ID

28841

Beschrijving

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: Run-In - Visit 3

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Versies (1)
  1. 08-02-18 08-02-18 -
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GlaxoSmithKline

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8 februari 2018

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Creative Commons BY-NC 3.0
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Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723

Engels

Run-In - Visit 3

1 Formulieren  
  1. StudyEvent: ODM
    1. Run-In - Visit 3
Adverse Events
Beschrijving

Adverse Events

Alias
UMLS CUI-1
C0877248
Center
Beschrijving

Center

Datatype

text

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

Subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Initials
Beschrijving

Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Are there any new adverse events/ serious adverse events observed or reported by the subject or any changes to ongoing adverse events?
Beschrijving

I f 'Yes', record details on the Adverse Events panel.

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
Has there been any changes to the subject's concomitant medication or any new medications taken since the last visit?
Beschrijving

If 'Yes', record details on the Concomitant Medications panel.

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2169461
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood Pressure - sitting, Systolic
Beschrijving

Blood Pressure - sitting, Systolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Blood Pressure - sitting, Diastolic
Beschrijving

Blood Pressure - sitting, Diastolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Central Laboratory
Beschrijving

Central Laboratory

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C0022885
Were lab samples obtained?
Beschrijving

lab samples

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0200354
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
Did the subject meet all of the inclusion criteria at Visit 3?
Beschrijving

If 'No', check the boxes corresponding to any of the inclusion criteria the subject failed.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1516637
inclusion criteria the subject failed
Beschrijving

inclusion criteria the subject failed

Datatype

integer

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1516637
UMLS CUI [1,3]
C0231175
Please clarify the exception(s) below:
Beschrijving

exception(s) Inclusion Criteria

Datatype

text

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C1516637
Subject Continuation
Beschrijving

Subject Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C2348568
Is the subject continuing in the study?
Beschrijving

If 'No', complete the Study Conclusion panel.

Datatype

boolean

Alias
UMLS CUI [1]
C0805733
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Similar models

Run-In - Visit 3

1 Formulieren
  1. StudyEvent: ODM
    1. Run-In - Visit 3
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
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])
adverse events
Item
Are there any new adverse events/ serious adverse events observed or reported by the subject or any changes to ongoing adverse events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
changes concomitant medication
Item
Has there been any changes to the subject's concomitant medication or any new medications taken since the last visit?
boolean
C2347852 (UMLS CUI [1,1])
C2169461 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Blood Pressure - sitting, Systolic
Item
Blood Pressure - sitting, Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Blood Pressure - sitting, Diastolic
Item
Blood Pressure - sitting, Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Central Laboratory
C1880016 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
lab samples
Item
Were lab samples obtained?
boolean
C0005834 (UMLS CUI [1])
C0200354 (UMLS CUI [2])
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Inclusion Criteria
Item
Did the subject meet all of the inclusion criteria at Visit 3?
boolean
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Item
inclusion criteria the subject failed
integer
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
inclusion criteria the subject failed
Code List
inclusion criteria the subject failed
CL Item
Subjects with FPG < = 270 mg/ dL (15mmol/ L) at Visit 3 (week -4). (1)
exception(s) Inclusion Criteria
Item
Please clarify the exception(s) below:
text
C1705847 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,3])
Item Group
Subject Continuation
C0805733 (UMLS CUI-1)
C2348568 (UMLS CUI-2)
subject continuing
Item
Is the subject continuing in the study?
boolean
C0805733 (UMLS CUI [1])
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