ID

15583

Beschrijving

CyBorD vs. PAD in the Treatment of Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02362165

Link

https://clinicaltrials.gov/show/NCT02362165

Trefwoorden

Versies (1)
  1. 03-06-16 03-06-16 -
Geüploaded op

3 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02362165

Engels

Eligibility Multiple Myeloma NCT02362165

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosis of multiple myeloma
Beschrijving

Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
eastern cooperative oncology group (ecog) status 0-3,
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
estimated survival time > 3 months
Beschrijving

Survival time Estimated

Datatype

boolean

Alias
UMLS CUI [1,1]
C2919552
UMLS CUI [1,2]
C0750572
acceptable liver function (bilirubin＜2.5×uln, alanine transaminase (alt) or aspartate aminotransferase (ast)＜2.5×uln)
Beschrijving

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
no history of other malignancies
Beschrijving

Malignant Neoplasms Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
no previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation
Beschrijving

Prior Therapy | Chemotherapy Regimen | Therapeutic radiology procedure | Targeted Therapy | Stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C2985566
UMLS CUI [5]
C1504389
no other serious diseases which conflict with the treatment in the present trial
Beschrijving

Disease Interferes with Clinical Trial Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0087111
no concurrent treatments that conflict with the treatments in the present trial
Beschrijving

Therapeutic procedure Interferes with Clinical Trial Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0087111
voluntary participation and signed the informed consent.
Beschrijving

voluntary participation | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0680274
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patients had the conditions below: clinically significant ventricular tachycardia (vt), atrial fibrillation (af), heart block, myocardial infarction (mi), congestive heart failure (chf), symptomatic coronary artery heart disease requiring medication;
Beschrijving

Tachycardia, Ventricular | Atrial Fibrillation | Heart Block | Myocardial Infarction | Congestive heart failure | Coronary heart disease Symptomatic

Datatype

boolean

Alias
UMLS CUI [1]
C0042514
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0018794
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0018802
UMLS CUI [6,1]
C0010068
UMLS CUI [6,2]
C0231220
the patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
the patients with neuropathy
Beschrijving

Neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0442874
the patients with mentally ill / unable to obtain informed consent
Beschrijving

Mental disorders Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1299582
the patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results
Beschrijving

Substance Use Disorders Affecting Evaluation of test results Long-term

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1285276
UMLS CUI [1,4]
C0443252
the patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Age | Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0001779
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
the patients with a history of allergy to test drug
Beschrijving

Hypersensitivity Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
the patients not suitable to participate in the investigator judged by researchers.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Multiple Myeloma NCT02362165

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
newly diagnosis of multiple myeloma
boolean
C0026764 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) status 0-3,
boolean
C1520224 (UMLS CUI [1])
Survival time Estimated
Item
estimated survival time > 3 months
boolean
C2919552 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
acceptable liver function (bilirubin＜2.5×uln, alanine transaminase (alt) or aspartate aminotransferase (ast)＜2.5×uln)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Malignant Neoplasms Other
Item
no history of other malignancies
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Prior Therapy | Chemotherapy Regimen | Therapeutic radiology procedure | Targeted Therapy | Stem cell transplant
Item
no previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation
boolean
C1514463 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C2985566 (UMLS CUI [4])
C1504389 (UMLS CUI [5])
Disease Interferes with Clinical Trial Therapeutic procedure
Item
no other serious diseases which conflict with the treatment in the present trial
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Therapeutic procedure Interferes with Clinical Trial Therapeutic procedure
Item
no concurrent treatments that conflict with the treatments in the present trial
boolean
C0087111 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
voluntary participation | Informed Consent
Item
voluntary participation and signed the informed consent.
boolean
C0680274 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Tachycardia, Ventricular | Atrial Fibrillation | Heart Block | Myocardial Infarction | Congestive heart failure | Coronary heart disease Symptomatic
Item
the patients had the conditions below: clinically significant ventricular tachycardia (vt), atrial fibrillation (af), heart block, myocardial infarction (mi), congestive heart failure (chf), symptomatic coronary artery heart disease requiring medication;
boolean
C0042514 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
C0018794 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0010068 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
Study Subject Participation Status
Item
the patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies
boolean
C2348568 (UMLS CUI [1])
Neuropathy
Item
the patients with neuropathy
boolean
C0442874 (UMLS CUI [1])
Mental disorders Informed Consent Unable
Item
the patients with mentally ill / unable to obtain informed consent
boolean
C0004936 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Substance Use Disorders Affecting Evaluation of test results Long-term
Item
the patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results
boolean
C0038586 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1285276 (UMLS CUI [1,3])
C0443252 (UMLS CUI [1,4])
Pregnancy | Breast Feeding | Childbearing Potential Age | Contraceptive methods Unwilling
Item
the patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Hypersensitivity Investigational New Drugs
Item
the patients with a history of allergy to test drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Study Subject Participation Status
Item
the patients not suitable to participate in the investigator judged by researchers.
boolean
C2348568 (UMLS CUI [1])
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