ID
35549
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 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
Keywords
Versions (2)
- 3/4/19 3/4/19 -
- 3/8/19 3/8/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
March 8, 2019
DOI
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License
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
- StudyEvent: ODM
Description
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Description
Event Diagnosis, non-serious AE
Data type
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C1518404
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2697888
Description
Outcome of AE
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
day month year. Fill in if there is a recovered/resolved or recovered/resolved with sequelae non-serious AE.
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0877248
Description
Record maximum intensity throughout duration of event.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1518404
Description
Action Taken with Investigational Product(s) as a Result of the AE
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1518404
Description
Withdraw
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1518404
Description
Use best judgment at initial entry. May be amended when additional information becomes available.
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Similar models
Non-Serious Adverse Events
- StudyEvent: ODM
C1518404 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
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