ID

27669

Description

Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate CRF Seiten: 934-977

Keywords

Versions (3)
  1. 11/9/17 11/9/17 -
  2. 11/9/17 11/9/17 -
  3. 11/26/17 11/26/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 26, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Screen visit GSK study Prostatic neoplasms NCT00883909

English

Screen visit GSK study Prostatic neoplasms NCT00883909

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Session number
Description

Session number

Data type

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Previous Subject number
Description

Previous Subject number

Alias
UMLS CUI-1
C2348585
UMLS CUI-2
C0205156
Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Previous Subject Number from the REDUCE (ARI40006) Study
Description

Subject Number Previous

Data type

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Inclusion / Exclusion Criteria Worksheet
Description

Inclusion / Exclusion Criteria Worksheet

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0680251
Inclusion criteria: 1. Has the subject signed and dated a written informed consent?
Description

If the INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C0021430
Inclusion criteria: 2. Did the subject participate in the REDUCE Study and meet the eligibility criteria for Part A, the 2 Year Observational Follow-Up Study and/or Part B, the Prostate Biopsy Tissue Study?
Description

If the INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C2348568
Exclusion criteria (Part A only): 1. Is the subject unable/unwilling to participate in the Follow-Up Study telephone calls?
Description

If any EXCLUSION CRITERIA question is answered YES, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
Inclusion/Exclusion Criteria
Description

Inclusion/Exclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0680251
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
Description

See INCLUSION / EXCLUSION CRITERIA WORKSHEET.

Data type

text

Alias
UMLS CUI [1]
C1516637
Check all boxes that represent a violation of the inclusion / exclusion criteria: Inclusion criteria 1.
Description

violation eligibility criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1516637
Check all boxes that represent a violation of the inclusion / exclusion criteria: Inclusion criteria 2.
Description

violation eligibility criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1516637
Check all boxes that represent a violation of the inclusion / exclusion criteria: Exclusion criteria 1.
Description

Follow-up study participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
Eligibility Criteria
Description

Eligibility Criteria

Alias
UMLS CUI-1
C1516637
1. Part A: Any subject who has participated in the REDUCE Study and meets one of the following eligibility criteria for Part A, 2 Year Observational Follow-Up Study.
Description

Study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
If Part A is checked, indicate which one of the following Part A Eligibility Criteria the subject meets:
Description

Eligibility Criteria

Data type

text

Alias
UMLS CUI [1]
C1516637
2. Part B: 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

study subject participation status; Prostate carcinoma; prostate biopsy

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0600139
UMLS CUI [3]
C0194804
Investigator’s Statement
Description

Investigator’s Statement

Alias
UMLS CUI-1
C1710187
UMLS CUI-2
C2826892
Date
Description

Sign and date this page after all relevant Screening CRF pages, including outstanding test results, are completed. Check that the date of signature is on or after the completion of the Screening Visit.

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator’s Signature
Description

Sign and date this page after all relevant Screening CRF pages, including outstanding test results, are completed. "I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date."

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator’s Name - Print
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Screen visit GSK study Prostatic neoplasms NCT00883909

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Session number
Item
Session number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Previous Subject number
C2348585 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Subject Number Previous
Item
Previous Subject Number from the REDUCE (ARI40006) Study
text
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Item Group
Inclusion / Exclusion Criteria Worksheet
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
Item
Inclusion criteria: 1. Has the subject signed and dated a written informed consent?
text
C0021430 (UMLS CUI [1])
informed consent
Code List
Inclusion criteria: 1. Has the subject signed and dated a written informed consent?
CL Item
Yes (Y)
CL Item
No (N)
Item
Inclusion criteria: 2. Did the subject participate in the REDUCE Study and meet the eligibility criteria for Part A, the 2 Year Observational Follow-Up Study and/or Part B, the Prostate Biopsy Tissue Study?
text
C2348568 (UMLS CUI [1])
informed consent
Code List
Inclusion criteria: 2. Did the subject participate in the REDUCE Study and meet the eligibility criteria for Part A, the 2 Year Observational Follow-Up Study and/or Part B, the Prostate Biopsy Tissue Study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Exclusion criteria (Part A only): 1. Is the subject unable/unwilling to participate in the Follow-Up Study telephone calls?
text
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
informed consent
Code List
Exclusion criteria (Part A only): 1. Is the subject unable/unwilling to participate in the Follow-Up Study telephone calls?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion/Exclusion Criteria
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
Item
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
text
C1516637 (UMLS CUI [1])
informed consent
Code List
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
CL Item
Yes (Y)
CL Item
No (N)
violation eligibility criteria
Item
Check all boxes that represent a violation of the inclusion / exclusion criteria: Inclusion criteria 1.
boolean
C1709750 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
violation eligibility criteria
Item
Check all boxes that represent a violation of the inclusion / exclusion criteria: Inclusion criteria 2.
boolean
C1709750 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Follow-up study participation
Item
Check all boxes that represent a violation of the inclusion / exclusion criteria: Exclusion criteria 1.
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item Group
Eligibility Criteria
C1516637 (UMLS CUI-1)
Study subject participation status
Item
1. Part A: Any subject who has participated in the REDUCE Study and meets one of the following eligibility criteria for Part A, 2 Year Observational Follow-Up Study.
boolean
C2348568 (UMLS CUI [1])
Item
If Part A is checked, indicate which one of the following Part A Eligibility Criteria the subject meets:
text
C1516637 (UMLS CUI [1])
Part A Eligibility Criteria
Code List
If Part A is checked, indicate which one of the following Part A Eligibility Criteria the subject meets:
CL Item
Completed 4 years on Investigational Product through the REDUCE 4-Year Study Visit (Visit 10). (a)
CL Item
Was diagnosed with prostate cancer during the REDUCE study, discontinued Investigational Product but participated in REDUCE prostate cancer follow-up visits through the 4-Year Study Visit (Visit 10P). (b)
CL Item
Withdrew from REDUCE study visit participation and Investigational Product (for any reasons) but participated in REDUCE follow-up phone calls every 6 months through the 4 Year Phone Call. (c)
study subject participation status; Prostate carcinoma; prostate biopsy
Item
2. Part B: 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
C2348568 (UMLS CUI [1])
C0600139 (UMLS CUI [2])
C0194804 (UMLS CUI [3])
Item Group
Investigator’s Statement
C1710187 (UMLS CUI-1)
C2826892 (UMLS CUI-2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
Investigator Name
Item
Investigator’s Name - Print
text
C2826892 (UMLS CUI [1])
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