Informações:
Falhas:
ID
29751
Descrição
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
Palavras-chave
Versões (1)
- 18/04/2018 18/04/2018 -
Titular dos direitos
GlaxoSmithKline (GSK)
Transferido a
18 de abril de 2018
DOI
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Licença
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
Visit 2 Laboratory tests, medical history and physical examination
Similar models
Visit 2 Laboratory tests, medical history and physical examination
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
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])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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])
C0679006 (UMLS CUI [1,2])
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])
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)
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])
C0011008 (UMLS CUI [1,2])
ALT
Item
ALT - Test result
integer
C0201836 (UMLS CUI [1])
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])
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])
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)
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])
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])
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)
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])
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])
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])
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])
C0011008 (UMLS CUI [1,2])
Item Group
General medical history / Physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
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])
C0009488 (UMLS CUI [2])
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])
C0009488 (UMLS CUI [1,2])
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])
CL Item
Past (1)
CL Item
Current (2)