ID

24555

Descripción

NCT00079911 Study ID 100181 Clinical Study ID HS2100181 Study Title: 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. Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00079911 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Terminated Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Genital Herpes; HIV infection

Palabras clave

Versiones (1)
  1. 6/8/17 6/8/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

6 de agosto de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons Subject Diary NCT00079911

Inglés

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons Subject Diary NCT00079911

1 formularios  
Subject Diary
Descripción

Subject Diary

Month number
Descripción

Month

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439231
Subject Number
Descripción

Subject ID

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date Diary Card Dispensed:
Descripción

Date Diary Card Dispensed

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2987124
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C1115441
Date of Next Clinic Visit
Descripción

Date of Next Clinic Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C2735342
Genital Herpes Recurrences
Descripción

Genital Herpes Recurrences

Date of Onset
Descripción

Date of Onset

Tipo de datos

date

Unidades de medida
  • day month year
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1274323
day month year
Was home viral swab obtained?
Descripción

viral swab

Tipo de datos

text

Alias
UMLS CUI [1]
C0563454
Oral/Other Herpes Recurrences
Descripción

Oral/Other Herpes Recurrences

Date of Onset
Descripción

date of onset

Tipo de datos

date

Unidades de medida
  • day month year
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1274323
day month year
Location
Descripción

location

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0744883
If Other, specify:
Descripción

If Other, specify

Tipo de datos

text

Alias
UMLS CUI [1]
C0449685
lnvestigational Product
Descripción

lnvestigational Product

Date
Descripción

date tablets missed

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1709043
Number of caplets/tablets missed
Descripción

tablets missed

Tipo de datos

integer

Alias
UMLS CUI [1]
C1709043
Record Any Adverse Events / Illnesses
Descripción

Record Any Adverse Events / Illnesses

Start Date
Descripción

ae start date

Tipo de datos

date

Alias
UMLS CUI [1]
C2697888
End Date
Descripción

ae end date

Tipo de datos

date

Alias
UMLS CUI [1]
C2697886
Adverse Event/Illnesses
Descripción

Adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Medication Record
Descripción

Medication Record

Start Date
Descripción

medication start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0808070
Stop Date
Descripción

medication end date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0806020
Name of Medication
Descripción

medication

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
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Similar models

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons Subject Diary NCT00079911

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Subject Diary
Month
Item
Month number
integer
C0439231 (UMLS CUI [1])
Subject ID
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date Diary Card Dispensed
Item
Date Diary Card Dispensed:
date
C2987124 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C1115441 (UMLS CUI [1,3])
Date of Next Clinic Visit
Item
Date of Next Clinic Visit
date
C2735342 (UMLS CUI [1])
Item Group
Genital Herpes Recurrences
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1274323 (UMLS CUI [1,2])
Item
Was home viral swab obtained?
text
C0563454 (UMLS CUI [1])
viral swab
Code List
Was home viral swab obtained?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Oral/Other Herpes Recurrences
date of onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1274323 (UMLS CUI [1,2])
Item
Location
integer
C0450429 (UMLS CUI [1,1])
C0744883 (UMLS CUI [1,2])
location
Code List
Location
CL Item
Oral (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify:
text
C0449685 (UMLS CUI [1])
Item Group
lnvestigational Product
date tablets missed
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1709043 (UMLS CUI [1,2])
tablets missed
Item
Number of caplets/tablets missed
integer
C1709043 (UMLS CUI [1])
Item Group
Record Any Adverse Events / Illnesses
ae start date
Item
Start Date
date
C2697888 (UMLS CUI [1])
ae end date
Item
End Date
date
C2697886 (UMLS CUI [1])
Adverse event
Item
Adverse Event/Illnesses
text
C0877248 (UMLS CUI [1])
Item Group
Medication Record
medication start date
Item
Start Date
date
C1521826 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
medication end date
Item
Stop Date
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
medication
Item
Name of Medication
text
C0013227 (UMLS CUI [1])
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