ID

30885

Beskrivning

Quality of Life of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib; ODM derived from: https://clinicaltrials.gov/show/NCT01060202

Länk

https://clinicaltrials.gov/show/NCT01060202

Nyckelord

Versioner (1)
  1. 2018-07-02 2018-07-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01060202

Engelsk

Eligibility Multiple Myeloma NCT01060202

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic multiple myeloma patient
Beskrivning

Multiple Myeloma Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
ecog score less than 3
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
patient is not a candidate for stem cell transplantation
Beskrivning

Patients Inappropriate Stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1504389
previous treatment duration is less than 6 months
Beskrivning

Prior Therapy Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0449238
previous treatment response is less than partial response (pr)
Beskrivning

Prior Therapy Partial response failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1521726
UMLS CUI [1,3]
C0231175
willing and able to complete the questionnaire
Beskrivning

Questionnaire Completion Willing | Questionnaire Completion Able

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0085732
patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Beskrivning

Informed Consent | Informed Consent Patient Representatives

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to bortezomib
Beskrivning

Hypersensitivity Bortezomib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
acute severe infection requiring antibiotics therapy
Beskrivning

Communicable Disease Severe Requirement Antibiotic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0338237
pre-existing peripheral neuropathy greater than or equal to grade 2
Beskrivning

Peripheral Neuropathy Pre-existing CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
uncontrolled or severe cardiovascular disease
Beskrivning

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
pregnancy or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Multiple Myeloma NCT01060202

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic
Item
symptomatic multiple myeloma patient
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
ECOG performance status
Item
ecog score less than 3
boolean
C1520224 (UMLS CUI [1])
Patients Inappropriate Stem cell transplant
Item
patient is not a candidate for stem cell transplantation
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1504389 (UMLS CUI [1,3])
Prior Therapy Duration
Item
previous treatment duration is less than 6 months
boolean
C1514463 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Prior Therapy Partial response failed
Item
previous treatment response is less than partial response (pr)
boolean
C1514463 (UMLS CUI [1,1])
C1521726 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Questionnaire Completion Willing | Questionnaire Completion Able
Item
willing and able to complete the questionnaire
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Informed Consent | Informed Consent Patient Representatives
Item
patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Bortezomib
Item
known hypersensitivity to bortezomib
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
Communicable Disease Severe Requirement Antibiotic therapy
Item
acute severe infection requiring antibiotics therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0338237 (UMLS CUI [1,4])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
pre-existing peripheral neuropathy greater than or equal to grade 2
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe
Item
uncontrolled or severe cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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