ID

38025

Description

Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01483300

Link

https://clinicaltrials.gov/show/NCT01483300

Keywords

  1. 9/9/19 9/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 9, 2019

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 Breast Cancer NCT01483300

Eligibility Breast Cancer NCT01483300

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic breast cancer
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
disease progression during or after previous 1st line chemotherapy
Description

Disease Progression During First line Prior Chemotherapy | Disease Progression Post First line Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1708063
UMLS CUI [1,4]
C1514457
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1708063
UMLS CUI [2,4]
C1514457
scheduled to receive 2nd line chemotherapy.
Description

Second line Chemotherapy Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C1710038
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205539
measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
Description

Measurable Disease | Lesion Quantity Measurable Linear

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1513040
UMLS CUI [2,4]
C0205132
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of greater than 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with one of the study drugs
Description

Prior Therapy Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0013230
application of other cytotoxic chemotherapy or radiotherapy
Description

Cytotoxic Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C1522449
insufficent renal function (creatinine clearance < 60ml/min)
Description

Renal function Insufficient | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0231180
UMLS CUI [2]
C0373595
clinically unstable brain metastasis
Description

Metastatic malignant neoplasm to brain Clinical Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0443343
pregancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of other malignancy within last 5 years.
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251

Similar models

Eligibility Breast Cancer NCT01483300

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
histologically confirmed metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Disease Progression During First line Prior Chemotherapy | Disease Progression Post First line Prior Chemotherapy
Item
disease progression during or after previous 1st line chemotherapy
boolean
C0242656 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1708063 (UMLS CUI [1,3])
C1514457 (UMLS CUI [1,4])
C0242656 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1708063 (UMLS CUI [2,3])
C1514457 (UMLS CUI [2,4])
Second line Chemotherapy Scheduled
Item
scheduled to receive 2nd line chemotherapy.
boolean
C1710038 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Measurable Disease | Lesion Quantity Measurable Linear
Item
measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
C0205132 (UMLS CUI [2,4])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 6 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Investigational New Drug
Item
previous treatment with one of the study drugs
boolean
C1514463 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Cytotoxic Chemotherapy | Therapeutic radiology procedure
Item
application of other cytotoxic chemotherapy or radiotherapy
boolean
C0677881 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Renal function Insufficient | Creatinine clearance measurement
Item
insufficent renal function (creatinine clearance < 60ml/min)
boolean
C0232804 (UMLS CUI [1,1])
C0231180 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Clinical Unstable
Item
clinically unstable brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other
Item
history of other malignancy within last 5 years.
boolean
C1707251 (UMLS CUI [1])

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