ID

27681

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

Trefwoorden

Versies (2)
  1. 15-11-17 15-11-17 -
  2. 26-11-17 26-11-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

26 november 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Concomitant Medications GSK study Prostatic neoplasms NCT00883909

Engels

Concomitant Medications GSK study Prostatic neoplasms NCT00883909

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Session number
Beschrijving

Session number

Datatype

integer

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

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Intake of concomitant Medications
Beschrijving

Intake of concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any chronic concomitant medications taken by the subject during the Follow-Up study?
Beschrijving

Check that either the YES or NO box at the top of the page is selected. • If NO is selected, check that no applicable concomitant medications are present. • If YES is selected, check that at least one applicable concomitant medication is present. If YES, record below.

Datatype

text

Alias
UMLS CUI [1]
C2347852
Record of Concomitant Medications
Beschrijving

Record of Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug (Trade name preferred)
Beschrijving

Check that the drug name (trade name preferred) is spelled correctly. If medication is given to treat a serious adverse event (SAE), then the event must be recorded on the SERIOUS ADVERSE EVENT page(s).

Datatype

text

Alias
UMLS CUI [1]
C0013227
Dose
Beschrijving

Dose

Datatype

float

Alias
UMLS CUI [1]
C3174092
Units
Beschrijving

Units

Datatype

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Date Started
Beschrijving

Check that either the ‘Date started’ is completed or ‘started Pre-Follow Up Study’ is completed. At least one must be completed, but it is acceptable if both are completed. • If both ‘Date started’ and ‘started Pre-Follow Up Study’ are completed, check that the start date is pre-study.

Datatype

date

Alias
UMLS CUI [1]
C3173309
Started Pre- Follow Up Study
Beschrijving

Check that either the ‘Date started’ is completed or ‘started Pre-Follow Up Study’ is completed. At least one must be completed, but it is acceptable if both are completed. • If both ‘Date started’ and ‘started Pre-Follow Up Study’ are completed, check that the start date is pre-study.

Datatype

boolean

Alias
UMLS CUI [1]
C0016441
Date Stopped
Beschrijving

Check that either the ‘Date stopped’ box is completed or the ‘continued Post-Follow Up Study’ is completed. Only one must be completed. • Check that the drug start date is before or equal to the drug stop date.

Datatype

date

Alias
UMLS CUI [1]
C1531784
Continued Post- Follow Up Study
Beschrijving

Check that either the ‘Date stopped’ box is completed or the ‘continued Post-Follow Up Study’ is completed. Only one must be completed.

Datatype

boolean

Alias
UMLS CUI [1]
C0016441
Conditions Treated / Indication
Beschrijving

Indication

Datatype

text

Alias
UMLS CUI [1]
C3146298
Prophylaxis
Beschrijving

Prophylaxis

Datatype

text

Alias
UMLS CUI [1]
C0199176
Was drug administered for an SAE?
Beschrijving

If the concomitant medication was taken for a serious adverse event (SAE), check that the event is entered on the SERIOUS ADVERSE EVENT page(s) and that the dates are consistent with the event.

Datatype

text

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C1519255
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Similar models

Concomitant Medications GSK study Prostatic neoplasms NCT00883909

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Intake of concomitant Medications
C2347852 (UMLS CUI-1)
Item
Were any chronic concomitant medications taken by the subject during the Follow-Up study?
text
C2347852 (UMLS CUI [1])
concomitant medications intake
Code List
Were any chronic concomitant medications taken by the subject during the Follow-Up study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Record of Concomitant Medications
C2347852 (UMLS CUI-1)
Drug
Item
Drug (Trade name preferred)
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Date Started
Item
Date Started
date
C3173309 (UMLS CUI [1])
Follow Up Study
Item
Started Pre- Follow Up Study
boolean
C0016441 (UMLS CUI [1])
Date Stopped
Item
Date Stopped
date
C1531784 (UMLS CUI [1])
Follow Up Study
Item
Continued Post- Follow Up Study
boolean
C0016441 (UMLS CUI [1])
Indication
Item
Conditions Treated / Indication
text
C3146298 (UMLS CUI [1])
Item
Prophylaxis
text
C0199176 (UMLS CUI [1])
concomitant medications intake
Code List
Prophylaxis
CL Item
Yes (Y)
CL Item
No (N)
Item
Was drug administered for an SAE?
text
C3469597 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
concomitant medications intake
Code List
Was drug administered for an SAE?
CL Item
Yes (Y)
CL Item
No (N)
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