ID

21870

Description

Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00411528

Link

https://clinicaltrials.gov/show/NCT00411528

Keywords

Versions (1)
  1. 5/5/17 5/5/17 -
Uploaded on

May 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Hormone Refractory Prostate Cancer DRKS00007583 NCT00411528

English

Eligibility Metastatic Hormone Refractory Prostate Cancer NCT00411528

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be ≥ 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
confirmed and documented diagnosis of prostate cancer
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
confirmed and documented evidence of progression of disease (hormone refractory)
Description

Disease Progression Evidence of | Hormone refractory prostate cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C1328504
low testosterone levels
Description

Low testosterone levels

Data type

boolean

Alias
UMLS CUI [1]
C4011625
chemotherapy-naïve
Description

Chemotherapy naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0919936
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
recent radiation therapy (within 4 weeks)
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
known brain metastasis
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
peripheral neuropathy
Description

Peripheral Neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
active diarrhea
Description

Diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0011991
significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections
Description

Illness | Heart Disease | Diabetes Mellitus | Communicable Diseases chronic | Communicable Diseases Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0011849
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205191
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C0205318
allergic reactions to patupilone or docetaxel or prednisone or similar compounds
Description

Allergic Reaction epothilone B | Allergic Reaction docetaxel | Prednisone allergy | Allergic Reaction Compound Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0297960
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0246415
UMLS CUI [3]
C0571591
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C1706082
UMLS CUI [4,3]
C2348205
other protocol-defined inclusion/exclusion criteria may apply
Description

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Metastatic Hormone Refractory Prostate Cancer NCT00411528

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
must be ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Prostate carcinoma
Item
confirmed and documented diagnosis of prostate cancer
boolean
C0600139 (UMLS CUI [1])
Disease Progression Evidence of | Hormone refractory prostate cancer
Item
confirmed and documented evidence of progression of disease (hormone refractory)
boolean
C0242656 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1328504 (UMLS CUI [2])
Low testosterone levels
Item
low testosterone levels
boolean
C4011625 (UMLS CUI [1])
Chemotherapy naive
Item
chemotherapy-naïve
boolean
C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure
Item
recent radiation therapy (within 4 weeks)
boolean
C1522449 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known brain metastasis
boolean
C0220650 (UMLS CUI [1])
Peripheral Neuropathy
Item
peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
Diarrhea
Item
active diarrhea
boolean
C0011991 (UMLS CUI [1])
Illness | Heart Disease | Diabetes Mellitus | Communicable Diseases chronic | Communicable Diseases Uncontrolled
Item
significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections
boolean
C0221423 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0009450 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Allergic Reaction epothilone B | Allergic Reaction docetaxel | Prednisone allergy | Allergic Reaction Compound Similar
Item
allergic reactions to patupilone or docetaxel or prednisone or similar compounds
boolean
C1527304 (UMLS CUI [1,1])
C0297960 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C0571591 (UMLS CUI [3])
C1527304 (UMLS CUI [4,1])
C1706082 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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