ID

35402

Beskrivning

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 Vital signs and medical conditions form. It has to be filled for screening.

Länk

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

Nyckelord

  1. 04/03/2019 04/03/2019 -
  2. 11/03/2019 11/03/2019 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 de março de 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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

Vital signs, medical conditions

Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Actual date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Body Height
Beskrivning

Body Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body Weight
Beskrivning

Body Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure: systolic
Beskrivning

Blood pressure: systolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure: diastolic
Beskrivning

Blood pressure: diastolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body Temperature
Beskrivning

Body Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Beskrivning

Location of temperature

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Medical conditions (other)
Beskrivning

Medical conditions (other)

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0205394
Specific condition
Beskrivning

Specific condition

Datatyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Medical history or condition status
Beskrivning

Medical history

Datatyp

integer

Alias
UMLS CUI [1]
C0262926

Similar models

Vital signs, medical conditions

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Actual date
Item
Actual date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Blood pressure: systolic
Item
Blood pressure: systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure: diastolic
Item
Blood pressure: diastolic
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
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Code List
Location of temperature
CL Item
Oral (1)
CL Item
Rectal (2)
CL Item
Axilla (3)
CL Item
Tympanic (4)
CL Item
Intra-arterial (5)
CL Item
Core (6)
Item Group
Medical conditions (other)
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Specific condition
Item
Specific condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Medical history or condition status
integer
C0262926 (UMLS CUI [1])
Code List
Medical history or condition status
CL Item
Current (1)
CL Item
Past (2)

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