ID

24393

Beschreibung

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

Stichworte

Versionen (1)
  1. 30.07.17 30.07.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

30. Juli 2017

DOI

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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 NON SERIOUS ADVERSE EVENTS NCT00079911

Englisch

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons NON SERIOUS ADVERSE EVENTS NCT00079911

1 Formulare  
Study administration
Beschreibung

Study administration

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
NON SERIOUS ADVERSE EVENTS
Beschreibung

NON SERIOUS ADVERSE EVENTS

Did the subject experience any non-serious adverse events during the study?
Beschreibung

If Yes, record details below.

Datentyp

text

Alias
UMLS CUI [1]
C0877248
NON SERIOUS ADVERSE EVENTS
Beschreibung

NON SERIOUS ADVERSE EVENTS

Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom e.g., Headache

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Start Date
Beschreibung

adverse event start date

Datentyp

date

Maßeinheiten
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2697888
DD/MMM/YY
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
End Date
Beschreibung

adverse event end date

Datentyp

date

Maßeinheiten
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2697886
DD/MMM/YY
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Action taken with investigational product(s) as a result of the non-serious AE
Beschreibung

Action taken with investigational product

Datentyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschreibung

Withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship to investigational products

Datentyp

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
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Ähnliche Modelle

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons NON SERIOUS ADVERSE EVENTS NCT00079911

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Study administration
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
NON SERIOUS ADVERSE EVENTS
Item
Did the subject experience any non-serious adverse events during the study?
text
C0877248 (UMLS CUI [1])
adverse event
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
NON SERIOUS ADVERSE EVENTS
Event
Item
Event
text
C0877248 (UMLS CUI [1])
adverse event start date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
adverse event end date
Item
End Date
date
C2697886 (UMLS CUI [1])
Item
Maximum Intensity
text
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action taken with investigational product(s) as a result of the non-serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action taken with investigational product
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
Investigational Product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
adverse event
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
adverse event
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
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