ID

25399

Beschreibung

IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

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  1. 03.09.17 03.09.17 -
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glaxoSmithKline

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3. September 2017

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IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

Englisch

IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 Formulare  
Rash
Beschreibung

Rash

Alias
UMLS CUI-1
C0015230
Rash Start Date
Beschreibung

Rash Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0808070
Episode number
Beschreibung

Episode number rash

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C4086638
Number of lesions
Beschreibung

Number of lesions

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0449788
Character of most lesions:
Beschreibung

Maximum intensity: Macular < Papular < Mostly vesicular < Hemorrhagic

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0332307
Fever
Beschreibung

Fever

Alias
UMLS CUI-1
C0015967
Fever
Beschreibung

Fever

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Systemic signs
Beschreibung

Systemic signs

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C0205373
Systemic signs
Beschreibung

Systemic signs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205373
Pain in back or abdomen
Beschreibung

Back pain or Pain in abdomen

Datentyp

boolean

Alias
UMLS CUI [1]
C0004604
UMLS CUI [2]
C0000737
Interstitial pneumonia
Beschreibung

Interstitial pneumonia

Datentyp

boolean

Alias
UMLS CUI [1]
C0206061
Encephalitis
Beschreibung

Encephalitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0596773
Subjective assessment of the illness by investigator
Beschreibung

Subjective assessment of the illness by investigator

Alias
UMLS CUI-1
C0221423
UMLS CUI-2
C0220825
UMLS CUI-3
C0035173
Subjective assessment of the illness by investigator
Beschreibung

Subjective assessment of the illness by investigator

Datentyp

integer

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0035173
Varicella Clinical Case?
Beschreibung

Varicella Clinical Case?

Alias
UMLS CUI-1
C0042338
UMLS CUI-2
C0205210
Varicella Clinical Case?
Beschreibung

Please provide the IDMC's rationale for rejecting the case

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0205210
Herpes Zoster case?
Beschreibung

Please provide the IDMC's rationale for rejecting the case

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0740380
UMLS CUI [1,2]
C0205210
Rash distribution is inconsistent with varicella
Beschreibung

Rash distribution is inconsistent with varicella

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0015230
UMLS CUI [1,3]
C0442809
Character of lesions is inconsistent with varicella
Beschreibung

Character of lesions is inconsistent with varicella

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0442809
Evolution of the rash is inconsistent with varicella
Beschreibung

Evolution of the rash is inconsistent with varicella

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0242656
UMLS CUI [1,3]
C0442809
Duration of illness is inconsistent with varicella
Beschreibung

Duration of illness is inconsistent with varicella

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C3176590
UMLS CUI [1,3]
C0442809
Other features of illness inconsistent with varicella
Beschreibung

Other features of illness inconsistent with varicella

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0008049
UMLS CUI [1,3]
C0442809
Other, please specify
Beschreibung

specify other reason

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
PCR result
Beschreibung

PCR result

Alias
UMLS CUI-1
C0042338
UMLS CUI-2
C0032520
UMLS CUI-3
C2825142
PCR result
Beschreibung

PCR result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042338
UMLS CUI [1,2]
C0032520
UMLS CUI [1,3]
C2825142
If Varicella Clinical Case = Yes, please encode the epidemiological link
Beschreibung

Only answer, if PCR result wasn't positive.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042338
UMLS CUI [1,2]
C0014507
Classification
Beschreibung

Classification

Alias
UMLS CUI-1
C0042338
UMLS CUI-2
C0008902
Classification
Beschreibung

According to the Varicella clinical case definition in the study protocol, please enter below the IDMC's classification of this case.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008902
UMLS CUI [1,2]
C0042338
Expert signature
Beschreibung

Expert signature

Alias
UMLS CUI-1
C1519316
UMLS CUI-2
C0600219
Expert number
Beschreibung

Expert 1 -5

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600219
UMLS CUI [1,2]
C0449788
Expert's signature
Beschreibung

I confirm that I have reviewed the consensus report and I am in agreement with it.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0600219
Printed expert's name
Beschreibung

Printed expert's name

Datentyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0600219
Date
Beschreibung

Date of expert's signature

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C0600219
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Ähnliche Modelle

IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Rash
C0015230 (UMLS CUI-1)
Rash Start Date
Item
Rash Start Date
date
C0015230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Episode number rash
Item
Episode number
integer
C0015230 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Number of lesions
integer
C0008049 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of lesions
Code List
Number of lesions
CL Item
1-50 (1)
CL Item
51-100 (2)
CL Item
101 - 500 (3)
CL Item
>500 (4)
CL Item
Information not available (5)
Item
Character of most lesions:
integer
C0008049 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Character of lesions
Code List
Character of most lesions:
CL Item
Macular (1)
CL Item
Papular (2)
CL Item
Mostly vesicular (3)
CL Item
Hemorrhagic (4)
CL Item
Information not available (5)
Item Group
Fever
C0015967 (UMLS CUI-1)
Item
Fever
integer
C0015967 (UMLS CUI [1])
Fever
Code List
Fever
CL Item
Temperature < 38.8°C (Rectally) or < 38.3°C (Axillary) (1)
CL Item
Temperature 38.8°C - 39.9°C (Rectally) or 38.3°C - 39.4°C (Axillary) (2)
CL Item
Temperature > 40.0°C (Rectally) or > 39.5°C (Axillary) (3)
CL Item
Temperature not taken (4)
Item Group
Systemic signs
C0037088 (UMLS CUI-1)
C0205373 (UMLS CUI-2)
Systemic signs
Item
Systemic signs
boolean
C0037088 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Back pain or Pain in abdomen
Item
Pain in back or abdomen
boolean
C0004604 (UMLS CUI [1])
C0000737 (UMLS CUI [2])
Interstitial pneumonia
Item
Interstitial pneumonia
boolean
C0206061 (UMLS CUI [1])
Encephalitis
Item
Encephalitis
boolean
C0596773 (UMLS CUI [1])
Item Group
Subjective assessment of the illness by investigator
C0221423 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0035173 (UMLS CUI-3)
Item
Subjective assessment of the illness by investigator
integer
C0221423 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
Subjective assessment of the illness by investigator
Code List
Subjective assessment of the illness by investigator
CL Item
Subject does not appear ill (1)
CL Item
Subject appears moderately ill (2)
CL Item
Subject appears severely ill (3)
CL Item
Information not available (4)
Item Group
Varicella Clinical Case?
C0042338 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
Varicella Clinical Case
Item
Varicella Clinical Case?
boolean
C0008049 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Herpes Zoster case
Item
Herpes Zoster case?
boolean
C0740380 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Rash distribution is inconsistent with varicella
Item
Rash distribution is inconsistent with varicella
boolean
C0008049 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C0442809 (UMLS CUI [1,3])
Character of lesions is inconsistent with varicella
Item
Character of lesions is inconsistent with varicella
boolean
C0008049 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0442809 (UMLS CUI [1,3])
Evolution of the rash is inconsistent with varicella
Item
Evolution of the rash is inconsistent with varicella
boolean
C0015230 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0442809 (UMLS CUI [1,3])
Duration of illness is inconsistent with varicella
Item
Duration of illness is inconsistent with varicella
boolean
C0008049 (UMLS CUI [1,1])
C3176590 (UMLS CUI [1,2])
C0442809 (UMLS CUI [1,3])
Other features of illness inconsistent with varicella
Item
Other features of illness inconsistent with varicella
boolean
C0221423 (UMLS CUI [1,1])
C0008049 (UMLS CUI [1,2])
C0442809 (UMLS CUI [1,3])
specify other reason
Item
Other, please specify
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
PCR result
C0042338 (UMLS CUI-1)
C0032520 (UMLS CUI-2)
C2825142 (UMLS CUI-3)
Item
PCR result
integer
C0042338 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
C2825142 (UMLS CUI [1,3])
PCR result
Code List
PCR result
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Invalid result (3)
CL Item
Result not available (4)
Item
If Varicella Clinical Case = Yes, please encode the epidemiological link
integer
C0042338 (UMLS CUI [1,1])
C0014507 (UMLS CUI [1,2])
Varicella epidemiological link
Code List
If Varicella Clinical Case = Yes, please encode the epidemiological link
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Information not available (3)
Item Group
Classification
C0042338 (UMLS CUI-1)
C0008902 (UMLS CUI-2)
Item
Classification
integer
C0008902 (UMLS CUI [1,1])
C0042338 (UMLS CUI [1,2])
Classification varicella
Code List
Classification
CL Item
No Varicella case (1)
CL Item
Probable Varicella case (2)
CL Item
PCR confirmed Varicella case (3)
CL Item
Epidemiologically confirmed Varicella case (4)
Item Group
Expert signature
C1519316 (UMLS CUI-1)
C0600219 (UMLS CUI-2)
Expert number
Item
Expert number
integer
C0600219 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Expert's signature
Item
Expert's signature
text
C1519316 (UMLS CUI [1,1])
C0600219 (UMLS CUI [1,2])
Printed expert's name
Item
Printed expert's name
text
C1519316 (UMLS CUI [1,1])
C0600219 (UMLS CUI [1,2])
Date of expert's signature
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0600219 (UMLS CUI [1,3])
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