ID

35588

Beschrijving

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 form. It has to be filled for screening.

Link

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

Trefwoorden

  1. 04-03-19 04-03-19 -
  2. 11-03-19 11-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 maart 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Vital signs

  1. StudyEvent: ODM
    1. Vital signs
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Vital signs
Beschrijving

Vital signs

Alias
UMLS CUI-1
C0518766
Actual date
Beschrijving

day month year

Datatype

date

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

Body Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body Weight
Beschrijving

Body Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure: systolic
Beschrijving

Blood pressure: systolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure: diastolic
Beschrijving

Blood pressure: diastolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body Temperature
Beschrijving

Body Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Beschrijving

Location of temperature

Datatype

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687

Similar models

Vital signs

  1. StudyEvent: ODM
    1. Vital signs
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (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)

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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