ID

22472

Descrizione

Study ID: 100273 Clinical Study ID: HS2100273 Study Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter 60-Day Study Comparing the Efficacy of Valtrex 1 Gram Once Daily vs. Placebo Once Daily in Reducing Viral Shedding in Immunocompetent Subjects with Recurrent HSV-2 Genital Herpes Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Herpes Genitalis Visit description: Serious Adverse Event

Keywords

versioni (1)
  1. 05/06/17 05/06/17 -
Caricato su

5 giugno 2017

DOI

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Licenza

Creative Commons BY-NC 3.0
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Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Serious Adverse Event

Inglese

Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Serious Adverse Event

1 moduli  
Serious Adverse Events
Descrizione

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Did the subject experience any serious adverse events during the study?
Descrizione

If YES, record details below

Tipo di dati

text

Alias
UMLS CUI [1]
C1519255
Serious adverse events: Diagnosis only (if known) or signs / symptoms
Descrizione

Serious adverse event

Tipo di dati

text

Alias
UMLS CUI [1]
C1519255
Start Date
Descrizione

Start Date

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Outcome
Descrizione

Outcome

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
End Date
Descrizione

If fatal, record date of death

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C1148348
Maximum Intensity
Descrizione

Maximum Intensity

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Action taken with investigational product(s) as a result of the non-serious AE
Descrizione

Action taken with investigational product

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did subject withdraw from study as a result of this serious AE?
Descrizione

Withdrawal

Tipo di dati

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(s)?
Descrizione

Relationship to investigational product(s)

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
If fatal, was a post-mortem/autopsy performed?
Descrizione

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

Tipo di dati

text

Alias
UMLS CUI [1]
C0004398
UMLS CUI [2]
C1519255
Seriousness, check all that apply
Descrizione

Seriousness

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Seriousness, if other please specify
Descrizione

Seriousness

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Date of birth
Descrizione

Date of birth

Tipo di dati

date

Alias
UMLS CUI [1]
C0421451
Sex
Descrizione

Sex

Tipo di dati

text

Alias
UMLS CUI [1]
C0079399
Weight
Descrizione

Weight

Tipo di dati

float

Unità di misura
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Possible Causes of SAE other than Investigational Product(s), check all that apply:
Descrizione

Cause of SAE

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Please specify cause of SAE if Other
Descrizione

Cause of SAE

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
Descrizione

recur of event

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Descrizione

Relevant Medical Conditions

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1519255
Date of onset
Descrizione

Specify any RELEVANT past or current medical disorders, allergies, Date of Onset Condition Present at Time of the If No, Date of Last OccutTence surgeries, etc. that can help explain the SAE

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C1519255
Condition present at time of the SAE?
Descrizione

Condition present at time of the SAE

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If NO, date of last occurrence
Descrizione

date of last occurrence

Tipo di dati

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [2]
C1519255
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
Descrizione

Other relevant risk factors

Tipo di dati

text

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Drug, Trade name preferred
Descrizione

Include any concomitant medications that may contribute to the occurrence of the SAE

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Dose
Descrizione

Dose

Tipo di dati

float

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Unit
Descrizione

Unit

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Frequency
Descrizione

Frequency

Tipo di dati

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Route
Descrizione

Route

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Start Date
Descrizione

Start Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Taken Prior to Study?
Descrizione

Taken Prior to Study

Tipo di dati

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Stop date
Descrizione

Stop date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Ongoing Medication?
Descrizione

Continued

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3494713
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Reason for Medication
Descrizione

indication

Tipo di dati

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Start Date, Double-Blind Therapy
Descrizione

Start Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Start Date, Open Label Treatment
Descrizione

Start Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Stop Date, Double-Blind Therapy
Descrizione

Stop Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Stop Date, Open-Label Treatment
Descrizione

Stop Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1519255
Narrative Remarks
Descrizione

Provide a textual description of the serious adverse event (including treatment of the event).

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Details of Relevant Assessments
Descrizione

Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
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Similar models

Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Serious Adverse Event

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Withdrawal
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Serious adverse event
Item
Serious adverse events: Diagnosis only (if known) or signs / symptoms
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date
text
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved/recovered  (1)
CL Item
resolving/recovering (2)
CL Item
Not resolved/recovered (3)
CL Item
Resolved/recovered with sequelae  (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
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 non-serious AE
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 (6)
Item
Did subject withdraw from study as a result of this serious AE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Did subject withdraw from study as a result of this serious AE?
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Withdrawal
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (A)
Item
If fatal, was a post-mortem/autopsy performed?
text
C0004398 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Withdrawal
Code List
If fatal, was a post-mortem/autopsy performed?
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Seriousness, check all that apply
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness
Code List
Seriousness, check all that apply
CL Item
Death (A)
CL Item
Life threatening (B)
CL Item
Hospitalization required or prolonged (C)
CL Item
Disabling or incapacitating (D)
CL Item
Congenital anomaly (E)
CL Item
Other (see definition) (F)
Seriousness
Item
Seriousness, if other please specify
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Possible Causes of SAE other than Investigational Product(s), check all that apply:
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Cause of SAE
Code List
Possible Causes of SAE other than Investigational Product(s), check all that apply:
CL Item
Disease under study (1)
CL Item
Treatment failure (2)
CL Item
Activity related to study participation (e.g., procedures) (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant disorder (5)
CL Item
Concomitant medication (6)
CL Item
Other (7)
Cause of SAE
Item
Please specify cause of SAE if Other
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Withdrawal
Code List
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (A)
Relevant Medical Conditions
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Condition present at time of the SAE?
text
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Sex
Code List
Condition present at time of the SAE?
CL Item
Male (M)
CL Item
Female (F)
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 [2])
Other relevant risk factors
Item
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C0035648 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Drug
Item
Relevant Concomitant Medications: Drug, Trade name preferred
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Dose
Item
Relevant Concomitant Medications: Dose
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Unit
Item
Relevant Concomitant Medications: Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Frequency
Item
Relevant Concomitant Medications: Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Route
Item
Relevant Concomitant Medications: Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Start Date
Item
Relevant Concomitant Medications: Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Relevant Concomitant Medications: Taken Prior to Study?
text
C2347852 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Sex
Code List
Relevant Concomitant Medications: Taken Prior to Study?
CL Item
Male (M)
CL Item
Female (F)
Stop date
Item
Relevant Concomitant Medications: Stop date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Relevant Concomitant Medications: Ongoing Medication?
text
C2347852 (UMLS CUI [1,1])
C3494713 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Sex
Code List
Relevant Concomitant Medications: Ongoing Medication?
CL Item
Male (M)
CL Item
Female (F)
indication
Item
Relevant Concomitant Medications: Reason for Medication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Start Date
Item
Details of Investigational Product(s): Start Date, Double-Blind Therapy
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Start Date
Item
Details of Investigational Product(s): Start Date, Open Label Treatment
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Stop Date
Item
Details of Investigational Product(s): Stop Date, Double-Blind Therapy
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Stop Date
Item
Details of Investigational Product(s): Stop Date, Open-Label Treatment
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Narrative
Item
Narrative Remarks
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Details of Relevant Assessments
Item
Details of Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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