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

Keywords

Versions (2)
  1. 7/30/17 7/30/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

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

English

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

1 forms  
Study administration
Description

Study administration

Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Description

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
SERIOUS ADVERSE EVENTS
Description

SERIOUS ADVERSE EVENTS

Did the subject experience a serious adverse event during the study?
Description

If Yes, record details below.

Data type

text

Alias
UMLS CUI [1]
C1519255
If fatal, was a post-mortem/autopsy performed
Description

If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.

Data type

text

Alias
UMLS CUI [1]
C4274690
Section 1 SERIOUS ADVERSE EVENTS
Description

Section 1 SERIOUS ADVERSE EVENTS

Event
Description

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

Data type

text

Alias
UMLS CUI [1]
C0877248
Start Date
Description

adverse event start date

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2697888
DD/MMM/YY
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
End Date
Description

If fatal, record date of death.

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2697886
DD/MMM/YY
Maximum Intensity
Description

Maximum Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Action taken with investigational product(s) as a result of the SAE
Description

Action taken with investigational product

Data type

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE?
Description

Withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Description

Relationship to investigational products

Data type

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Section 2 Seriousness
Description

Section 2 Seriousness

[A] Results in death
Description

patient dead

Data type

boolean

Alias
UMLS CUI [1]
C0011065
[B] Is life-threatening
Description

life threatening

Data type

boolean

Alias
UMLS CUI [1]
C2826244
[C] Requires hospitalisation or prolongation of existing hospitalisation
Description

hospitalisation

Data type

boolean

Alias
UMLS CUI [1]
C0019993
[D] Results in disability/incapacity
Description

disability

Data type

boolean

Alias
UMLS CUI [1]
C0231170
[E] Congenital anomaly/birth defect
Description

congenital anomaly

Data type

boolean

Alias
UMLS CUI [1]
C2826727
[F] Other, specify
Description

(see definition of SAE)

Data type

boolean

Alias
UMLS CUI [1]
C1710056
[F] Other, specify
Description

(see definition of SAE)

Data type

text

Alias
UMLS CUI [1]
C1710056
Section 3 Demography Data
Description

Section 3 Demography Data

Date of birth
Description

Date of birth

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C0421451
DD/MMM/YY
Sex
Description

Sex

Data type

integer

Alias
UMLS CUI [1]
C0079399
Weight
Description

Weight

Data type

float

Alias
UMLS CUI [1]
C0005910
Section 4 If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Description

Section 4 If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?

If deliberate or inadvertant administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Description

inadvertant administration

Data type

text

Alias
UMLS CUI [1]
C1536055
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Description

ae after readministration of drug

Data type

integer

Alias
UMLS CUI [1,1]
C0376495
UMLS CUI [1,2]
C0877248
Section 5 Possible Causes of SAE Other Than lnvestigational Product(s)
Description

Section 5 Possible Causes of SAE Other Than lnvestigational Product(s)

Disease under study
Description

Disease under study

Data type

boolean

Alias
UMLS CUI [1]
C0012634
Medical condition(s)
Description

(record in Section 6)

Data type

boolean

Alias
UMLS CUI [1]
C0012634
Lack of efficacy
Description

Lack of efficacy

Data type

boolean

Alias
UMLS CUI [1]
C0235828
Withdrawal of investigational products
Description

Withdrawal of investigational product

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant medication
Description

(record in Section 8)

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Activity related to study participation (e.g. procedures)
Description

Activity related to study participation

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Other, specify
Description

other cause sae

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Other, specify
Description

other cause sae

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Section 6 RELEVANT Medical Conditions
Description

Section 6 RELEVANT Medical Conditions

Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Description

SAE causation

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Date of Onset
Description

Onset Date

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0348080
DD/MMM/YY
Condition Present at Time of the SAE?
Description

present at sae

Data type

text

Alias
UMLS CUI [1,1]
C3827351
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence
Description

Date of Last Occurrence

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1519255
DD/MMM/YY
Section 7 Other RELEVANT Risk Factors
Description

Section 7 Other RELEVANT Risk Factors

Other RELEVANT Risk Factors
Description

risk factor

Data type

text

Alias
UMLS CUI [1]
C0035648
Section 8 RELEVANT Concomitant Medications
Description

Section 8 RELEVANT Concomitant Medications

Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Dose
Description

Dose

Data type

text

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C2348328
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

administration route

Data type

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Description

taken prior to study

Data type

text

Alias
UMLS CUI [1]
C2826667
Start Date
Description

concomitant medication start date

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2826734
DD/MMM/YY
Stop Date
Description

concomitant medication end date

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2826744
DD/MMM/YY
Ongoing Medication?
Description

Ongoing Medication

Data type

text

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Section 9 Details of lnvestigational Product(s)
Description

Section 9 Details of lnvestigational Product(s)

Double-Blind Therapy Start Date
Description

Double-Blind Therapy Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013072
UMLS CUI [1,2]
C0808070
Double-Blind Therapy Stop Date
Description

Double-Blind Therapy End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013072
UMLS CUI [1,2]
C0806020
Open-Label Treatment Start Date
Description

Open-Label Treatment Start Date

Data type

date

Alias
UMLS CUI [1,1]
C3640652
UMLS CUI [1,2]
C0808070
Open-Label Treatment Stop Date
Description

Open-Label Treatment End Date

Data type

date

Alias
UMLS CUI [1,1]
C3640652
UMLS CUI [1,2]
C0806020
Section 10 Details of RELEVANT Assessments
Description

Section 10 Details of RELEVANT Assessments

Details of RELEVANT Assessments
Description

assessment adverse event

Data type

text

Alias
UMLS CUI [1]
C1161049
Section 11 Narrative Remarks
Description

Section 11 Narrative Remarks

Provide a brief narrative description of the SAE and details of treatment given
Description

SAE description

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study administration
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
SERIOUS ADVERSE EVENTS
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
adverse event
Code List
Did the subject experience a serious adverse event during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If fatal, was a post-mortem/autopsy performed
text
C4274690 (UMLS CUI [1])
adverse event
Code List
If fatal, was a post-mortem/autopsy performed
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Section 1 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)
CL Item
Fatal (5)
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 SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action taken with investigational product
Code List
Action taken with investigational product(s) as a result of the SAE
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 SAE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
adverse event
Code List
Did the subject withdraw from study as a result of this SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
adverse event
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Section 2 Seriousness
patient dead
Item
[A] Results in death
boolean
C0011065 (UMLS CUI [1])
life threatening
Item
[B] Is life-threatening
boolean
C2826244 (UMLS CUI [1])
hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
disability
Item
[D] Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
congenital anomaly
Item
[E] Congenital anomaly/birth defect
boolean
C2826727 (UMLS CUI [1])
Other seriousness
Item
[F] Other, specify
boolean
C1710056 (UMLS CUI [1])
Other seriousness
Item
[F] Other, specify
text
C1710056 (UMLS CUI [1])
Item Group
Section 3 Demography Data
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Section 4 If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
inadvertant administration
Item
If deliberate or inadvertant administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
text
C1536055 (UMLS CUI [1])
Item
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
integer
C0376495 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
ae after readministration of drug
Code List
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Section 5 Possible Causes of SAE Other Than lnvestigational Product(s)
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1])
Medical condition
Item
Medical condition(s)
boolean
C0012634 (UMLS CUI [1])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product
Item
Withdrawal of investigational products
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1])
Activity related to study participation
Item
Activity related to study participation (e.g. procedures)
boolean
C2348568 (UMLS CUI [1])
other cause sae
Item
Other, specify
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
other cause sae
Item
Other, specify
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Item Group
Section 6 RELEVANT Medical Conditions
SAE causation
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Onset Date
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
Item
Condition Present at Time of the SAE?
text
C3827351 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
adverse event
Code List
Condition Present at Time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item Group
Section 7 Other RELEVANT Risk Factors
risk factor
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1])
Item Group
Section 8 RELEVANT Concomitant Medications
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C2348328 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
administration route
Item
Route
text
C0013153 (UMLS CUI [1])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
adverse event
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
concomitant medication start date
Item
Start Date
date
C2826734 (UMLS CUI [1])
concomitant medication end date
Item
Stop Date
date
C2826744 (UMLS CUI [1])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
adverse event
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Section 9 Details of lnvestigational Product(s)
Double-Blind Therapy Start Date
Item
Double-Blind Therapy Start Date
date
C0013072 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Double-Blind Therapy End Date
Item
Double-Blind Therapy Stop Date
date
C0013072 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Open-Label Treatment Start Date
Item
Open-Label Treatment Start Date
date
C3640652 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Open-Label Treatment End Date
Item
Open-Label Treatment Stop Date
date
C3640652 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Section 10 Details of RELEVANT Assessments
assessment adverse event
Item
Details of RELEVANT Assessments
text
C1161049 (UMLS CUI [1])
Item Group
Section 11 Narrative Remarks
SAE description
Item
Provide a brief narrative description of the SAE and details of treatment given
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
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