ID

44571

Descrição

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

Palavras-chave

  1. 19/09/2018 19/09/2018 -
  2. 19/09/2018 19/09/2018 -
  3. 27/09/2021 27/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Prostatic Neoplasms NCT00537381

Eligibility Prostatic Neoplasms NCT00537381

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed cancer of the prostate
Descrição

Prostate carcinoma

Tipo de dados

boolean

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

Neoplasm Metastasis

Tipo de dados

boolean

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

Life Expectancy

Tipo de dados

boolean

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

Major surgery

Tipo de dados

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
Descrição

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

Tipo de dados

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)
Descrição

CNS metastases

Tipo de dados

boolean

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

Systemic therapy Hormone refractory prostate cancer

Tipo de dados

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
Descrição

HIV Seropositivity | Hepatitis B | Hepatitis C

Tipo de dados

boolean

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

Major surgery Planned

Tipo de dados

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
Descrição

Non-Prescription Drugs Prostate carcinoma | Herbal therapy Prostate carcinoma

Tipo de dados

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
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])

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