ID

27681

Beschreibung

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

Stichworte

Versionen (2)
  1. 15.11.17 15.11.17 -
  2. 26.11.17 26.11.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

26. November 2017

DOI

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

Englisch

Concomitant Medications GSK study Prostatic neoplasms NCT00883909

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Session number
Beschreibung

Session number

Datentyp

integer

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

Subject number

Datentyp

text

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

Intake of concomitant Medications

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

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.

Datentyp

text

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

Record of Concomitant Medications

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

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).

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beschreibung

Dose

Datentyp

float

Alias
UMLS CUI [1]
C3174092
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Date Started
Beschreibung

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.

Datentyp

date

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

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.

Datentyp

boolean

Alias
UMLS CUI [1]
C0016441
Date Stopped
Beschreibung

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.

Datentyp

date

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

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

Datentyp

boolean

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

Indication

Datentyp

text

Alias
UMLS CUI [1]
C3146298
Prophylaxis
Beschreibung

Prophylaxis

Datentyp

text

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

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C1519255
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Ähnliche Modelle

Concomitant Medications GSK study Prostatic neoplasms NCT00883909

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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