ID

18189

Beschrijving

A Multiple Myeloma Trial in Patients With Bone Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00104104

Link

https://clinicaltrials.gov/show/NCT00104104

Trefwoorden

  1. 24-10-16 24-10-16 -
Geüploaded op

24 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00104104

Eligibility Multiple Myeloma NCT00104104

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 18 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
confirmed diagnosis of multiple myeloma
Beschrijving

Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
stable renal function defined as two serum creatinine determinations of < 3 mg/dl
Beschrijving

Renal function Stable | Serum creatinine measurement Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0201976
UMLS CUI [2,2]
C1265611
calculated creatinine clearance of greater than or equal to 30 ml/min
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
ecog performance status of 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of greater than or equal to 9 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
if the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
Beschrijving

Childbearing Potential Pregnancy test negative | Postmenopausal | Amenorrhea Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0449238
ability to comply with trial requirements and give informed consent.
Beschrijving

Protocol Compliance | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
iv bisphosphonate therapy for more than 3 years.
Beschrijving

Diphosphonates Intravenous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C1522726
patients with a diagnosis of amyloidosis.
Beschrijving

amyloidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0002726
known hypersensitivity to zoledronic acid or other bisphosphonates
Beschrijving

Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0257685
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0012544
pregnant patients or lactating patients.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential not on a medically recognized form of contraception
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
patients with uncontrolled cardiovascular disease, hypertension, and type 2 diabetes mellitus.
Beschrijving

Cardiovascular Disease Uncontrolled | Uncontrolled hypertension | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0743118

Similar models

Eligibility Multiple Myeloma NCT00104104

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma
Item
confirmed diagnosis of multiple myeloma
boolean
C0026764 (UMLS CUI [1])
Renal function Stable | Serum creatinine measurement Quantity
Item
stable renal function defined as two serum creatinine determinations of < 3 mg/dl
boolean
C0232804 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance of greater than or equal to 30 ml/min
boolean
C2711451 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than or equal to 9 months
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Postmenopausal | Amenorrhea Duration
Item
if the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Protocol Compliance | Informed Consent
Item
ability to comply with trial requirements and give informed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diphosphonates Intravenous
Item
iv bisphosphonate therapy for more than 3 years.
boolean
C0012544 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
amyloidosis
Item
patients with a diagnosis of amyloidosis.
boolean
C0002726 (UMLS CUI [1])
Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates
Item
known hypersensitivity to zoledronic acid or other bisphosphonates
boolean
C0020517 (UMLS CUI [1,1])
C0257685 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant patients or lactating patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential not on a medically recognized form of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Cardiovascular Disease Uncontrolled | Uncontrolled hypertension | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED
Item
patients with uncontrolled cardiovascular disease, hypertension, and type 2 diabetes mellitus.
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0743118 (UMLS CUI [3])

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