ID

29751

Beschreibung

https://clinicaltrials.gov/show/NCT00197028 Visit 2 Laboratory tests, medical history and physical examination Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

Link

https://clinicaltrials.gov/show/NCT00197028

Stichworte

Versionen (1)
  1. 18.04.18 18.04.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

18. April 2018

DOI

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Creative Commons BY-NC 3.0
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RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028

Englisch

Visit 2 Laboratory tests, medical history and physical examination

1 Formulare  
Check for study continuation
Beschreibung

Check for study continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for visit 2?
Beschreibung

Visit 2 participation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
If you answered the previous question with 'No' Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beschreibung

Withdrawal reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Please tick who took the decision:
Beschreibung

Withdrawal decision maker

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Record treatment number:
Beschreibung

Randomisation / Treatment allocation

Datentyp

integer

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0237753
Body weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Laboratory tests, Biochemistry
Beschreibung

Laboratory tests, Biochemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005477
Has a blood sample been taken for biochemistry (at Screening - Visit 1)?
Beschreibung

Blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Please complete the date:
Beschreibung

Date of blood sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
ALT - Test result
Beschreibung

ALT

Datentyp

integer

Maßeinheiten
  • IU/L
Alias
UMLS CUI [1]
C0201836
IU/L
Out of range values: Codes
Beschreibung

1. Laboratory Error 2. Preexisting/concomitant medical condition, please specify in table above 3. Prior/Concomitant Medication 4. Child is well – not investigated further 5: Other, please specify in table above

Datentyp

integer

Alias
UMLS CUI [1]
C0438215
Out of ranges values: Specify
Beschreibung

Out of ranges values

Datentyp

integer

Maßeinheiten
  • IU/L
Alias
UMLS CUI [1]
C0438215
IU/L
Creatinine - test result
Beschreibung

Creatinine

Datentyp

integer

Maßeinheiten
  • μmol/L
Alias
UMLS CUI [1]
C0201976
μmol/L
Out of range values: Codes
Beschreibung

Codes 1. Laboratory Error 2. Preexisting/concomitant medical condition, please specify in table above 3. Prior/Concomitant Medication 4. Child is well not investigated further 5: Other, please specify in table above

Datentyp

integer

Alias
UMLS CUI [1]
C0438215
Out of ranges values: Specify
Beschreibung

Out of ranges values

Datentyp

integer

Maßeinheiten
  • μmol/L
Alias
UMLS CUI [1]
C0438215
μmol/L
Bilirubin - test result
Beschreibung

Bilirubin

Datentyp

float

Maßeinheiten
  • μmol/L
Alias
UMLS CUI [1]
C1278039
μmol/L
Out of range values: Codes
Beschreibung

Codes 1. Laboratory Error 2. Preexisting/concomitant medical condition, please specify in table above 3. Prior/Concomitant Medication 4. Child is well not investigated further 5: Other, please specify in table above

Datentyp

integer

Alias
UMLS CUI [1]
C0438215
Out of ranges values: Specify
Beschreibung

Out of ranges values

Datentyp

float

Maßeinheiten
  • μmol/L
Alias
UMLS CUI [1]
C0438215
μmol/L
Laboratory tests, heamatology
Beschreibung

Laboratory tests, heamatology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Has a blood sample been taken for haematology (at Screening - Visit 1)?
Beschreibung

Blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Please complete the date:
Beschreibung

Date of blood sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Haemoglobin - test result
Beschreibung

Haemoglobin

Datentyp

float

Maßeinheiten
  • g/L
Alias
UMLS CUI [1]
C0518015
g/L
WBC (White blood cells) total:
Beschreibung

WBC (White blood cells) total

Datentyp

float

Maßeinheiten
  • x 109/L
Alias
UMLS CUI [1]
C0023508
x 109/L
PCV (Packed cell volume) / Hematocrit:
Beschreibung

PCV (Packed cell volume) / Hematocrit

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0518014
%
Platelets:
Beschreibung

Platelets

Datentyp

integer

Maßeinheiten
  • x 109/L
Alias
UMLS CUI [1]
C0005821
x 109/L
Out of range values: Codes
Beschreibung

Codes 1. Laboratory Error 2. Preexisting/concomitant medical condition, please specify in table above 3. Prior/Concomitant Medication 4. Child is well not investigated further 5: Other, please specify in table above

Datentyp

integer

Alias
UMLS CUI [1]
C0438215
Out of ranges values: Specify
Beschreibung

Out of ranges values

Datentyp

float

Alias
UMLS CUI [1]
C0438215
Laboratory tests, Serology and CMI
Beschreibung

Laboratory tests, Serology and CMI

Alias
UMLS CUI-1
C0020966
UMLS CUI-2
C0005834
UMLS CUI-4
C0022885
UMLS CUI-5
C0036743
Has a blood sample been taken for serology (antibodies to pertussis , antibodies to CS and antibodies to HBs) (at Screening - Visit 1)?
Beschreibung

Serology blood sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0036743
Please complete the date:
Beschreibung

Date of blood sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Has a blood sample been taken for CMI (at Screening - Visit 1)?
Beschreibung

Blood sample CMI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020966
UMLS CUI [1,2]
C0005834
Please complete the date:
Beschreibung

Date of blood sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
General medical history / Physical examination
Beschreibung

General medical history / Physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Beschreibung

Pre-existing conditions

Datentyp

text

Alias
UMLS CUI [1]
C0521987
UMLS CUI [2]
C0009488
Organ system, Comorbidity
Beschreibung

Organ system

Datentyp

integer

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0009488
Diagnosis
Beschreibung

Diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Status: Past or current?
Beschreibung

Status

Datentyp

integer

Alias
UMLS CUI [1]
C0018759
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Ähnliche Modelle

Visit 2 Laboratory tests, medical history and physical examination

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject return for visit 2?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Visit 2 participation
Code List
Did the subject return for visit 2?
CL Item
Yes, please complete the next pages. (1)
CL Item
No (2)
Item
If you answered the previous question with 'No' Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Withdrawal reason
Code List
If you answered the previous question with 'No' Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
[SAE] Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N°: |__|__| (1)
CL Item
[OTH] Other, please specify: ____________________________________________________ (e.g.: consent withdrawal, Protocol violation, …) (2)
Item
Please tick who took the decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Withdrawal decision maker
Code List
Please tick who took the decision:
CL Item
[I] Investigator (1)
(Comment:en)
CL Item
[P] Parents/Guardians (2)
(Comment:en)
Randomisation / Treatment allocation
Item
Record treatment number:
integer
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0034656 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Item Group
Laboratory tests, Biochemistry
C0022885 (UMLS CUI-1)
C0005477 (UMLS CUI-2)
Blood sample
Item
Has a blood sample been taken for biochemistry (at Screening - Visit 1)?
boolean
C0005834 (UMLS CUI [1])
Date of blood sample
Item
Please complete the date:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ALT
Item
ALT - Test result
integer
C0201836 (UMLS CUI [1])
Item
Out of range values: Codes
integer
C0438215 (UMLS CUI [1])
Out of range values
Code List
Out of range values: Codes
CL Item
1. Laboratory Error (1)
CL Item
2. Preexisting/concomitant medical condition, please specify in table above (2)
CL Item
3. Prior/Concomitant Medication (3)
CL Item
4. Child is well – not investigated further (4)
CL Item
5: Other, please specify in table above (5)
Out of ranges values
Item
Out of ranges values: Specify
integer
C0438215 (UMLS CUI [1])
Creatinine
Item
Creatinine - test result
integer
C0201976 (UMLS CUI [1])
Item
Out of range values: Codes
integer
C0438215 (UMLS CUI [1])
Out of range values
Code List
Out of range values: Codes
CL Item
1. Laboratory Error (1)
CL Item
2. Preexisting/concomitant medical condition, please specify in table above (2)
CL Item
3. Prior/Concomitant Medication (3)
CL Item
4. Child is well not investigated further (4)
CL Item
5: Other, please specify in table above (5)
Out of ranges values
Item
Out of ranges values: Specify
integer
C0438215 (UMLS CUI [1])
Bilirubin
Item
Bilirubin - test result
float
C1278039 (UMLS CUI [1])
Item
Out of range values: Codes
integer
C0438215 (UMLS CUI [1])
Out of range values
Code List
Out of range values: Codes
CL Item
1. Laboratory Error (1)
CL Item
2. Preexisting/concomitant medical condition, please specify in table above (2)
CL Item
3. Prior/Concomitant Medication (3)
CL Item
4. Child is well not investigated further (4)
CL Item
5: Other, please specify in table above (5)
Out of ranges values
Item
Out of ranges values: Specify
float
C0438215 (UMLS CUI [1])
Item Group
Laboratory tests, heamatology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Blood sample
Item
Has a blood sample been taken for haematology (at Screening - Visit 1)?
boolean
C0005834 (UMLS CUI [1])
Date of blood sample
Item
Please complete the date:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Haemoglobin
Item
Haemoglobin - test result
float
C0518015 (UMLS CUI [1])
WBC (White blood cells) total
Item
WBC (White blood cells) total:
float
C0023508 (UMLS CUI [1])
PCV (Packed cell volume) / Hematocrit
Item
PCV (Packed cell volume) / Hematocrit:
float
C0518014 (UMLS CUI [1])
Platelets
Item
Platelets:
integer
C0005821 (UMLS CUI [1])
Item
Out of range values: Codes
integer
C0438215 (UMLS CUI [1])
Out of range values
Code List
Out of range values: Codes
CL Item
1. Laboratory Error (1)
CL Item
2. Preexisting/concomitant medical condition, please specify in table above (2)
CL Item
3. Prior/Concomitant Medication (3)
CL Item
4. Child is well not investigated further (4)
CL Item
5: Other, please specify in table above (5)
Out of ranges values
Item
Out of ranges values: Specify
float
C0438215 (UMLS CUI [1])
Item Group
Laboratory tests, Serology and CMI
C0020966 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0022885 (UMLS CUI-4)
C0036743 (UMLS CUI-5)
Serology blood sample
Item
Has a blood sample been taken for serology (antibodies to pertussis , antibodies to CS and antibodies to HBs) (at Screening - Visit 1)?
boolean
C0005834 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
Date of blood sample
Item
Please complete the date:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Blood sample CMI
Item
Has a blood sample been taken for CMI (at Screening - Visit 1)?
boolean
C0020966 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date of blood sample
Item
Please complete the date:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
General medical history / Physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
text
C0521987 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
Pre-existing conditions
Code List
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
CL Item
No (No)
CL Item
Yes → Please tick appropriate box(es) and give diagnosis. (Yes → Please tick appropriate box(es) and give diagnosis.)
Item
Organ system, Comorbidity
integer
C0678852 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Organ system
Code List
Organ system, Comorbidity
CL Item
[10] Cutaneous (1)
CL Item
[5] Eyes (2)
CL Item
[6] Ears-Nose-Throat (3)
CL Item
[2] Cardiovascular (4)
CL Item
[3] Respiratory (5)
CL Item
[1] Gastrointestinal (6)
CL Item
[7] Muskuloskeletal (7)
CL Item
[8] Neurological (8)
CL Item
[12] Genitourinary (9)
CL Item
[11] Haematology (10)
CL Item
[4] Allergies (11)
CL Item
[9] Endocrine (12)
CL Item
[99] Other (specify) (13)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Status: Past or current?
integer
C0018759 (UMLS CUI [1])
Status
Code List
Status: Past or current?
CL Item
Past (1)
CL Item
Current (2)
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