ID
43964
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 (2)
- 30.07.17 30.07.17 -
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
20. September 2021
DOI
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Lizenz
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
Beschreibung
SERIOUS ADVERSE EVENTS
Beschreibung
If Yes, record details below.
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Datentyp
text
Alias
- UMLS CUI [1]
- C4274690
Beschreibung
Section 1 SERIOUS ADVERSE EVENTS
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom e.g., Headache
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
adverse event start date
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2697888
Beschreibung
Outcome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
If fatal, record date of death.
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2697886
Beschreibung
Maximum Intensity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1518404
Beschreibung
Action taken with investigational product
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschreibung
Withdrawal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschreibung
Relationship to investigational products
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
Beschreibung
Section 2 Seriousness
Beschreibung
patient dead
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschreibung
life threatening
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826244
Beschreibung
hospitalisation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019993
Beschreibung
disability
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0231170
Beschreibung
congenital anomaly
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschreibung
(see definition of SAE)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1710056
Beschreibung
(see definition of SAE)
Datentyp
text
Alias
- UMLS CUI [1]
- C1710056
Beschreibung
Section 3 Demography Data
Beschreibung
Section 4 If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Beschreibung
inadvertant administration
Datentyp
text
Alias
- UMLS CUI [1]
- C1536055
Beschreibung
ae after readministration of drug
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0877248
Beschreibung
Section 5 Possible Causes of SAE Other Than lnvestigational Product(s)
Beschreibung
Disease under study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
(record in Section 6)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Lack of efficacy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0235828
Beschreibung
Withdrawal of investigational product
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Beschreibung
(record in Section 8)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Activity related to study participation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
other cause sae
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschreibung
other cause sae
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschreibung
Section 6 RELEVANT Medical Conditions
Beschreibung
SAE causation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschreibung
Onset Date
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0348080
Beschreibung
present at sae
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Beschreibung
Date of Last Occurrence
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Beschreibung
Section 7 Other RELEVANT Risk Factors
Beschreibung
Section 8 RELEVANT Concomitant Medications
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Dose
Datentyp
text
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C2348328
Beschreibung
Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
administration route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
taken prior to study
Datentyp
text
Alias
- UMLS CUI [1]
- C2826667
Beschreibung
concomitant medication start date
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
concomitant medication end date
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Ongoing Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
Section 9 Details of lnvestigational Product(s)
Beschreibung
Double-Blind Therapy Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013072
- UMLS CUI [1,2]
- C0808070
Beschreibung
Double-Blind Therapy End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013072
- UMLS CUI [1,2]
- C0806020
Beschreibung
Open-Label Treatment Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3640652
- UMLS CUI [1,2]
- C0808070
Beschreibung
Open-Label Treatment End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3640652
- UMLS CUI [1,2]
- C0806020
Beschreibung
Section 10 Details of RELEVANT Assessments
Beschreibung
Section 11 Narrative Remarks
Ähnliche Modelle
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])