ID

27681

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

Nyckelord

Versioner (2)
  1. 2017-11-15 2017-11-15 -
  2. 2017-11-26 2017-11-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 november 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Concomitant Medications GSK study Prostatic neoplasms NCT00883909

Engelsk

Concomitant Medications 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
Intake of concomitant Medications
Beskrivning

Intake of concomitant Medications

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

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.

Datatyp

text

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

Record of Concomitant Medications

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

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).

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beskrivning

Dose

Datatyp

float

Alias
UMLS CUI [1]
C3174092
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beskrivning

Frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Date Started
Beskrivning

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.

Datatyp

date

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

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.

Datatyp

boolean

Alias
UMLS CUI [1]
C0016441
Date Stopped
Beskrivning

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.

Datatyp

date

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

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

Datatyp

boolean

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

Indication

Datatyp

text

Alias
UMLS CUI [1]
C3146298
Prophylaxis
Beskrivning

Prophylaxis

Datatyp

text

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

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.

Datatyp

text

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C1519255
Tillbaka till toppen

Similar models

Concomitant Medications 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
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)
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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