ID

38448

Beschrijving

Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Trefwoorden

  1. 17-10-19 17-10-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

17 oktober 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)

Follow-up-studies; Study conclusion; Investigator signature; Tracking Document Safety Follow-Up; Serious Adverse Event Safety Follow-Up

Administration
Beschrijving

Administration

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Center
Beschrijving

Center

Datatype

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Follow-up studies
Beschrijving

Follow-up studies

Alias
UMLS CUI-1
C0016441
Would the subject be willing to participate in a follow-up study?
Beschrijving

If no, specify reason

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
If subject would not be willing to participate in a follow-up study, specify the reason
Beschrijving

If subject would not be willing to participate in a follow-up study, specify the reason

Datatype

integer

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C2348235
If reason is Adverse Event, or Serious Adverse Event, please specify
Beschrijving

If reason is Adverse Event, or Serious Adverse Event, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2348235
UMLS CUI [2,1]
C0566251
UMLS CUI [2,2]
C1519255
UMLS CUI [2,3]
C2348235
If other reason, please specify
Beschrijving

If other reason, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348235
Study conclusion
Beschrijving

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Has the code been broken?
Beschrijving

Has the code been broken?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0805701
Did any elimination criteria become applicable during the study?
Beschrijving

Did any elimination criteria become applicable during the study?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706839
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C0347984
If any elimination criteria become applicabe during the study, please specify.
Beschrijving

If any elimination criteria become applicabe during the study, please specify.

Datatype

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706839
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C2348235
Has the subject dropped out of the study?
Beschrijving

(a drop out is a subject who did not come back for the concluding visit foreseen in the protocol.)

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
If subject dropped out, please mark the one most appropriate category for drop out
Beschrijving

If subject dropped out, please mark the one most appropriate category for drop out

Datatype

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0683312
Please specify Adverse event number
Beschrijving

Please specify Adverse event number

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C2348235
Please specify protocol violation.
Beschrijving

Please specify protocol violation.

Datatype

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
If other reason for drop out, please specify.
Beschrijving

If other reason for drop out, please specify.

Datatype

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C2348235
Date of last contact
Beschrijving

Date of last contact

Datatype

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Beschrijving

If no, please give details within the Adverse Events section.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0805839
Investigator signature
Beschrijving

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator signature
Beschrijving

I certify that I have reviewed the data in this case report form, the Non-Serious Adverse Events and Serious Adverse Event sections including any laboratory data (if appropriate) and that all information is complete and accurate.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Signature date
Beschrijving

Signature date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Tracking Document Safety Follow-Up
Beschrijving

Tracking Document Safety Follow-Up

Alias
UMLS CUI-1
C3889409
UMLS CUI-3
C1522577
UMLS CUI-4
C0036043
Follow-up
Beschrijving

Follow-up

Datatype

integer

Alias
UMLS CUI [1]
C1522577
Investigator name
Beschrijving

(please PRINT name)

Datatype

text

Alias
UMLS CUI [1]
C2826892
Signature
Beschrijving

Signature

Datatype

text

Alias
UMLS CUI [1]
C1519316
Signature Date
Beschrijving

Signature Date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Tracking Document Safety Follow-Up
Beschrijving

Tracking Document Safety Follow-Up

Alias
UMLS CUI-1
C3889409
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Subject initials
Beschrijving

First name, family name

Datatype

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Did the subject experience any SAE(s) since the last contact?
Beschrijving

Did the subject experience any SAE(s) since the last contact?

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705415
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1711239
Date of contact
Beschrijving

Date of contact

Datatype

date

Alias
UMLS CUI [1]
C0805839
Serious adverse event safety follow-up - Administrative
Beschrijving

Serious adverse event safety follow-up - Administrative

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
UMLS CUI-4
C1320722
Protocol
Beschrijving

Protocol

Datatype

text

Alias
UMLS CUI [1]
C2348563
Center
Beschrijving

Center

Datatype

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Country
Beschrijving

Country

Datatype

text

Alias
UMLS CUI [1]
C0454664
GSK Receipt Date
Beschrijving

GSK Receipt Date

Datatype

date

Alias
UMLS CUI [1]
C2985846
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Serious adverse event safety follow-up
Beschrijving

Serious adverse event safety follow-up

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
Serious adverse event
Beschrijving

Serious adverse event

Datatype

integer

Alias
UMLS CUI [1]
C1519255
Subject Demography - Initials - First name
Beschrijving

Subject Demography - Initials - First name

Datatype

text

Alias
UMLS CUI [1]
C0011298
UMLS CUI [2,1]
C2986440
UMLS CUI [2,2]
C1443235
Subject Demography - Initials - Last name
Beschrijving

Subject Demography - Initials - Last name

Datatype

text

Alias
UMLS CUI [1]
C0011298
UMLS CUI [2,1]
C2986440
UMLS CUI [2,2]
C1301584
Subject Demography - Date of Birth
Beschrijving

Subject Demography - Date of Birth

Datatype

date

Alias
UMLS CUI [1]
C0011298
UMLS CUI [2]
C0421451
Subject Demography - Gende
Beschrijving

Subject Demography - Gender

Datatype

text

Alias
UMLS CUI [1]
C0011298
UMLS CUI [2]
C0079399
Adverse Event Diagnosis
Beschrijving

(or signs and symptoms if not known)

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
SAE - Date and time started
Beschrijving

(Adverse event first symptoms)

Datatype

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826806
SAE - Date and time stopped
Beschrijving

(If ongoing please leave blank)

Datatype

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826793
SAE - Intensity
Beschrijving

SAE - Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
In your opinion, did the vaccine possibly contribute to the SAE
Beschrijving

In your opinion, did the vaccine possibly contribute to the SAE

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0042210
SAE - Other possible contributors
Beschrijving

(mark all that apply)

Datatype

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0205394
SAE - If other possible contributors, specify
Beschrijving

SAE - If other possible contributors, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
SAE - Outcome
Beschrijving

(maximum)

Datatype

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
SAE - Action taken with respect to Study Vaccine
Beschrijving

SAE - Action taken with respect to Study Vaccine

Datatype

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C1519255
SAE - Events after further vaccination
Beschrijving

SAE - Events after further vaccination

Datatype

integer

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C1519255
Specify criteria for considering this as a Serious Adverse Event
Beschrijving

(mark all that apply).

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0243161
If SAE resulted in death, was autopsy performed?
Beschrijving

Send autopsy report when available.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1320832
UMLS CUI [1,3]
C1519255
If SAE required in-patient hospitalization, enter admission date
Beschrijving

If SAE required in-patient hospitalization, enter admission date

Datatype

date

Alias
UMLS CUI [1,1]
C2826664
UMLS CUI [1,2]
C1302393
UMLS CUI [1,3]
C1519255
If SAE required in-patient hospitalization, enter discharge date
Beschrijving

If SAE required in-patient hospitalization, enter discharge date

Datatype

date

Alias
UMLS CUI [1,1]
C2826664
UMLS CUI [1,2]
C2361123
UMLS CUI [1,3]
C1519255
If SAE required prolongation of existing hospitalization, enter discharge date
Beschrijving

If SAE required prolongation of existing hospitalization, enter discharge date

Datatype

date

Alias
UMLS CUI [1,1]
C0745041
UMLS CUI [1,2]
C2361123
UMLS CUI [1,3]
C1519255
If "medically important" event, specify
Beschrijving

If "medically important" event, specify

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3898777
UMLS CUI [1,3]
C2348235
Other events (not SAE) to be reported in the same way
Beschrijving

Other events (not SAE) to be reported in the same way

Datatype

integer

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0684224
Was subject withdrawn due to this specific SAE?
Beschrijving

Was subject withdrawn due to this specific SAE?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Serious adverse event safety follow-up - Study vaccine information
Beschrijving

Serious adverse event safety follow-up - Study vaccine information

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
UMLS CUI-4
C0304229
UMLS CUI-5
C0042210
Vaccine
Beschrijving

(specify mixed or separate)

Datatype

text

Alias
UMLS CUI [1]
C0042210
Vaccine Dose No
Beschrijving

Vaccine Dose No

Datatype

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0042210
Vaccine Lot No
Beschrijving

Vaccine Lot No

Datatype

text

Alias
UMLS CUI [1,1]
C2826710
UMLS CUI [1,2]
C0042210
Vaccine Route/ Site
Beschrijving

Vaccine Route/ Site

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0013153
UMLS CUI [2,3]
C0042210
Study Vaccine Date
Beschrijving

Study Vaccine Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0011008
Serious adverse event safety follow-up - Concomitant medication/ Vaccination that could have contributed to this SAE
Beschrijving

Serious adverse event safety follow-up - Concomitant medication/ Vaccination that could have contributed to this SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
UMLS CUI-5
C2347852
UMLS CUI-6
C0042210
UMLS CUI-7
C1519255
UMLS CUI-8
C0085978
Drug/ vaccine
Beschrijving

Drug/ vaccine

Datatype

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0042210
Medication dosage
Beschrijving

Medication dosage

Datatype

text

Alias
UMLS CUI [1]
C3174092
Medication frequency
Beschrijving

Medication frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beschrijving

Medication Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Medication start date
Beschrijving

Medication start date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Medication end date
Beschrijving

Medication end date

Datatype

date

Alias
UMLS CUI [1]
C2826744
Serious adverse event safety follow-up - Relevant intercurrent illness & medical history that could have contributed to this SAE
Beschrijving

Serious adverse event safety follow-up - Relevant intercurrent illness & medical history that could have contributed to this SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
UMLS CUI-4
C3640977
UMLS CUI-5
C1880177
UMLS CUI-6
C1519255
UMLS CUI-7
C0262926
UMLS CUI-8
C1880177
UMLS CUI-9
C1519255
Condition
Beschrijving

Condition

Datatype

text

Alias
UMLS CUI [1]
C0012634
Condition still present?
Beschrijving

Condition still present?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
Serious adverse event safety follow-up - Drug(s) used to treat this SAE
Beschrijving

Serious adverse event safety follow-up - Drug(s) used to treat this SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
UMLS CUI-4
C0013227
UMLS CUI-5
C0087111
UMLS CUI-6
C1519255
Drug(s) used to treat this SAE
Beschrijving

Drug(s) used to treat this SAE

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1519255
Drug for SAE - Dosage
Beschrijving

Drug for SAE - Dosage

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3174092
Drug for SAE - Frequency
Beschrijving

Drug for SAE - Frequency

Datatype

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C1519255
Drug for SAE - Route
Beschrijving

Drug for SAE - Route

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C1519255
Drug for SAE - Start date
Beschrijving

Drug for SAE - Start date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1519255
Drug for SAE - End date
Beschrijving

Drug for SAE - End date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1519255
Serious adverse event safety follow-up - Surgical treatment for this SAE
Beschrijving

Serious adverse event safety follow-up - Surgical treatment for this SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
UMLS CUI-4
C0543467
UMLS CUI-5
C1519255
Serious adverse event - Surgical treatment for this SAE
Beschrijving

(please specify)

Datatype

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1519255
Serious adverse event safety follow-up - Description
Beschrijving

Serious adverse event safety follow-up - Description

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
UMLS CUI-4
C0678257
UMLS CUI-5
C1519255
SAE- Description
Beschrijving

(provide a brief narrative description of the SAE including relevant diagnostic findings, lab data & evolution of the events etc)

Datatype

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
Serious adverse event safety follow-up - Comments
Beschrijving

Serious adverse event safety follow-up - Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
UMLS CUI-4
C0947611
UMLS CUI-5
C1519255
SAE - Comments
Beschrijving

(provide further comments concerning the case)

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Serious adverse event safety follow-up - Investigator signature
Beschrijving

Serious adverse event safety follow-up - Investigator signature

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C0036043
UMLS CUI-4
C2346576
Investigator Signature
Beschrijving

Investigator Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Beschrijving

Investigator signature date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Signature Clinical Development Manager
Beschrijving

Signature Clinical Development Manager

Datatype

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0681803
Clinical Development Manager Name
Beschrijving

Clinical Development Manager Name

Datatype

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0681803
Signature Clinical Development Manager Signature Date
Beschrijving

Signature Clinical Development Manager Signature Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0681803
UMLS CUI [1,3]
C0011008
AEGIS Number
Beschrijving

AEGIS Number

Datatype

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0600091

Similar models

Follow-up-studies; Study conclusion; Investigator signature; Tracking Document Safety Follow-Up; Serious Adverse Event Safety Follow-Up

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Follow-up studies
C0016441 (UMLS CUI-1)
Would the subject be willing to participate in a follow-up study?
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
If subject would not be willing to participate in a follow-up study, specify the reason
integer
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
If subject would not be willing to participate in a follow-up study, specify the reason
CL Item
Adverse Events, or Serious Adverse Eventsm please specify (1)
CL Item
Other, please specify (2)
If reason is Adverse Event, or Serious Adverse Event, please specify
Item
If reason is Adverse Event, or Serious Adverse Event, please specify
text
C0566251 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0566251 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
If other reason, please specify
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Has the code been broken?
Item
Has the code been broken?
boolean
C0008972 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Did any elimination criteria become applicable during the study?
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
If any elimination criteria become applicabe during the study, please specify.
Item
If any elimination criteria become applicabe during the study, please specify.
text
C0680251 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Has the subject dropped out of the study?
Item
Has the subject dropped out of the study?
boolean
C2348568 (UMLS CUI [1])
Item
If subject dropped out, please mark the one most appropriate category for drop out
text
C2348568 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Code List
If subject dropped out, please mark the one most appropriate category for drop out
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-serious adverse event (complete the Non-serious Adverse Event form) (AEX)
CL Item
Protocol violation, please specify (PTV)
CL Item
Consent withdrawal, not due to an adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other, please specify (OTH)
Please specify Adverse event number
Item
Please specify Adverse event number
text
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Please specify protocol violation.
Item
Please specify protocol violation.
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
If other reason for drop out, please specify.
Item
If other reason for drop out, please specify.
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject in good condition at date of last contact?
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Signature date
Item
Signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Tracking Document Safety Follow-Up
C3889409 (UMLS CUI-1)
C1522577 (UMLS CUI-3)
C0036043 (UMLS CUI-4)
Item
Follow-up
integer
C1522577 (UMLS CUI [1])
Code List
Follow-up
CL Item
Prospective Follow-Up for all subjects  (1)
CL Item
Retrospective Safety Follow-Up (time elapsed between the last contact of the preceding study and the new study contact as  (2)
CL Item
specified in the protocol.) (3)
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Signature Date
Item
Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Tracking Document Safety Follow-Up
C3889409 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Subject initials
Item
Subject initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Did the subject experience any SAE(s) since the last contact?
integer
C1519255 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
Code List
Did the subject experience any SAE(s) since the last contact?
CL Item
Yes, please complete the Safety Follow-up Serious Adverse Event SAE) form  (1)
CL Item
No  (2)
CL Item
Unknown (subject lost to follow-up or could not be reached) (3)
Date of contact
Item
Date of contact
date
C0805839 (UMLS CUI [1])
Item Group
Serious adverse event safety follow-up - Administrative
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C1320722 (UMLS CUI-4)
Protocol
Item
Protocol
text
C2348563 (UMLS CUI [1])
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
GSK Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Serious adverse event safety follow-up
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
Item
Serious adverse event
integer
C1519255 (UMLS CUI [1])
Code List
Serious adverse event
CL Item
Initial report  (1)
CL Item
Additional info  (2)
CL Item
Additional info  (3)
CL Item
Additional info (4)
Subject Demography - Initials - First name
Item
Subject Demography - Initials - First name
text
C0011298 (UMLS CUI [1])
C2986440 (UMLS CUI [2,1])
C1443235 (UMLS CUI [2,2])
Subject Demography - Initials - Last name
Item
Subject Demography - Initials - Last name
text
C0011298 (UMLS CUI [1])
C2986440 (UMLS CUI [2,1])
C1301584 (UMLS CUI [2,2])
Subject Demography - Date of Birth
Item
Subject Demography - Date of Birth
date
C0011298 (UMLS CUI [1])
C0421451 (UMLS CUI [2])
Item
Subject Demography - Gende
text
C0011298 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Code List
Subject Demography - Gende
CL Item
Female (F)
CL Item
Male (M)
Adverse Event Diagnosis
Item
Adverse Event Diagnosis
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
SAE - Date and time started
Item
SAE - Date and time started
datetime
C1519255 (UMLS CUI [1,1])
C2826806 (UMLS CUI [1,2])
SAE - Date and time stopped
Item
SAE - Date and time stopped
datetime
C1519255 (UMLS CUI [1,1])
C2826793 (UMLS CUI [1,2])
Item
SAE - Intensity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
SAE - Intensity
CL Item
1  (1)
CL Item
2  (2)
CL Item
3 (3)
In your opinion, did the vaccine possibly contribute to the SAE
Item
In your opinion, did the vaccine possibly contribute to the SAE
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
SAE - Other possible contributors
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Code List
SAE - Other possible contributors
CL Item
Medical history  (1)
CL Item
Other medication (2)
CL Item
Protocol required procedure  (3)
CL Item
Other procedure  (4)
CL Item
Lack of efficacy  (5)
CL Item
Erroneous administration  (6)
CL Item
Other, specify (7)
SAE - If other possible contributors, specify
Item
SAE - If other possible contributors, specify
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
SAE - Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
SAE - Outcome
CL Item
Recovered  (1)
CL Item
Recovered with sequelae  (2)
CL Item
Ongoing  (3)
CL Item
Died (4)
Item
SAE - Action taken with respect to Study Vaccine
integer
C2826626 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
SAE - Action taken with respect to Study Vaccine
CL Item
None  (1)
CL Item
Vaccination course postponed  (2)
CL Item
Vaccination course stopped (3)
Item
SAE - Events after further vaccination
integer
C0035020 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
SAE - Events after further vaccination
CL Item
Event reappeared  (1)
CL Item
Event did not reappear  (2)
CL Item
Unknown at this time  (3)
CL Item
Not applicable (4)
Item
Specify criteria for considering this as a Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Code List
Specify criteria for considering this as a Serious Adverse Event
CL Item
Result in death (1)
CL Item
Life threatening (2)
CL Item
Result in persistent or significant disability/ incapacity (3)
CL Item
Requires in-patienthospitalization (4)
CL Item
Prolongation of existing hospitalization (5)
CL Item
Congenital anomaly/ birth defect in the offspring of a study subject (6)
CL Item
"Medically important" event, specify (7)
If SAE resulted in death, was autopsy performed?
Item
If SAE resulted in death, was autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C1320832 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If SAE required in-patient hospitalization, enter admission date
Item
If SAE required in-patient hospitalization, enter admission date
date
C2826664 (UMLS CUI [1,1])
C1302393 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If SAE required in-patient hospitalization, enter discharge date
Item
If SAE required in-patient hospitalization, enter discharge date
date
C2826664 (UMLS CUI [1,1])
C2361123 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If SAE required prolongation of existing hospitalization, enter discharge date
Item
If SAE required prolongation of existing hospitalization, enter discharge date
date
C0745041 (UMLS CUI [1,1])
C2361123 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If "medically important" event, specify
Item
If "medically important" event, specify
text
C1519255 (UMLS CUI [1,1])
C3898777 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Other events (not SAE) to be reported in the same way
integer
C0441471 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,3])
Code List
Other events (not SAE) to be reported in the same way
CL Item
Cancer (1)
Was subject withdrawn due to this specific SAE?
Item
Was subject withdrawn due to this specific SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious adverse event safety follow-up - Study vaccine information
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
C0042210 (UMLS CUI-5)
Vaccine
Item
Vaccine
text
C0042210 (UMLS CUI [1])
Vaccine Dose No
Item
Vaccine Dose No
text
C3174092 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine Lot No
Item
Vaccine Lot No
text
C2826710 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccine Route/ Site
Item
Vaccine Route/ Site
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0013153 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Study Vaccine Date
Item
Study Vaccine Date
date
C0042210 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Serious adverse event safety follow-up - Concomitant medication/ Vaccination that could have contributed to this SAE
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C2347852 (UMLS CUI-5)
C0042210 (UMLS CUI-6)
C1519255 (UMLS CUI-7)
C0085978 (UMLS CUI-8)
Drug/ vaccine
Item
Drug/ vaccine
text
C2347852 (UMLS CUI [1])
C0042210 (UMLS CUI [2])
Medication dosage
Item
Medication dosage
text
C3174092 (UMLS CUI [1])
Medication frequency
Item
Medication frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication start date
Item
Medication start date
date
C2826734 (UMLS CUI [1])
Medication end date
Item
Medication end date
date
C2826744 (UMLS CUI [1])
Item Group
Serious adverse event safety follow-up - Relevant intercurrent illness & medical history that could have contributed to this SAE
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C3640977 (UMLS CUI-4)
C1880177 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
C0262926 (UMLS CUI-7)
C1880177 (UMLS CUI-8)
C1519255 (UMLS CUI-9)
Condition
Item
Condition
text
C0012634 (UMLS CUI [1])
Condition still present?
Item
Condition still present?
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Item Group
Serious adverse event safety follow-up - Drug(s) used to treat this SAE
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0087111 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
Drug(s) used to treat this SAE
Item
Drug(s) used to treat this SAE
text
C0013227 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Drug for SAE - Dosage
Item
Drug for SAE - Dosage
text
C1519255 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Drug for SAE - Frequency
Item
Drug for SAE - Frequency
text
C3476109 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Drug for SAE - Route
Item
Drug for SAE - Route
text
C0013153 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Drug for SAE - Start date
Item
Drug for SAE - Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Drug for SAE - End date
Item
Drug for SAE - End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
Serious adverse event safety follow-up - Surgical treatment for this SAE
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0543467 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
Serious adverse event - Surgical treatment for this SAE
Item
Serious adverse event - Surgical treatment for this SAE
text
C0543467 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious adverse event safety follow-up - Description
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0678257 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
SAE- Description
Item
SAE- Description
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious adverse event safety follow-up - Comments
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0947611 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
SAE - Comments
Item
SAE - Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious adverse event safety follow-up - Investigator signature
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C2346576 (UMLS CUI-4)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Signature Clinical Development Manager
Item
Signature Clinical Development Manager
text
C1519316 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
Clinical Development Manager Name
Item
Clinical Development Manager Name
text
C0027365 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
Signature Clinical Development Manager Signature Date
Item
Signature Clinical Development Manager Signature Date
date
C1519316 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
AEGIS Number
Item
AEGIS Number
text
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])

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