have obtained disease control (cr or pr od sd)
boolean
C4524693 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,4])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
C2911690 (UMLS CUI [3])
C0677874 (UMLS CUI [4])
C1521726 (UMLS CUI [5])
C0677946 (UMLS CUI [6])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status < 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow Function | Blood coagulation Function
Item
6. adequate bone marrow and coagulation function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0005778 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Liver function
Item
7. adequate liver function
boolean
C0232741 (UMLS CUI [1])
Renal function
Item
8. adequate renal function
boolean
C0232804 (UMLS CUI [1])
Fasting cholesterol level | Serum fasting triglyceride measurement
Item
9. fasting serum cholesterol ≤ 300 mg/dl or 7.75 mmol/l and fasting triglycerides ≤ 2.5
boolean
C1282513 (UMLS CUI [1])
C0582824 (UMLS CUI [2])
Upper Limit of Normal Out of range Statin therapy | Upper Limit of Normal Out of range Hypolipidemic Agents | Fibrates
Item
× upper limit of normal (uln). in case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy or other lipid lowering drugs (eg fibrates), and when the above mentioned values have been achieved
boolean
C1519815 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
C1278454 (UMLS CUI [1,3])
C1519815 (UMLS CUI [2,1])
C3845292 (UMLS CUI [2,2])
C0086440 (UMLS CUI [2,3])
C1449704 (UMLS CUI [3])
Glucose measurement, fasting
Item
10. fasting glucose < 1.5 × uln
boolean
C0202045 (UMLS CUI [1])
Informed Consent
Item
11. written informed consent obtained before any screening procedure and according to local guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HER2 Protein Overexpression Immunohistochemistry
Item
1. her2-overexpressing patients by local laboratory testing (immunohistochemistry 3+
boolean
C1515560 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
HER2 Protein Overexpression Staining | HER2 Protein Overexpression In Situ Hybridization
Item
staining or in situ hybridization positive)
boolean
C1515560 (UMLS CUI [1,1])
C0487602 (UMLS CUI [1,2])
C1515560 (UMLS CUI [2,1])
C0162788 (UMLS CUI [2,2])
mTOR Inhibitors
Item
2. previous treatment with mammalian target of rapamycin (mtor) inhibitors
boolean
C1515672 (UMLS CUI [1])
Hypersensitivity mTOR Inhibitors | Hypersensitivity Sirolimus
Item
3. known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin)
boolean
C0020517 (UMLS CUI [1,1])
C1515672 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
Line of Chemotherapy Quantity Neoplasm Metastasis
Item
4. more than one chemotherapy line for metastatic disease
boolean
C4524693 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,4])
Compound Angiogenic Maintenance therapy | bevacizumab
Item
5. treatment with angiogenetic compounds as maintenance therapy (eg. bevacizumab)
boolean
C1706082 (UMLS CUI [1,1])
C0302600 (UMLS CUI [1,2])
C0677908 (UMLS CUI [1,3])
C0796392 (UMLS CUI [2])
Therapeutic radiology procedure | Toxicity due to radiotherapy Patient recovered
Item
6. radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. patients must have recovered from radiotherapy toxicities prior to enrollment
boolean
C1522449 (UMLS CUI [1])
C1302210 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
CNS metastases Symptomatic
Item
7. symptomatic central nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
HIV Seropositivity
Item
8. patients with a known history of hiv positivity
boolean
C0019699 (UMLS CUI [1])
Bleeding tendency | Vitamin K Antagonist Oral | Exception Warfarin Low dose | Exception Aspirin Low Dose | Exception Equivalent | Relationship International Normalized Ratio
Item
9. active, bleeding diathesis, or on oral anti-vitamin k medication (except low dose warfarin and acetylsalicylic acid or equivalent, as long as the international normalized ratio (inr) is ≤ 2.0)
boolean
C1458140 (UMLS CUI [1])
C2267235 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0043031 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C2608320 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
C0439849 (UMLS CUI [6,1])
C0525032 (UMLS CUI [6,2])
Medical condition Severe | Medical condition Uncontrolled
Item
10. any severe and / or uncontrolled medical conditions such as:
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Angina, Unstable | Symptomatic congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled
Item
unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to enrollment, serious uncontrolled cardiac arrhythmia
boolean
C0002965 (UMLS CUI [1])
C0742758 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
DIABETES MELLITUS UNCONTROLLED | Serum fasting glucose measurement
Item
uncontrolled diabetes as defined by fasting serum glucose > 1.5 × uln
boolean
C0743131 (UMLS CUI [1])
C0583334 (UMLS CUI [2])
Communicable Diseases | Chronic infectious disease | Illness Non-Malignant Uncontrolled | Complications Due to Investigational Therapy
Item
acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C1518371 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0009566 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0949266 (UMLS CUI [4,3])
Abnormal digestive tract function | Gastrointestinal Disease Changing Absorption Investigational New Drugs | Ulcer | Nausea Uncontrolled | Vomiting | Diarrhea | Malabsorption Syndrome
Item
impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0041582 (UMLS CUI [3])
C0027497 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0042963 (UMLS CUI [5])
C0011991 (UMLS CUI [6])
C0024523 (UMLS CUI [7])
Deterioration of lung function Symptomatic | Indication Pulmonary function tests | Indication Lung Volume Measurements predicted | Carbon Monoxide Diffusing Capability Test | Oxygen saturation measurement At rest On room air | Restrictive pulmonary disease Excluded | Pneumonitis Excluded | Pulmonary Infiltrates Excluded
Item
significant symptomatic deterioration of lung function. if clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusion capacity of lung for carbon monoxide (dlco) and o2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.
boolean
C4014536 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0024119 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0024129 (UMLS CUI [3,2])
C0681842 (UMLS CUI [3,3])
C1516251 (UMLS CUI [4])
C0523807 (UMLS CUI [5,1])
C0443144 (UMLS CUI [5,2])
C2709070 (UMLS CUI [5,3])
C0877013 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C3714636 (UMLS CUI [7,1])
C0332196 (UMLS CUI [7,2])
C0235896 (UMLS CUI [8,1])
C0332196 (UMLS CUI [8,2])
Hepatitis B positive | Hepatitis C positive
Item
11. patients who test positive for hepatitis b or c (patients who test negative for hepatitis b virus (hbv)-dna, hbsag, and hbcab but positive for hbsab with prior history of vaccination against hepatitis b will be eligible)
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
CYP3A Inhibitors Strong | CYP3A Inducers Strong | Rifabutin | Rifampin | Clarithromycin | Ketoconazole | Itraconazole | voriconazole | Ritonavir | telithromycin
Item
12. patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cytochrome p3a (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) within the last 5 days prior to enrollment
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850044 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C0140575 (UMLS CUI [3])
C0035608 (UMLS CUI [4])
C0055856 (UMLS CUI [5])
C0022625 (UMLS CUI [6])
C0064113 (UMLS CUI [7])
C0393080 (UMLS CUI [8])
C0292818 (UMLS CUI [9])
C0907410 (UMLS CUI [10])
Compliance Lacking Therapy
Item
13. history of non-compliance to medical regimens
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
14. patients unwilling to or unable to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])

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