ID

35525

Beskrivning

Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

Nyckelord

Versioner (1)
  1. 3/7/19 3/7/19 -
Rättsinnehavare

GSK group of companies

Uppladdad den

March 7, 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652

Engelsk

Visit 7 - Day 67 (7-8 day after visit 5)

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Visit Number
Beskrivning

Visit Number

Datatyp

text

Date of Visit
Beskrivning

Date of Visit

Datatyp

date

CHECK FOR STUDY CONTINUATION
Beskrivning

CHECK FOR STUDY CONTINUATION

Did the subject return for visit 1?
Beskrivning

Check for Study Continuation

Datatyp

boolean

If No, please record ONE most appropriate reason and skip the following forms of this visit.
Beskrivning

If No, please record ONE most appropriate reason and skip the following forms of this visit.

Datatyp

text

HEMATOLOGY / BIOCHEMISTRY
Beskrivning

HEMATOLOGY / BIOCHEMISTRY

Has a blood sample been taken for haematology/ biochemistry testing?
Beskrivning

Hematology / Biochemistry Question

Datatyp

text

Date
Beskrivning

Date

Datatyp

date

Laboratory Name
Beskrivning

Laboratory Name

Datatyp

text

Laboratory Code
Beskrivning

Laboratory Code

Datatyp

integer

HEMATOLOGY
Beskrivning

HEMATOLOGY

[HB] Hemoglobin
Beskrivning

Result

Datatyp

float

Måttenheter
  • g/dL
g/dL
[RBC] Red Blood Cells
Beskrivning

Result below

Datatyp

integer

[PLA] Platelets
Beskrivning

Result below

Datatyp

text

[WBC] White Blood Cells
Beskrivning

White Blood Cells

Datatyp

text

[NEU] Neutrophils
Beskrivning

Result below

Datatyp

text

Måttenheter
  • abs
abs
[LYM] Lymphocytes
Beskrivning

Result below

Datatyp

integer

Måttenheter
  • /l
/l
[MON] Monocytes
Beskrivning

Result below

Datatyp

text

[EOS] Eosinophils
Beskrivning

Result below

Datatyp

text

[BAS] Basophils
Beskrivning

Result below

Datatyp

text

[RET] Reticulocytes
Beskrivning

Result below

Datatyp

text

BIOCHEMISTRY
Beskrivning

BIOCHEMISTRY

[BUN] BUN
Beskrivning

BUN

Datatyp

float

Måttenheter
  • mg/dL
mg/dL
[CREA] Creatinine
Beskrivning

Result below

Datatyp

float

Måttenheter
  • mg/dL
mg/dL
[AST] AST/SGOT
Beskrivning

Result below

Datatyp

float

Måttenheter
  • U/L
U/L
[ALT] ALT/SGPT
Beskrivning

Result below

Datatyp

float

Måttenheter
  • U/L
U/L
[CHOL] Cholesterol
Beskrivning

Cholesterol

Datatyp

float

[CPK] Creatine phosphokinase
Beskrivning

Creatine phosphokinase

Datatyp

float

[HAP] Serum Haptoglobin
Beskrivning

Serum Haptoglobin

Datatyp

float

Måttenheter
  • mg/dL
mg/dL
[LDH] Lactate Dehydrogenase
Beskrivning

Please complete the following informationwith LDH isoenzymes if the grade 2 or greater LDH is observed (> 1.5 ULN)

Datatyp

text

LDH
Beskrivning

LDH

LD1
Beskrivning

Result

Datatyp

text

LD2
Beskrivning

Result

Datatyp

text

LD3
Beskrivning

Result

Datatyp

text

LD4
Beskrivning

Result

Datatyp

text

LD5
Beskrivning

Result

Datatyp

text

Has a blood sample been taken for immunogenicity assays?
Beskrivning

Blood Sample for Immunogenicity Assays

Datatyp

boolean

Date
Beskrivning

Date

Datatyp

date

URINALYSIS
Beskrivning

URINALYSIS

Has a urine sample been taken for dipstick?
Beskrivning

Urine Sample Question

Datatyp

boolean

Date
Beskrivning

Date

Datatyp

date

Urinalysis (Dipstick) Test
Beskrivning

Urinalysis (Dipstick) Test

pH (via dipstick)
Beskrivning

Result

Datatyp

integer

Proteins (via dipstick)
Beskrivning

Proteins (via dipstick)

Datatyp

text

Glucose (via dipstick)
Beskrivning

Glucose (via dipstick)

Datatyp

text

Ketones (via dipstick)
Beskrivning

Ketones (via dipstick)

Datatyp

text

Blood and myoglobin (via dipstick)
Beskrivning

Blood and myoglobin (via dipstick)

Datatyp

text

Bilirubin (via dipstick)
Beskrivning

Bilirubin (via dipstick)

Datatyp

text

Urobilinogen (via dipstick)
Beskrivning

Urobilinogen (via dipstick)

Datatyp

text

Nitrites (via dipstick)
Beskrivning

Nitrites (via dipstick)

Datatyp

text

Leukocyte esterase (via dipstick)
Beskrivning

Leukocyte esterase (via dipstick)

Datatyp

text

Has a urine sample been taken for development of diagnostic assay?
Beskrivning

Urina Sample for Diagnostic Sssay?

Datatyp

boolean

Date
Beskrivning

Date

Datatyp

date

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Similar models

Visit 7 - Day 67 (7-8 day after visit 5)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Visit Number
Item
Visit Number
text
Date of Visit
Item
Date of Visit
date
Item Group
CHECK FOR STUDY CONTINUATION
Check for Study Continuation
Item
Did the subject return for visit 1?
boolean
If No, please record ONE most appropriate reason and skip the following forms of this visit.
Item
If No, please record ONE most appropriate reason and skip the following forms of this visit.
text
Item Group
HEMATOLOGY / BIOCHEMISTRY
Item
Has a blood sample been taken for haematology/ biochemistry testing?
text
Hematology / Biochemistry Question
Code List
Has a blood sample been taken for haematology/ biochemistry testing?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (Only if Visit 1 occurred within 48 hours from blood sample taken at screening visit) (3)
Date
Item
Date
date
Laboratory Name
Item
Laboratory Name
text
Laboratory Code
Item
Laboratory Code
integer
Item Group
HEMATOLOGY
[HB] Hemoglobin
Item
[HB] Hemoglobin
float
Red Blood Cells
Item
[RBC] Red Blood Cells
integer
Platelets
Item
[PLA] Platelets
text
White Blood Cells
Item
[WBC] White Blood Cells
text
Neutrophils
Item
[NEU] Neutrophils
text
Lymphocytes
Item
[LYM] Lymphocytes
integer
Monocytes
Item
[MON] Monocytes
text
Eosinophils
Item
[EOS] Eosinophils
text
Basophils
Item
[BAS] Basophils
text
Reticulocytes
Item
[RET] Reticulocytes
text
Item Group
BIOCHEMISTRY
BUN
Item
[BUN] BUN
float
Creatinine
Item
[CREA] Creatinine
float
AST/SGOT
Item
[AST] AST/SGOT
float
ALT/SGPT
Item
[ALT] ALT/SGPT
float
Cholesterol
Item
[CHOL] Cholesterol
float
Creatine phosphokinase
Item
[CPK] Creatine phosphokinase
float
Serum Haptoglobin
Item
[HAP] Serum Haptoglobin
float
Lactate Dehydrogenase
Item
[LDH] Lactate Dehydrogenase
text
Item Group
LDH
LD1
Item
LD1
text
LD2
Item
LD2
text
LD3
Item
LD3
text
LD4
Item
LD4
text
LD5
Item
LD5
text
Blood Sample for Immunogenicity Assays
Item
Has a blood sample been taken for immunogenicity assays?
boolean
Date
Item
Date
date
Item Group
URINALYSIS
Urine Sample Question
Item
Has a urine sample been taken for dipstick?
boolean
Date
Item
Date
date
Item Group
Urinalysis (Dipstick) Test
pH (via dipstick)
Item
pH (via dipstick)
integer
Item
Proteins (via dipstick)
text
Proteins (via dipstick)
Code List
Proteins (via dipstick)
CL Item
negative  (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
Item
Glucose (via dipstick)
text
Glucose (via dipstick)
Code List
Glucose (via dipstick)
CL Item
normal (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
4+ (5)
Item
Ketones (via dipstick)
text
Ketones (via dipstick)
Code List
Ketones (via dipstick)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
Item
Blood and myoglobin (via dipstick)
text
Blood and myoglobin (via dipstick)
Code List
Blood and myoglobin (via dipstick)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
4+ (5)
Item
Bilirubin (via dipstick)
text
Bilirubin (via dipstick)
Code List
Bilirubin (via dipstick)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
Item
Urobilinogen (via dipstick)
text
Urobilinogen (via dipstick)
Code List
Urobilinogen (via dipstick)
CL Item
normal (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
4+ (5)
Item
Nitrites (via dipstick)
text
Nitrites (via dipstick)
Code List
Nitrites (via dipstick)
CL Item
negative (1)
CL Item
positive (2)
Item
Leukocyte esterase (via dipstick)
text
Leukocyte esterase (via dipstick)
Code List
Leukocyte esterase (via dipstick)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
Urina Sample for Diagnostic Sssay?
Item
Has a urine sample been taken for development of diagnostic assay?
boolean
Date
Item
Date
date
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