ID

22469

Description

Study ID: 100273 Clinical Study ID: HS2100273 Study Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter 60-Day Study Comparing the Efficacy of Valtrex 1 Gram Once Daily vs. Placebo Once Daily in Reducing Viral Shedding in Immunocompetent Subjects with Recurrent HSV-2 Genital Herpes Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Herpes Genitalis Visit description: Non-Serious Adverse Event

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Versions (1)
  1. 05/06/2017 05/06/2017 -
Téléchargé le

5 juin 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Non-Serious Adverse Event

Anglais

Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Non-Serious Adverse Event

1 Formulaires  
Non-serious Adverse Events
Description

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Description

If YES, record details below

Type de données

text

Alias
UMLS CUI [1]
C1518404
Non-serious adverse events: Diagnosis only (if known) or signs / symptoms
Description

Non-serious adverse event

Type de données

text

Alias
UMLS CUI [1]
C1518404
Start Date
Description

Start Date

Type de données

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Outcome
Description

Outcome

Type de données

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
End Date
Description

End Date

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Intensity
Description

Maximum Intensity

Type de données

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Action taken with investigational product(s) as a result of the non-serious AE
Description

Action taken with investigational product

Type de données

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did subject withdraw from study as a result of this non-serious AE?
Description

Withdrawal

Type de données

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
Description

Relationship to investigational product(s)

Type de données

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
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Similar models

Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Non-Serious Adverse Event

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Withdrawal
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
Not applicable (4)
Non-serious adverse event
Item
Non-serious adverse events: Diagnosis only (if known) or signs / symptoms
text
C1518404 (UMLS CUI [1])
Start Date
Item
Start Date
text
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved/Recovered (1)
CL Item
Resolving/Recovering (2)
CL Item
Not resolved (3)
CL Item
Resolved/Recovered with sequelae (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Maximum Intensity
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 non-serious AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action taken with investigational product
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose interrupted (4)
CL Item
Not applicable (6)
Item
Did subject withdraw from study as a result of this non-serious AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Did subject withdraw from study as a result of this non-serious AE?
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
Not applicable (4)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Withdrawal
Code List
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
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