ID

22467

Beschrijving

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

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  1. 05-06-17 05-06-17 -
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5 juni 2017

DOI

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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

Demography
Beschrijving

Demography

Alias
UMLS CUI-1
C0011298
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0008952
Date of birth
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
Race
Beschrijving

Race

Datatype

integer

Alias
UMLS CUI [1]
C0034510
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Beschrijving

Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Medical conditions
Beschrijving

Medical conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0012634
Blood and lymphatic system disorders
Beschrijving

Check only one response for each system organ class

Datatype

integer

Alias
UMLS CUI [1]
C0851353
Cardiac disorders
Beschrijving

Cardiac disorders

Datatype

integer

Alias
UMLS CUI [1]
C0018799
Ear and labyrinth disorders
Beschrijving

Ear and labyrinth disorders

Datatype

integer

Alias
UMLS CUI [1]
C0851354
Endocrine disorders
Beschrijving

Endocrine disorders

Datatype

integer

Alias
UMLS CUI [1]
C0014130
Eye disorders
Beschrijving

Eye disorders

Datatype

integer

Alias
UMLS CUI [1]
C0015397
Gastrointestinal disorders
Beschrijving

Gastrointestinal disorders

Datatype

integer

Alias
UMLS CUI [1]
C0017178
Hepatobiliary disorders
Beschrijving

Hepatobiliary disorders

Datatype

integer

Alias
UMLS CUI [1]
C0267792
Immune system disorders
Beschrijving

Immune system disorders

Datatype

integer

Alias
UMLS CUI [1]
C1334156
Metabolism and nutrition disorders
Beschrijving

Metabolism and nutrition disorders

Datatype

integer

Alias
UMLS CUI [1]
C0851358
Musculoskeletal and connective tissue disorders
Beschrijving

Musculoskeletal and connective tissue disorders

Datatype

integer

Alias
UMLS CUI [1]
C0263660
Nervous system disorders
Beschrijving

Nervous system disorders

Datatype

integer

Alias
UMLS CUI [1]
C0810273
Psychiatric disorders
Beschrijving

Psychiatric disorders

Datatype

integer

Alias
UMLS CUI [1]
C0004936
Renal and urinary disorders
Beschrijving

Renal and urinary disorders

Datatype

integer

Alias
UMLS CUI [1]
C0042075
Reproductive system and breast disorders
Beschrijving

Reproductive system and breast disorders

Datatype

integer

Alias
UMLS CUI [1]
C0851366
Respiratory, thoracic and mediastinal disorders
Beschrijving

Respiratory, thoracic and mediastinal disorders

Datatype

integer

Alias
UMLS CUI [1]
C0851355
Skin and subcutaneous tissue disorders
Beschrijving

Skin and subcutaneous tissue disorders

Datatype

integer

Alias
UMLS CUI [1]
C0178301
Vascular disorders
Beschrijving

Vascular disorders

Datatype

integer

Alias
UMLS CUI [1]
C0042373
Infections and infestations
Beschrijving

Infections and infestations

Datatype

integer

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0851565
Congenital, familial and genetic disorders
Beschrijving

Congenital, familial and genetic disorders

Datatype

integer

Alias
UMLS CUI [1]
C0851352
General disorders and administration site conditions
Beschrijving

General disorders and administration site conditions

Datatype

integer

Alias
UMLS CUI [1]
C0851362
Injury, poisoning and procedural complications
Beschrijving

Injury, poisoning and procedural complications

Datatype

integer

Alias
UMLS CUI [1]
C0947733
Randomisation
Beschrijving

Randomisation

Alias
UMLS CUI-1
C0034656
Record randomisation number.
Beschrijving

randomisation number

Datatype

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Beschrijving

Date of randomisation

Datatype

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Record the identifying number from the investigational product container dispensed at this visit.
Beschrijving

identifying number investigational product container

Datatype

integer

Alias
UMLS CUI [1]
C0600091
Genital Examination
Beschrijving

Genital Examination

Alias
UMLS CUI-1
C0849001
UMLS CUI-2
C0849002
Was a genital examination performed on the subject?
Beschrijving

Genital Examination

Datatype

text

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

If Yes, complete the following:

Datatype

text

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

other abnormal findings

Datatype

text

Alias
UMLS CUI [1]
C2826636
UMLS CUI [2,1]
C0849001
UMLS CUI [2,2]
C0849002
If Yes, specify:
Beschrijving

specify abnormal findings

Datatype

text

Alias
UMLS CUI [1]
C2826636
UMLS CUI [2,1]
C0849001
UMLS CUI [2,2]
C0849002

Similar models

Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Randomisation Visit

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Demography
C0011298 (UMLS CUI-1)
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])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Code List
Race
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)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Medical conditions
C0262926 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Item
Blood and lymphatic system disorders
integer
C0851353 (UMLS CUI [1])
Code List
Blood and lymphatic system disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Cardiac disorders
integer
C0018799 (UMLS CUI [1])
Code List
Cardiac disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Ear and labyrinth disorders
integer
C0851354 (UMLS CUI [1])
Code List
Ear and labyrinth disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Endocrine disorders
integer
C0014130 (UMLS CUI [1])
Code List
Endocrine disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Eye disorders
integer
C0015397 (UMLS CUI [1])
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Gastrointestinal disorders
integer
C0017178 (UMLS CUI [1])
Code List
Gastrointestinal disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Hepatobiliary disorders
integer
C0267792 (UMLS CUI [1])
Code List
Hepatobiliary disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Immune system disorders
integer
C1334156 (UMLS CUI [1])
Code List
Immune system disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Metabolism and nutrition disorders
integer
C0851358 (UMLS CUI [1])
Code List
Metabolism and nutrition disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Musculoskeletal and connective tissue disorders
integer
C0263660 (UMLS CUI [1])
Code List
Musculoskeletal and connective tissue disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Nervous system disorders
integer
C0810273 (UMLS CUI [1])
Code List
Nervous system disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Psychiatric disorders
integer
C0004936 (UMLS CUI [1])
Code List
Psychiatric disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Renal and urinary disorders
integer
C0042075 (UMLS CUI [1])
Code List
Renal and urinary disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Reproductive system and breast disorders
integer
C0851366 (UMLS CUI [1])
Code List
Reproductive system and breast disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Respiratory, thoracic and mediastinal disorders
integer
C0851355 (UMLS CUI [1])
Code List
Respiratory, thoracic and mediastinal disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Skin and subcutaneous tissue disorders
integer
C0178301 (UMLS CUI [1])
Code List
Skin and subcutaneous tissue disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Vascular disorders
integer
C0042373 (UMLS CUI [1])
Code List
Vascular disorders
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])
Code List
Infections and infestations
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Congenital, familial and genetic disorders
integer
C0851352 (UMLS CUI [1])
Code List
Congenital, familial and genetic disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
General disorders and administration site conditions
integer
C0851362 (UMLS CUI [1])
Code List
General disorders and administration site conditions
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Injury, poisoning and procedural complications
integer
C0947733 (UMLS CUI [1])
Code List
Injury, poisoning and procedural complications
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item Group
Randomisation
C0034656 (UMLS CUI-1)
randomisation number
Item
Record randomisation number.
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
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 Group
Genital Examination
C0849001 (UMLS CUI-1)
C0849002 (UMLS CUI-2)
Item
Was a genital examination performed on the subject?
text
C0849001 (UMLS CUI [1])
C0849002 (UMLS CUI [2])
Code List
Was a genital examination performed on the subject?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any Herpes lesions present?
text
C0744883 (UMLS CUI [1])
Code List
Were any Herpes lesions present?
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])
Code List
Were any other abnormal findings present?
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])

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