ID

37967

Description

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.

Keywords

  1. 9/3/19 9/3/19 -
  2. 10/17/19 10/17/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

September 3, 2019

DOI

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License

Creative Commons BY-NC 3.0

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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010

  1. StudyEvent: ODM
    1. SAE
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Country
Description

Country

Data type

text

Alias
UMLS CUI [1]
C0454664
Center Number
Description

Center Number

Data type

integer

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

Treatment Number

Data type

integer

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

SAE Report No

Data type

integer

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

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

Data type

date

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

Type of report

Data type

integer

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

Section 1: General SAE information

Alias
UMLS CUI-1
C1508263
UMLS CUI-2
C1519255
Serious Adverse Event
Description

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.

Data type

text

Alias
UMLS CUI [1]
C1519255
SAE Start Date
Description

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.

Data type

date

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

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.

Data type

integer

Alias
UMLS CUI [1]
C1705586
SAE End date
Description

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”.

Data type

date

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

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’.

Data type

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the SAE
Description

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.

Data type

text

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

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

Data type

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?
Description

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.

Data type

boolean

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

Refer to protocol for full definition

Data type

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?
Description

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

Data type

boolean

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

Section 2: Seriousness

Alias
UMLS CUI-1
C1710056
Results in death
Description

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.

Data type

boolean

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

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.

Data type

boolean

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

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”.

Data type

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
Description

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.

Data type

boolean

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

Congenital anomaly/birth defect in the offspring

Data type

boolean

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

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.

Data type

boolean

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

Other SAE seriousness specification

Data type

text

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

if hospitalisation is reason of why AE is serious

Data type

date

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

if hospitalisation is reason of why AE is serious

Data type

date

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

Section 3: Demography Data

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight
Description

(US only; give ounces in next item)

Data type

integer

Measurement units
  • pounds
Alias
UMLS CUI [1]
C0005910
pounds
Weight
Description

(US only; give pounds in next item)

Data type

integer

Measurement units
  • ounces
Alias
UMLS CUI [1]
C0005910
ounces
Section 4: SAE reccurence
Description

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?
Description

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

Data type

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)
Description

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
Description

(not applicable for prophylactic vaccine studies)

Data type

boolean

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

(record in Section 6)

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Lack of efficacy
Description

Lack of efficacy

Data type

boolean

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

Withdrawal of investigational product

Data type

boolean

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

Concomitant medication(s)

Data type

boolean

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

(e.g., procedures)

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Other SAE causation
Description

please specify in next item

Data type

boolean

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

Specify other SAE causation

Data type

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
Description

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.
Description

Relevant Medical Conditions

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C0012634
UMLS CUI [3]
C0020517
UMLS CUI [4]
C0543467
Date of onset
Description

Date of onset

Data type

date

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

If no, record date of last occurrence

Data type

boolean

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

Date of Last Occurrence

Data type

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
Description

Section 7: Other Relevant Risk Factors

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

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

Data type

text

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

Section 8: Relevant Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Description

(Trade name preferred)

Data type

text

Alias
UMLS CUI [1]
C2347852
Dose
Description

Concomitant Medication Dose

Data type

integer

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

Concomitant Medication Unit

Data type

text

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

Concomitant Medication Frequency

Data type

text

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

Concomitant Medication Route

Data type

text

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

Concomitant Medication Taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Description

Concomitant Medication Start Date

Data type

date

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

Concomitant Medication Stop Date

Data type

date

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

Ongoing Concomitant Medication ?

Data type

boolean

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

Reason for Concomitant Medication

Data type

text

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

Section 9: Details of investigational product(s)

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

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

Data type

text

Alias
UMLS CUI [1]
C0042210
Dose No
Description

Dose number

Data type

integer

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

Lot number

Data type

integer

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

Route / site

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0042210
Administration date
Description

Administration date

Data type

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?
Description

Randomization code broken

Data type

integer

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

Section 10: Details of Relevant Assessments

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

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

Data type

text

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

Section 11: Narrative Remarks

Alias
UMLS CUI-1
C0947611
Narrative Remarks
Description

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

Data type

text

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

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
Description

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

Data type

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
Description

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Description

Investigator's signature

Data type

text

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

Printed Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892
Type of report
Description

Type of report

Data type

integer

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

Date of investigator's signature

Data type

date

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

Similar models

  1. StudyEvent: ODM
    1. SAE
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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])
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])
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])
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])
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])
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])
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
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2])
C0020517 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
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])
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])
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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