ID

35746

Beschrijving

Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the vital signs form. It has to be filled in for screening and for all Visits (Visit 1-6).

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Trefwoorden

  1. 20-03-19 20-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 maart 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

Vital signs

  1. StudyEvent: ODM
    1. Vital signs
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
Visit type
Beschrijving

Visit type

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Vital signs
Beschrijving

Vital signs

Alias
UMLS CUI-1
C0518766
Blood pressure: systolic
Beschrijving

(in a seated position)

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure: diastolic
Beschrijving

(in a seated position)

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Examination of body temperature
Beschrijving

Examination of body temperature

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0005903
Body temperature
Beschrijving

Only for Screening, Visit 2, Visit 4, Visit 5, Visit 6

Datatype

float

Alias
UMLS CUI [1]
C0005903
Body temperature, unit of measure
Beschrijving

Only for Screening, Visit 2, Visit 4, Visit 5, Visit 6

Datatype

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Route of measurement
Beschrijving

Only for Screening, Visit 2, Visit 4, Visit 5, Visit 6

Datatype

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444

Similar models

Vital signs

  1. StudyEvent: ODM
    1. Vital signs
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C0011008 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Screening (1)
CL Item
Visit 1 (2)
CL Item
Visit 2 (3)
CL Item
Visit 3 (4)
CL Item
Visit 4 (5)
CL Item
Visit 5 (6)
CL Item
Visit 6 (7)
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Blood pressure: systolic
Item
Blood pressure: systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure: diastolic
Item
Blood pressure: diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Examination of body temperature
C0031809 (UMLS CUI-1)
C0005903 (UMLS CUI-2)
Body temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1])
Item
Body temperature, unit of measure
integer
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Body temperature, unit of measure
CL Item
°C (1)
CL Item
°F (2)
Item
Route of measurement
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Code List
Route of measurement
CL Item
Axillary (A)
CL Item
Oral (Mandatory) (O)
CL Item
Rectal (R)

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