ID

28840

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: Baseline/Randomisation - Visit 4

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

Baseline/Randomisation - Visit 4

1 Formulare  
Adverse Events
Beschreibung

Adverse Events

Alias
UMLS CUI-1
C0877248
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
Are there any new adverse events/ serious adverse events observed or reported by the subject or any changes to ongoing adverse events?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Concomitant Medications
Beschreibung

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?
Beschreibung

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

Datentyp

boolean

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood Pressure - sitting, Systolic
Beschreibung

Blood Pressure - sitting, Systolic

Datentyp

integer

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

Blood Pressure - sitting, Diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Waist circumference
Beschreibung

Waist circumference

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0455829
cm
Central Laboratory
Beschreibung

Central Laboratory

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

lab samples

Datentyp

boolean

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

Date Sample Taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Investigational Product Compliance
Beschreibung

Investigational Product Compliance

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
Beschreibung

Investigational Product Compliance

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1321605
I f compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
Beschreibung

Investigational Product Compliance Reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0392360
If other reason, please specify
Beschreibung

Investigational Product Compliance Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0392360
Subject Continuation
Beschreibung

Subject Continuation

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

If 'No', complete the Study Conclusion panel.

Datentyp

boolean

Alias
UMLS CUI [1]
C0805733
Randomisation Number
Beschreibung

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Randomisation Number
Beschreibung

Randomisation Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Baseline/Randomisation - Visit 4

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Waist circumference
Item
Waist circumference
float
C0455829 (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
Investigational Product Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Item
What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
integer
C0304229 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Investigational Product Compliance
Code List
What is your assessment of the subject's investigational product compliance (in % ) since the last visit?
CL Item
0% compliant (subject did not take any doses) (1)
CL Item
> 0% and < 80% compliant (subject missed a number of doses) (2)
CL Item
>=80% and <=120% (number of doses taken was within compliance range) (3)
CL Item
> 120% compliant (number of doses taken exceeds compliance limits) (4)
Item
I f compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
integer
C0304229 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
inclusion criteria the subject failed
Code List
I f compliance is < 80% or > 120% , check the box next to any reason(s) below that apply.
CL Item
Adverse event (ensure that details are recorded in the Adverse Events panel) (1)
CL Item
Dispensing error (2)
CL Item
Subject did not take medication according to protocol (3)
CL Item
Other (4)
Investigational Product Compliance Reason
Item
If other reason, please specify
text
C0304229 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0392360 (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])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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