Informações:
Falhas:
ID
19065
Descrição
A Study of Pertuzumab in Participants With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02480010
Link
https://clinicaltrials.gov/show/NCT02480010
Palavras-chave
Versões (1)
- 02/12/2016 02/12/2016 -
Transferido a
2 de dezembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Prostate Cancer DRKS00010313 NCT02480010
Eligibility Prostate Cancer NCT02480010
- StudyEvent: Eligibility
Similar models
Eligibility Prostate Cancer NCT02480010
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Adult | Age
Item
adults greater than (>) 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate Hormone Therapy Resistant | Androgen Antagonists Withdrawal | Disease Progression
Item
histologically documented adenocarcinoma of the prostate resistant to hormone therapy, progressed at 4 to 6 weeks following anti-androgen withdrawal
boolean
C0007112 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0332325 (UMLS CUI [1,3])
C0002842 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
C0279025 (UMLS CUI [1,2])
C0332325 (UMLS CUI [1,3])
C0002842 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
Prostate specific antigen measurement Asymptomatic Disease | Prostate specific antigen measurement Disease Symptomatic Mild
Item
prostate-specific antigen (psa) values at least 20 ng/ml among those with asymptomatic or mildly symptomatic disease
boolean
C0201544 (UMLS CUI [1,1])
C2936329 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C2945599 (UMLS CUI [2,4])
C2936329 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C2945599 (UMLS CUI [2,4])
Karnofsky Performance Status
Item
karnofsky performance status (kps) at least 80 percent (%)
boolean
C0206065 (UMLS CUI [1])
Castrated male Testosterone measurement
Item
castrate testosterone less than (<) 50 ng/dl
boolean
C1319065 (UMLS CUI [1,1])
C0523912 (UMLS CUI [1,2])
C0523912 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) at least 50%
boolean
C0428772 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic, and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Chemotherapy Prostate carcinoma | Immunotherapy Prostate carcinoma
Item
prior chemotherapy, radionucleotide therapy, or immunotherapy for prostate cancer
boolean
C0392920 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0600139 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
Adrenal Cortex Hormones Systemic
Item
systemic corticosteroids within 1 month prior to screening
boolean
C0001617 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,2])
Diphosphonates | Narcotic Analgesics | Investigational New Drugs
Item
bisphosphonates within 6 months, narcotic analgesics within 2 weeks, or any investigational agent with 28 days of study drug
boolean
C0012544 (UMLS CUI [1])
C0027409 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0027409 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Doxorubicin Cumulative Dose
Item
prior cumulative doxorubicin dose of > 360 mg/m^2 or equivalent
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,2])
CNS metastases | Secondary malignant neoplasm of lung
Item
central nervous system (cns) or pulmonary metastases
boolean
C0686377 (UMLS CUI [1])
C0153676 (UMLS CUI [2])
C0153676 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated
Item
other malignancies, except adequately treated basal or squamous cell skin cancer
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Cardiovascular Disease Significant
Item
significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Communicable Disease Uncontrolled
Item
active/uncontrolled concurrent illness or infection
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
major surgery | Traumatic injury
Item
major surgery or traumatic injury within 4 weeks of study drug
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
C3263723 (UMLS CUI [2])