Informações:
Falhas:
ID
31571
Descrição
Efficacy and Safety Study of Panobinostat in Patients With Metastatic Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00667862
Link
https://clinicaltrials.gov/show/NCT00667862
Palavras-chave
Versões (1)
- 05/09/2018 05/09/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
5 de setembro de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00667862
Eligibility Prostate Cancer NCT00667862
- StudyEvent: Eligibility
Similar models
Eligibility Prostate Cancer NCT00667862
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Adenocarcinoma of prostate
Item
confirmed diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Hormone refractory prostate cancer metastatic
Item
patients with metastatic hormone refractory prostate cancer
boolean
C1328504 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,2])
Cytotoxic therapy Quantity Prostate carcinoma
Item
patients that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Disease Progression | Criteria Quantity
Item
evidence of disease progression by at least one of the following
boolean
C0242656 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Lesion Quantity Bone scan
Item
1. two or more lesions on bone scan
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
Measurable Disease Progressive
Item
2. progressive measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,2])
Raised prostate specific antigen Quantity
Item
3. two documented increases in psa
boolean
C0178415 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Contraceptive methods Willing
Item
willing to use contraception throughout the study and for 12 weeks after study completion
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,2])
Sign or Symptom CNS disorder
Item
history or clinical signs of cns disease
boolean
C3540840 (UMLS CUI [1,1])
C0007682 (UMLS CUI [1,2])
C0007682 (UMLS CUI [1,2])
Cancer Other Disease length | Curative treatment Absent
Item
history of other cancers not curatively treated with no evidence of disease for more than 5 years
boolean
C1707251 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1273390 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0872146 (UMLS CUI [1,2])
C1273390 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Prior radiation therapy
Item
prior radiotherapy within 3 weeks of starting study treatment
boolean
C0279134 (UMLS CUI [1])
Radiopharmaceuticals | Strontium | Samarium
Item
prior radiopharmaceuticals (strontium, samarium)
boolean
C0182638 (UMLS CUI [1])
C0038467 (UMLS CUI [2])
C0036147 (UMLS CUI [3])
C0038467 (UMLS CUI [2])
C0036147 (UMLS CUI [3])
Decreased cardiac function
Item
impaired cardiac function
boolean
C0232166 (UMLS CUI [1])
Heart Disease
Item
heart disease
boolean
C0018799 (UMLS CUI [1])
Liver disease | Kidney Disease | Liver Dysfunction | Renal Insufficiency
Item
liver or renal disease with impaired function
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
C0022658 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])