ID

21979

Description

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

Keywords

  1. 5/12/17 5/12/17 -
Uploaded on

May 12, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

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

Study administration
Description

Study administration

Subject Identifier
Description

subject identifier

Data type

integer

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

History of Herpes Infections

Date of initial episode of genital herpes
Description

herpes onset

Data type

date

Measurement units
  • 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?
Description

herpes treatment

Data type

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?
Description

genital herpes recurrences

Data type

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
Description

If Yes, complete the following:

Data type

date

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

If Yes, complete the following:

Data type

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?
Description

If yes, complete the following:

Data type

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?
Description

oral herpes

Data type

boolean

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

non-genital/non-oral herpes

Data type

boolean

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

specify non-genital/non-oral herpes

Data type

text

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

Genital Examination

Was a genital examination performed on the subject?
Description

Genital Examination

Data type

boolean

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

If Yes, complete the following:

Data type

boolean

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

other abnormal findings

Data type

boolean

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

specify other abnormal findings

Data type

text

Alias
UMLS CUI [1]
C2826636

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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