ID

35525

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.03.19 07.03.19 -
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GSK group of companies

Hochgeladen am

7. März 2019

DOI

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Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652

Englisch

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

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Visit Number
Beschreibung

Visit Number

Datentyp

text

Date of Visit
Beschreibung

Date of Visit

Datentyp

date

CHECK FOR STUDY CONTINUATION
Beschreibung

CHECK FOR STUDY CONTINUATION

Did the subject return for visit 1?
Beschreibung

Check for Study Continuation

Datentyp

boolean

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

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

Datentyp

text

HEMATOLOGY / BIOCHEMISTRY
Beschreibung

HEMATOLOGY / BIOCHEMISTRY

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

Hematology / Biochemistry Question

Datentyp

text

Date
Beschreibung

Date

Datentyp

date

Laboratory Name
Beschreibung

Laboratory Name

Datentyp

text

Laboratory Code
Beschreibung

Laboratory Code

Datentyp

integer

HEMATOLOGY
Beschreibung

HEMATOLOGY

[HB] Hemoglobin
Beschreibung

Result

Datentyp

float

Maßeinheiten
  • g/dL
g/dL
[RBC] Red Blood Cells
Beschreibung

Result below

Datentyp

integer

[PLA] Platelets
Beschreibung

Result below

Datentyp

text

[WBC] White Blood Cells
Beschreibung

White Blood Cells

Datentyp

text

[NEU] Neutrophils
Beschreibung

Result below

Datentyp

text

Maßeinheiten
  • abs
abs
[LYM] Lymphocytes
Beschreibung

Result below

Datentyp

integer

Maßeinheiten
  • /l
/l
[MON] Monocytes
Beschreibung

Result below

Datentyp

text

[EOS] Eosinophils
Beschreibung

Result below

Datentyp

text

[BAS] Basophils
Beschreibung

Result below

Datentyp

text

[RET] Reticulocytes
Beschreibung

Result below

Datentyp

text

BIOCHEMISTRY
Beschreibung

BIOCHEMISTRY

[BUN] BUN
Beschreibung

BUN

Datentyp

float

Maßeinheiten
  • mg/dL
mg/dL
[CREA] Creatinine
Beschreibung

Result below

Datentyp

float

Maßeinheiten
  • mg/dL
mg/dL
[AST] AST/SGOT
Beschreibung

Result below

Datentyp

float

Maßeinheiten
  • U/L
U/L
[ALT] ALT/SGPT
Beschreibung

Result below

Datentyp

float

Maßeinheiten
  • U/L
U/L
[CHOL] Cholesterol
Beschreibung

Cholesterol

Datentyp

float

[CPK] Creatine phosphokinase
Beschreibung

Creatine phosphokinase

Datentyp

float

[HAP] Serum Haptoglobin
Beschreibung

Serum Haptoglobin

Datentyp

float

Maßeinheiten
  • mg/dL
mg/dL
[LDH] Lactate Dehydrogenase
Beschreibung

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

Datentyp

text

LDH
Beschreibung

LDH

LD1
Beschreibung

Result

Datentyp

text

LD2
Beschreibung

Result

Datentyp

text

LD3
Beschreibung

Result

Datentyp

text

LD4
Beschreibung

Result

Datentyp

text

LD5
Beschreibung

Result

Datentyp

text

Has a blood sample been taken for immunogenicity assays?
Beschreibung

Blood Sample for Immunogenicity Assays

Datentyp

boolean

Date
Beschreibung

Date

Datentyp

date

URINALYSIS
Beschreibung

URINALYSIS

Has a urine sample been taken for dipstick?
Beschreibung

Urine Sample Question

Datentyp

boolean

Date
Beschreibung

Date

Datentyp

date

Urinalysis (Dipstick) Test
Beschreibung

Urinalysis (Dipstick) Test

pH (via dipstick)
Beschreibung

Result

Datentyp

integer

Proteins (via dipstick)
Beschreibung

Proteins (via dipstick)

Datentyp

text

Glucose (via dipstick)
Beschreibung

Glucose (via dipstick)

Datentyp

text

Ketones (via dipstick)
Beschreibung

Ketones (via dipstick)

Datentyp

text

Blood and myoglobin (via dipstick)
Beschreibung

Blood and myoglobin (via dipstick)

Datentyp

text

Bilirubin (via dipstick)
Beschreibung

Bilirubin (via dipstick)

Datentyp

text

Urobilinogen (via dipstick)
Beschreibung

Urobilinogen (via dipstick)

Datentyp

text

Nitrites (via dipstick)
Beschreibung

Nitrites (via dipstick)

Datentyp

text

Leukocyte esterase (via dipstick)
Beschreibung

Leukocyte esterase (via dipstick)

Datentyp

text

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

Urina Sample for Diagnostic Sssay?

Datentyp

boolean

Date
Beschreibung

Date

Datentyp

date

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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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