ID

16018

Description

Documentation part: Subject demography & Vital Signs 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. 6/26/16 6/26/16 -
Uploaded on

June 26, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Subject demography & Vital Signs Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

English

Subject demography & Vital Signs Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 forms  
Demography (DEMOG)
Description

Demography (DEMOG)

Date of birth
Description

Will be automatically mapped to demography form

Data type

date

Measurement units
  • DDMONYYYY
Alias
UMLS CUI [1]
C0421451
DDMONYYYY
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
If "Female", record child-bearing potential
Description

Child-bearing potential

Data type

text

Alias
UMLS CUI [1]
C1960468
Ethnicity
Description

Ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Vital Signs (vS)
Description

Vital Signs (vS)

Height
Description

Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Body Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Description

Location of temperature

Data type

text

Alias
UMLS CUI [1]
C0489453
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Similar models

Subject demography & Vital Signs 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
Demography (DEMOG)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
If "Female", record child-bearing potential
text
C1960468 (UMLS CUI [1])
Child-bearing potential
Code List
If "Female", record child-bearing potential
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Vital Signs (vS)
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Item
Location of temperature
text
C0489453 (UMLS CUI [1])
Location of temperature
Code List
Location of temperature
CL Item
Oral (1)
CL Item
Rectal (2)
CL Item
Axilla (3)
CL Item
Tympanic (4)
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