Information:
Fel:
ID
22467
Beskrivning
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: Randomisation Visit
Nyckelord
Versioner (1)
- 2017-06-05 2017-06-05 -
Uppladdad den
5 juni 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Randomisation Visit
Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Randomisation Visit
Similar models
Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Randomisation Visit
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C0011008 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
American Hispanic (1)
CL Item
Arabic/North African (2)
CL Item
Black (3)
CL Item
East and South East Asian (4)
CL Item
Japanese (5)
CL Item
South Asian (6)
CL Item
White/Caucasian (7)
CL Item
Other (8)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Blood and lymphatic system disorders
integer
C0851353 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Metabolism and nutrition disorders
integer
C0851358 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Musculoskeletal and connective tissue disorders
integer
C0263660 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Reproductive system and breast disorders
integer
C0851366 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Respiratory, thoracic and mediastinal disorders
integer
C0851355 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Skin and subcutaneous tissue disorders
integer
C0178301 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical Condition (2)
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Infections and infestations
integer
C0009450 (UMLS CUI [1,1])
C0851565 (UMLS CUI [1,2])
C0851565 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Congenital, familial and genetic disorders
integer
C0851352 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
General disorders and administration site conditions
integer
C0851362 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Injury, poisoning and procedural complications
integer
C0947733 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical Condition (2)
randomisation number
Item
Record randomisation number.
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
identifying number investigational product container
Item
Record the identifying number from the investigational product container dispensed at this visit.
integer
C0600091 (UMLS CUI [1])
Item
Was a genital examination performed on the subject?
text
C0849001 (UMLS CUI [1])
C0849002 (UMLS CUI [2])
C0849002 (UMLS CUI [2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any other abnormal findings present?
text
C2826636 (UMLS CUI [1])
C0849001 (UMLS CUI [2,1])
C0849002 (UMLS CUI [2,2])
C0849001 (UMLS CUI [2,1])
C0849002 (UMLS CUI [2,2])
CL Item
Yes (Y)
CL Item
No (N)
specify abnormal findings
Item
If Yes, specify:
text
C2826636 (UMLS CUI [1])
C0849001 (UMLS CUI [2,1])
C0849002 (UMLS CUI [2,2])
C0849001 (UMLS CUI [2,1])
C0849002 (UMLS CUI [2,2])