ID

27673

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2017-11-13 2017-11-13 -
  2. 2017-11-26 2017-11-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 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

Engelsk

Contact #2 Year 2 GSK study Prostatic neoplasms NCT00883909

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Session number
Beskrivning

Session number

Datatyp

integer

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

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Subject contact
Beskrivning

Subject contact

Alias
UMLS CUI-1
C0332158
UMLS CUI-2
C0681850
Was contact made?
Beskrivning

If YES, record the date and type of contact.

Datatyp

text

Alias
UMLS CUI [1,1]
C0597535
UMLS CUI [1,2]
C1516084
UMLS CUI [1,3]
C1705415
Date of contact
Beskrivning

Date of contact

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Type of contact
Beskrivning

Type of contact

Datatyp

text

Was the subject interview completed?
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1,1]
C0021822
UMLS CUI [1,2]
C0805732
Primary reason interview was not completed
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1548386
Other, specify
Beskrivning

Other

Datatyp

text

Alias
UMLS CUI [1]
C0205394
CONTACT #2 - Since Contact #1 (if contact #1 was performed) OR Since the REDUCE 4 Year Contact (if contact #1 was not performed):
Beskrivning

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

Alias
UMLS CUI-1
C3812666
UMLS CUI-2
C0449788
1. Have you had any PSA tests?
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1]
C0201544
2. Have you had any biopsies?
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1]
C0005558
3. Have you had treatment for prostate cancer?
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600139
4. Have you had prostate surgery for reasons other than PCa?
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1]
C0194790
5. Have you had any medical problems or hospitalisations?
Beskrivning

comorbidity; hospitalization

Datatyp

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0019993
For site response only: Do any of the medical conditions reported by the patient meet the criteria for a serious adverse event?
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1]
C1519255
6. Were there changes in any of your chronic medications (e.g., changes in dose, starting or stopping medications)?
Beskrivning

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).

Datatyp

text

Alias
UMLS CUI [1]
C0580105
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Similar models

Contact #2 Year 2 GSK study Prostatic neoplasms NCT00883909

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Subject contact
C0332158 (UMLS CUI-1)
C0681850 (UMLS CUI-2)
Item
Was contact made?
text
C0597535 (UMLS CUI [1,1])
C1516084 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,3])
Succesful Contact Attempt
Code List
Was contact made?
CL Item
Yes (Y)
CL Item
No (N)
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
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
C0021822 (UMLS CUI [1,1])
C0805732 (UMLS CUI [1,2])
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
C0566251 (UMLS CUI [1,1])
C1548386 (UMLS CUI [1,2])
Primary reason interview was not completed
Code List
Primary reason interview was not completed
CL Item
Subject died (D)
C0011065 (UMLS CUI-1)
(Comment:en)
CL Item
Subject withdrew consent (C)
C1707492 (UMLS CUI-1)
(Comment:en)
CL Item
Subject lost to follow-up (F)
C1302313 (UMLS CUI-1)
(Comment:en)
CL Item
Other (X)
C0205394 (UMLS CUI-1)
(Comment:en)
Other
Item
Other, specify
text
C0205394 (UMLS CUI [1])
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):
C3812666 (UMLS CUI-1)
C0449788 (UMLS CUI-2)
Item
1. Have you had any PSA tests?
text
C0201544 (UMLS CUI [1])
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
C0005558 (UMLS CUI [1])
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
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
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
C0194790 (UMLS CUI [1])
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
C0009488 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
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
C1519255 (UMLS CUI [1])
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
C0580105 (UMLS CUI [1])
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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