ID

22310

Description

A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01801436

Link

https://clinicaltrials.gov/show/NCT01801436

Keywords

  1. 5/29/17 5/29/17 -
Uploaded on

May 29, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT01801436

Eligibility Multiple Myeloma NCT01801436

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants previously diagnosed with multiple myeloma based on standard criteria
Description

multiple myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
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
Description

prior therapy for multiple myeloma, relapsed or progressive disease, requires therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0035020
UMLS CUI [2,3]
C1335499
UMLS CUI [2,4]
C0815189
female participants either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control from screening through the final visit
Description

postmenopausal, sterilization, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0700589
if male, the participant agrees to use an acceptable barrier method for contraception from screening through the final visit
Description

barrier method for contraception

Data type

boolean

Alias
UMLS CUI [1]
C0004764
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
Description

karnofsky

Data type

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
if the participant received bortezomib in a previous trial, the participants' best response to bortezomib must be progressive disease
Description

prior therapy, bortezomib, progressive disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1176309
UMLS CUI [1,3]
C1335499
if the participant received bortezomib in a previous trial, the participant must have experienced 1 or more serious adverse events
Description

prior therapy bortezomib, serious adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1176309
UMLS CUI [1,3]
C1519255
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
Description

nitrosoureas, prior chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C3540781
UMLS CUI [2]
C1514457
participants who have received corticosteroids (greater than 10 milligram per day prednisone or equivalent) within 3 weeks before enrollment
Description

steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
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
Description

hiv, hep b, hep c

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0019196

Similar models

Eligibility Multiple Myeloma NCT01801436

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])

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