ID

41663

Beschreibung

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.

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Stichworte

Versionen (1)
  1. 05.12.20 05.12.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Dezember 2020

DOI

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Lizenz

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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

Englisch

Serious Adverse Event Report

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre number
Beschreibung

Centre number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Country
Beschreibung

Country

Datentyp

text

Alias
UMLS CUI [1]
C0454664
Treatment Number
Beschreibung

Treatment Number

Datentyp

integer

Alias
UMLS CUI [1]
C1522541
SAE Report Number
Beschreibung

Mandatory. Attribute a sequential number to each new SAE report, starting from 01 for each subject.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0600091
GSK receipt date
Beschreibung

To be completed by GSK only. The GSK receipt date is the date on which the first GSK employee/designee is notified of the SAE.

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2985846
UMLS CUI [1,3]
C2347796
Report type
Beschreibung

Report type

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0332307
SAE
Beschreibung

SAE

Alias
UMLS CUI-1
C1519255
Event
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschreibung

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.

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
SAE Outcome
Beschreibung

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)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End date
Beschreibung

If fatal, record date of death Record the date of resolution or the date of death as applicable. (rest of paragraph not readable)

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Maximum intensity
Beschreibung

Record the maximum intensity that occurred over the duration of the event (see protocol for definition of intensity). Amend the intensity if it increases.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Action taken with investigational product(s) as a result of the SAE
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of SAE?
Beschreibung

Withdrawal due to SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschreibung

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)

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Medically attended visit
Beschreibung

Medically attended visit because of SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1519255
If fatal, was a post-mortem/autopsy performed?
Beschreibung

Outcome fatal, autopsy performed

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0004398
Seriousness
Beschreibung

Seriousness

Alias
UMLS CUI-1
C1710056
Specify reason(s) for considering this a SAE. 1. Results in death
Beschreibung

SAE Results in death

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C1519255
Specify reason(s) for considering this a SAE. 2. Is life threatening
Beschreibung

SAE is life threatening

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517874
UMLS CUI [1,2]
C1519255
Specify reason(s) for considering this a SAE. 3. Requires hospitalisation or prolongation of existing hospitalisation.
Beschreibung

SAE requires or prolongs hospitalization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826664
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
Hospitalisation: Date of admission
Beschreibung

Hospitalisation: Date of admission

Datentyp

date

Alias
UMLS CUI [1,1]
C0806429
UMLS CUI [1,2]
C1519255
Hospitalisation: Date of discharge
Beschreibung

Hospitalisation: Date of discharge

Datentyp

date

Alias
UMLS CUI [1,1]
C2710998
UMLS CUI [1,2]
C1519255
Specify reason(s) for considering this a SAE. 4. Results in disability / incapacity
Beschreibung

SAE results in disability / incapacity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Specify reason(s) for considering this a SAE. 5. Congenital anomaly / birth defect in the offspring
Beschreibung

SAE causes Congenital anomaly / birth defect in the offspring

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Specify reason(s) for considering this a SAE. 6. Other reason (clinically significant / intervention required), specify
Beschreibung

Other Reason for SAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3840932
Specify reason(s) for considering this a SAE. 6. Other reason (clinically significant / intervention required), specify
Beschreibung

Other Reason for SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3840932
Demography Data
Beschreibung

Demography Data

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight (US only)
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • Pounds
Alias
UMLS CUI [1]
C0005910
Pounds
Weight (US only)
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • Ounces
Alias
UMLS CUI [1]
C0005910
Ounces
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Beschreibung

If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C1517331
UMLS CUI [1,4]
C0304229
Possible causes of SAE
Beschreibung

Possible causes of SAE

Alias
UMLS CUI-1
C3828190
Possible cause of SAE other than investigational product: Disease under study (not applicable for prophylactic vaccine studies)
Beschreibung

Possible cause of SAE other than investigational product: Disease under study

Datentyp

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
Possible cause of SAE other than investigational product: Medical condition(s) (record in Section 6)
Beschreibung

Possible cause of SAE other than investigational product: Medical condition

Datentyp

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
Possible cause of SAE other than investigational product: Lack of efficacy
Beschreibung

Possible cause of SAE other than investigational product: Lack of efficacy

Datentyp

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
Possible cause of SAE other than investigational product: Withdrawal of investigational product
Beschreibung

Possible cause of SAE other than investigational product: Withdrawal of investigational product

Datentyp

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
Possible cause of SAE other than investigational product: Concomitant medication (Record in Section 8)
Beschreibung

Possible cause of SAE other than investigational product: Concomitant medication

Datentyp

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
Possible cause of SAE other than investigational product: Activity related to study participation (e.g. procedures)
Beschreibung

Possible cause of SAE other than investigational product: Activity related to study participation

Datentyp

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
Possible cause of SAE other than investigational product: Other, specify
Beschreibung

Possible cause of SAE other than investigational product: Other

Datentyp

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
Possible cause of SAE other than investigational product: Other, specify
Beschreibung

Possible cause of SAE other than investigational product: Other

Datentyp

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
Relevant Medical Conditions
Beschreibung

Relevant Medical Conditions

Alias
UMLS CUI-1
C0262926
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc., that can help explain the SAE
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Date of onset
Beschreibung

Date of onset of medical condition

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Condition present at time of SAE
Beschreibung

Condition present at time of SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1519255
If No, date of last occurrence
Beschreibung

Date of last occurrence of medical condition

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0011008
Other relevant risk factors
Beschreibung

Other relevant risk factors

Alias
UMLS CUI-1
C0035648
Specify any family or social history (smoking, diet, drug abuse, occupational hazard) relevant to the SAE
Beschreibung

Family or social history relevant to SAE

Datentyp

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
Relevant Concomitant Medication
Beschreibung

Relevant Concomitant Medication

Alias
UMLS CUI-1
C2347852
Drug name (Trade name preferred)
Beschreibung

Drug name Concomitant Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Dose
Beschreibung

Concomitant Medication Dose

Datentyp

text

Alias
UMLS CUI [1]
C2826811
Unit
Beschreibung

Concomitant Medication Unit

Datentyp

text

Alias
UMLS CUI [1]
C2826646
Frequency
Beschreibung

Concomitant Medication Frequency

Datentyp

text

Alias
UMLS CUI [1]
C2826654
Route
Beschreibung

Concomitant Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C2826730
Taken prior to study?
Beschreibung

Concomitant Medication taken prior to study

Datentyp

text

Alias
UMLS CUI [1]
C2826667
Date started
Beschreibung

Concomitant Medication Date started

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Date stopped
Beschreibung

Concomitant Medication Date stopped

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Reason for medication
Beschreibung

Concomitant Medication Reason for medication

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Details of investigational product(s)
Beschreibung

Details of investigational product(s)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1522508
Vaccine name (in case of multiple vaccination, please specify if vaccines were administered mixed or separately)
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C2360065
Dose N°
Beschreibung

Vaccine Dose Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1115464
Lot N°
Beschreibung

Vaccine Lot Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1115660
Route / site
Beschreibung

Vaccine Route / site

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0042210
Date of administration
Beschreibung

Vaccine Date of administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Was treatment blind broken at investigational site?
Beschreibung

Treatment blind broken at investigational site

Datentyp

text

Alias
UMLS CUI [1]
C3897431
Details of relevant assessments
Beschreibung

Details of relevant assessments

Alias
UMLS CUI-1
C1261322
UMLS CUI-2
C1519255
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
Beschreibung

Details of tests/procedures to diagnose/confirm SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C1519255
Narrative remarks
Beschreibung

Narrative remarks

Alias
UMLS CUI-1
C0947611
Narrative remarks: description of signs/symptoms and details of TREATMENT given for SAE
Beschreibung

Narrative remarks: description of signs/symptoms and details of TREATMENT given for SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0037088
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2981656
SAE additional / Follow-up information
Beschreibung

SAE additional / Follow-up information

Alias
UMLS CUI-1
C1524062
UMLS CUI-2
C1533716
UMLS CUI-3
C1519255
UMLS CUI-4
C1522577
Use this page to provide any additional details on the SAE not already captured on the previous pages.
Beschreibung

SAE additional / follow-up information

Datentyp

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
Investigator's signature
Beschreibung

Investigator's signature

Alias
UMLS CUI-1
C2346576
Report Type
Beschreibung

Report Type

Datentyp

integer

Alias
UMLS CUI [1]
C0585733
Investigator's signature
Beschreibung

Investigator's signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date of signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name (print)
Beschreibung

Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Serious Adverse Event Report

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Centre number
Item
Centre number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
integer
C1522541 (UMLS CUI [1])
SAE Report Number
Item
SAE Report Number
integer
C3897642 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
GSK receipt date
Item
GSK receipt date
date
C1519255 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
Item
Report type
integer
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Report type
Code List
Report type
CL Item
Initial report (1)
CL Item
First follow-up (2)
CL Item
Second follow-up (3)
CL Item
Third follow-up (4)
Item Group
SAE
C1519255 (UMLS CUI-1)
Event
Item
Event
text
C1519255 (UMLS CUI [1])
SAE Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
SAE Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
SAE Outcome
Code List
SAE Outcome
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered / resolved with sequelae (4)
CL Item
Fatal (5)
SAE End date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
SAE Maximum intensity
Code List
Maximum intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action taken with investigational product(s) as a result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action taken with investigational product as result of SAE
Code List
Action taken with investigational product(s) as a result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Dose interrupted (3)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of SAE?
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal due to SAE
Code List
Did the subject withdraw from study as a result of SAE?
CL Item
Yes, please complete the Study Conclusion page in the CRF of the subject and tick SAE as reason for withdrawal. (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Relationship to investigational product
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Doctor (MD)
Item
If fatal, was a post-mortem/autopsy performed?
text
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Outcome fatal, autopsy performed
Code List
If fatal, was a post-mortem/autopsy performed?
CL Item
No (N)
CL Item
Yes, summarize findings in Section 11 Narrative Remarks of this SAE form. (Y)
Item Group
Seriousness
C1710056 (UMLS CUI-1)
SAE Results in death
Item
Specify reason(s) for considering this a SAE. 1. Results in death
boolean
C1705232 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE is life threatening
Item
Specify reason(s) for considering this a SAE. 2. Is life threatening
boolean
C1517874 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE requires or prolongs hospitalization
Item
Specify reason(s) for considering this a SAE. 3. Requires hospitalisation or prolongation of existing hospitalisation.
boolean
C2826664 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
Hospitalisation: Date of admission
Item
Hospitalisation: Date of admission
date
C0806429 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Hospitalisation: Date of discharge
Item
Hospitalisation: Date of discharge
date
C2710998 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE results in disability / incapacity
Item
Specify reason(s) for considering this a SAE. 4. Results in disability / incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE causes Congenital anomaly / birth defect in the offspring
Item
Specify reason(s) for considering this a SAE. 5. Congenital anomaly / birth defect in the offspring
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other Reason for SAE
Item
Specify reason(s) for considering this a SAE. 6. Other reason (clinically significant / intervention required), specify
boolean
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Other Reason for SAE
Item
Specify reason(s) for considering this a SAE. 6. Other reason (clinically significant / intervention required), specify
text
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Item Group
Demography Data
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Weight
Item
Weight (US only)
integer
C0005910 (UMLS CUI [1])
Weight
Item
Weight (US only)
integer
C0005910 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Code List
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (A)
Item Group
Possible causes of SAE
C3828190 (UMLS CUI-1)
Possible cause of SAE other than investigational product: Disease under study
Item
Possible cause of SAE other than investigational product: Disease under study (not applicable for prophylactic vaccine studies)
boolean
C1519255 (UMLS CUI [1,1])
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])
Possible cause of SAE other than investigational product: Medical condition
Item
Possible cause of SAE other than investigational product: Medical condition(s) (record in Section 6)
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C4745084 (UMLS CUI [1,5])
Possible cause of SAE other than investigational product: Lack of efficacy
Item
Possible cause of SAE other than investigational product: Lack of efficacy
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0235828 (UMLS CUI [1,5])
Possible cause of SAE other than investigational product: Withdrawal of investigational product
Item
Possible cause of SAE other than investigational product: Withdrawal of investigational product
boolean
C1519255 (UMLS CUI [1,1])
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])
Possible cause of SAE other than investigational product: Concomitant medication
Item
Possible cause of SAE other than investigational product: Concomitant medication (Record in Section 8)
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,5])
Possible cause of SAE other than investigational product: Activity related to study participation
Item
Possible cause of SAE other than investigational product: Activity related to study participation (e.g. procedures)
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2348568 (UMLS CUI [1,5])
Possible cause of SAE other than investigational product: Other
Item
Possible cause of SAE other than investigational product: Other, specify
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Possible cause of SAE other than investigational product: Other
Item
Possible cause of SAE other than investigational product: Other, specify
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Item Group
Relevant Medical Conditions
C0262926 (UMLS CUI-1)
Medical disorders relevant for SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc., that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset of medical condition
Item
Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Condition present at time of SAE
text
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Condition present at time of SAE
Code List
Condition present at time of SAE
CL Item
Yes (Y)
CL Item
No (N)
Date of last occurrence of medical condition
Item
If No, date of last occurrence
date
C0012634 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item Group
Other relevant risk factors
C0035648 (UMLS CUI-1)
Family or social history relevant to SAE
Item
Specify any family or social history (smoking, diet, drug abuse, occupational hazard) relevant to the SAE
text
C0241889 (UMLS CUI [1,1])
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])
Item Group
Relevant Concomitant Medication
C2347852 (UMLS CUI-1)
Drug name Concomitant Medication
Item
Drug name (Trade name preferred)
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medication Dose
Item
Dose
text
C2826811 (UMLS CUI [1])
Concomitant Medication Unit
Item
Unit
text
C2826646 (UMLS CUI [1])
Concomitant Medication Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant Medication Route
Item
Route
text
C2826730 (UMLS CUI [1])
Item
Taken prior to study?
text
C2826667 (UMLS CUI [1])
Concomitant Medication taken prior to study
Code List
Taken prior to study?
CL Item
No (N)
CL Item
Yes (Y)
Concomitant Medication Date started
Item
Date started
date
C2826734 (UMLS CUI [1])
Concomitant Medication Date stopped
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Concomitant Medication Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Item Group
Details of investigational product(s)
C0304229 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Vaccine name
Item
Vaccine name (in case of multiple vaccination, please specify if vaccines were administered mixed or separately)
text
C0042210 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Vaccine Dose Number
Item
Dose N°
text
C0042210 (UMLS CUI [1,1])
C1115464 (UMLS CUI [1,2])
Vaccine Lot Number
Item
Lot N°
text
C0042210 (UMLS CUI [1,1])
C1115660 (UMLS CUI [1,2])
Vaccine Route / site
Item
Route / site
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
Vaccine Date of administration
Item
Date of administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational site?
text
C3897431 (UMLS CUI [1])
undefined item
Code List
Was treatment blind broken at investigational site?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not applicable (A)
Item Group
Details of relevant assessments
C1261322 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Details of tests/procedures to diagnose/confirm SAE
Item
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
C0022885 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Item Group
Narrative remarks
C0947611 (UMLS CUI-1)
Narrative remarks: description of signs/symptoms and details of TREATMENT given for SAE
Item
Narrative remarks: description of signs/symptoms and details of TREATMENT given for SAE
text
C1519255 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2981656 (UMLS CUI [2,2])
Item Group
SAE additional / Follow-up information
C1524062 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
SAE additional / follow-up information
Item
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 [2,1])
C1533716 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Item
Report Type
integer
C0585733 (UMLS CUI [1])
Report type
Code List
Report Type
CL Item
Initial report (1)
CL Item
First follow-up (2)
CL Item
Second follow-up (3)
CL Item
Third follow-up (4)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
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