ID

35420

Descrição

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

Palavras-chave

  1. 04/03/2019 04/03/2019 -
  2. 08/03/2019 08/03/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

4 de março de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

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
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

text

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

Non-Serious Adverse Events

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

Event Diagnosis, non-serious AE

Tipo de dados

text

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

day month year

Tipo de dados

date

Alias
UMLS CUI [1]
C2697888
Outcome of AE
Descrição

Outcome of AE

Tipo de dados

integer

Alias
UMLS CUI [1]
C1705586
Stop Date of AE
Descrição

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

Tipo de dados

date

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

Maximum Intensity

Tipo de dados

integer

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

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

Tipo de dados

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?
Descrição

Withdraw

Tipo de dados

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?
Descrição

Relationship to investigational products

Tipo de dados

text

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

Similar models

Non-Serious Adverse Events

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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)
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Event Diagnosis Only (if known) Otherwise Sign/Symptom
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
Stop 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)

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

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