ID
41663
Beskrivning
Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form is to be used in case of a Serious Adverse Event (SAE), which is here defined as: A serious adverse event (SAE) is any untoward medical occurrence that: a. results in death, b. is life-threatening, NOTE: The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c. requires hospitalization or prolongation of existing hospitalization, NOTE: In general, hospitalization signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalization are AEs. If a complication prolongs hospitalization or fulfils any other serious criteria, the event is serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE should be considered serious. Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE. d. results in disability/incapacity, or NOTE: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g. sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e. is a congenital anomaly/birth defect in the offspring of a study subject. f. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately lifethreatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization. Serious Adverse Events (SAEs) related to study participation (e.g. procedures, invasive tests, change from existing therapy) or SAEs related to GSK concurrent medication will be collected and recorded from the time the subject consents to participate in the study. For all other SAEs, the standard time period for collecting and recording SAEs will begin from the administration of the first dose of vaccine / placebo / comparator and will end minimum 30 days (see protocol) following administration of the last dose of vaccine / placebo / comparator for each subject.
Länk
https://clinicaltrials.gov/ct2/show/NCT00307021
Nyckelord
Versioner (1)
- 2020-12-05 2020-12-05 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
5 december 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021
Serious Adverse Event Report
- StudyEvent: ODM
Beskrivning
SAE
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Diagnosis only (if known), otherwise sign/symptom. A separate form should be used for each SAE however if multiple SAEs which are temporarily or clinically related are apparent at the time of initial reporting then these may be reported on the same page.
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
The start date should document the first occurrence of the SAE. This is generally the start date of the signs/symptoms and not necessarily the date that the event met the definition of serious.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Beskrivning
All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. (rest of the paragraph not readable)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beskrivning
If fatal, record date of death Record the date of resolution or the date of death as applicable. (rest of paragraph not readable)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Beskrivning
Record the maximum intensity that occurred over the duration of the event (see protocol for definition of intensity). Amend the intensity if it increases.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
If administration of the investigational product was stopped permanently and not restarted enter 1-Investigational product(s) withdrawn and enter the date that investigational product was discontinued in section 9. If administration of the investigational product was not modified and all scheduled doses were given enter 2-Dose not changed. If administration of investigational product was temporarily interrupted but then restarted enter 3-Dose Interrupted. If the subject did not receive investigational product dose at the time of the event or if the subject has received all his doses or if the subject died and there was no prior decision to discontinue investigational product enter X-Not applicable.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
Withdrawal due to SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beskrivning
This box is mandatory and has to be completed before faxing the form. It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. (...) Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered. (Rest of paragraph not readable)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beskrivning
Medically attended visit because of SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1519255
Beskrivning
Outcome fatal, autopsy performed
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Beskrivning
Seriousness
Alias
- UMLS CUI-1
- C1710056
Beskrivning
SAE Results in death
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C1519255
Beskrivning
SAE is life threatening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517874
- UMLS CUI [1,2]
- C1519255
Beskrivning
SAE requires or prolongs hospitalization
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0745041
Beskrivning
Hospitalisation: Date of admission
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806429
- UMLS CUI [1,2]
- C1519255
Beskrivning
Hospitalisation: Date of discharge
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2710998
- UMLS CUI [1,2]
- C1519255
Beskrivning
SAE results in disability / incapacity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Beskrivning
SAE causes Congenital anomaly / birth defect in the offspring
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Beskrivning
Other Reason for SAE
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Beskrivning
Other Reason for SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Beskrivning
Demography Data
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Sex
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Weight
Datatyp
integer
Måttenheter
- Pounds
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Weight
Datatyp
integer
Måttenheter
- Ounces
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beskrivning
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Beskrivning
Possible causes of SAE
Alias
- UMLS CUI-1
- C3828190
Beskrivning
Possible cause of SAE other than investigational product: Disease under study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0012634
- UMLS CUI [1,6]
- C0347984
- UMLS CUI [1,7]
- C0008976
Beskrivning
Possible cause of SAE other than investigational product: Medical condition
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C4745084
Beskrivning
Possible cause of SAE other than investigational product: Lack of efficacy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0235828
Beskrivning
Possible cause of SAE other than investigational product: Withdrawal of investigational product
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2349954
- UMLS CUI [1,6]
- C0304229
Beskrivning
Possible cause of SAE other than investigational product: Concomitant medication
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2347852
Beskrivning
Possible cause of SAE other than investigational product: Activity related to study participation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2348568
Beskrivning
Possible cause of SAE other than investigational product: Other
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0205394
Beskrivning
Possible cause of SAE other than investigational product: Other
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0205394
Beskrivning
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0262926
Beskrivning
Give any concomitant medication(s) which may have contributed to the event. There is no need to list medications which are definitely not linked to the event.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Beskrivning
Date of onset of medical condition
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beskrivning
Condition present at time of SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C1519255
Beskrivning
Date of last occurrence of medical condition
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beskrivning
Other relevant risk factors
Alias
- UMLS CUI-1
- C0035648
Beskrivning
Family or social history relevant to SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2,1]
- C3714536
- UMLS CUI [2,2]
- C2347946
- UMLS CUI [2,3]
- C1519255
- UMLS CUI [3]
- C1519384
- UMLS CUI [4]
- C0013146
- UMLS CUI [5]
- C0337074
Beskrivning
Relevant Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Drug name Concomitant Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beskrivning
Concomitant Medication Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C2826811
Beskrivning
Concomitant Medication Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C2826646
Beskrivning
Concomitant Medication Frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C2826654
Beskrivning
Concomitant Medication Route
Datatyp
text
Alias
- UMLS CUI [1]
- C2826730
Beskrivning
Concomitant Medication taken prior to study
Datatyp
text
Alias
- UMLS CUI [1]
- C2826667
Beskrivning
Concomitant Medication Date started
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
Concomitant Medication Date stopped
Datatyp
date
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Concomitant Medication Reason for medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826696
Beskrivning
Details of investigational product(s)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1522508
Beskrivning
Vaccine should be given as described on the CRF vaccination page (or protocol). In case of multiple vaccinations on the same day, it is important to also mention if the vaccines were administered mixed or separetely.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C2360065
Beskrivning
Vaccine Dose Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C1115464
Beskrivning
Vaccine Lot Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C1115660
Beskrivning
Vaccine Route / site
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C0042210
Beskrivning
Vaccine Date of administration
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2368628
Beskrivning
Treatment blind broken at investigational site
Datatyp
text
Alias
- UMLS CUI [1]
- C3897431
Beskrivning
Details of relevant assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Beskrivning
Details of tests/procedures to diagnose/confirm SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0011900
- UMLS CUI [2,2]
- C1519255
Beskrivning
Narrative remarks
Alias
- UMLS CUI-1
- C0947611
Beskrivning
Narrative remarks: description of signs/symptoms and details of TREATMENT given for SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0037088
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2981656
Beskrivning
SAE additional / Follow-up information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Beskrivning
SAE additional / follow-up information
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2,1]
- C1522577
- UMLS CUI [2,2]
- C1533716
- UMLS CUI [2,3]
- C1519255
Beskrivning
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
Report Type
Datatyp
integer
Alias
- UMLS CUI [1]
- C0585733
Beskrivning
Investigator's signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Date of signature
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator's name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Serious Adverse Event Report
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2985846 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0012634 (UMLS CUI [1,5])
C0347984 (UMLS CUI [1,6])
C0008976 (UMLS CUI [1,7])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C4745084 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0235828 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2349954 (UMLS CUI [1,5])
C0304229 (UMLS CUI [1,6])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2348568 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C3714536 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
C1519384 (UMLS CUI [3])
C0013146 (UMLS CUI [4])
C0337074 (UMLS CUI [5])
C2360065 (UMLS CUI [1,2])
C1522508 (UMLS CUI-2)
C2360065 (UMLS CUI [1,2])
C1115464 (UMLS CUI [1,2])
C1115660 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C2368628 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0037088 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2981656 (UMLS CUI [2,2])
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])