ID

27681

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

Palavras-chave

Versões (2)
  1. 15/11/2017 15/11/2017 -
  2. 26/11/2017 26/11/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

26 de novembro de 2017

DOI

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Licença

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

Inglês

Concomitant Medications GSK study Prostatic neoplasms NCT00883909

1 Formulários  
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Session number
Descrição

Session number

Tipo de dados

integer

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

Subject number

Tipo de dados

text

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

Intake of concomitant Medications

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

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.

Tipo de dados

text

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

Record of Concomitant Medications

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

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).

Tipo de dados

text

Alias
UMLS CUI [1]
C0013227
Dose
Descrição

Dose

Tipo de dados

float

Alias
UMLS CUI [1]
C3174092
Units
Descrição

Units

Tipo de dados

text

Alias
UMLS CUI [1]
C1519795
Frequency
Descrição

Frequency

Tipo de dados

text

Alias
UMLS CUI [1]
C3476109
Route
Descrição

Route

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
Date Started
Descrição

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.

Tipo de dados

date

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

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.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0016441
Date Stopped
Descrição

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.

Tipo de dados

date

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

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

Tipo de dados

boolean

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

Indication

Tipo de dados

text

Alias
UMLS CUI [1]
C3146298
Prophylaxis
Descrição

Prophylaxis

Tipo de dados

text

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

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.

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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)
Voltar ao início da página 

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