ID

27681

Descrizione

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

Keywords

versioni (2)
  1. 15/11/17 15/11/17 -
  2. 26/11/17 26/11/17 -
Titolare del copyright

GlaxoSmithKline

Caricato su

26 novembre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Concomitant Medications GSK study Prostatic neoplasms NCT00883909

Inglese

Concomitant Medications GSK study Prostatic neoplasms NCT00883909

1 moduli  
Administrative data
Descrizione

Administrative data

Alias
UMLS CUI-1
C1320722
Session number
Descrizione

Session number

Tipo di dati

integer

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

Subject number

Tipo di dati

text

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

Intake of concomitant Medications

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

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 di dati

text

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

Record of Concomitant Medications

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

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 di dati

text

Alias
UMLS CUI [1]
C0013227
Dose
Descrizione

Dose

Tipo di dati

float

Alias
UMLS CUI [1]
C3174092
Units
Descrizione

Units

Tipo di dati

text

Alias
UMLS CUI [1]
C1519795
Frequency
Descrizione

Frequency

Tipo di dati

text

Alias
UMLS CUI [1]
C3476109
Route
Descrizione

Route

Tipo di dati

text

Alias
UMLS CUI [1]
C0013153
Date Started
Descrizione

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 di dati

date

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

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 di dati

boolean

Alias
UMLS CUI [1]
C0016441
Date Stopped
Descrizione

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 di dati

date

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

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

Tipo di dati

boolean

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

Indication

Tipo di dati

text

Alias
UMLS CUI [1]
C3146298
Prophylaxis
Descrizione

Prophylaxis

Tipo di dati

text

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

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 di dati

text

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C1519255
Ritorna all'inizio della pagina

Similar models

Concomitant Medications GSK study Prostatic neoplasms NCT00883909

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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)
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial