Informações:
Falhas:
ID
29748
Descrição
https://clinicaltrials.gov/show/NCT00197028 Sample Case Report Form 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
Sample Case Report Form: Laboratory Reference Ranges and Serious Adverse Events
Similar models
Sample Case Report Form: Laboratory Reference Ranges and Serious Adverse Events
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Laboratory Name
Item
Laboratory Name
text
C1882331 (UMLS CUI [1])
Laboratory Code
Item
Lab Code
integer
C0022877 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Date of reference range
Item
Date these reference ranges became effective:
date
C0883335 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Age range
Item
Age range: low - high
integer
C0001779 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C1514721 (UMLS CUI [1,2])
CL Item
years (1)
CL Item
months (2)
CL Item
weeks (3)
CL Item
days (4)
CL Item
Male reference range (1)
CL Item
Female reference range (2)
CL Item
Male and Female reference range (3)
CL Item
ALT (1)
CL Item
Creatinine (2)
CL Item
Bilirubin (3)
CL Item
Haemoglobin (4)
CL Item
WBC (White blood cells) total: (5)
CL Item
PCV (Packed cell volume)/ Haematocrit (6)
CL Item
Platelets (7)
Laboratory test unit
Item
Unit
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,2])
Low Reference Value
Item
Low Reference Value
float
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C1522609 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
High Reference value
Item
High Reference value
float
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
C1522609 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
GSK Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
CL Item
Initial report (1)
CL Item
Additional information (2)
CL Item
Additional information (3)
CL Item
Additional information (4)
Serious adverse event number
Item
SAE N°
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Event
Item
Diagnosis only (if known), otherwise sign / symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Start date
Item
Start date
date
C2697888 (UMLS CUI [1])
CL Item
1: Recovered/ Resolved (1)
CL Item
2: Recovering / Resolving (2)
CL Item
3: Not recovered/ Not resolved (3)
CL Item
4: Recovered/ Resolved with sequelae (4)
CL Item
5: Fatal (5)
End date
Item
End date
date
C2697886 (UMLS CUI [1])
CL Item
1: Mild (1)
CL Item
2: Moderate (2)
CL Item
3: Severe (3)
CL Item
X:Not applicable (4)
Item
Action taken with investigational product(s) as a result of the SAE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Action taken with investigational product(s) as a result of the SAE
CL Item
1: Investigational product(s) withdrawn (1)
CL Item
2: Dose not changed (2)
CL Item
3: Dose Interrupted (3)
CL Item
X:Not applicable (4)
Withdrawal
Item
Did the subject withdraw from study as a result of this SAE? (*)
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Relationship to investigational product(s)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Medically attended visit?
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
CL Item
[HO] (1)
CL Item
[ER] (2)
CL Item
[MD] (3)
Autopsy
Item
Was a post-mortem / autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
Seriousness, specify reason(s) for considering this a SAE, tick all that apply):
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Seriousness, specify reason(s) for considering this a SAE, tick all that apply):
CL Item
Results in death (1)
CL Item
Results in disability / incapacity (2)
CL Item
Is life threatening (3)
CL Item
Congenital anomaly / birth defect in the offspring (4)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (5)
CL Item
Other, specify: ___________________________________________________ (6)
CL Item
___________________________________________________ (7)
Item Group
Section 3 - Demography Data
C1828479 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
C0011298 (UMLS CUI-2)
Date of birth
Item
Date of birth:
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Weight
Item
Weight (US only)
integer
C0005910 (UMLS CUI [1])
Item
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
integer
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
Code List
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Section 5 - Causes of SAE
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
C0085978 (UMLS CUI-2)
Item
Possible causes of SAE other than investigational product: (tick all that apply)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
Code List
Possible causes of SAE other than investigational product: (tick all that apply)
CL Item
Disease under study (1)
CL Item
Concomitant medication (record in Section 8) (2)
CL Item
Medical condition(s) (record in Section 6) (3)
CL Item
Activity related to study participation (e.g. procedures) (4)
CL Item
Lack of efficacy (5)
CL Item
Withdrawal of investigational product (6)
CL Item
Other, specify: ____________________________________________________ (7)
CL Item
____________________________________________________ (8)
Item Group
Section 6 – Relevant Medical Conditions
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Medical disorders
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc., that can help explain the SAE
text
C0012634 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
Present condition
Item
Condition present at time of SAE?
boolean
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
Date of last occurence
Item
If no, date of last occurrence
date
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
Item Group
Section 7 - Other relevant risk factors
C1828479 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C0035648 (UMLS CUI-2)
Other relevant risk factors
Item
Other relevant risk factors: (specify any family or social history (smoking, diet, drug abuse, occupational hazard) relevant to the SAE):
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Section 8 – Relevant Concomitant Medications
C1828479 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Drug name
Item
Drug Name (Trade name preferred)
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Concomitant Medications
Item
Taken prior to study?
boolean
C2347852 (UMLS CUI [1])
Date started
Item
Date started
date
C2826734 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Ongoing
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Item Group
Section 9 – Details of investigational product(s)
C1828479 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0013230 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Vaccine
Item
Vaccine (specify mixed or separate)
text
C0042210 (UMLS CUI [1])
Dose number
Item
Dose N°
integer
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Lot number
Item
Lot N°
integer
C2826710 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Route / site
Item
Route / site
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])
Administration date
Item
Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Was randomization code broken at investigational site?
integer
C0034656 (UMLS CUI [1,1])
C0443289 (UMLS CUI [1,2])
C0443289 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (3)
Item Group
Section 10 – Details of relevant assessments
C1828479 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
Details of relevant assessments
Item
Details of relevant assessments: (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE, e.g. laboratory data with units and normal range)
text
C1519255 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item Group
Section 11 – Narrative remarks
C1828479 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI-2)
Narrative remarks
Item
Narrative remarks: (provide a brief narrative description of the SAE and details of treatment given):
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Section 12 – SAE additional / follow-up information
C1524062 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
SAE additional / follow-up information
Item
SAE additional / follow-up information (use this page to provide any additional details on the SAE not already captured on the previous pages):
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
Investigator’s signature
Item
Investigator’s signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Printed name
Item
Please PRINT name:
text
C2826892 (UMLS CUI [1])