ID

31202

Description

Study to Evaluate RAD001 in Combination With Radiotherapy in Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01167530

Link

https://clinicaltrials.gov/show/NCT01167530

Keywords

Versions (1)
  1. 7/28/18 7/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01167530

English

Eligibility Non-small Cell Lung Cancer NCT01167530

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. unresectable non-small cell lung cancer, stage iiia/b, or stage iv for which the primary tumor is symptomatic (cough, dyspnea, pain) without extra-thoracic lesions rapidly evolving for which patients should receive radiotherapy at curative dose
Description

Non-Small Cell Lung Carcinoma unresectable TNM clinical staging | Primary tumor Symptomatic | Cough | Dyspnea | Pain | Lesion Rapidly progressive Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0010200
UMLS CUI [4]
C0013404
UMLS CUI [5]
C0030193
UMLS CUI [6,1]
C0221198
UMLS CUI [6,2]
C1838681
UMLS CUI [6,3]
C0332197
2. measurable lesion, documented histologically, potentially accessible during fiberoptic bronchoscopy.
Description

Measurable lesion | Access During Fiberoptic bronchoscopy

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0189391
3. age > 18 years, who 0-1,
Description

Age | WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1298650
4. neutrophil count > 1500 /mm3, hemoglobin > 9 g/dl, platelet count > 100,000/mm3
Description

Neutrophil count | Hemoglobin measurement | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
5. bilirubin < 1.5 mg/dl, transaminases < 3 n, albumin >30 g / l, pt > 70%
Description

Serum total bilirubin measurement | Transaminase Assay | Albumin measurement | Prothrombin time assay

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0919834
UMLS CUI [3]
C0201838
UMLS CUI [4]
C0033707
6. creatinine < 120 μm/l
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
7. patient information and informed consent form signed.
Description

Patient Information | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C1955348
UMLS CUI [2]
C0021430
8. no previous treatment for lung cancer (surgery, radiotherapy, chemotherapy).
Description

Prior Therapy Absent Malignant neoplasm of lung | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent | Chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0242379
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients previously treated with rad001 (everolimus) or any other mtor inhibitor
Description

RAD 001 | everolimus | mTOR Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0962969
UMLS CUI [2]
C0541315
UMLS CUI [3]
C2746052
2. stage iv for which the primary tumor is not symptomatic with extra-thoracic lesions rapidly evolving requiring systemic treatment
Description

TNM clinical staging | Primary tumor Asymptomatic | Lesion Rapidly progressive Requirement Systemic therapy

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0231221
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1838681
UMLS CUI [3,3]
C1514873
UMLS CUI [3,4]
C1515119
3. previous radiotherapy,
Description

Prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279134
4. venous or arterial thrombosis, pulmonary embolism during the previous six months
Description

Venous Thrombosis | Arterial thrombosis | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C0042487
UMLS CUI [2]
C0151942
UMLS CUI [3]
C0034065
5. concomitant treatment with phenytoin, phenobarbital or any other antiepileptic agent, history of epilepsy
Description

Phenytoin | Phenobarbital | Antiepileptic Agents | Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0031507
UMLS CUI [2]
C0031412
UMLS CUI [3]
C0003299
UMLS CUI [4]
C0014544
6. concomitant treatment with medicinal products that inhibit, induce or are substrates for cyp3a4(inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, ciclosporin, voriconazoleinducers: rifampicin, carbamazepine, rifabutinsubstrates: midazolam, buspirone, felodipine)
Description

CYP3A4 Inhibitor | CYP3A4 Inducer | CYP3A4 Substrate | Atazanavir | Clarithromycin | Indinavir | Itraconazole | Ketoconazole | nefazodone | Nelfinavir | Ritonavir | Saquinavir | telithromycin | Amprenavir | aprepitant | Diltiazem | Erythromycin | Fluconazole | fosamprenavir | Verapamil | Cyclosporine | voriconazole | Rifampin | Carbamazepine | Rifabutin | Midazolam | Buspirone | Felodipine

Data type

boolean

Alias
UMLS CUI [1]
C3830624
UMLS CUI [2]
C3830625
UMLS CUI [3,1]
C3714798
UMLS CUI [3,2]
C3891814
UMLS CUI [4]
C1145759
UMLS CUI [5]
C0055856
UMLS CUI [6]
C0376637
UMLS CUI [7]
C0064113
UMLS CUI [8]
C0022625
UMLS CUI [9]
C0068485
UMLS CUI [10]
C0525005
UMLS CUI [11]
C0292818
UMLS CUI [12]
C0286738
UMLS CUI [13]
C0907410
UMLS CUI [14]
C0754188
UMLS CUI [15]
C1176306
UMLS CUI [16]
C0012373
UMLS CUI [17]
C0014806
UMLS CUI [18]
C0016277
UMLS CUI [19]
C1176315
UMLS CUI [20]
C0042523
UMLS CUI [21]
C0010592
UMLS CUI [22]
C0393080
UMLS CUI [23]
C0035608
UMLS CUI [24]
C0006949
UMLS CUI [25]
C0140575
UMLS CUI [26]
C0026056
UMLS CUI [27]
C0006462
UMLS CUI [28]
C0015772
7. concomitant therapy with agents otherwise used in the treatment of cancer (for example methotrexate for rheumatoid arthritis).
Description

Pharmaceutical Preparations Cancer treatment | Methotrexate Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0920425
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0003873
8. chronic treatment with corticosteroids or another immunosuppressant
Description

Adrenal Cortex Hormones chronic | Immunosuppressive Agents chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205191
9. patients with an active bleeding diathesis or taking an oral vitamin k antagonist (except low-dose coumadin (warfarin sodium))
Description

Bleeding tendency | Vitamin K Antagonist Oral | Exception Coumadin Low dose | Exception Warfarin Sodium Low dose

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]
C0699129
UMLS CUI [3,3]
C0445550
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0376218
UMLS CUI [4,3]
C0445550
10. other concurrent severe and/or uncontrolled disease which could compromise participation in the study (i.e. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure -
Description

Disease Severe compromises Study Subject Participation Status | Disease Uncontrolled compromises Study Subject Participation Status | Diabetic - poor control | Uncontrolled hypertension | Communicable Disease Severe | Severe malnutrition | Angina, Unstable | Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C2348568
UMLS CUI [3]
C0421258
UMLS CUI [4]
C1868885
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0311276
UMLS CUI [7]
C0002965
UMLS CUI [8,1]
C0018802
UMLS CUI [8,2]
C1275491
new york heart association class iii or iv, ventricular arrhythmia, active ischemic heart disease, myocardial infarction during the previous six months, chronic liver or renal disease, active upper gi tract ulceration)
Description

Ventricular arrhythmia | Myocardial Ischemia | Myocardial Infarction | Chronic liver disease | Kidney Failure, Chronic | Upper Gastrointestinal Tract Ulceration

Data type

boolean

Alias
UMLS CUI [1]
C0085612
UMLS CUI [2]
C0151744
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0341439
UMLS CUI [5]
C0022661
UMLS CUI [6,1]
C3203348
UMLS CUI [6,2]
C3887532
11. impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of rad001 (everolimus) (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
Description

Abnormal digestive tract function Changing Absorption RAD 001 | Gastrointestinal Diseases Changing Absorption RAD 001 | Abnormal digestive tract function Changing Absorption Everolimus | Gastrointestinal Diseases Changing Absorption Everolimus | Ulcer | Nausea Uncontrolled | Vomiting | Diarrhea | Malabsorption Syndrome | Small intestine excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0232459
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0962969
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0962969
UMLS CUI [3,1]
C0232459
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0237442
UMLS CUI [3,4]
C0541315
UMLS CUI [4,1]
C0017178
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C0237442
UMLS CUI [4,4]
C0541315
UMLS CUI [5]
C0041582
UMLS CUI [6,1]
C0027497
UMLS CUI [6,2]
C0205318
UMLS CUI [7]
C0042963
UMLS CUI [8]
C0011991
UMLS CUI [9]
C0024523
UMLS CUI [10]
C0192601
12. hiv seropositivity
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
13. patient with a virological test positive to hepatitis b (hbs positive)
Description

Hepatitis B virus test positive | Hepatitis B virus surface Positive

Data type

boolean

Alias
UMLS CUI [1]
C2748184
UMLS CUI [2,1]
C1440684
UMLS CUI [2,2]
C1514241
14. patients with active cutaneous, mucosal, ocular or gastrointestinal disorders of grade > 1
Description

Dermatologic disorders Grade | Disease of mucous membrane Grade | Disorder of eye Grade | Gastrointestinal Diseases Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0151785
UMLS CUI [2,2]
C0441800
UMLS CUI [3,1]
C0015397
UMLS CUI [3,2]
C0441800
UMLS CUI [4,1]
C0017178
UMLS CUI [4,2]
C0441800
15. previous cancer (except basal cell skin cancer or cervical carcinoma in situ) during the 3 years prior to entering the trial.
Description

Malignant Neoplasms Previous | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
16. important pulmonary fibrosis on x-ray
Description

Pulmonary Fibrosis Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0034069
UMLS CUI [1,2]
C0034571
17. women who are or could become pregnant or who are currently breastfeeding,
Description

Pregnancy | Pregnancy Possible | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332149
UMLS CUI [3]
C0006147
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01167530

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma unresectable TNM clinical staging | Primary tumor Symptomatic | Cough | Dyspnea | Pain | Lesion Rapidly progressive Absent
Item
1. unresectable non-small cell lung cancer, stage iiia/b, or stage iv for which the primary tumor is symptomatic (cough, dyspnea, pain) without extra-thoracic lesions rapidly evolving for which patients should receive radiotherapy at curative dose
boolean
C0007131 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0010200 (UMLS CUI [3])
C0013404 (UMLS CUI [4])
C0030193 (UMLS CUI [5])
C0221198 (UMLS CUI [6,1])
C1838681 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Measurable lesion | Access During Fiberoptic bronchoscopy
Item
2. measurable lesion, documented histologically, potentially accessible during fiberoptic bronchoscopy.
boolean
C1513041 (UMLS CUI [1])
C0444454 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0189391 (UMLS CUI [2,3])
Age | WHO performance status scale
Item
3. age > 18 years, who 0-1,
boolean
C0001779 (UMLS CUI [1])
C1298650 (UMLS CUI [2])
Neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
4. neutrophil count > 1500 /mm3, hemoglobin > 9 g/dl, platelet count > 100,000/mm3
boolean
C0200633 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Serum total bilirubin measurement | Transaminase Assay | Albumin measurement | Prothrombin time assay
Item
5. bilirubin < 1.5 mg/dl, transaminases < 3 n, albumin >30 g / l, pt > 70%
boolean
C1278039 (UMLS CUI [1])
C0919834 (UMLS CUI [2])
C0201838 (UMLS CUI [3])
C0033707 (UMLS CUI [4])
Creatinine measurement, serum
Item
6. creatinine < 120 μm/l
boolean
C0201976 (UMLS CUI [1])
Patient Information | Informed Consent
Item
7. patient information and informed consent form signed.
boolean
C1955348 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Prior Therapy Absent Malignant neoplasm of lung | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent | Chemotherapy Absent
Item
8. no previous treatment for lung cancer (surgery, radiotherapy, chemotherapy).
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0242379 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
RAD 001 | everolimus | mTOR Inhibitor
Item
1. patients previously treated with rad001 (everolimus) or any other mtor inhibitor
boolean
C0962969 (UMLS CUI [1])
C0541315 (UMLS CUI [2])
C2746052 (UMLS CUI [3])
TNM clinical staging | Primary tumor Asymptomatic | Lesion Rapidly progressive Requirement Systemic therapy
Item
2. stage iv for which the primary tumor is not symptomatic with extra-thoracic lesions rapidly evolving requiring systemic treatment
boolean
C3258246 (UMLS CUI [1])
C0677930 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1838681 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C1515119 (UMLS CUI [3,4])
Prior radiation therapy
Item
3. previous radiotherapy,
boolean
C0279134 (UMLS CUI [1])
Venous Thrombosis | Arterial thrombosis | Pulmonary Embolism
Item
4. venous or arterial thrombosis, pulmonary embolism during the previous six months
boolean
C0042487 (UMLS CUI [1])
C0151942 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
Phenytoin | Phenobarbital | Antiepileptic Agents | Epilepsy
Item
5. concomitant treatment with phenytoin, phenobarbital or any other antiepileptic agent, history of epilepsy
boolean
C0031507 (UMLS CUI [1])
C0031412 (UMLS CUI [2])
C0003299 (UMLS CUI [3])
C0014544 (UMLS CUI [4])
CYP3A4 Inhibitor | CYP3A4 Inducer | CYP3A4 Substrate | Atazanavir | Clarithromycin | Indinavir | Itraconazole | Ketoconazole | nefazodone | Nelfinavir | Ritonavir | Saquinavir | telithromycin | Amprenavir | aprepitant | Diltiazem | Erythromycin | Fluconazole | fosamprenavir | Verapamil | Cyclosporine | voriconazole | Rifampin | Carbamazepine | Rifabutin | Midazolam | Buspirone | Felodipine
Item
6. concomitant treatment with medicinal products that inhibit, induce or are substrates for cyp3a4(inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, ciclosporin, voriconazoleinducers: rifampicin, carbamazepine, rifabutinsubstrates: midazolam, buspirone, felodipine)
boolean
C3830624 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
C3714798 (UMLS CUI [3,1])
C3891814 (UMLS CUI [3,2])
C1145759 (UMLS CUI [4])
C0055856 (UMLS CUI [5])
C0376637 (UMLS CUI [6])
C0064113 (UMLS CUI [7])
C0022625 (UMLS CUI [8])
C0068485 (UMLS CUI [9])
C0525005 (UMLS CUI [10])
C0292818 (UMLS CUI [11])
C0286738 (UMLS CUI [12])
C0907410 (UMLS CUI [13])
C0754188 (UMLS CUI [14])
C1176306 (UMLS CUI [15])
C0012373 (UMLS CUI [16])
C0014806 (UMLS CUI [17])
C0016277 (UMLS CUI [18])
C1176315 (UMLS CUI [19])
C0042523 (UMLS CUI [20])
C0010592 (UMLS CUI [21])
C0393080 (UMLS CUI [22])
C0035608 (UMLS CUI [23])
C0006949 (UMLS CUI [24])
C0140575 (UMLS CUI [25])
C0026056 (UMLS CUI [26])
C0006462 (UMLS CUI [27])
C0015772 (UMLS CUI [28])
Pharmaceutical Preparations Cancer treatment | Methotrexate Rheumatoid Arthritis
Item
7. concomitant therapy with agents otherwise used in the treatment of cancer (for example methotrexate for rheumatoid arthritis).
boolean
C0013227 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Adrenal Cortex Hormones chronic | Immunosuppressive Agents chronic
Item
8. chronic treatment with corticosteroids or another immunosuppressant
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Bleeding tendency | Vitamin K Antagonist Oral | Exception Coumadin Low dose | Exception Warfarin Sodium Low dose
Item
9. patients with an active bleeding diathesis or taking an oral vitamin k antagonist (except low-dose coumadin (warfarin sodium))
boolean
C1458140 (UMLS CUI [1])
C2267235 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699129 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0376218 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
Disease Severe compromises Study Subject Participation Status | Disease Uncontrolled compromises Study Subject Participation Status | Diabetic - poor control | Uncontrolled hypertension | Communicable Disease Severe | Severe malnutrition | Angina, Unstable | Congestive heart failure New York Heart Association Classification
Item
10. other concurrent severe and/or uncontrolled disease which could compromise participation in the study (i.e. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure -
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0421258 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0009450 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0311276 (UMLS CUI [6])
C0002965 (UMLS CUI [7])
C0018802 (UMLS CUI [8,1])
C1275491 (UMLS CUI [8,2])
Ventricular arrhythmia | Myocardial Ischemia | Myocardial Infarction | Chronic liver disease | Kidney Failure, Chronic | Upper Gastrointestinal Tract Ulceration
Item
new york heart association class iii or iv, ventricular arrhythmia, active ischemic heart disease, myocardial infarction during the previous six months, chronic liver or renal disease, active upper gi tract ulceration)
boolean
C0085612 (UMLS CUI [1])
C0151744 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0341439 (UMLS CUI [4])
C0022661 (UMLS CUI [5])
C3203348 (UMLS CUI [6,1])
C3887532 (UMLS CUI [6,2])
Abnormal digestive tract function Changing Absorption RAD 001 | Gastrointestinal Diseases Changing Absorption RAD 001 | Abnormal digestive tract function Changing Absorption Everolimus | Gastrointestinal Diseases Changing Absorption Everolimus | Ulcer | Nausea Uncontrolled | Vomiting | Diarrhea | Malabsorption Syndrome | Small intestine excision
Item
11. impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of rad001 (everolimus) (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
boolean
C0232459 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0962969 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0962969 (UMLS CUI [2,4])
C0232459 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0237442 (UMLS CUI [3,3])
C0541315 (UMLS CUI [3,4])
C0017178 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0237442 (UMLS CUI [4,3])
C0541315 (UMLS CUI [4,4])
C0041582 (UMLS CUI [5])
C0027497 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0042963 (UMLS CUI [7])
C0011991 (UMLS CUI [8])
C0024523 (UMLS CUI [9])
C0192601 (UMLS CUI [10])
HIV Seropositivity
Item
12. hiv seropositivity
boolean
C0019699 (UMLS CUI [1])
Hepatitis B virus test positive | Hepatitis B virus surface Positive
Item
13. patient with a virological test positive to hepatitis b (hbs positive)
boolean
C2748184 (UMLS CUI [1])
C1440684 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Dermatologic disorders Grade | Disease of mucous membrane Grade | Disorder of eye Grade | Gastrointestinal Diseases Grade
Item
14. patients with active cutaneous, mucosal, ocular or gastrointestinal disorders of grade > 1
boolean
C0037274 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0151785 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0015397 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C0017178 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
Malignant Neoplasms Previous | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
15. previous cancer (except basal cell skin cancer or cervical carcinoma in situ) during the 3 years prior to entering the trial.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Pulmonary Fibrosis Radiography
Item
16. important pulmonary fibrosis on x-ray
boolean
C0034069 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Pregnancy | Pregnancy Possible | Breast Feeding
Item
17. women who are or could become pregnant or who are currently breastfeeding,
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
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