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Informações:
Falhas:
ID
27360
Descrição
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
Palavras-chave
Versões (3)
- 09/11/2017 09/11/2017 -
- 09/11/2017 09/11/2017 -
- 26/11/2017 26/11/2017 -
Titular dos direitos
GlaxoSmithKline
Transferido a
9 de novembro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Screen visit GSK study Prostate neoplasms NCT00883909
Screen visit GSK study Prostate neoplasms NCT00883909
- StudyEvent: ODM
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Screen visit GSK study Prostate neoplasms NCT00883909
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Session number
Item
Session number
integer
Subject number
Item
Subject number
text
Date of assessment
Item
Date of assessment
date
Previous Subject Number
Item
Previous Subject Number from the REDUCE (ARI40006) Study
text
Item
Inclusion criteria: 1. Has the subject signed and dated a written informed consent?
text
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
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
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
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
text
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)
informed consent violation
Item
Check all boxes that represent a violation of the inclusion / exclusion criteria: Inclusion criteria 1.
boolean
eligibility criteria violation
Item
Check all boxes that represent a violation of the inclusion / exclusion criteria: Inclusion criteria 2.
boolean
participation in Follow-Up Study telephone calls violation
Item
Check all boxes that represent a violation of the inclusion / exclusion criteria: Exclusion criteria 1.
boolean
eligibility part A
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
Item
If Part A is checked, indicate which one of the following Part A Eligibility Criteria the subject meets:
text
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)
eligibility part B
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
Date
Item
Date
date
Investigator’s Signature
Item
Investigator’s Signature
text
Investigator’s Name
Item
Investigator’s Name - Print
text