ID

28850

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: Additional Forms - Adverse Event

Trefwoorden

Versies (1)
  1. 08-02-18 08-02-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

8 februari 2018

DOI

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Licentie

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

Additional Forms - Adverse Event

1 Formulieren  
Adverse Event
Beschrijving

Adverse Event

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
Adverse event
Beschrijving

Adverse event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Is this a Serious Adverse Event?
Beschrijving

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
If fatal, was post-mortem/ autopsy performed
Beschrijving

autopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0004398
Start Date Adverse Event
Beschrijving

Start Date Adverse Event

Datatype

date

Alias
UMLS CUI [1]
C2697888
Start Time Adverse Event
Beschrijving

Start Time Adverse Event

Datatype

time

Alias
UMLS CUI [1]
C2697889
Outcome Adverse Event
Beschrijving

Outcome Adverse Event

Datatype

integer

Alias
UMLS CUI [1]
C1705586
End Date Adverse Event
Beschrijving

End Date Adverse Event

Datatype

date

Alias
UMLS CUI [1]
C2697886
End Time Adverse Event
Beschrijving

End Time Adverse Event

Datatype

time

Alias
UMLS CUI [1]
C2826658
Frequency Adverse Event
Beschrijving

Frequency Adverse Event

Datatype

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C0877248
Maximum Intensity Adverse Event
Beschrijving

Maximum Intensity Adverse Event

Datatype

integer

Alias
UMLS CUI [1]
C1710066
Action taken with Investigational product(s) as a result of the AE
Beschrijving

Action taken with Investigational product(s) as a result of the AE

Datatype

integer

Alias
UMLS CUI [1]
C1704758
Did the subject withdraw from study as a result of this AE?
Beschrijving

subject withdraw from study as a result of this AE

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C0877248
Is there a reasonable possibility that the AE may have been caused by the Investigational Product?
Beschrijving

Relationship to Investigational Product(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0877248
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Similar models

Additional Forms - Adverse Event

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adverse Event
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 event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Serious Adverse Event
Item
Is this a Serious Adverse Event?
boolean
C1519255 (UMLS CUI [1])
autopsy
Item
If fatal, was post-mortem/ autopsy performed
boolean
C0004398 (UMLS CUI [1])
Start Date Adverse Event
Item
Start Date Adverse Event
date
C2697888 (UMLS CUI [1])
Start Time Adverse Event
Item
Start Time Adverse Event
time
C2697889 (UMLS CUI [1])
Item
Outcome Adverse Event
integer
C1705586 (UMLS CUI [1])
Outcome Adverse Event
Code List
Outcome Adverse Event
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date Adverse Event
Item
End Date Adverse Event
date
C2697886 (UMLS CUI [1])
End Time Adverse Event
Item
End Time Adverse Event
time
C2826658 (UMLS CUI [1])
Item
Frequency Adverse Event
integer
C0439603 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Frequency Adverse Event
Code List
Frequency Adverse Event
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity Adverse Event
integer
C1710066 (UMLS CUI [1])
Maximum Intensity Adverse Event
Code List
Maximum Intensity Adverse Event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action taken with Investigational product(s) as a result of the AE
integer
C1704758 (UMLS CUI [1])
Action taken with Investigational product(s) as a result of the AE
Code List
Action taken with Investigational product(s) as a result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
subject withdraw from study as a result of this AE
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility that the AE may have been caused by the Investigational Product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
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