ID

27403

Beschrijving

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

Trefwoorden

Versies (2)
  1. 13-11-17 13-11-17 -
  2. 26-11-17 26-11-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

13 november 2017

DOI

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Creative Commons BY-NC 3.0
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Contact #2 Year 2 GSK study Prostatic neoplasms NCT00883909

Engels

Contact #2 Year 2 GSK study Prostatic neoplasms NCT00883909

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Session number
Beschrijving

Session number

Datatype

integer

Subject number
Beschrijving

Subject number

Datatype

text

Subject contact
Beschrijving

Subject contact

Was contact made?
Beschrijving

If YES, record the date and type of contact.

Datatype

text

Date of contact
Beschrijving

Date of contact

Datatype

date

Type of contact
Beschrijving

Type of contact

Datatype

text

Was the subject interview completed?
Beschrijving

If YES, ensure that all questions in the CONTACT #2 section have been completed. If NO, check primary reason interview was not completed and do not complete the questions in the CONTACT #2 section.

Datatype

text

Primary reason interview was not completed
Beschrijving

If subject died, record details on the SERIOUS ADVERSE EVENT pages.

Datatype

text

Other, specify
Beschrijving

Other primary reason interview was not completed

Datatype

text

CONTACT #2 - Since Contact #1 (if contact #1 was performed) OR Since the REDUCE 4 Year Contact (if contact #1 was not performed):
Beschrijving

CONTACT #2 - Since Contact #1 (if contact #1 was performed) OR Since the REDUCE 4 Year Contact (if contact #1 was not performed):

1. Have you had any PSA tests?
Beschrijving

If YES, Record the date of collection and local PSA results on the PSA RESULTS page.

Datatype

text

2. Have you had any biopsies?
Beschrijving

If YES, • Enter the biopsy information and the local pathology results on the LOCAL PATHOLOGY RESULTS page. • Send biopsy sample to Central Pathology for Confirmatory Review only if the result is positive for prostate cancer. • If biopsy is positive for PCa enter any available new TNM stage information on the TNM STAGING HISTORY page.

Datatype

text

3. Have you had treatment for prostate cancer?
Beschrijving

If YES, • Enter surgical treatment for PCa on the PROSTATIC SURGICAL INTERVENTION page; and, • For radical prostatectomy, enter any local pathology information/ result on LOCAL PATHOLOGY RESULTS page. • For radical prostatectomies, send surgical sample to Central Pathology for confirmatory review, regardless of whether the result is positive or negative for prostate cancer. • For all prostate surgeries other than radical prostatectomies, send surgical sample to Central Pathology for confirmatory review only if the result is positive for prostate cancer. • Enter non-surgical treatment for PCa, on the NON-SURGICAL INTERVENTION FOR PROSTATE CANCER page. • Complete any further TNM staging information on the TNM STAGING HISTORY page.

Datatype

text

4. Have you had prostate surgery for reasons other than PCa?
Beschrijving

If YES, • Enter the prostate surgery information on the PROSTATE SURGICAL INTERVENTION page; and, • Enter local pathology results for the surgery on the LOCAL PATHOLOGY RESULTS page. • Send surgical sample to Central Pathology for confirmatory review only if the result is positive for prostate cancer. • Complete any further TNM staging information on the TNM Staging History page.

Datatype

text

5. Have you had any medical problems or hospitalisations?
Beschrijving

medical problems or hospitalisations

Datatype

text

For site response only: Do any of the medical conditions reported by the patient meet the criteria for a serious adverse event?
Beschrijving

If YES, Complete the SERIOUS ADVERSE EVENT pages and ensure they are faxed to GSK within 24 hours of becoming aware of the event.

Datatype

text

6. Were there changes in any of your chronic medications (e.g., changes in dose, starting or stopping medications)?
Beschrijving

Chronic concomitant medications include all prescription and nonprescription medication including vitamins, supplements and herbal remedies. Specifically include the use of dutasteride [Avodart ®] or finasteride [Proscar ® and Propecia ®]. If YES, • Enter information for all changes in chronic medications on the CONCOMITANT MEDICATIONS page(s).

Datatype

text

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Similar models

Contact #2 Year 2 GSK study Prostatic neoplasms NCT00883909

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Session number
Item
Session number
integer
Subject number
Item
Subject number
text
Item Group
Subject contact
Item
Was contact made?
text
Succesful Contact Attempt
Code List
Was contact made?
CL Item
Yes (Y)
CL Item
No (N)
Date of contact
Item
Date of contact
date
Item
Type of contact
text
Type of contact
Code List
Type of contact
CL Item
Telephone (T)
CL Item
Screening Visit (V)
Item
Was the subject interview completed?
text
Succesful Contact Attempt
Code List
Was the subject interview completed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Primary reason interview was not completed
text
Primary reason interview was not completed
Code List
Primary reason interview was not completed
CL Item
Subject died (D)
CL Item
Subject withdrew consent (C)
CL Item
Subject lost to follow-up (F)
CL Item
Other (X)
Other primary reason interview was not completed
Item
Other, specify
text
Item Group
CONTACT #2 - Since Contact #1 (if contact #1 was performed) OR Since the REDUCE 4 Year Contact (if contact #1 was not performed):
Item
1. Have you had any PSA tests?
text
Succesful Contact Attempt
Code List
1. Have you had any PSA tests?
CL Item
Yes (Y)
CL Item
No (N)
Item
2. Have you had any biopsies?
text
Succesful Contact Attempt
Code List
2. Have you had any biopsies?
CL Item
Yes (Y)
CL Item
No (N)
Item
3. Have you had treatment for prostate cancer?
text
Succesful Contact Attempt
Code List
3. Have you had treatment for prostate cancer?
CL Item
Yes (Y)
CL Item
No (N)
Item
4. Have you had prostate surgery for reasons other than PCa?
text
Succesful Contact Attempt
Code List
4. Have you had prostate surgery for reasons other than PCa?
CL Item
Yes (Y)
CL Item
No (N)
Item
5. Have you had any medical problems or hospitalisations?
text
Succesful Contact Attempt
Code List
5. Have you had any medical problems or hospitalisations?
CL Item
Yes (Y)
CL Item
No (N)
Item
For site response only: Do any of the medical conditions reported by the patient meet the criteria for a serious adverse event?
text
Succesful Contact Attempt
Code List
For site response only: Do any of the medical conditions reported by the patient meet the criteria for a serious adverse event?
CL Item
Yes (Y)
CL Item
No (N)
Item
6. Were there changes in any of your chronic medications (e.g., changes in dose, starting or stopping medications)?
text
Succesful Contact Attempt
Code List
6. Were there changes in any of your chronic medications (e.g., changes in dose, starting or stopping medications)?
CL Item
Yes (Y)
CL Item
No (N)
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