ID

15836

Beskrivning

Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00117312

Länk

https://clinicaltrials.gov/show/NCT00117312

Nyckelord

Versioner (1)
  1. 2016-06-15 2016-06-15 -
Uppladdad den

15 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00117312

Engelsk

Eligibility Prostate Cancer NCT00117312

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
has given written consent before any study related activity is performed. a study related activity is defined as any procedure that would not have been performed during the normal management of the patient.
Beskrivning

each patient must meet the following inclusion criteria before entry into the study:

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
has had sufficient testosterone suppression (as defined in the withdrawal criteria of fe200486 cs06) for at least 28 days.
Beskrivning

testosterone suppression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0563648
UMLS CUI [1,2]
C0039601
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
has been withdrawn from study fe200486 cs06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (psa) suppression as defined in study fe200486 cs06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures.
Beskrivning

any patient meeting any of the following exclusion criteria will not be entered into the study:

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C2348568
requires hormonal therapy for neoadjuvant purposes.
Beskrivning

neoadjuvant hormonal therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600558
requires treatment with any other drug modifying the testosterone level or function.
Beskrivning

medication modifying testosterone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2066646
UMLS CUI [1,3]
C0039601
is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after visit 1.
Beskrivning

radical prostatectomy or radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0194810
UMLS CUI [2]
C1522449
has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
Beskrivning

severe asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0581126
has hypersensitivity towards any component of the investigational product.
Beskrivning

hypersensitivity to investigational product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
Beskrivning

cancer disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study, as judged by the investigator.
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0009488
any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits).
Beskrivning

laboratory abnormalities

Datatyp

boolean

Alias
UMLS CUI [1]
C1853129
has a mental incapacity or language barrier precluding adequate understanding or co-operation.
Beskrivning

mental incapacity or language barrier

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0237167
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Similar models

Eligibility Prostate Cancer NCT00117312

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
has given written consent before any study related activity is performed. a study related activity is defined as any procedure that would not have been performed during the normal management of the patient.
boolean
C0021430 (UMLS CUI [1])
testosterone suppression
Item
has had sufficient testosterone suppression (as defined in the withdrawal criteria of fe200486 cs06) for at least 28 days.
boolean
C0563648 (UMLS CUI [1,1])
C0039601 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
withdrawn from other study
Item
has been withdrawn from study fe200486 cs06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (psa) suppression as defined in study fe200486 cs06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures.
boolean
C2349954 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
neoadjuvant hormonal therapy
Item
requires hormonal therapy for neoadjuvant purposes.
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
medication modifying testosterone
Item
requires treatment with any other drug modifying the testosterone level or function.
boolean
C0013227 (UMLS CUI [1,1])
C2066646 (UMLS CUI [1,2])
C0039601 (UMLS CUI [1,3])
radical prostatectomy or radiotherapy
Item
is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after visit 1.
boolean
C0194810 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
severe asthma
Item
has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
boolean
C0581126 (UMLS CUI [1])
hypersensitivity to investigational product
Item
has hypersensitivity towards any component of the investigational product.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
cancer disease
Item
has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
comorbidity
Item
has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study, as judged by the investigator.
boolean
C0009488 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
laboratory abnormalities
Item
any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits).
boolean
C1853129 (UMLS CUI [1])
mental incapacity or language barrier
Item
has a mental incapacity or language barrier precluding adequate understanding or co-operation.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0237167 (UMLS CUI [2])
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