ID

28842

Beschreibung

Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Pre-Screening - Visit 1

Stichworte

Versionen (1)
  1. 08.02.18 08.02.18 -
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GlaxoSmithKline

Hochgeladen am

8. Februar 2018

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Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723

Englisch

Pre-Screening - Visit 1

1 Formulare  
Subject Eligibility for Continuation
Beschreibung

Subject Eligibility for Continuation

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C0805733
UMLS CUI-3
C0013893
Center
Beschreibung

Center

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject ID
Beschreibung

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Initials
Beschreibung

Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
I f known, record local lab HbA1c value drawn within 6 weeks prior to Pre-Screening visit
Beschreibung

HbA1c

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0019018
%
Based upon their prior diabetes therapy does the subject meet one of the following HbA1c criteria? - Drug Naïve and HbA1c > = 7.5 and < = 11% - Oral antidiabetic monotherapy and HbA1c > = 7 and < = 10% - Oral antidiabetic combinationtherapy and HbA1c > = 6.5 and < = 10%
Beschreibung

HbA1c Criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C1516637
I f 'No', select the criteria that was not met.
Beschreibung

HbA1c criteria that was not met

Datentyp

integer

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C1516637
Were lab samples obtained?
Beschreibung

lab samples

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0005834
Date Sample Taken
Beschreibung

Date Sample Taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
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Ähnliche Modelle

Pre-Screening - Visit 1

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Subject Eligibility for Continuation
C2348568 (UMLS CUI-1)
C0805733 (UMLS CUI-2)
C0013893 (UMLS CUI-3)
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
HbA1c
Item
I f known, record local lab HbA1c value drawn within 6 weeks prior to Pre-Screening visit
float
C0019018 (UMLS CUI [1])
HbA1c Criteria
Item
Based upon their prior diabetes therapy does the subject meet one of the following HbA1c criteria? - Drug Naïve and HbA1c > = 7.5 and < = 11% - Oral antidiabetic monotherapy and HbA1c > = 7 and < = 10% - Oral antidiabetic combinationtherapy and HbA1c > = 6.5 and < = 10%
boolean
C0019018 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Item
I f 'No', select the criteria that was not met.
integer
C0019018 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
HbA1c criteria that was not met
Code List
I f 'No', select the criteria that was not met.
CL Item
Drug Naïve and HbA1c > = 7.5 and < = 11% (1)
CL Item
Oral antidiabetic monotherapy and HbA1c > = 7 and < = 10%  (2)
CL Item
Oral antidiabetic combinationtherapy and HbA1c > = 6.5 and < = 10% (3)
lab samples
Item
Were lab samples obtained?
boolean
C0005834 (UMLS CUI [1])
C0005834 (UMLS CUI [2])
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
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