ID
24406
Beskrivning
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
Nyckelord
Versioner (2)
- 2017-07-30 2017-07-30 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
30 juli 2017
DOI
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Licens
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 SERIOUS ADVERSE EVENTS NCT00079911
GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons SERIOUS ADVERSE EVENTS NCT00079911
Beskrivning
SERIOUS ADVERSE EVENTS
Beskrivning
If Yes, record details below.
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Datatyp
text
Alias
- UMLS CUI [1]
- C3656695
Beskrivning
Section 1 SERIOUS ADVERSE EVENTS
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom e.g., Headache
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
adverse event start date
Datatyp
date
Måttenheter
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
Outcome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
If fatal, record date of death.
Datatyp
date
Måttenheter
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2697886
Beskrivning
Maximum Intensity
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1518404
Beskrivning
Action taken with investigational product
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
Withdrawal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beskrivning
Relationship to investigational products
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
Beskrivning
Section 2 Seriousness
Beskrivning
patient dead
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beskrivning
life threatening
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826244
Beskrivning
hospitalisation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019993
Beskrivning
disability
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0231170
Beskrivning
congenital anomaly
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826727
Beskrivning
(see definition of SAE)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1710056
Beskrivning
(see definition of SAE)
Datatyp
text
Alias
- UMLS CUI [1]
- C1710056
Beskrivning
Section 3 Demography Data
Beskrivning
Section 4 If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Beskrivning
inadvertant administration
Datatyp
text
Alias
- UMLS CUI [1]
- C1536055
Beskrivning
ae after readministration of drug
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0877248
Beskrivning
Section 5 Possible Causes of SAE Other Than lnvestigational Product(s)
Beskrivning
Disease under study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0012634
Beskrivning
(record in Section 6)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0012634
Beskrivning
Lack of efficacy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0235828
Beskrivning
Withdrawal of investigational product
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Beskrivning
(record in Section 8)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Activity related to study participation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beskrivning
other cause sae
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beskrivning
other cause sae
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beskrivning
Section 6 RELEVANT Medical Conditions
Beskrivning
SAE causation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beskrivning
Onset Date
Datatyp
date
Måttenheter
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0348080
Beskrivning
present at sae
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Beskrivning
Date of Last Occurrence
Datatyp
date
Måttenheter
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Beskrivning
Section 7 Other RELEVANT Risk Factors
Beskrivning
Section 8 RELEVANT Concomitant Medications
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C2348328
Beskrivning
Frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
administration route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
taken prior to study
Datatyp
text
Alias
- UMLS CUI [1]
- C2826667
Beskrivning
concomitant medication start date
Datatyp
date
Måttenheter
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
concomitant medication end date
Datatyp
date
Måttenheter
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Ongoing Medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
Section 9 Details of lnvestigational Product(s)
Beskrivning
Double-Blind Therapy Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013072
- UMLS CUI [1,2]
- C0808070
Beskrivning
Double-Blind Therapy End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013072
- UMLS CUI [1,2]
- C0806020
Beskrivning
Open-Label Treatment Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3640652
- UMLS CUI [1,2]
- C0808070
Beskrivning
Open-Label Treatment End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3640652
- UMLS CUI [1,2]
- C0806020
Beskrivning
Section 10 Details of RELEVANT Assessments
Beskrivning
Section 11 Narrative Remarks
Similar models
GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons SERIOUS ADVERSE EVENTS NCT00079911
C0019994 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0348080 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])