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Informações:
Falhas:
ID
28038
Descrição
Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00439231
Link
https://clinicaltrials.gov/show/NCT00439231
Palavras-chave
Versões (2)
- 12/12/2017 12/12/2017 -
- 13/12/2017 13/12/2017 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
12 de dezembro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00439231
Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00439231
- StudyEvent: Eligibility
Similar models
Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00439231
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Chronic Lymphocytic Leukemia | Other Coding | Small Lymphocytic Lymphoma
Item
1. diagnosed with chronic lymphocytic leukemia (cll) or small lymphocytic leukemia (sll).
boolean
C0023434 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C0855095 (UMLS CUI [3])
C3846158 (UMLS CUI [2])
C0855095 (UMLS CUI [3])
Standard of Care failed Chronic Lymphocytic Leukemia
Item
2. failed prior standard of care therapy for cll.
boolean
C2936643 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
Neutrophil count
Item
3. neutrophil count (anc) greater than or equal to 500/microliter (mcl).
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
4. platelet count greater than or equal to 20,000/mcl.
boolean
C0032181 (UMLS CUI [1])
Age
Item
5. age 21-99.
boolean
C0001779 (UMLS CUI [1])
Chronic infectious disease | Communicable Disease | HIV Seropositivity | Communicable Disease Uncontrolled
Item
1. chronic or current clinically significant infection, including hiv positivity or uncontrolled infection.
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0009450 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
ECOG performance status
Item
2. eastern cooperative oncology group (ecog) performance greater than 2.
boolean
C1520224 (UMLS CUI [1])
Cancer treatment
Item
3. other concurrent anticancer therapies.
boolean
C0920425 (UMLS CUI [1])
Systemic therapy Chronic Lymphocytic Leukemia | Steroids allowed
Item
4. less than 4 weeks from last systemic therapy for cll. steroids up to 2 weeks before the start of treatment are permissible.
boolean
C1515119 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0038317 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0023434 (UMLS CUI [1,2])
C0038317 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Moribund | Comorbidity Severe | Investigational Therapy Unsuccessful | Liver disease | Kidney Disease | Heart Disease | Nervous system disorder | Lung disease | Communicable Disease | Metabolic Diseases
Item
5. moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy.
boolean
C0424547 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0949266 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0018799 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0009450 (UMLS CUI [9])
C0025517 (UMLS CUI [10])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0949266 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0018799 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0009450 (UMLS CUI [9])
C0025517 (UMLS CUI [10])
Serum creatinine raised
Item
6. creatinine greater than 1.5 times the upper limit of normal.
boolean
C0700225 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive method Double Unwilling
Item
7. women who are pregnant or nursing, as well as women of childbearing potential who are unwilling to use a dual method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
Gender | Barrier Contraception Unwilling
Item
8. men who are unwilling to use a barrier protection.
boolean
C0079399 (UMLS CUI [1])
C0004764 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0004764 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Study Protocol Comprehension Unable | Informed Consent Unable
Item
9. inability to understand the investigational nature of the study; inability to provide informed consent.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])