ID
43964
Description
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
Mots-clés
Versions (2)
- 30/07/2017 30/07/2017 -
- 20/09/2021 20/09/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
20 septembre 2021
DOI
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Licence
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
Description
SERIOUS ADVERSE EVENTS
Description
If Yes, record details below.
Type de données
text
Alias
- UMLS CUI [1]
- C1519255
Description
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Type de données
text
Alias
- UMLS CUI [1]
- C4274690
Description
Section 1 SERIOUS ADVERSE EVENTS
Description
Diagnosis Only (if known) Otherwise Sign/Symptom e.g., Headache
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
adverse event start date
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2697888
Description
Outcome
Type de données
integer
Alias
- UMLS CUI [1]
- C1705586
Description
If fatal, record date of death.
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2697886
Description
Maximum Intensity
Type de données
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1518404
Description
Action taken with investigational product
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Withdrawal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Description
Relationship to investigational products
Type de données
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
Description
Section 2 Seriousness
Description
patient dead
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011065
Description
life threatening
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826244
Description
hospitalisation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0019993
Description
disability
Type de données
boolean
Alias
- UMLS CUI [1]
- C0231170
Description
congenital anomaly
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826727
Description
(see definition of SAE)
Type de données
boolean
Alias
- UMLS CUI [1]
- C1710056
Description
(see definition of SAE)
Type de données
text
Alias
- UMLS CUI [1]
- C1710056
Description
Section 3 Demography Data
Description
Section 4 If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Description
inadvertant administration
Type de données
text
Alias
- UMLS CUI [1]
- C1536055
Description
ae after readministration of drug
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0877248
Description
Section 5 Possible Causes of SAE Other Than lnvestigational Product(s)
Description
Disease under study
Type de données
boolean
Alias
- UMLS CUI [1]
- C0012634
Description
(record in Section 6)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0012634
Description
Lack of efficacy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0235828
Description
Withdrawal of investigational product
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Description
(record in Section 8)
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Activity related to study participation
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
other cause sae
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Description
other cause sae
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Description
Section 6 RELEVANT Medical Conditions
Description
SAE causation
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Description
Onset Date
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0348080
Description
present at sae
Type de données
text
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Description
Date of Last Occurrence
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Description
Section 7 Other RELEVANT Risk Factors
Description
Section 8 RELEVANT Concomitant Medications
Description
(Trade Name preferred)
Type de données
text
Alias
- UMLS CUI [1]
- C0013227
Description
Dose
Type de données
text
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Type de données
text
Alias
- UMLS CUI [1]
- C2348328
Description
Frequency
Type de données
text
Alias
- UMLS CUI [1]
- C3476109
Description
administration route
Type de données
text
Alias
- UMLS CUI [1]
- C0013153
Description
taken prior to study
Type de données
text
Alias
- UMLS CUI [1]
- C2826667
Description
concomitant medication start date
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2826734
Description
concomitant medication end date
Type de données
date
Unités de mesure
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2826744
Description
Ongoing Medication
Type de données
text
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Section 9 Details of lnvestigational Product(s)
Description
Double-Blind Therapy Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013072
- UMLS CUI [1,2]
- C0808070
Description
Double-Blind Therapy End Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013072
- UMLS CUI [1,2]
- C0806020
Description
Open-Label Treatment Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C3640652
- UMLS CUI [1,2]
- C0808070
Description
Open-Label Treatment End Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C3640652
- UMLS CUI [1,2]
- C0806020
Description
Section 10 Details of RELEVANT Assessments
Description
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])