ID

22467

Beschreibung

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

Englisch

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

1 Formulare  
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

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

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Medical conditions
Beschreibung

Medical conditions

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

Check only one response for each system organ class

Datentyp

integer

Alias
UMLS CUI [1]
C0851353
Cardiac disorders
Beschreibung

Cardiac disorders

Datentyp

integer

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

Ear and labyrinth disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0851354
Endocrine disorders
Beschreibung

Endocrine disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0014130
Eye disorders
Beschreibung

Eye disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0015397
Gastrointestinal disorders
Beschreibung

Gastrointestinal disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0017178
Hepatobiliary disorders
Beschreibung

Hepatobiliary disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0267792
Immune system disorders
Beschreibung

Immune system disorders

Datentyp

integer

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

Metabolism and nutrition disorders

Datentyp

integer

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

Musculoskeletal and connective tissue disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0263660
Nervous system disorders
Beschreibung

Nervous system disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0810273
Psychiatric disorders
Beschreibung

Psychiatric disorders

Datentyp

integer

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

Renal and urinary disorders

Datentyp

integer

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

Reproductive system and breast disorders

Datentyp

integer

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

Respiratory, thoracic and mediastinal disorders

Datentyp

integer

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

Skin and subcutaneous tissue disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0178301
Vascular disorders
Beschreibung

Vascular disorders

Datentyp

integer

Alias
UMLS CUI [1]
C0042373
Infections and infestations
Beschreibung

Infections and infestations

Datentyp

integer

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

Congenital, familial and genetic disorders

Datentyp

integer

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

General disorders and administration site conditions

Datentyp

integer

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

Injury, poisoning and procedural complications

Datentyp

integer

Alias
UMLS CUI [1]
C0947733
Randomisation
Beschreibung

Randomisation

Alias
UMLS CUI-1
C0034656
Record randomisation number.
Beschreibung

randomisation number

Datentyp

integer

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

Date of randomisation

Datentyp

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.
Beschreibung

identifying number investigational product container

Datentyp

integer

Alias
UMLS CUI [1]
C0600091
Genital Examination
Beschreibung

Genital Examination

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

Genital Examination

Datentyp

text

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

If Yes, complete the following:

Datentyp

text

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

other abnormal findings

Datentyp

text

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

specify abnormal findings

Datentyp

text

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

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
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])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
Code List
Cardiac disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Ear and labyrinth disorders
integer
C0851354 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Ear and labyrinth disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Endocrine disorders
integer
C0014130 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Endocrine disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Eye disorders
integer
C0015397 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Eye disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Gastrointestinal disorders
integer
C0017178 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Gastrointestinal disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Hepatobiliary disorders
integer
C0267792 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Hepatobiliary disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Immune system disorders
integer
C1334156 (UMLS CUI [1])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
Code List
Nervous system disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Psychiatric disorders
integer
C0004936 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Psychiatric disorders
CL Item
Current (1)
CL Item
No Medical Condition (2)
Item
Renal and urinary disorders
integer
C0042075 (UMLS CUI [1])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
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])
Blood and lymphatic system disorders
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])
Genital Examination
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])
genital herpes lesions
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])
Genital Examination
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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