ID

35549

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 Non-Serious Adverse Events form. It has to be filled in if a non-serious adverse event occurs during study.

Link

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

Trefwoorden

  1. 04-03-19 04-03-19 -
  2. 08-03-19 08-03-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

8 maart 2019

DOI

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Licentie

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

Non-Serious Adverse Events

Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Beschrijving

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Beschrijving

Event Diagnosis, non-serious AE

Datatype

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1518404
Start Date of AE
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C2697888
Outcome of AE
Beschrijving

Outcome of AE

Datatype

integer

Alias
UMLS CUI [1]
C1705586
End Date of AE
Beschrijving

day month year. Fill in if there is a recovered/resolved or recovered/resolved with sequelae non-serious AE.

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0877248
Maximum Intensity of AE
Beschrijving

Record maximum intensity throughout duration of event.

Datatype

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Action Taken with Investigational Product(s) as a Result of the AE
Beschrijving

Action Taken with Investigational Product(s) as a Result of the AE

Datatype

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschrijving

Withdraw

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Use best judgment at initial entry. May be amended when additional information becomes available.

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849

Similar models

Non-Serious Adverse Events

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])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Event Diagnosis, non-serious AE
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start Date of AE
Item
Start Date of AE
date
C2697888 (UMLS CUI [1])
Item
Outcome of AE
integer
C1705586 (UMLS CUI [1])
Code List
Outcome of AE
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Stop Date of AE
Item
End Date of AE
date
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Maximum Intensity of AE
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Maximum Intensity of AE
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe  (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Item
Did the subject withdraw from study as a result of this AE?
text
C2349954 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)

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