ID
43964
Beschrijving
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
Trefwoorden
Versies (2)
- 30-07-17 30-07-17 -
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 september 2021
DOI
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Licentie
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
Beschrijving
SERIOUS ADVERSE EVENTS
Beschrijving
If Yes, record details below.
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Datatype
text
Alias
- UMLS CUI [1]
- C4274690
Beschrijving
Section 1 SERIOUS ADVERSE EVENTS
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom e.g., Headache
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
adverse event start date
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2697888
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
If fatal, record date of death.
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2697886
Beschrijving
Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1518404
Beschrijving
Action taken with investigational product
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschrijving
Withdrawal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschrijving
Relationship to investigational products
Datatype
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
Beschrijving
Section 2 Seriousness
Beschrijving
patient dead
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschrijving
life threatening
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826244
Beschrijving
hospitalisation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019993
Beschrijving
disability
Datatype
boolean
Alias
- UMLS CUI [1]
- C0231170
Beschrijving
congenital anomaly
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschrijving
(see definition of SAE)
Datatype
boolean
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
(see definition of SAE)
Datatype
text
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
Section 3 Demography Data
Beschrijving
Section 4 If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Beschrijving
inadvertant administration
Datatype
text
Alias
- UMLS CUI [1]
- C1536055
Beschrijving
ae after readministration of drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0877248
Beschrijving
Section 5 Possible Causes of SAE Other Than lnvestigational Product(s)
Beschrijving
Disease under study
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
(record in Section 6)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Lack of efficacy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0235828
Beschrijving
Withdrawal of investigational product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Beschrijving
(record in Section 8)
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Activity related to study participation
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
other cause sae
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschrijving
other cause sae
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschrijving
Section 6 RELEVANT Medical Conditions
Beschrijving
SAE causation
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschrijving
Onset Date
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0348080
Beschrijving
present at sae
Datatype
text
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Beschrijving
Date of Last Occurrence
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Beschrijving
Section 7 Other RELEVANT Risk Factors
Beschrijving
Section 8 RELEVANT Concomitant Medications
Beschrijving
(Trade Name preferred)
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Dose
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C2348328
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
administration route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
taken prior to study
Datatype
text
Alias
- UMLS CUI [1]
- C2826667
Beschrijving
concomitant medication start date
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
concomitant medication end date
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Ongoing Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
Section 9 Details of lnvestigational Product(s)
Beschrijving
Double-Blind Therapy Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013072
- UMLS CUI [1,2]
- C0808070
Beschrijving
Double-Blind Therapy End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013072
- UMLS CUI [1,2]
- C0806020
Beschrijving
Open-Label Treatment Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C3640652
- UMLS CUI [1,2]
- C0808070
Beschrijving
Open-Label Treatment End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C3640652
- UMLS CUI [1,2]
- C0806020
Beschrijving
Section 10 Details of RELEVANT Assessments
Beschrijving
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])