ID

42521

Beschreibung

Study ID: 106464 Clinical Study ID: 106464 Study Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS, S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00380393 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/study/NCT00380393. This Phase IIb randomized, double-blind, controlled study of the efficacy against episodes of clinical malaria due to Plasmodium falciparum infection of GlaxoSmithKline Biologicals’ candidate vaccine RTS, S/AS01E, administered IM according to a 0, 1, 2-month vaccination schedule in children aged 5 months to 17 months living in Tanzania and Kenya. This study includes the following 7 clinical study visits (3 different visit types) during a double-blind phase (Day -60 to Month 6 1/2) and a single-blind phase including an extension for a subset of patients (month 7 to month 14). Clinical visit 1: Baseline visit, screening, and randomisation (DAY -60 to 0) Clinical visit 2: Vaccination I (MONTH 0, DAY 0 | DOSE 1 | 0 - 60 DAYS AFTER VISIT 1) Clinical visit 3: Vaccination II (MONTH 1, DAY 30 | DOSE 2 | 21 - 35 DAYS AFTER VISIT 2) Clinical visit 4: Vaccination III (MONTH 2, DAY 60 | DOSE 3 | 21 - 35 DAYS AFTER VISIT 3) Clinical visit 5: Blood Sample, ACD (MONTH 3, DAY 90 | 21 - 42 DAYS AFTER VISIT 4) Clinical visit 6: Blood Sample, ACD (MONTH 6 1/2 | CROSS-SECTIONAL VISIT FOR ACD | FINAL STUDY VISIT FOR DOUBLE-BLIND PHASE) Clinical visit 7: Blood Sample, ACD (MONTH 14 | FINAL STUDY VISIT SINGLE-BLIND PHASE) Field-worker home visits: During the vaccination period, clinical visits are accompanied by daily field-worker visits for a one-week period subsequent to each vaccine administration at clinical visits 2, 3, and 4 (visit code 21-26 following clinical visit 2; visit code 27-32 following clinical visit 3; visit code 33-38 following clinical visit 4). After completion of the vaccination period, clinical visits are then accompanied by weekly field-worker home visits (visit code 39-40 following clinical visit 4/dose 3; visit code 41-55 following clinical visit 5; visit code 56-86 following clinical visit 6). These visits serve the additional purpose of Active Case Detection (ACD). Passive Case Detection (PCD) for clinical malaria disease is performed both during the course of the double-blind (day -60 to month 6 1/2) and the single-blind phase (month 7 to month 14). Definition of Serious Adverse Events (SAE): A serious adverse event (SAE) is any untoward medical occurrence that (a) results in death, (b) is life-threatening, (c) requires hospitalization or prolongation of existing hospitalization, (d) results in disability/incapacity, or (e) is a congenital anomaly/birth defect in the offspring of a study subject. Also see item descriptions for additional specification. Instructions for reporting Serious Adverse Events (SAE): Please report any serious adverse event (SAE) as specified in the study protocol by filling in this form. Serious Adverse Events (SAEs) related to study participation (e.g. procedures, invasive tests, change from existing therapy) or SAEs related to 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 (ref to protocol) following administration of the last dose of vaccine / placebo / comparator for each subject. (1) Complete this form for each Serious Adverse Event as fully and accurately as possible in order to allow the safety department to make an assessment of the initially reported information and to minimize the time spent dealing with data queries. Ensure that all information on the SAE pages is consistent with information given on CRF pages: * Demography * General Medical History / Physical Examination * Vaccine administration page(s) (for administered doses) * Medication * Concomitant Vaccination (2) Sign and date below section 11 and section 12. Complete section 12 of the SAE form if needed only. (3) Send the SAE form to: * The GSK Biologicals study contact. Refer to protocol for contact name and number. * In the event of a death determined by the investigator to be related to the vaccination, sending of the fax must be accompanied by phone call to the study contact for reporting SAEs. The SAE form must be sent to GlaxoSmithKline within 24 hours of becoming aware of these events. (4) The Serious Adverse Event (SAE) report must be checked for final assessment at the end of the study. Note that informed consent has to be obtained prior to any study procedure.

Link

https://clinicaltrials.gov/ct2/show/study/NCT00380393

Stichworte

Versionen (2)
  1. 17.08.21 17.08.21 -
  2. 17.08.21 17.08.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. August 2021

DOI

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Creative Commons BY-NC 4.0
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Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393

Deutsch Englisch

Serious Adverse Event Report

1 Formulare  
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Country
Beschreibung

Country

Datentyp

text

Alias
UMLS CUI [1]
C0454664
Center Number
Beschreibung

Hospital identifier

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Treatment Number
Beschreibung

Randomisation Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Serious Adverse Event (SAE)
Beschreibung

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
SAE Report N°
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0237753
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]
C2985846
UMLS CUI [1,2]
C2347796
Initial report
Beschreibung

SAE report initial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0205265
First follow-up
Beschreibung

SAE follow-up report

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704685
Second follow-up
Beschreibung

SAE follow-up report

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704685
Third follow-up
Beschreibung

SAE follow-up report

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704685
Section 1
Beschreibung

Section 1

Alias
UMLS CUI-1
C1828479
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 in the same form.

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]
C1519255
UMLS CUI [1,2]
C0808070
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. Indicate if the event was "Recovered/Resolved" or "Recovered/Resolved with sequelae". If the SAE is ongoing at the time the subject completed the study or becomes lost to follow-up, the outcome must be recorded as "Recovering/Resolving" or "Not recovered/Not resolved". Also enter "Not recovered/Nor resolved" if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was direct cause of death.

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. Leave blank only if the outcome of the event is "Not resolved" – "Recovering / resolving".

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
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]
C2826626
UMLS CUI [1,2]
C1519255
Withdrawal: Did the subject withdraw from study as a result of this SAE?
Beschreibung

If Yes, please complete the Study Conclusion in the CRF of the subject and tick SAE as reason for withdrawal.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Relationship to investigational product(s): 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 sending the form. It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. "A reasonable possibility" is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support "a reasonable possibility" include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Medically attended visit
Beschreibung

Refer to protocol for full definition.

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

If Yes, summarize findings in Section 11 Narrative Remarks of this SAE form.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Section 2 – Seriousness of Adverse Event
Beschreibung

Section 2 – Seriousness of Adverse Event

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1519255
Results in death
Beschreibung

Specify reason(s) for considering this an SAE, tick all items in this item group that apply.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011065
Is life threatening
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826244
Requires hospitalisation or prolongation of existing hospitalisation
Beschreibung

This box is to be ticked only if there is at least an overnight stay. 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. The following cases are not defined as serious AEs and no SAE report is no to be submitted: * Hospitalization for elective surgery related to a pre-existing condition which did not increase in severity or frequency following initiation of the study (e.g. : aesthetic surgery or surgery planned before subject enrolled), * Hospitalisation for routine clinical procedure or for social reason (e.g. : elderly person had an extension of hospitalization because of room is available in a resting home) that are not the result of an adverse event These latter cases have to be recorded in the CRF only. If the hospitalization arises from a pre- existing condition or was planned prior to the first vaccination, it should be recorded in the Medical History section of the CRF. If the hospitalisation was planned after the first vaccination, it should be recorded in the AE section. In both cases, it should be recorded as "Hospitalisation" (not an adverse event) or "Hospitalisation for social reason" (not an adverse event) or "Elective surgery" (not an adverse event) and the relationship to vaccination will be checked "No".

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
Date of admission
Beschreibung

If hospitalization or prolonged hospitalization, please indicate admission date.

Datentyp

date

Alias
UMLS CUI [1,1]
C1302393
UMLS CUI [1,2]
C1519255
Date of discharge
Beschreibung

If hospitalization or prolonged hospitalization, please indicate discharge date.

Datentyp

date

Alias
UMLS CUI [1,1]
C2361123
UMLS CUI [1,2]
C1519255
Results in disability/incapacity
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Congenital anomaly/birth defect
Beschreibung

NOTE: congenital anomaly/birth defect in the offspring of a study subject.

Datentyp

boolean

Alias
UMLS CUI [1]
C2826727
Other (clinically significant/intervention required)(see definition of SAE)
Beschreibung

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 life- threatening 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. See also protocol for possible additional specification.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0205394
If other, please specify.
Beschreibung

Other SAE seriousness to specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1710056
UMLS CUI [1,3]
C1521902
Section 3 – Demography Data
Beschreibung

Section 3 – Demography Data

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight
Beschreibung

OR indicate weight in Pounds and Ounces (US only).

Datentyp

integer

Maßeinheiten
  • Pounds
Alias
UMLS CUI [1]
C0005910
Pounds
Weight
Beschreibung

OR indicate weight in Pounds and Ounces (US only).

Datentyp

integer

Maßeinheiten
  • Ounces
Alias
UMLS CUI [1]
C0005910
Ounces
Section 4 – Serious adverse events recurrence
Beschreibung

Section 4 – Serious adverse events recurrence

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1519255
UMLS CUI-3
C0034897
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]
C2347900
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0457454
UMLS CUI [1,6]
C0304229
Section 5 – Possible causes of SAE other than investigational product
Beschreibung

Section 5 – Possible causes of SAE other than investigational product

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1519255
UMLS CUI-3
C0085978
Disease under study
Beschreibung

Specify possible causes for occurrence of SAE other than investigational product, tick all items in this item group that apply. To be completed in any case, whether relationship is Yes or No. Indicate all possible explanations/circumstances which may have contributed to the SAE. Disease under study is not applicable for prophylactic vaccine studies.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1519255
Medical condition(s)
Beschreibung

Record medical conditions in Section 6.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Lack of efficacy
Beschreibung

Lack of efficacy SAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235828
UMLS CUI [1,2]
C1519255
Withdrawal of investigational product(s)
Beschreibung

Withdrawal of investigational drug SAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1519255
Concomitant medication
Beschreibung

Record concomitant medication in Section 8.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1519255
Activity related to study participation (e.g., procedures)
Beschreibung

Study subject participation status SAE | Medical procedure study protocol SAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0199171
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C1519255
Other
Beschreibung

Other SAE causation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0085978
Other, specify
Beschreibung

If other, please specify other possible causes of SAE. Indicate all possible explanations/circumstances which may have contributed to the SAE.

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C1521902
Section 6 – Relevant Medical Conditions
Beschreibung

Section 6 – Relevant Medical Conditions

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0012634
Specify any relevant past or current medical disorders, allergies, surgeries, etc., that can help explain the SAE
Beschreibung

Relevant disease, hypersensitivity, or operative surgical procedure for SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C1519255
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C1519255
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C2347946
UMLS CUI [3,3]
C1519255
Date of onset
Beschreibung

Date of onset relevant disease | hypersensitivity | operative surgical procedure

Datentyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2347946
UMLS CUI [1,4]
C1519255
UMLS CUI [2,1]
C0574845
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C2347946
UMLS CUI [2,4]
C1519255
UMLS CUI [3,1]
C0574845
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C2347946
UMLS CUI [3,4]
C1519255
Condition present at time of SAE?
Beschreibung

If No, indicate the date of last occurrence in the following item.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C1519255
Date of last occurrence
Beschreibung

Date of last occurrence disease SAE

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0012634
UMLS CUI [1,5]
C1519255
Section 7 – Other Relevant Risk Factors
Beschreibung

Section 7 – Other Relevant Risk Factors

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0035648
Other relevant risk factors: Specify any family or social history (smoking, diet, drug abuse, occupational hazard) relevant to the SAE)
Beschreibung

Risk factors SAE in family or social history (smoking, diet, drug abuse, occupational hazard)

Datentyp

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0241889
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C1519255
UMLS CUI [2,3]
C3714536
UMLS CUI [3]
C1519384
UMLS CUI [4]
C0001948
UMLS CUI [5]
C0012155
UMLS CUI [6]
C0013146
UMLS CUI [7]
C0337074
Section 8 – Relevant Concomitant Medications
Beschreibung

Section 8 – Relevant Concomitant Medications

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0013227
Drug Name
Beschreibung

Please fill in the following items in this item group for any concomitant medication. Give and include details of 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. The trade name of the drug is preferred.

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Dose
Beschreibung

Dose

Datentyp

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beschreibung

Unit of medication dose

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C3174092
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Taken prior to study?
Beschreibung

Concomitant medication previous occurrence

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beschreibung

Start date pharmaceutical preparations

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013227
Stop Date
Beschreibung

Stop date pharmaceutical preparations

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013227
Ongoing medication?
Beschreibung

Pharmaceutical preparations continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Reason for medication
Beschreibung

Indication pharmaceutical preparations

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Section 9 – Details of Investigational Product(s)
Beschreibung

Section 9 – Details of Investigational Product(s)

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0013230
UMLS CUI-3
C1522508
Vaccine name
Beschreibung

Vaccine should given as described within the CRF vaccination information (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

Dose number vaccines

Datentyp

integer

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

Lot number vaccines

Datentyp

text

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

Administration of vaccine route | anatomic site

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
UMLS CUI [2,1]
C2368628
UMLS CUI [2,2]
C1515974
Date of administration
Beschreibung

Date of vaccine administration

Datentyp

date

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

Only answer once for section 9.

Datentyp

text

Alias
UMLS CUI [1]
C3897431
Section 10 – Details of Relevant Assessments
Beschreibung

Section 10 – Details of Relevant Assessments

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1261322
Details of relevant assessments
Beschreibung

(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)

Datentyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
Section 11 – Narrative Remarks
Beschreibung

Section 11 – Narrative Remarks

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0947611
Narrative remarks (description of signs/symptoms and details of TREATMENT given for SAE)
Beschreibung

Comment SAE | signs and symptoms and treatment of SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C1519255
UMLS CUI [2,3]
C0678257
UMLS CUI [3]
C2981656
Investigator's Signature
Beschreibung

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Type of SAE report
Beschreibung

Please fill in the following items once for every SAE report stage.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0332307
Investigator’s signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date of investigator signature

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2346576
Investigator’s name
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Type of report
Beschreibung

Type of report

Datentyp

integer

Alias
UMLS CUI [1,2]
C0332307
UMLS CUI [1,1]
C3897642
Section 12 – SAE additional / follow-up information
Beschreibung

Section 12 – SAE additional / follow-up information

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1533716
UMLS CUI-3
C1522577
SAE additional / follow-up information
Beschreibung

Use this section to provide any additional details on the SAE not already captured in previous sections of the form.

Datentyp

text

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1522577
Investigator's Signature
Beschreibung

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Type of SAE report
Beschreibung

Please fill in the following items once for every SAE report stage.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0332307
Investigator’s signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date of investigator signature

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2346576
Investigator’s name
Beschreibung

Investigator 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 Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Hospital identifier
Item
Center Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Treatment Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
SAE Report Number
Item
SAE Report N°
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Receipt date clinical study sponsor
Item
GSK receipt date
date
C2985846 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
SAE report initial
Item
Initial report
boolean
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
SAE follow-up report
Item
First follow-up
boolean
C1519255 (UMLS CUI [1,1])
C1704685 (UMLS CUI [1,2])
SAE follow-up report
Item
Second follow-up
boolean
C1519255 (UMLS CUI [1,1])
C1704685 (UMLS CUI [1,2])
SAE follow-up report
Item
Third follow-up
boolean
C1519255 (UMLS CUI [1,1])
C1704685 (UMLS CUI [1,2])
Item Group
Section 1
C1828479 (UMLS CUI-1)
Serious adverse event
Item
Event
text
C1519255 (UMLS CUI [1])
Serious adverse event start date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome
Code List
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)
Serious adverse event end date
Item
End date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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
C2826626 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken
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)
Patient withdrawn from trial due to SAE
Item
Withdrawal: Did the subject withdraw from study as a result of this SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE investigational new drugs relationships
Item
Relationship to investigational product(s): Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
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)
SAE autopsy
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Section 2 – Seriousness of Adverse Event
C1828479 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
SAE death
Item
Results in death
boolean
C1519255 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
SAE life-threatening
Item
Is life threatening
boolean
C1519255 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
SAE hospitalisation | prolonged hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
SAE admission date
Item
Date of admission
date
C1302393 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE discharge date
Item
Date of discharge
date
C2361123 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE disability
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE congenital anomaly
Item
Congenital anomaly/birth defect
boolean
C2826727 (UMLS CUI [1])
Other SAE seriousness
Item
Other (clinically significant/intervention required)(see definition of SAE)
boolean
C1710056 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other SAE seriousness to specify
Item
If other, please specify.
text
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Section 3 – Demography Data
C1828479 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
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 (Male)
CL Item
Female (Female)
Body weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Body Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item Group
Section 4 – Serious adverse events recurrence
C1828479 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0034897 (UMLS CUI-3)
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])
C2347900 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0457454 (UMLS CUI [1,5])
C0304229 (UMLS CUI [1,6])
Adverse event Recurrence
Code List
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
Section 5 – Possible causes of SAE other than investigational product
C1828479 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0085978 (UMLS CUI-3)
Disease during clinical trial SAE
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Disease medical history SAE
Item
Medical condition(s)
boolean
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Lack of efficacy SAE
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal of investigational drug SAE
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Pharmaceutical preparations SAE
Item
Concomitant medication
boolean
C0013227 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Study subject participation status SAE | Medical procedure study protocol SAE
Item
Activity related to study participation (e.g., procedures)
boolean
C2348568 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0199171 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
Other SAE causation
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Other SAE seriousness causation to specify
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
Section 6 – Relevant Medical Conditions
C1828479 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Relevant disease, hypersensitivity, or operative surgical procedure 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])
C2347946 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C2347946 (UMLS CUI [3,2])
C1519255 (UMLS CUI [3,3])
Date of onset relevant disease | hypersensitivity | operative surgical procedure
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0574845 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C1519255 (UMLS CUI [2,4])
C0574845 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C2347946 (UMLS CUI [3,3])
C1519255 (UMLS CUI [3,4])
Disease present SAE
Item
Condition present at time of SAE?
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of last occurrence disease SAE
Item
Date of last occurrence
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,5])
Item Group
Section 7 – Other Relevant Risk Factors
C1828479 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Risk factors SAE in family or social history (smoking, diet, drug abuse, occupational hazard)
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])
C0241889 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C3714536 (UMLS CUI [2,3])
C1519384 (UMLS CUI [3])
C0001948 (UMLS CUI [4])
C0012155 (UMLS CUI [5])
C0013146 (UMLS CUI [6])
C0337074 (UMLS CUI [7])
Item Group
Section 8 – Relevant Concomitant Medications
C1828479 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Pharmaceutical preparations medication name
Item
Drug Name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit of medication dose
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Concomitant medication previous occurrence
Item
Taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Start date pharmaceutical preparations
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Stop date pharmaceutical preparations
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Pharmaceutical preparations continuous
Item
Ongoing medication?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Indication pharmaceutical preparations
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Section 9 – Details of Investigational Product(s)
C1828479 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Vaccines medication name
Item
Vaccine name
text
C0042210 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Dose number vaccines
Item
Dose N°
integer
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Lot number vaccines
Item
Lot N°
text
C1115660 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration of vaccine route | anatomic site
Item
Route/site
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C2368628 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
Date of vaccine 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])
Subject unblinding event record
Code List
Was treatment blind broken at investigational site?
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Not applicable (Not applicable)
Item Group
Section 10 – Details of Relevant Assessments
C1828479 (UMLS CUI-1)
C1261322 (UMLS CUI-2)
Assessments
Item
Details of relevant assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Section 11 – Narrative Remarks
C1828479 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Comment SAE | signs and symptoms and treatment of SAE
Item
Narrative remarks (description of signs/symptoms and details of TREATMENT given for SAE)
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0678257 (UMLS CUI [2,3])
C2981656 (UMLS CUI [3])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Item
Type of SAE report
integer
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
SAE report type
Code List
Type of SAE report
CL Item
Initial report (1)
CL Item
First follow-up (2)
CL Item
Second follow-up (3)
CL Item
Third follow-up (4)
Investigator signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Date of investigator signature
Item
Date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Investigator name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Item
Type of report
integer
C0332307 (UMLS CUI [1,2])
C3897642 (UMLS CUI [1,1])
Type of report
Code List
Type of report
CL Item
 (1)
CL Item
 (2)
CL Item
Final report by the sponsor (3)
CL Item
 (4)
Item Group
Section 12 – SAE additional / follow-up information
C1519255 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Additional information SAE follow-up
Item
SAE additional / follow-up information
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Item
Type of SAE report
integer
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
SAE report type
Code List
Type of SAE report
CL Item
Initial report (1)
CL Item
First follow-up (2)
CL Item
Second follow-up (3)
CL Item
Third follow-up (4)
Investigator signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Date of investigator signature
Item
Date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Investigator name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
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