ID

35082

Description

Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus This form contains information about Laboratory Reference Ranges and should be filled in for each test. If the reference ranges for any test differ by age range, ageunits or sex, complete a separate form for each variation (e.g., males 0-16, males 17-99, females 0-16, females 17-99 years).

Link

https://clinicaltrials.gov/ct2/show/NCT00290277

Keywords

Versions (1)
  1. 2/14/19 2/14/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 14, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277

English

Laboratory Reference Ranges

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Laboratory Name
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C3258037
Protocol number
Description

Protocol number

Data type

integer

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0237753
Centre number
Description

Centre number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Validity of laboratory reference ranges
Description

Validity of laboratory reference ranges

Alias
UMLS CUI-1
C0883335
UMLS CUI-2
C2349101
UMLS CUI-3
C0815172
Date these reference ranges became effective:
Description

Date of reference ranges

Data type

date

Alias
UMLS CUI [1,1]
C0883335
UMLS CUI [1,2]
C0011008
Age range low
Description

If the reference ranges for any test differ by age range, ageunits or sex, complete a separate form for each variation (e.g., males 0-16, males 17-99, females 0-16, females 17-99 years)

Data type

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1524031
Age range high
Description

If the reference ranges for any test differ by age range, ageunits or sex, complete a separate form for each variation (e.g., males 0-16, males 17-99, females 0-16, females 17-99 years)

Data type

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0806909
Age units. Tick one box:
Description

Age units

Data type

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1519795
Sex
Description

If the reference ranges for any test differ by age range, ageunits or sex, complete a separate form for each variation (e.g., males 0-16, males 17-99, females 0-16, females 17-99 years)

Data type

text

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0883335
Laboratory Reference Ranges
Description

Laboratory Reference Ranges

Alias
UMLS CUI-1
C0883335
Laboratory Test
Description

Enter the reference range for each test one after the other. Creatinine and Alanine amino-transferase are Biochemistry Lab Tests. The other tests are Haematology Lab Tests.

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005477
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C0474523
Unit of Laboratory Test
Description

Enter the unit for each test one after the other.

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0022885
Low reference Value
Description

Enter the low reference value for each test one after the other.

Data type

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C1522609
UMLS CUI [1,3]
C0205251
High Reference value
Description

Enter the high reference value for each test one after the other.

Data type

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C1522609
UMLS CUI [1,3]
C0205250
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Similar models

Laboratory Reference Ranges

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Protocol number
Item
Protocol number
integer
C2348563 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Centre number
Item
Centre number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Validity of laboratory reference ranges
C0883335 (UMLS CUI-1)
C2349101 (UMLS CUI-2)
C0815172 (UMLS CUI-3)
Date of reference ranges
Item
Date these reference ranges became effective:
date
C0883335 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Age range Minimum
Item
Age range low
integer
C0001779 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Age range Maximum
Item
Age range high
integer
C0001779 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Item
Age units. Tick one box:
integer
C0001779 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Age units
Code List
Age units. Tick one box:
CL Item
years (1)
CL Item
months (2)
CL Item
weeks (3)
CL Item
days (4)
Item
Sex
text
C0079399 (UMLS CUI [1,1])
C0883335 (UMLS CUI [1,2])
Sex
Code List
Sex
CL Item
Male reference range (1)
CL Item
Female reference range (2)
CL Item
Male and Female reference range (3)
Item Group
Laboratory Reference Ranges
C0883335 (UMLS CUI-1)
Item
Laboratory Test
text
C0022885 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0474523 (UMLS CUI [2,2])
Laboratory Test
Code List
Laboratory Test
CL Item
Creatinine (1)
CL Item
Alanine amino-transferase (2)
CL Item
White blood cells: Lymphocytes (3)
CL Item
White blood cells: Eosinophils (4)
CL Item
White blood cells: Neutrophils (5)
CL Item
White blood cells: Monocytes (6)
CL Item
White blood cells: Basophils (7)
CL Item
Red blood cellls (8)
CL Item
Haematocrit (9)
CL Item
Platelets (10)
Unit
Item
Unit of Laboratory Test
text
C1519795 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Low Reference Value
Item
Low reference Value
text
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
High Reference value
Item
High Reference value
text
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
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