ID

31031

Description

ARI103094-Follow-Up Study for REDUCE Study Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00883909

Lien

https://clinicaltrials.gov/show/NCT00883909

Mots-clés

Versions (1)
  1. 12/07/2018 12/07/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

12 juillet 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Neoplasms, Prostate NCT00883909

Anglais

Eligibility Neoplasms, Prostate NCT00883909

1 Formulaires  
Criteria
Description

Criteria

any subject who has participated in the reduce study and meets one of the following eligibility criteria is eligible for part a, 2 year observational follow-up study:
Description

Study Subject Participation Status | Criteria Fulfill

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
completed 4 years on investigational product through the reduce 4 year study visit (visit 10) or
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
was diagnosed with prostate cancer during the reduce study, discontinued investigational product (ip) but participated in reduce prostate cancer follow-up visits through the 4 year study visit (visit 10p) or
Description

Prostate carcinoma | Investigational New Drugs Discontinued | Participation Follow-up

Type de données

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C3274571
withdrew from reduce study visit participation and ip (for any reasons) but participated in reduce follow-up phone calls every 6 months through the 4 year phone call
Description

Participation Clinical Trial Visit Withdrawn | Investigational New Drugs Withdrawn | Participation Follow-up Telephone call

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1512346
UMLS CUI [1,4]
C0424092
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0424092
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C3274571
UMLS CUI [3,3]
C0302186
exclusion criteria: part a subjects meeting the following criterion must not be enrolled in part a of the study
Description

Exclusion Criteria Part Roman letter

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0439102
inability/unwillingness to participate in the follow-up study phone calls.
Description

Participation Follow-up Telephone call Unable | Participation Follow-up Telephone call Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C0302186
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C0302186
UMLS CUI [2,4]
C0558080
inclusion criteria: part b
Description

Inclusion criteria Part Roman letter

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0439102
subjects eligible for enrolment in part b of the study must meet the following criteria:
Description

Criteria Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
any subject who was diagnosed with prostate cancer based on a prostate biopsy during participation in the reduce study, regardless of when their reduce study participation ended.
Description

Prostate carcinoma Biopsy of prostate

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0194804
exclusion criteria: part b
Description

Exclusion Criteria Part Roman letter

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0439102
the exclusion criterion only applies to part a, the 2 year observational follow-up study. there are no exclusion criteria for part b, prostate biopsy tissue study.
Description

Unspecified

Type de données

boolean

Alias
UMLS CUI [1]
C0205370
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Similar models

Eligibility Neoplasms, Prostate NCT00883909

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Study Subject Participation Status | Criteria Fulfill
Item
any subject who has participated in the reduce study and meets one of the following eligibility criteria is eligible for part a, 2 year observational follow-up study:
boolean
C2348568 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Investigational New Drugs
Item
completed 4 years on investigational product through the reduce 4 year study visit (visit 10) or
boolean
C0013230 (UMLS CUI [1])
Prostate carcinoma | Investigational New Drugs Discontinued | Participation Follow-up
Item
was diagnosed with prostate cancer during the reduce study, discontinued investigational product (ip) but participated in reduce prostate cancer follow-up visits through the 4 year study visit (visit 10p) or
boolean
C0600139 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0679823 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
Participation Clinical Trial Visit Withdrawn | Investigational New Drugs Withdrawn | Participation Follow-up Telephone call
Item
withdrew from reduce study visit participation and ip (for any reasons) but participated in reduce follow-up phone calls every 6 months through the 4 year phone call
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1512346 (UMLS CUI [1,3])
C0424092 (UMLS CUI [1,4])
C0013230 (UMLS CUI [2,1])
C0424092 (UMLS CUI [2,2])
C0679823 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0302186 (UMLS CUI [3,3])
Exclusion Criteria Part Roman letter
Item
exclusion criteria: part a subjects meeting the following criterion must not be enrolled in part a of the study
boolean
C0680251 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
Participation Follow-up Telephone call Unable | Participation Follow-up Telephone call Unwilling
Item
inability/unwillingness to participate in the follow-up study phone calls.
boolean
C0679823 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0302186 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0679823 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C0302186 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Inclusion criteria Part Roman letter
Item
inclusion criteria: part b
boolean
C1512693 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
Criteria Fulfill
Item
subjects eligible for enrolment in part b of the study must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Prostate carcinoma Biopsy of prostate
Item
any subject who was diagnosed with prostate cancer based on a prostate biopsy during participation in the reduce study, regardless of when their reduce study participation ended.
boolean
C0600139 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
Exclusion Criteria Part Roman letter
Item
exclusion criteria: part b
boolean
C0680251 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
Unspecified
Item
the exclusion criterion only applies to part a, the 2 year observational follow-up study. there are no exclusion criteria for part b, prostate biopsy tissue study.
boolean
C0205370 (UMLS CUI [1])
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