ID

35525

Descripción

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

Palabras clave

Versiones (1)
  1. 7/3/19 7/3/19 -
Titular de derechos de autor

GSK group of companies

Subido en

7 de marzo de 2019

DOI

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Licencia

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

Inglés

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

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Visit Number
Descripción

Visit Number

Tipo de datos

text

Date of Visit
Descripción

Date of Visit

Tipo de datos

date

CHECK FOR STUDY CONTINUATION
Descripción

CHECK FOR STUDY CONTINUATION

Did the subject return for visit 1?
Descripción

Check for Study Continuation

Tipo de datos

boolean

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

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

Tipo de datos

text

HEMATOLOGY / BIOCHEMISTRY
Descripción

HEMATOLOGY / BIOCHEMISTRY

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

Hematology / Biochemistry Question

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

Laboratory Name
Descripción

Laboratory Name

Tipo de datos

text

Laboratory Code
Descripción

Laboratory Code

Tipo de datos

integer

HEMATOLOGY
Descripción

HEMATOLOGY

[HB] Hemoglobin
Descripción

Result

Tipo de datos

float

Unidades de medida
  • g/dL
g/dL
[RBC] Red Blood Cells
Descripción

Result below

Tipo de datos

integer

[PLA] Platelets
Descripción

Result below

Tipo de datos

text

[WBC] White Blood Cells
Descripción

White Blood Cells

Tipo de datos

text

[NEU] Neutrophils
Descripción

Result below

Tipo de datos

text

Unidades de medida
  • abs
abs
[LYM] Lymphocytes
Descripción

Result below

Tipo de datos

integer

Unidades de medida
  • /l
/l
[MON] Monocytes
Descripción

Result below

Tipo de datos

text

[EOS] Eosinophils
Descripción

Result below

Tipo de datos

text

[BAS] Basophils
Descripción

Result below

Tipo de datos

text

[RET] Reticulocytes
Descripción

Result below

Tipo de datos

text

BIOCHEMISTRY
Descripción

BIOCHEMISTRY

[BUN] BUN
Descripción

BUN

Tipo de datos

float

Unidades de medida
  • mg/dL
mg/dL
[CREA] Creatinine
Descripción

Result below

Tipo de datos

float

Unidades de medida
  • mg/dL
mg/dL
[AST] AST/SGOT
Descripción

Result below

Tipo de datos

float

Unidades de medida
  • U/L
U/L
[ALT] ALT/SGPT
Descripción

Result below

Tipo de datos

float

Unidades de medida
  • U/L
U/L
[CHOL] Cholesterol
Descripción

Cholesterol

Tipo de datos

float

[CPK] Creatine phosphokinase
Descripción

Creatine phosphokinase

Tipo de datos

float

[HAP] Serum Haptoglobin
Descripción

Serum Haptoglobin

Tipo de datos

float

Unidades de medida
  • mg/dL
mg/dL
[LDH] Lactate Dehydrogenase
Descripción

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

Tipo de datos

text

LDH
Descripción

LDH

LD1
Descripción

Result

Tipo de datos

text

LD2
Descripción

Result

Tipo de datos

text

LD3
Descripción

Result

Tipo de datos

text

LD4
Descripción

Result

Tipo de datos

text

LD5
Descripción

Result

Tipo de datos

text

Has a blood sample been taken for immunogenicity assays?
Descripción

Blood Sample for Immunogenicity Assays

Tipo de datos

boolean

Date
Descripción

Date

Tipo de datos

date

URINALYSIS
Descripción

URINALYSIS

Has a urine sample been taken for dipstick?
Descripción

Urine Sample Question

Tipo de datos

boolean

Date
Descripción

Date

Tipo de datos

date

Urinalysis (Dipstick) Test
Descripción

Urinalysis (Dipstick) Test

pH (via dipstick)
Descripción

Result

Tipo de datos

integer

Proteins (via dipstick)
Descripción

Proteins (via dipstick)

Tipo de datos

text

Glucose (via dipstick)
Descripción

Glucose (via dipstick)

Tipo de datos

text

Ketones (via dipstick)
Descripción

Ketones (via dipstick)

Tipo de datos

text

Blood and myoglobin (via dipstick)
Descripción

Blood and myoglobin (via dipstick)

Tipo de datos

text

Bilirubin (via dipstick)
Descripción

Bilirubin (via dipstick)

Tipo de datos

text

Urobilinogen (via dipstick)
Descripción

Urobilinogen (via dipstick)

Tipo de datos

text

Nitrites (via dipstick)
Descripción

Nitrites (via dipstick)

Tipo de datos

text

Leukocyte esterase (via dipstick)
Descripción

Leukocyte esterase (via dipstick)

Tipo de datos

text

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

Urina Sample for Diagnostic Sssay?

Tipo de datos

boolean

Date
Descripción

Date

Tipo de datos

date

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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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