ID

18189

Description

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

Link

https://clinicaltrials.gov/show/NCT00104104

Keywords

  1. 10/24/16 10/24/16 -
Uploaded on

October 24, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Multiple Myeloma NCT00104104

Eligibility Multiple Myeloma NCT00104104

Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

Multiple Myeloma

Data type

boolean

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

Renal function Stable | Serum creatinine measurement Quantity

Data type

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
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Life Expectancy

Data type

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.
Description

Childbearing Potential Pregnancy test negative | Postmenopausal | Amenorrhea Duration

Data type

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.
Description

Protocol Compliance | Informed Consent

Data type

boolean

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

Exclusion Criteria

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

Diphosphonates Intravenous

Data type

boolean

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

amyloidosis

Data type

boolean

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

Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates

Data type

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.
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Childbearing Potential Contraceptive methods

Data type

boolean

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

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

Data type

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)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial