ID

35627

Description

Study ID: 110978 Clinical Study ID: 110978 Study Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00852540 https://clinicaltrials.gov/ct2/show/NCT00852540 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Retapamulin Ointment, Oral Linezolid Trade Name: N/A Study Indication: Skin Infections, Bacterial The study consists of 5 vists. The studys period extends over 19 days: Visit 1 (Day 1): Baseline (for both, topical and oral visit) Visit 2 (Day 3-4): On-Therapy (for both, topical and oral visit) Visit 3 (Day 7-9): End of Therapy for topical visit, On-Therapy for oral visit. Visit 4 (Day 12-14): Follow-up for topical visit, End of Therapy for oral visit. Visit 5 (Day 17-19): Final Follow-up for topical visit, Follow-up for oral visit. This document contains the Wound or lesion details and SIRS score form. It has to be filled in for each Visit (1-5).

Link

https://clinicaltrials.gov/ct2/show/NCT00852540

Keywords

  1. 3/11/19 3/11/19 -
  2. 3/12/19 3/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 12, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540

Wound or lesion details, SIRS score

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Wound or lesion details
Description

Wound or lesion details

Alias
UMLS CUI-1
C0043250
UMLS CUI-2
C0221198
Left or right side?
Description

Side of wound/lesion

Data type

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0043250
Front or back of the body?
Description

Site of wound/lesion

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0043250
Wound in the front
Description

Wound in the front

Data type

integer

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C0205094
Wound in the back
Description

Wound in the back

Data type

integer

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C0205095
Wound length
Description

Wound length

Data type

float

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C1444754
Wound width
Description

Wound width

Data type

float

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C0487742
Wound area
Description

Wound area

Data type

text

Alias
UMLS CUI [1]
C3534343
SIRS score
Description

SIRS score

Alias
UMLS CUI-1
C0243026
UMLS CUI-2
C2964552
SIRS total score
Description

SIRS total score

Data type

text

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C2964552

Similar models

Wound or lesion details, SIRS score

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Wound or lesion details
C0043250 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
Item
Left or right side?
integer
C0441987 (UMLS CUI [1,1])
C0043250 (UMLS CUI [1,2])
Code List
Left or right side?
CL Item
Right (1)
CL Item
Left (2)
CL Item
Midline (3)
Item
Front or back of the body?
integer
C1515974 (UMLS CUI [1,1])
C0043250 (UMLS CUI [1,2])
Code List
Front or back of the body?
CL Item
Front (1)
CL Item
Back (2)
Item
Wound in the front
integer
C0043250 (UMLS CUI [1,1])
C0205094 (UMLS CUI [1,2])
Code List
Wound in the front
CL Item
Face neck  (1)
CL Item
Anterior trunk  (2)
CL Item
Genitalia  (3)
CL Item
Arms  (4)
CL Item
Forearms  (5)
CL Item
Palms  (6)
CL Item
Thighs  (7)
CL Item
Knees (8)
CL Item
Legs  (9)
CL Item
Feet (dorsal)  (10)
CL Item
Fingers (11)
Item
Wound in the back
integer
C0043250 (UMLS CUI [1,1])
C0205095 (UMLS CUI [1,2])
Code List
Wound in the back
CL Item
Scalp neck  (1)
CL Item
Back  (2)
CL Item
Buttocks  (3)
CL Item
Arms  (4)
CL Item
Elbow  (5)
CL Item
Forearms  (6)
CL Item
Hand (dorsal)  (7)
CL Item
Thighs  (8)
CL Item
Legs (9)
CL Item
Soles  (10)
CL Item
Fingers (11)
CL Item
Toes (12)
Wound length
Item
Wound length
float
C0043250 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Wound width
Item
Wound width
float
C0043250 (UMLS CUI [1,1])
C0487742 (UMLS CUI [1,2])
Wound area
Item
Wound area
text
C3534343 (UMLS CUI [1])
Item Group
SIRS score
C0243026 (UMLS CUI-1)
C2964552 (UMLS CUI-2)
SIRS total score
Item
SIRS total score
text
C0243026 (UMLS CUI [1,1])
C2964552 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial