ID

16057

Description

Documentation part: Log Status & Randomisation Number A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo. ClinicalTrials.gov Identifier: NCT00133874 Other Study ID Numbers: TOC100224 Responsible Party: GlaxoSmithKline

Keywords

Versions (1)
  1. 6/27/16 6/27/16 -
Uploaded on

June 27, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Log Status & Randomisation Number Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

English

Log Status & Randomisation Number Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 forms  
Log Status
Description

Log Status

Did the subject experience any adverse events during the study?
Description

Did the subject experience any adverse events during the study?

Data type

text

Alias
UMLS CUI [1]
C0877248
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Description

Were any concomitant medications taken by the subject prior to screening and/or during the study?

Data type

text

Alias
UMLS CUI [1]
C2347852
Case book ready for signature
Description

CRA should check the box when data cleaning is complete. This item is used for Phase I trials only. Remove for Phase II-IV

Data type

text

Alias
UMLS CUI [1]
C1519316
For inform only: Do not data enter
Description

For inform only: Do not data enter

Q1
Description

Q1

Data type

text

Q2
Description

Q2

Data type

text

Randomisation Number (RAND)
Description

Randomisation Number (RAND)

Randomisation number
Description

Randomisation number

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0034656
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Similar models

Log Status & Randomisation Number Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Log Status
Item
Did the subject experience any adverse events during the study?
text
C0877248 (UMLS CUI [1])
Did the subject experience any adverse events during the study?
Code List
Did the subject experience any adverse events during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
text
C2347852 (UMLS CUI [1])
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Code List
Were any concomitant medications taken by the subject prior to screening and/or during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Case book ready for signature
text
C1519316 (UMLS CUI [1])
Case book ready for signature
Code List
Case book ready for signature
CL Item
Yes (Y)
Item Group
For inform only: Do not data enter
Item
Q1
text
Q1
Code List
Q1
CL Item
Yes (Y)
CL Item
No (N)
Item
Q2
text
Q2
Code List
Q2
CL Item
PF_SC_LOST (1)
CL Item
PF_SC_DEATH (2)
CL Item
PF_SC_SPONSORDECISlON (3)
CL Item
PF_SC_PHYS[ClANDEClSlON (4)
CL Item
PF_SC_PATIENTDEClSION (5)
CL Item
PF_SC_AE (6)
CL Item
PF_SC_CRlTERIA (7)
CL Item
PF_SC_OTHER (8)
Item Group
Randomisation Number (RAND)
Randomisation number
Item
Randomisation number
integer
C0449788 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
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