Information:
Fel:
ID
22310
Beskrivning
A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01801436
Länk
https://clinicaltrials.gov/show/NCT01801436
Nyckelord
Versioner (1)
- 2017-05-29 2017-05-29 -
Uppladdad den
29 maj 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01801436
Eligibility Multiple Myeloma NCT01801436
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Myeloma NCT01801436
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
multiple myeloma
Item
participants previously diagnosed with multiple myeloma based on standard criteria
boolean
C0026764 (UMLS CUI [1])
prior therapy for multiple myeloma, relapsed or progressive disease, requires therapy
Item
participant has received at least 2 previous lines of therapy for multiple myeloma and, in the investigator's opinion, currently requires therapy because of relapsed (the return of a medical problem) or progressive disease
boolean
C1514463 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C1335499 (UMLS CUI [2,3])
C0815189 (UMLS CUI [2,4])
C0026764 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C1335499 (UMLS CUI [2,3])
C0815189 (UMLS CUI [2,4])
postmenopausal, sterilization, contraception
Item
female participants either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control from screening through the final visit
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
barrier method for contraception
Item
if male, the participant agrees to use an acceptable barrier method for contraception from screening through the final visit
boolean
C0004764 (UMLS CUI [1])
karnofsky
Item
participant has a karnofsky performance status classifies participants as to their functional impairment and is used to compare effectiveness of different therapies and to assess the prognosis [outlook, probable outcomes] in individual participants) greater than 60
boolean
C0206065 (UMLS CUI [1])
prior therapy, bortezomib, progressive disease
Item
if the participant received bortezomib in a previous trial, the participants' best response to bortezomib must be progressive disease
boolean
C1514463 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1335499 (UMLS CUI [1,3])
C1176309 (UMLS CUI [1,2])
C1335499 (UMLS CUI [1,3])
prior therapy bortezomib, serious adverse event
Item
if the participant received bortezomib in a previous trial, the participant must have experienced 1 or more serious adverse events
boolean
C1514463 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1176309 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
nitrosoureas, prior chemotherapy
Item
participants who have received nitrosoureas within 6 weeks or any other chemotherapy (treatment of disease, usually cancer, by chemical agents) within 3 weeks before enrollment
boolean
C3540781 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
C1514457 (UMLS CUI [2])
steroid therapy
Item
participants who have received corticosteroids (greater than 10 milligram per day prednisone or equivalent) within 3 weeks before enrollment
boolean
C0149783 (UMLS CUI [1])
hiv, hep b, hep c
Item
human immunodeficiency virus (hiv - a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person)-positive or hepatitis-b surface antigen-positive participants or participants with known active hepatitis-c infection
boolean
C0019682 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])