ID

16059

Description

Documentation part: Subject/Guardian Activity Diary & Concomitant Medication 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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Subject/Guardian Activity Diary & Concomitant Medication Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

English

Subject/Guardian Activity Diary & Concomitant Medication Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 forms  
Subject/Guardian Activity Diary (DIARY)
Description

Subject/Guardian Activity Diary (DIARY)

How much effort has your child having had impetigo had on your daily activities (attendance at work, household chores, etc.) today?
Description

How much effort has your child having had impetigo had on your daily activities (attendance at work, household chores, etc.) today?

Data type

text

Alias
UMLS CUI [1,1]
C0871707
UMLS CUI [1,2]
C0162468
Has your child having impetigo had any effect on his or her normal daily activities (Attendance at school, day care, play dates, recreational activity, etc) today?
Description

Has your child having impetigo had any effect on his or her normal daily activities (Attendance at school, day care, play dates, recreational activity, etc) today?

Data type

text

Alias
UMLS CUI [1,1]
C0871707
UMLS CUI [1,2]
C0162468
Concomitant Medications (CONMEDS)
Description

Concomitant Medications (CONMEDS)

Drug name (Trade Name preferred)
Description

Drug name

Data type

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Description

Modified reported term

Data type

text

Total Daily Dose
Description

total daily dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

Reason for medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start date
Description

Start date

Data type

date

Measurement units
  • DDMONYYYY
Alias
UMLS CUI [1]
C0808070
DDMONYYYY
Ongoing?
Description

Ongoing?

Data type

text

Alias
UMLS CUI [1]
C0549178
If "No", specify End date
Description

End date

Data type

date

Measurement units
  • DDMONYYYY
Alias
UMLS CUI [1]
C0806020
DDMONYYYY
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Similar models

Subject/Guardian Activity Diary & Concomitant Medication 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
Subject/Guardian Activity Diary (DIARY)
Item
How much effort has your child having had impetigo had on your daily activities (attendance at work, household chores, etc.) today?
text
C0871707 (UMLS CUI [1,1])
C0162468 (UMLS CUI [1,2])
How much effort has your child having had impetigo had on your daily activities (attendance at work, household chores, etc.) today?
Code List
How much effort has your child having had impetigo had on your daily activities (attendance at work, household chores, etc.) today?
CL Item
0 - Not at All (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 - Very Much (4)
Item
Has your child having impetigo had any effect on his or her normal daily activities (Attendance at school, day care, play dates, recreational activity, etc) today?
text
C0871707 (UMLS CUI [1,1])
C0162468 (UMLS CUI [1,2])
Has your child having impetigo had any effect on his or her normal daily activities (Attendance at school, day care, play dates, recreational activity, etc) today?
Code List
Has your child having impetigo had any effect on his or her normal daily activities (Attendance at school, day care, play dates, recreational activity, etc) today?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Concomitant Medications (CONMEDS)
Drug name
Item
Drug name (Trade Name preferred)
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
total daily dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
Bouth eyes (OU)
CL Item
Epidural (EP)
CL Item
Gastrostomy tube (GTT)
CL Item
Inhalation (IH)
CL Item
Injection (INJ)
CL Item
Intra-arterial (IA)
CL Item
Intra-bursa (IB)
CL Item
Intramuscular (IM)
CL Item
Intranasal (IN)
CL Item
Inraocular (IO)
CL Item
Intraosteal (IOS)
CL Item
Intrathekal (IT)
CL Item
Intrauterine (IU)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Topical (TP)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
CL Item
Vaginal (VG)
Reason for medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Item
Ongoing?
text
C0549178 (UMLS CUI [1])
Ongoing?
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End date
Item
If "No", specify End date
date
C0806020 (UMLS CUI [1])
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