0 Bedömningar
ID

38433

Beskrivning

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. 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.

Nyckelord

Versioner (2)
  1. 2019-09-03 2019-09-03 -
  2. 2019-10-17 2019-10-17 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 oktober 2019

DOI

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Creative Commons BY-NC 3.0
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    10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010

    Engelsk

    SAE

    1 Formulär  
    1. StudyEvent: ODM
      1. SAE
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beskrivning

    Clinical Trial Subject Unique Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Country
    Beskrivning

    Country

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0454664
    Center Number
    Beskrivning

    Center Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Treatment Number
    Beskrivning

    Treatment Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1522541
    UMLS CUI [1,2]
    C0600091
    SAE Report No
    Beskrivning

    SAE Report No

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0684224
    UMLS CUI [1,3]
    C0237753
    Sponsor receipt date
    Beskrivning

    (for GSK use) SAE’s MUST BE REPORTED TO GSK STUDY CONTACT WITHIN 24 HOURS

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2985846
    UMLS CUI [1,2]
    C2347796
    Type of report
    Beskrivning

    Type of report

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0585733
    Section 1: General SAE information
    Beskrivning

    Section 1: General SAE information

    Alias
    UMLS CUI-1
    C1508263
    UMLS CUI-2
    C1519255
    Serious Adverse Event
    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
    SAE Start Date
    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
    SAE Outcome
    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. 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.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1705586
    SAE End date
    Beskrivning

    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”.

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1519255
    SAE maximum Intensity
    Beskrivning

    Record the maximum intensity that occurred over the duration of the event (see protocol for 1-2-3 definition of intensity). Amend the intensity if it increases. Enter X (not Applicable) if grading can not be applied. For example, intensity for ‘broken leg’.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C1519255
    Action Taken with Investigational Product(s) as a Result of the SAE
    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]
    C2826626
    UMLS CUI [1,2]
    C1519255
    Did the subject withdraw from study as a result of this SAE?
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1519255
    Is there a reasonable possibility the SAE may have been caused by the investigational product?
    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. 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 pharmacologicallypredicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0085978
    Medically attended visit for SAE
    Beskrivning

    Refer to protocol for full definition

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1519255
    If fatal, was a post-mortem/autopsy performed?
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004398
    UMLS CUI [1,2]
    C0011065
    UMLS CUI [1,3]
    C1519255
    Section 2: Seriousness
    Beskrivning

    Section 2: Seriousness

    Alias
    UMLS CUI-1
    C1710056
    Results in death
    Beskrivning

    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.

    Datatyp

    boolean

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

    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.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1517874
    Requires hospitalization or prolongation of existing hospitalization
    Beskrivning

    Note: In general, hospitalisation 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 hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is 'serious'. When in doubt as to whether 'hospitalisation' occurred or was necessary, the AE should be considered 'serious'. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE. Record date of admission and discharge Requires hospitalisation or prolongation of existing hospitalisation 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 preexisting 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 pages. 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”.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [2,1]
    C0745041
    UMLS CUI [2,2]
    C1519255
    Results in disability/incapacity
    Beskrivning

    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.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0231170
    Congenital anomaly/birth defect in the offspring
    Beskrivning

    Congenital anomaly/birth defect in the offspring

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C1519255
    Other seriousness
    Beskrivning

    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 hospitalisation but may jeopardise 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 hospitalisation, or development of drug dependency or drug abuse.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1710056
    Other SAE seriousness specification
    Beskrivning

    Other SAE seriousness specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1710056
    UMLS CUI [1,3]
    C1521902
    Hospital date of admission
    Beskrivning

    if hospitalisation is reason of why AE is serious

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0806429
    Hospital date of discharge
    Beskrivning

    if hospitalisation is reason of why AE is serious

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2361123
    Section 3: Demography Data
    Beskrivning

    Section 3: Demography Data

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Beskrivning

    Date of birth

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Beskrivning

    Sex

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Weight
    Beskrivning

    Weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Weight
    Beskrivning

    (US only; give ounces in next item)

    Datatyp

    integer

    Måttenheter
    • pounds
    Alias
    UMLS CUI [1]
    C0005910
    pounds
    Weight
    Beskrivning

    (US only; give pounds in next item)

    Datatyp

    integer

    Måttenheter
    • ounces
    Alias
    UMLS CUI [1]
    C0005910
    ounces
    Section 4: SAE reccurence
    Beskrivning

    Section 4: SAE reccurence

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0034897
    If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
    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]
    C0304229
    Section: 5 Possible Causes of SAE Other Than Investigational Product(s)
    Beskrivning

    Section: 5 Possible Causes of SAE Other Than Investigational Product(s)

    Alias
    UMLS CUI-1
    C1519255
    UMLS CUI-2
    C0205394
    UMLS CUI-3
    C0085978
    UMLS CUI-4
    C0304229
    Disease under study
    Beskrivning

    (not applicable for prophylactic vaccine studies)

    Datatyp

    boolean

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

    (record in Section 6)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    Lack of efficacy
    Beskrivning

    Lack of efficacy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0235828
    Withdrawal of investigational product
    Beskrivning

    Withdrawal of investigational product

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0304229
    Concomitant medication(s) (record in Section 8)
    Beskrivning

    Concomitant medication(s)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Activity related to study participation
    Beskrivning

    (e.g., procedures)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    Other SAE causation
    Beskrivning

    please specify in next item

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C0085978
    Specify other SAE causation
    Beskrivning

    Specify other SAE causation

    Datatyp

    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
    Beskrivning

    Section 6: Relevant Medical Conditions

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C0262926
    UMLS CUI-3
    C1519255
    Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
    Beskrivning

    Relevant Medical Conditions

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C1519255
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0262926
    UMLS CUI [2,3]
    C1519255
    UMLS CUI [3,1]
    C0543467
    UMLS CUI [3,2]
    C0262926
    UMLS CUI [3,3]
    C1519255
    Date of onset
    Beskrivning

    Date of onset

    Datatyp

    date

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

    If no, record date of last occurrence

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C1519255
    Date of last occurrence
    Beskrivning

    Date of Last Occurrence

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1517741
    UMLS CUI [1,2]
    C2745955
    UMLS CUI [1,3]
    C0012634
    UMLS CUI [1,4]
    C0011008
    Section 7: Other Relevant Risk Factors
    Beskrivning

    Section 7: Other Relevant Risk Factors

    Alias
    UMLS CUI-1
    C0205394
    UMLS CUI-2
    C0035648
    UMLS CUI-3
    C1519255
    Other Relevant Risk Factors
    Beskrivning

    provide any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0035648
    UMLS CUI [1,2]
    C1519255
    Section 8: Relevant Concomitant Medications
    Beskrivning

    Section 8: Relevant Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Drug Name
    Beskrivning

    (Trade name preferred)

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2347852
    Dose
    Beskrivning

    Concomitant Medication Dose

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C2347852
    Unit
    Beskrivning

    Concomitant Medication Unit

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C2347852
    Frequency
    Beskrivning

    Concomitant Medication Frequency

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3476109
    UMLS CUI [1,2]
    C2347852
    Route
    Beskrivning

    Concomitant Medication Route

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C2347852
    Taken Prior to Study?
    Beskrivning

    Concomitant Medication Taken Prior to Study?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Start Date
    Beskrivning

    Concomitant Medication Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C2347852
    Stop Date
    Beskrivning

    Concomitant Medication Stop Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C2347852
    Ongoing Concomitant Medication ?
    Beskrivning

    Ongoing Concomitant Medication ?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Reason for Concomitant Medication
    Beskrivning

    Reason for Concomitant Medication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C2347852
    Section 9: Details of investigational product(s)
    Beskrivning

    Section 9: Details of investigational product(s)

    Alias
    UMLS CUI-1
    C0013230
    UMLS CUI-2
    C1522508
    Vaccine
    Beskrivning

    in case of multiple vaccination, please specify if vaccines were administered mixed or separately

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0042210
    Dose No
    Beskrivning

    Dose number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1115464
    UMLS CUI [1,2]
    C0042210
    Lot No
    Beskrivning

    Lot number

    Datatyp

    integer

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

    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
    Administration date
    Beskrivning

    Administration date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0042210
    Was randomization code broken on investigational site's request?
    Beskrivning

    Randomization code broken

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C3897431
    Section 10: Details of Relevant Assessments
    Beskrivning

    Section 10: Details of Relevant Assessments

    Alias
    UMLS CUI-1
    C1261322
    UMLS CUI-2
    C1519255
    Details of Relevant Assessments
    Beskrivning

    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

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1261322
    UMLS CUI [1,2]
    C1519255
    Section 11: Narrative Remarks
    Beskrivning

    Section 11: Narrative Remarks

    Alias
    UMLS CUI-1
    C0947611
    Narrative Remarks
    Beskrivning

    description of signs/symptoms and details of TREATMENT given for SAE

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1519255
    Section 12: SAE additional / follow-up information
    Beskrivning

    Section 12: SAE additional / follow-up information

    Alias
    UMLS CUI-1
    C1524062
    UMLS CUI-2
    C1533716
    UMLS CUI-3
    C1519255
    UMLS CUI-4
    C1522577
    SAE additional / follow-up information
    Beskrivning

    use this page to provide any additional details on the SAE not already captured on the previous pages

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1524062
    UMLS CUI [1,2]
    C1533716
    UMLS CUI [1,3]
    C1519255
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C1522577
    Investigator's signature
    Beskrivning

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Beskrivning

    Investigator's signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Printed Investigator's name
    Beskrivning

    Printed Investigator's name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Type of report
    Beskrivning

    Type of report

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0585733
    Date of investigator's signature
    Beskrivning

    Date of investigator's signature

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    SAE

    1 Formulär
    1. StudyEvent: ODM
      1. SAE
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Country
    Item
    Country
    text
    C0454664 (UMLS CUI [1])
    Center Number
    Item
    Center Number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Treatment Number
    Item
    Treatment Number
    integer
    C1522541 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    SAE Report No
    Item
    SAE Report No
    integer
    C1519255 (UMLS CUI [1,1])
    C0684224 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Sponsor receipt date
    Item
    Sponsor receipt date
    date
    C2985846 (UMLS CUI [1,1])
    C2347796 (UMLS CUI [1,2])
    Item
    Type of report
    integer
    C0585733 (UMLS CUI [1])
    Type of report
    Code List
    Type of report
    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
    Section 1: General SAE information
    C1508263 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Serious Adverse Event
    Item
    Serious Adverse Event
    text
    C1519255 (UMLS CUI [1])
    SAE Start Date
    Item
    SAE Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    SAE Outcome
    integer
    C1705586 (UMLS CUI [1])
    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
    SAE End date
    date
    C0806020 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    SAE maximum Intensity
    text
    C0518690 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Maximum Intensity
    Code List
    SAE 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)
    subject withdraw from study as a result of SAE
    Item
    Did the subject withdraw from study as a result of this SAE?
    boolean
    C0422727 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    SAE causation
    Item
    Is there a reasonable possibility the SAE may have been caused by the investigational product?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    Item
    Medically attended visit for SAE
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Medically attended visit
    Code List
    Medically attended visit for SAE
    CL Item
    Hospitalisation (HO)
    CL Item
    Emergency Room (ER)
    CL Item
    Medical Doctor (MD)
    autopsy if fatal SAE
    Item
    If fatal, was a post-mortem/autopsy performed?
    boolean
    C0004398 (UMLS CUI [1,1])
    C0011065 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Item Group
    Section 2: Seriousness
    C1710056 (UMLS CUI-1)
    Results in death
    Item
    Results in death
    boolean
    C0011065 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Life-threatening
    Item
    Is life-threatening
    boolean
    C1517874 (UMLS CUI [1])
    Hospitalization/ prolongation of existing hospitalization
    Item
    Requires hospitalization or prolongation of existing hospitalization
    boolean
    C0019993 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0745041 (UMLS CUI [2,1])
    C1519255 (UMLS CUI [2,2])
    Results in disability/incapacity
    Item
    Results in disability/incapacity
    boolean
    C1519255 (UMLS CUI [1,1])
    C0231170 (UMLS CUI [1,2])
    Congenital anomaly/birth defect in the offspring
    Item
    Congenital anomaly/birth defect in the offspring
    boolean
    C0000768 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Other seriousness
    Item
    Other seriousness
    boolean
    C0205394 (UMLS CUI [1,1])
    C1710056 (UMLS CUI [1,2])
    Other SAE seriousness specification
    Item
    Other SAE seriousness specification
    text
    C0205394 (UMLS CUI [1,1])
    C1710056 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Hospital date of admission
    Item
    Hospital date of admission
    date
    C0806429 (UMLS CUI [1])
    Hospital date of discharge
    Item
    Hospital date of discharge
    date
    C2361123 (UMLS CUI [1])
    Item Group
    Section 3: 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])
    Seriousness
    Code List
    Sex
    CL Item
    Male (Male)
    CL Item
    Female (Female)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Weight
    Item
    Weight
    integer
    C0005910 (UMLS CUI [1])
    Weight
    Item
    Weight
    integer
    C0005910 (UMLS CUI [1])
    Item Group
    Section 4: SAE reccurence
    C1519255 (UMLS CUI-1)
    C0034897 (UMLS CUI-2)
    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])
    C0304229 (UMLS CUI [1,3])
    If Investigational Product(s) 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 (NA)
    Item Group
    Section: 5 Possible Causes of SAE Other Than Investigational Product(s)
    C1519255 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    C0085978 (UMLS CUI-3)
    C0304229 (UMLS CUI-4)
    Disease under study
    Item
    Disease under study
    boolean
    C0012634 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Medical condition(s)
    Item
    Medical condition(s)
    boolean
    C0009488 (UMLS CUI [1])
    Lack of efficacy
    Item
    Lack of efficacy
    boolean
    C0235828 (UMLS CUI [1])
    Withdrawal of investigational product
    Item
    Withdrawal of investigational product
    boolean
    C2349954 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Concomitant medication(s)
    Item
    Concomitant medication(s) (record in Section 8)
    boolean
    C2347852 (UMLS CUI [1])
    Activity related to study participation
    Item
    Activity related to study participation
    boolean
    C2348568 (UMLS CUI [1])
    Other SAE causation
    Item
    Other SAE causation
    boolean
    C0205394 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0085978 (UMLS CUI [1,3])
    Specify other SAE causation
    Item
    Specify other SAE causation
    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
    C0012634 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    Relevant Medical Conditions
    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])
    C0020517 (UMLS CUI [2,1])
    C0262926 (UMLS CUI [2,2])
    C1519255 (UMLS CUI [2,3])
    C0543467 (UMLS CUI [3,1])
    C0262926 (UMLS CUI [3,2])
    C1519255 (UMLS CUI [3,3])
    Date of onset
    Item
    Date of onset
    date
    C0574845 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Condition present at time of the SAE
    Item
    Condition present at time of the SAE?
    boolean
    C0012634 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Date of Last Occurrence
    Item
    Date of last occurrence
    date
    C1517741 (UMLS CUI [1,1])
    C2745955 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item Group
    Section 7: Other Relevant Risk Factors
    C0205394 (UMLS CUI-1)
    C0035648 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    Other relevant risk factors
    Item
    Other Relevant Risk Factors
    text
    C0035648 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    Section 8: Relevant Concomitant Medications
    C2347852 (UMLS CUI-1)
    Drug Name
    Item
    Drug Name
    text
    C2347852 (UMLS CUI [1])
    Concomitant Medication Dose
    Item
    Dose
    integer
    C3174092 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Concomitant Medication Unit
    Item
    Unit
    text
    C1519795 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Concomitant Medication Frequency
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Concomitant Medication Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Concomitant Medication Taken Prior to Study?
    Item
    Taken Prior to Study?
    boolean
    C2826667 (UMLS CUI [1])
    Concomitant Medication Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Concomitant Medication Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Ongoing Concomitant Medication ?
    Item
    Ongoing Concomitant Medication ?
    boolean
    C2826666 (UMLS CUI [1])
    Reason for Concomitant Medication
    Item
    Reason for Concomitant Medication
    text
    C0392360 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item Group
    Section 9: Details of investigational product(s)
    C0013230 (UMLS CUI-1)
    C1522508 (UMLS CUI-2)
    Vaccine
    Item
    Vaccine
    text
    C0042210 (UMLS CUI [1])
    Dose number
    Item
    Dose No
    integer
    C1115464 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Lot number
    Item
    Lot No
    integer
    C1115660 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Route / site
    Item
    Route / site
    text
    C0013153 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    C1515974 (UMLS CUI [2,1])
    C0042210 (UMLS CUI [2,2])
    Administration date
    Item
    Administration date
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Item
    Was randomization code broken on investigational site's request?
    integer
    C0034656 (UMLS CUI [1,1])
    C3897431 (UMLS CUI [1,2])
    Randomization code
    Code List
    Was randomization code broken on investigational site's request?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Not applicable (3)
    Item Group
    Section 10: Details of Relevant Assessments
    C1261322 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Details of Relevant Assessments
    Item
    Details of Relevant Assessments
    text
    C1261322 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    Section 11: Narrative Remarks
    C0947611 (UMLS CUI-1)
    Narrative Remarks
    Item
    Narrative Remarks
    text
    C0947611 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    Section 12: SAE additional / follow-up information
    C1524062 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    C1522577 (UMLS CUI-4)
    SAE additional / follow-up information
    Item
    SAE additional / follow-up information
    text
    C1524062 (UMLS CUI [1,1])
    C1533716 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    C1519255 (UMLS CUI [2,1])
    C1522577 (UMLS CUI [2,2])
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Printed Investigator's name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Item
    Type of report
    integer
    C0585733 (UMLS CUI [1])
    Type of report
    Code List
    Type of report
    CL Item
    Initial report (1)
    CL Item
    First follow-up (2)
    CL Item
    Second follow-up (3)
    CL Item
    Third follow-up (4)
    Date of investigator's signature
    Item
    Date of investigator's signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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