ID

35525

Description

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

Keywords

Versions (1)
  1. 3/7/19 3/7/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 7, 2019

DOI

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License

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

English

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

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Visit Number
Description

Visit Number

Data type

text

Date of Visit
Description

Date of Visit

Data type

date

CHECK FOR STUDY CONTINUATION
Description

CHECK FOR STUDY CONTINUATION

Did the subject return for visit 1?
Description

Check for Study Continuation

Data type

boolean

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

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

Data type

text

HEMATOLOGY / BIOCHEMISTRY
Description

HEMATOLOGY / BIOCHEMISTRY

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

Hematology / Biochemistry Question

Data type

text

Date
Description

Date

Data type

date

Laboratory Name
Description

Laboratory Name

Data type

text

Laboratory Code
Description

Laboratory Code

Data type

integer

HEMATOLOGY
Description

HEMATOLOGY

[HB] Hemoglobin
Description

Result

Data type

float

Measurement units
  • g/dL
g/dL
[RBC] Red Blood Cells
Description

Result below

Data type

integer

[PLA] Platelets
Description

Result below

Data type

text

[WBC] White Blood Cells
Description

White Blood Cells

Data type

text

[NEU] Neutrophils
Description

Result below

Data type

text

Measurement units
  • abs
abs
[LYM] Lymphocytes
Description

Result below

Data type

integer

Measurement units
  • /l
/l
[MON] Monocytes
Description

Result below

Data type

text

[EOS] Eosinophils
Description

Result below

Data type

text

[BAS] Basophils
Description

Result below

Data type

text

[RET] Reticulocytes
Description

Result below

Data type

text

BIOCHEMISTRY
Description

BIOCHEMISTRY

[BUN] BUN
Description

BUN

Data type

float

Measurement units
  • mg/dL
mg/dL
[CREA] Creatinine
Description

Result below

Data type

float

Measurement units
  • mg/dL
mg/dL
[AST] AST/SGOT
Description

Result below

Data type

float

Measurement units
  • U/L
U/L
[ALT] ALT/SGPT
Description

Result below

Data type

float

Measurement units
  • U/L
U/L
[CHOL] Cholesterol
Description

Cholesterol

Data type

float

[CPK] Creatine phosphokinase
Description

Creatine phosphokinase

Data type

float

[HAP] Serum Haptoglobin
Description

Serum Haptoglobin

Data type

float

Measurement units
  • mg/dL
mg/dL
[LDH] Lactate Dehydrogenase
Description

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

Data type

text

LDH
Description

LDH

LD1
Description

Result

Data type

text

LD2
Description

Result

Data type

text

LD3
Description

Result

Data type

text

LD4
Description

Result

Data type

text

LD5
Description

Result

Data type

text

Has a blood sample been taken for immunogenicity assays?
Description

Blood Sample for Immunogenicity Assays

Data type

boolean

Date
Description

Date

Data type

date

URINALYSIS
Description

URINALYSIS

Has a urine sample been taken for dipstick?
Description

Urine Sample Question

Data type

boolean

Date
Description

Date

Data type

date

Urinalysis (Dipstick) Test
Description

Urinalysis (Dipstick) Test

pH (via dipstick)
Description

Result

Data type

integer

Proteins (via dipstick)
Description

Proteins (via dipstick)

Data type

text

Glucose (via dipstick)
Description

Glucose (via dipstick)

Data type

text

Ketones (via dipstick)
Description

Ketones (via dipstick)

Data type

text

Blood and myoglobin (via dipstick)
Description

Blood and myoglobin (via dipstick)

Data type

text

Bilirubin (via dipstick)
Description

Bilirubin (via dipstick)

Data type

text

Urobilinogen (via dipstick)
Description

Urobilinogen (via dipstick)

Data type

text

Nitrites (via dipstick)
Description

Nitrites (via dipstick)

Data type

text

Leukocyte esterase (via dipstick)
Description

Leukocyte esterase (via dipstick)

Data type

text

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

Urina Sample for Diagnostic Sssay?

Data type

boolean

Date
Description

Date

Data type

date

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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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