ID

35525

Beschrijving

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

Trefwoorden

Versies (1)
  1. 07-03-19 07-03-19 -
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GSK group of companies

Geüploaded op

7 maart 2019

DOI

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Licentie

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

Engels

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

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Visit Number
Beschrijving

Visit Number

Datatype

text

Date of Visit
Beschrijving

Date of Visit

Datatype

date

CHECK FOR STUDY CONTINUATION
Beschrijving

CHECK FOR STUDY CONTINUATION

Did the subject return for visit 1?
Beschrijving

Check for Study Continuation

Datatype

boolean

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

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

Datatype

text

HEMATOLOGY / BIOCHEMISTRY
Beschrijving

HEMATOLOGY / BIOCHEMISTRY

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

Hematology / Biochemistry Question

Datatype

text

Date
Beschrijving

Date

Datatype

date

Laboratory Name
Beschrijving

Laboratory Name

Datatype

text

Laboratory Code
Beschrijving

Laboratory Code

Datatype

integer

HEMATOLOGY
Beschrijving

HEMATOLOGY

[HB] Hemoglobin
Beschrijving

Result

Datatype

float

Maateenheden
  • g/dL
g/dL
[RBC] Red Blood Cells
Beschrijving

Result below

Datatype

integer

[PLA] Platelets
Beschrijving

Result below

Datatype

text

[WBC] White Blood Cells
Beschrijving

White Blood Cells

Datatype

text

[NEU] Neutrophils
Beschrijving

Result below

Datatype

text

Maateenheden
  • abs
abs
[LYM] Lymphocytes
Beschrijving

Result below

Datatype

integer

Maateenheden
  • /l
/l
[MON] Monocytes
Beschrijving

Result below

Datatype

text

[EOS] Eosinophils
Beschrijving

Result below

Datatype

text

[BAS] Basophils
Beschrijving

Result below

Datatype

text

[RET] Reticulocytes
Beschrijving

Result below

Datatype

text

BIOCHEMISTRY
Beschrijving

BIOCHEMISTRY

[BUN] BUN
Beschrijving

BUN

Datatype

float

Maateenheden
  • mg/dL
mg/dL
[CREA] Creatinine
Beschrijving

Result below

Datatype

float

Maateenheden
  • mg/dL
mg/dL
[AST] AST/SGOT
Beschrijving

Result below

Datatype

float

Maateenheden
  • U/L
U/L
[ALT] ALT/SGPT
Beschrijving

Result below

Datatype

float

Maateenheden
  • U/L
U/L
[CHOL] Cholesterol
Beschrijving

Cholesterol

Datatype

float

[CPK] Creatine phosphokinase
Beschrijving

Creatine phosphokinase

Datatype

float

[HAP] Serum Haptoglobin
Beschrijving

Serum Haptoglobin

Datatype

float

Maateenheden
  • mg/dL
mg/dL
[LDH] Lactate Dehydrogenase
Beschrijving

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

Datatype

text

LDH
Beschrijving

LDH

LD1
Beschrijving

Result

Datatype

text

LD2
Beschrijving

Result

Datatype

text

LD3
Beschrijving

Result

Datatype

text

LD4
Beschrijving

Result

Datatype

text

LD5
Beschrijving

Result

Datatype

text

Has a blood sample been taken for immunogenicity assays?
Beschrijving

Blood Sample for Immunogenicity Assays

Datatype

boolean

Date
Beschrijving

Date

Datatype

date

URINALYSIS
Beschrijving

URINALYSIS

Has a urine sample been taken for dipstick?
Beschrijving

Urine Sample Question

Datatype

boolean

Date
Beschrijving

Date

Datatype

date

Urinalysis (Dipstick) Test
Beschrijving

Urinalysis (Dipstick) Test

pH (via dipstick)
Beschrijving

Result

Datatype

integer

Proteins (via dipstick)
Beschrijving

Proteins (via dipstick)

Datatype

text

Glucose (via dipstick)
Beschrijving

Glucose (via dipstick)

Datatype

text

Ketones (via dipstick)
Beschrijving

Ketones (via dipstick)

Datatype

text

Blood and myoglobin (via dipstick)
Beschrijving

Blood and myoglobin (via dipstick)

Datatype

text

Bilirubin (via dipstick)
Beschrijving

Bilirubin (via dipstick)

Datatype

text

Urobilinogen (via dipstick)
Beschrijving

Urobilinogen (via dipstick)

Datatype

text

Nitrites (via dipstick)
Beschrijving

Nitrites (via dipstick)

Datatype

text

Leukocyte esterase (via dipstick)
Beschrijving

Leukocyte esterase (via dipstick)

Datatype

text

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

Urina Sample for Diagnostic Sssay?

Datatype

boolean

Date
Beschrijving

Date

Datatype

date

Terug naar het begin van de pagina

Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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