ID

35746

Description

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).

Lien

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

Mots-clés

  1. 20/03/2019 20/03/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

20 mars 2019

DOI

Pour une demande vous connecter.

Licence

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
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

day month year

Type de données

date

Alias
UMLS CUI [1]
C0011008
Visit type
Description

Visit type

Type de données

integer

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

Vital signs

Alias
UMLS CUI-1
C0518766
Blood pressure: systolic
Description

(in a seated position)

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure: diastolic
Description

(in a seated position)

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Examination of body temperature
Description

Examination of body temperature

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

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

Type de données

float

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

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

Type de données

integer

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

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

Type de données

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)
Type de données
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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