Informações:
Falhas:
ID
21066
Descrição
An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01902862
Link
https://clinicaltrials.gov/show/NCT01902862
Palavras-chave
Versões (1)
- 7/4/17 7/4/17 -
Transferido a
7 de abril de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT01902862
Eligibility Lymphoma, Follicular NCT01902862
- StudyEvent: Eligibility
Similar models
Eligibility Lymphoma, Follicular NCT01902862
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Lymphoma, Follicular; histological diagnosis; Recurrent disease; Refractory Disease | Lymphoma stage | Cell positive for CD20 antigen
Item
participants with histologically confirmed relapsed or refractory follicular stage iii or iv, grade 1 and 2, cluster of differentiation 20 plus (cd20+) lymphoma (who-world health organization) that requires therapy
boolean
C0024301 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C1514815 (UMLS CUI [1,4])
C1272836 (UMLS CUI [2])
C0882818 (UMLS CUI [3])
C0679557 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C1514815 (UMLS CUI [1,4])
C1272836 (UMLS CUI [2])
C0882818 (UMLS CUI [3])
rituximab planned, prior chemotherapy
Item
participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
boolean
C0393022 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2])
C1301732 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2])
postmenopausal state, sterilized, pregnancy
Item
women must be either postmenopausal or sterilized; negative pregnancy test at screening
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0015787 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
total bilirubin, creatinine
Item
participants with total bilirubin below 1.5-fold upper limit of normal (uln) and creatinine below 2-fold uln
boolean
C0201913 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201976 (UMLS CUI [2])
karnofsky
Item
participants with karnofsky status greater than or equal to 60 percent
boolean
C0206065 (UMLS CUI [1])
Prior Therapy; bortezomib | Prior Therapy; bortezomib/rituximab
Item
participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
boolean
C1514463 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1541445 (UMLS CUI [2,2])
C1176309 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1541445 (UMLS CUI [2,2])
previous known allergic reaction to bortezomib, boron or mannitol
Item
participants with previous known allergic reaction to bortezomib, boron or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0006030 (UMLS CUI [3,2])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0006030 (UMLS CUI [3,2])
life-expectancy
Item
participants with life-expectancy of less than 3 months
boolean
C0023671 (UMLS CUI [1])
history of cancer, basalioma
Item
participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0007117 (UMLS CUI [2])
peripheral neuropathy, common terminology criteria for adverse events (ctcae)
Item
participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (ctcae) grade greater than or equal to 2
boolean
C0031117 (UMLS CUI [1,1])
C3888020 (UMLS CUI [1,2])
C3888020 (UMLS CUI [1,2])