ID

21979

Beskrivning

The GlaxoSmithKline group of companies Condensed Clinical Study Report for Study HS2100181 (Phase IV) An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count <100 cells/mm3 Initiation Date: 19 May 2004 Early Termination Date: 14 Sep 2004 Date of Report: July 2005

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  1. 2017-05-12 2017-05-12 -
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12 maj 2017

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Medical History GlaxoSmithKline Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons

Engelsk

Medical History GlaxoSmithKline Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons

1 Formulär  
Study administration
Beskrivning

Study administration

Subject Identifier
Beskrivning

subject identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
History of Herpes Infections
Beskrivning

History of Herpes Infections

Date of initial episode of genital herpes
Beskrivning

herpes onset

Datatyp

date

Måttenheter
  • MMM-YYYY
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0019342
MMM-YYYY
Has the subject received chronic suppressive anti-herpetic therapy within the previous 12 months?
Beskrivning

herpes treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0319232
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C3843288
If No, what was the approximate number of genital Herpes recurrences in the previous 12 months?
Beskrivning

genital herpes recurrences

Datatyp

integer

Alias
UMLS CUI [1,1]
C0019342
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0449788
Date of most recent suppressive therapy period: From
Beskrivning

If Yes, complete the following:

Datatyp

date

Alias
UMLS CUI [1,1]
C0319232
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C0808070
To
Beskrivning

If Yes, complete the following:

Datatyp

date

Alias
UMLS CUI [1,1]
C0319232
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C0806020
What was the approximate number of genital Herpes recurrences in the 12 months Prior to initiating suppressive therapy?
Beskrivning

If yes, complete the following:

Datatyp

integer

Alias
UMLS CUI [1,1]
C0019342
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0319232
UMLS CUI [1,5]
C0013216
Has the subject ever had herpes infections in the oral area?
Beskrivning

oral herpes

Datatyp

boolean

Alias
UMLS CUI [1]
C0341012
Has the subject ever had herpes infections in any other non-genital/non-oral areas?
Beskrivning

non-genital/non-oral herpes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019348
UMLS CUI [1,2]
C0205394
If Yes, specify:
Beskrivning

specify non-genital/non-oral herpes

Datatyp

text

Alias
UMLS CUI [1,1]
C0019348
UMLS CUI [1,2]
C0205394
Genital Examination
Beskrivning

Genital Examination

Was a genital examination performed on the subject?
Beskrivning

Genital Examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0849001
UMLS CUI [2]
C0849002
Were any Herpes lesions present?
Beskrivning

If Yes, complete the following:

Datatyp

boolean

Alias
UMLS CUI [1]
C0744883
Were any other abnormal findings present?
Beskrivning

other abnormal findings

Datatyp

boolean

Alias
UMLS CUI [1]
C2826636
If Yes, specify:
Beskrivning

specify other abnormal findings

Datatyp

text

Alias
UMLS CUI [1]
C2826636
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Similar models

Medical History GlaxoSmithKline Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Study administration
subject identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
History of Herpes Infections
herpes onset
Item
Date of initial episode of genital herpes
date
C0574845 (UMLS CUI [1,1])
C0019342 (UMLS CUI [1,2])
herpes treatment
Item
Has the subject received chronic suppressive anti-herpetic therapy within the previous 12 months?
boolean
C0319232 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C3843288 (UMLS CUI [1,3])
genital herpes recurrences
Item
If No, what was the approximate number of genital Herpes recurrences in the previous 12 months?
integer
C0019342 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
suppressive therapy start date
Item
Date of most recent suppressive therapy period: From
date
C0319232 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
suppressive therapy end date
Item
To
date
C0319232 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
herpes recurrences prior to therapy
Item
What was the approximate number of genital Herpes recurrences in the 12 months Prior to initiating suppressive therapy?
integer
C0019342 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0319232 (UMLS CUI [1,4])
C0013216 (UMLS CUI [1,5])
oral herpes
Item
Has the subject ever had herpes infections in the oral area?
boolean
C0341012 (UMLS CUI [1])
non-genital/non-oral herpes
Item
Has the subject ever had herpes infections in any other non-genital/non-oral areas?
boolean
C0019348 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
specify non-genital/non-oral herpes
Item
If Yes, specify:
text
C0019348 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Genital Examination
Genital Examination
Item
Was a genital examination performed on the subject?
boolean
C0849001 (UMLS CUI [1])
C0849002 (UMLS CUI [2])
genital herpes lesions
Item
Were any Herpes lesions present?
boolean
C0744883 (UMLS CUI [1])
other abnormal findings
Item
Were any other abnormal findings present?
boolean
C2826636 (UMLS CUI [1])
specify other abnormal findings
Item
If Yes, specify:
text
C2826636 (UMLS CUI [1])
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