ID

44571

Description

An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00537381

Link

https://clinicaltrials.gov/show/NCT00537381

Keywords

  1. 9/19/18 9/19/18 -
  2. 9/19/18 9/19/18 -
  3. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

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 Prostatic Neoplasms NCT00537381

Eligibility Prostatic Neoplasms NCT00537381

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed cancer of the prostate
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
evidence of metastatic disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
have a life expectancy greater than 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
have at least 4 weeks from previous major surgery to date of first study agent given
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
have progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or antiandrogen treatment within 6 months prior to the first study agent administration exclusion criteria
Description

Progressive Disease Hormone Refractory | Status post Orchiectomy | Status post Gonadotropin-Releasing Hormone Analog | Status post Antiandrogen therapy | Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0019932
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0029189
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1518041
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0279492
UMLS CUI [5]
C0680251
have known central nervous system metastases (cancerous tumors that have spread to the brain from somewhere else in the body)
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
had prior systemic non-hormonal therapy for hormone refractory prostate cancer
Description

Systemic therapy Hormone refractory prostate cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1328504
have known human immunodeficiency virus (hiv, a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) seropositivity or known hepatitis b or c infection
Description

HIV Seropositivity | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
have planned major surgery during the study
Description

Major surgery Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1301732
have taken any over-the-counter (medicine that can be bought without a prescription) or herbal treatment for prostate cancer within 4 weeks prior to the first study treatment administration
Description

Non-Prescription Drugs Prostate carcinoma | Herbal therapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0242388
UMLS CUI [2,2]
C0600139

Similar models

Eligibility Prostatic Neoplasms NCT00537381

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma
Item
confirmed cancer of the prostate
boolean
C0600139 (UMLS CUI [1])
Neoplasm Metastasis
Item
evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
Life Expectancy
Item
have a life expectancy greater than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Major surgery
Item
have at least 4 weeks from previous major surgery to date of first study agent given
boolean
C0679637 (UMLS CUI [1])
Progressive Disease Hormone Refractory | Status post Orchiectomy | Status post Gonadotropin-Releasing Hormone Analog | Status post Antiandrogen therapy | Exclusion Criteria
Item
have progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or antiandrogen treatment within 6 months prior to the first study agent administration exclusion criteria
boolean
C1335499 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0029189 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1518041 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0279492 (UMLS CUI [4,2])
C0680251 (UMLS CUI [5])
CNS metastases
Item
have known central nervous system metastases (cancerous tumors that have spread to the brain from somewhere else in the body)
boolean
C0686377 (UMLS CUI [1])
Systemic therapy Hormone refractory prostate cancer
Item
had prior systemic non-hormonal therapy for hormone refractory prostate cancer
boolean
C1515119 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
have known human immunodeficiency virus (hiv, a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) seropositivity or known hepatitis b or c infection
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Major surgery Planned
Item
have planned major surgery during the study
boolean
C0679637 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Non-Prescription Drugs Prostate carcinoma | Herbal therapy Prostate carcinoma
Item
have taken any over-the-counter (medicine that can be bought without a prescription) or herbal treatment for prostate cancer within 4 weeks prior to the first study treatment administration
boolean
C0013231 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0242388 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])

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