ID

22509

Beschreibung

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: Study Visit 1 / Day 15

Stichworte

Versionen (2)
  1. 05.06.17 05.06.17 -
  2. 06.06.17 06.06.17 -
Hochgeladen am

6. Juni 2017

DOI

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Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Study Visit 1

Englisch

Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Study Visit 1

1 Formulare  
Clinic Visit Assessment
Beschreibung

Clinic Visit Assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0008952
UMLS CUI-3
C0019348
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0008952
Record the identifying number from the investigational product container dispensed at this visit.
Beschreibung

identifying number investigational product container

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0600091
Has the subject had a recurrence(s) of genital herpes since the last visit?
Beschreibung

If Yes, complete the Genital Herpes Recurrences page

Datentyp

text

Alias
UMLS CUI [1,1]
C0019342
UMLS CUI [1,2]
C0034897
Has the subject had a recurrence(s) of oral/other non-genital herpes since the last visit?
Beschreibung

If Yes, complete the Oral/Other Non-Genital Herpes Recurrences page.

Datentyp

text

Alias
UMLS CUI [1,1]
C0341012
UMLS CUI [1,2]
C0008952
UMLS CUI [2,1]
C0019348
UMLS CUI [2,2]
C0008952
Serious Adverse Events
Beschreibung

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0019348
Did the subject experience any serious adverse events during the study?
Beschreibung

If YES, record details below

Datentyp

text

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

Serious adverse event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschreibung

Start Date

Datentyp

text

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

Outcome

Datentyp

integer

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

If fatal, record date of death

Datentyp

date

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

Maximum Intensity

Datentyp

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
Beschreibung

Action taken with investigational product

Datentyp

integer

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

Withdrawal

Datentyp

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)?
Beschreibung

Relationship to investigational product(s)

Datentyp

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?
Beschreibung

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

Datentyp

text

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

Seriousness

Datentyp

text

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

Seriousness

Datentyp

text

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

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Weight

Datentyp

float

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

Cause of SAE

Datentyp

integer

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

Cause of SAE

Datentyp

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?
Beschreibung

recur of event

Datentyp

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.
Beschreibung

Relevant Medical Conditions

Datentyp

text

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

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

Datentyp

date

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

Condition present at time of the SAE

Datentyp

text

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

date of last occurrence

Datentyp

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.
Beschreibung

Other relevant risk factors

Datentyp

text

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

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

Datentyp

text

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

Dose

Datentyp

float

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

Unit

Datentyp

text

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

Frequency

Datentyp

text

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

Route

Datentyp

text

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

Start Date

Datentyp

date

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

Taken Prior to Study

Datentyp

text

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

Stop date

Datentyp

date

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

Continued

Datentyp

text

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

indication

Datentyp

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
Beschreibung

Start Date

Datentyp

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
Beschreibung

Start Date

Datentyp

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
Beschreibung

Stop Date

Datentyp

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
Beschreibung

Stop Date

Datentyp

date

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

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

Datentyp

text

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

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

Datentyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
Non-serious Adverse Events
Beschreibung

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C0019348
Did the subject experience any non-serious adverse events during the study?
Beschreibung

If YES, record details below

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Non-serious adverse events: Diagnosis only (if known) or signs / symptoms
Beschreibung

Non-serious adverse event

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Start Date
Beschreibung

Start Date

Datentyp

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
End Date
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Action taken with investigational product(s) as a result of the non-serious AE
Beschreibung

Action taken with investigational product

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did subject withdraw from study as a result of this non-serious AE?
Beschreibung

Withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
Beschreibung

Relationship to investigational product(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0019348
Were any concomitant medications taken by the subject during the study?
Beschreibung

Concomitant Medication

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Drug Name
Beschreibung

If Yes, record each medication on a separate line using Trade Names where possible.

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Reason tor Medication
Beschreibung

Reason tor Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
Taken prior to Study
Beschreibung

Taken prior to Study

Datentyp

text

Alias
UMLS CUI [1]
C2826667
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
Ongoing Medication?
Beschreibung

Ongoing Medication

Datentyp

text

Alias
UMLS CUI [1]
C2826666
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Ähnliche Modelle

Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Study Visit 1

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Clinic Visit Assessment
C0220825 (UMLS CUI-1)
C0008952 (UMLS CUI-2)
C0019348 (UMLS CUI-3)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C0011008 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
identifying number investigational product container
Item
Record the identifying number from the investigational product container dispensed at this visit.
integer
C0304229 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Has the subject had a recurrence(s) of genital herpes since the last visit?
text
C0019342 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
recurrence(s) of genital herpes
Code List
Has the subject had a recurrence(s) of genital herpes since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
Item
Has the subject had a recurrence(s) of oral/other non-genital herpes since the last visit?
text
C0341012 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0019348 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
recurrence(s) of genital herpes
Code List
Has the subject had a recurrence(s) of oral/other non-genital herpes since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
C0019348 (UMLS CUI-2)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Seriousness
Code List
Did the subject experience any serious adverse events during the study?
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)
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])
Sex
Code List
Outcome
CL Item
Male (M)
CL Item
Female (F)
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])
Seriousness
Code List
Maximum Intensity
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)
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])
Withdrawal
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Did subject withdraw from study as a result of this serious AE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness
Code List
Did subject withdraw from study as a result of this serious AE?
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)
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])
Cause of SAE
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
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)
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])
Seriousness
Code List
Sex
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)
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])
Cause of SAE
Code List
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
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)
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])
Seriousness
Code List
Condition present at time of the SAE?
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)
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])
Seriousness
Code List
Relevant Concomitant Medications: Taken Prior to Study?
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)
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])
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
C0019348 (UMLS CUI-2)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Withdrawal
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
Not applicable (4)
Non-serious adverse event
Item
Non-serious adverse events: Diagnosis only (if known) or signs / symptoms
text
C1518404 (UMLS CUI [1])
Start Date
Item
Start Date
text
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved/Recovered (1)
CL Item
Resolving/Recovering (2)
CL Item
Not resolved (3)
CL Item
Resolved/Recovered with sequelae (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Seriousness
Code List
Maximum Intensity
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)
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (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 interrupted (4)
CL Item
Not applicable (6)
Item
Did subject withdraw from study as a result of this non-serious AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Seriousness
Code List
Did subject withdraw from study as a result of this non-serious AE?
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)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Withdrawal
Code List
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
C0019348 (UMLS CUI-2)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1])
Concomitant Medication
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Reason tor Medication
Item
Reason tor Medication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Taken prior to Study
text
C2826667 (UMLS CUI [1])
recurrence(s) of genital herpes
Code List
Taken prior to Study
CL Item
Yes (Y)
CL Item
No (N)
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
recurrence(s) of genital herpes
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
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