ID

38446

Beschreibung

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

Stichworte

Versionen (2)
  1. 17.10.19 17.10.19 -
  2. 17.10.19 17.10.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. Oktober 2019

DOI

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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)

Englisch

Concomitant Vaccination; Medication; Non-serious adverse events; Serious adverse events

1 Formulare  
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Center
Beschreibung

Center

Datentyp

text

Alias
UMLS CUI [1]
C1301943
Country
Beschreibung

Country

Datentyp

text

Alias
UMLS CUI [1]
C0454664
GSK Receipt Date
Beschreibung

GSK Receipt Date

Datentyp

date

Alias
UMLS CUI [1]
C2985846
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Concomitant Vaccination
Beschreibung

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol?
Beschreibung

If yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0304229
UMLS CUI [2,1]
C2368628
UMLS CUI [2,2]
C2348563
Concomitant Vaccination
Beschreibung

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade / Generic Name
Beschreibung

Trade / Generic Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2360065
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0592502
Concomitant vaccination Administration date
Beschreibung

Concomitant vaccination Administration date

Datentyp

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1533734
UMLS CUI [1,4]
C0011008
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
Have any of the above mentioned medications/treatments been administered during study period?
Beschreibung

--> Any immunosuppressants or other immune-modifying drugs or treatments and any antipyretics (and any drugs or treatments as specified in protocol) administered at ANY time during the period starting 30 days prior to the first dose of study vaccine(s) and ending one month (minimum 30 days) after the last dose of study vaccine(s) must be recorded with trade name and/or generic name of the medication, medical indication, total daily dose, route of administration, start and end dates of treatment. In addition, medications used in treating AEs should also be recorded. --> Any other concomitant medication administered prophylactically in anticipation of reaction to the vaccination must also be recorded with trade name and/or generic name of the medication, medical indication (check box if prophylactic), total daily dose, route of administration, start and end dates of treatment. If yes, please complete the following table.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1533734
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
Medication Trade / Generic Name
Beschreibung

Medication Trade / Generic Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0592502
Medical Indication
Beschreibung

Medical Indication

Datentyp

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Medication total daily dose
Beschreibung

Medication total daily dose

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
Medication Route
Beschreibung

Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Medication start date
Beschreibung

Medication start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication stop date
Beschreibung

Medication stop date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication continuing at end of study
Beschreibung

Medication continuing at end of study

Datentyp

integer

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2983670
Non-serious adverse events
Beschreibung

Non-serious adverse events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschreibung

If yes, please complete the following table.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0687676
UMLS CUI [2]
C0877248
Non-serious adverse events
Beschreibung

Non-serious adverse events

Alias
UMLS CUI-1
C1518404
Non-serious adverse event number
Beschreibung

Non-serious adverse event number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Non-serious adverse event Description
Beschreibung

Non-serious adverse event Description

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Non-serious adverse event site / Vaccine
Beschreibung

Non-serious adverse event site / Vaccine

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0205145
UMLS CUI [2]
C0042210
Non-serious adverse event start date
Beschreibung

Non-serious adverse event start date

Datentyp

date

Alias
UMLS CUI [1,1]
C2697888
UMLS CUI [1,2]
C1518404
Non-serious advers event started during immediate post-vaccination period specified in protocol
Beschreibung

Non-serious advers event started during immediate post-vaccination period specified in protocol

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439659
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0687676
UMLS CUI [3]
C2348563
Date non-serious adverse event stopped
Beschreibung

Date non-serious adverse event stopped

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-serious adverse event intensity
Beschreibung

Non-serious adverse event intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
In your opinion, did the vaccine possibly contribute to this AE?
Beschreibung

In your opinion, did the vaccine possibly contribute to this AE?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C1518404
Non-serious adverse event outcome
Beschreibung

Non-serious adverse event outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Serious adverse event
Beschreibung

Serious adverse event

Alias
UMLS CUI-1
C1519255
Serious adverse event
Beschreibung

Serious adverse event

Datentyp

integer

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

Subject Demography - Initials - First name

Datentyp

text

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

Subject Demography - Initials - Last name

Datentyp

text

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

Subject Demography - Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0011298
UMLS CUI [2]
C0421451
Subject Demography - Gender
Beschreibung

Subject Demography - Gender

Datentyp

text

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

(or signs and symptoms if not known)

Datentyp

text

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

(Adverse event first symptoms)

Datentyp

datetime

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

(If ongoing please leave blank)

Datentyp

datetime

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

SAE - Intensity

Datentyp

integer

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

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

Datentyp

boolean

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

(mark all that apply)

Datentyp

integer

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

SAE - If other possible contributors, specify

Datentyp

text

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

(maximum)

Datentyp

integer

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

SAE - Action taken with respect to Study Vaccine

Datentyp

integer

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

SAE - Events after further vaccination

Datentyp

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
Beschreibung

(mark all that apply).

Datentyp

integer

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

Send autopsy report when available

Datentyp

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
Beschreibung

If SAE required in-patient hospitalization, enter admission date

Datentyp

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
Beschreibung

If SAE required in-patient hospitalization, enter discharge date

Datentyp

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
Beschreibung

If SAE required prolongation of existing hospitalization, enter discharge date

Datentyp

date

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

If

Datentyp

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
Beschreibung

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

Datentyp

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?
Beschreibung

Was subject withdrawn due to this specific SAE?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Serious adverse event - Study vaccine information
Beschreibung

Serious adverse event - Study vaccine information

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0304229
UMLS CUI-4
C0042210
Vaccine
Beschreibung

(specify mixed or separate)

Datentyp

text

Alias
UMLS CUI [1]
C0042210
Vaccine Dose No
Beschreibung

Vaccine Dose No

Datentyp

text

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

Vaccine Lot No

Datentyp

text

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

Vaccine Route/ Site

Datentyp

text

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

Study Vaccine Date

Datentyp

date

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

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

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C2347852
UMLS CUI-5
C0042210
UMLS CUI-6
C1519255
UMLS CUI-7
C0085978
Drug/ vaccine
Beschreibung

Drug/ vaccine

Datentyp

text

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

Medication dosage

Datentyp

text

Alias
UMLS CUI [1]
C3174092
Medication frequency
Beschreibung

Medication frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beschreibung

Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Medication start date
Beschreibung

Medication start date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Medication end date
Beschreibung

Medication end date

Datentyp

date

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

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

Alias
UMLS CUI-1
C3640977
UMLS CUI-2
C1880177
UMLS CUI-3
C1519255
UMLS CUI-4
C0262926
UMLS CUI-5
C1880177
UMLS CUI-6
C1519255
Condition
Beschreibung

Condition

Datentyp

text

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

Condition still present?

Datentyp

boolean

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

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

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0087111
UMLS CUI-3
C1519255
Drug(s) used to treat this SAE
Beschreibung

Drug(s) used to treat this SAE

Datentyp

text

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

Drug for SAE - Dosage

Datentyp

text

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

Drug for SAE - Frequency

Datentyp

text

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

Drug for SAE - Route

Datentyp

text

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

Drug for SAE - Start date

Datentyp

date

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

Drug for SAE - End date

Datentyp

date

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

Serious adverse event - Surgical treatment for this SAE

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C1519255
Serious adverse event - Surgical treatment for this SAE
Beschreibung

(please specify)

Datentyp

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1519255
SAE- Description
Beschreibung

SAE- Description

Alias
UMLS CUI-1
C0678257
UMLS CUI-2
C1519255
SAE- Description
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
SAE - Comments
Beschreibung

SAE - Comments

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1519255
SAE - Comments
Beschreibung

(provide further comments concerning the case)

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigator signature
Beschreibung

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Beschreibung

Investigator signature date

Datentyp

date

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

Signature Clinical Development Manager

Datentyp

text

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

Clinical Development Manager Name

Datentyp

text

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

Clinical Development Manager

Datentyp

date

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

AEGIS Number

Datentyp

text

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

Concomitant Vaccination; Medication; Non-serious adverse events; Serious adverse events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Center
Item
Center
text
C1301943 (UMLS CUI [1])
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
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol?
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol?
boolean
C0042210 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2368628 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade / Generic Name
Item
Trade / Generic Name
text
C0042196 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0592502 (UMLS CUI [2,2])
Concomitant vaccination Administration date
Item
Concomitant vaccination Administration date
date
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item Group
Medication
C0013227 (UMLS CUI-1)
Have any of the above mentioned medications/treatments been administered during study period?
Item
Have any of the above mentioned medications/treatments been administered during study period?
boolean
C0013227 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,3])
Item Group
Medication
C0013227 (UMLS CUI-1)
Medication Trade / Generic Name
Item
Medication Trade / Generic Name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0592502 (UMLS CUI [2,2])
Item
Medical Indication
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Code List
Medical Indication
CL Item
Prophylactic (1)
Medication total daily dose
Item
Medication total daily dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication start date
Item
Medication start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication stop date
Item
Medication stop date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Medication continuing at end of study
integer
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
Medication continuing at end of study
Code List
Medication continuing at end of study
CL Item
Medication continuing (1)
Item Group
Non-serious adverse events
C1518404 (UMLS CUI-1)
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2])
Item Group
Non-serious adverse events
C1518404 (UMLS CUI-1)
Non-serious adverse event number
Item
Non-serious adverse event number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serious adverse event Description
Item
Non-serious adverse event Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Non-serious adverse event site / Vaccine
integer
C1518404 (UMLS CUI [1,1])
C0205145 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2])
Non-serious adverse event site / Vaccine
Code List
Non-serious adverse event site / Vaccine
CL Item
Local (administration sites) (1)
CL Item
Engerix-B (5)
CL Item
Infanrix (14)
CL Item
Prevnar (103)
CL Item
HibTITER (96)
CL Item
ActHib (3)
CL Item
Liquid PedvaxHIB (113)
CL Item
Comvax Vaccine (172)
CL Item
General (non administration site) (2)
Non-serious adverse event start date
Item
Non-serious adverse event start date
date
C2697888 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Non-serious advers event started during immediate post-vaccination period specified in protocol
integer
C1518404 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2348563 (UMLS CUI [3])
Non-serious advers event started during immediate post-vaccination period specified in protocol
Code List
Non-serious advers event started during immediate post-vaccination period specified in protocol
CL Item
during immediate post-vaccination period (1)
Date non-serious adverse event stopped
Item
Date non-serious adverse event stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-serious adverse event intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Non-serious adverse event intensity
Code List
Non-serious adverse event intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
In your opinion, did the vaccine possibly contribute to this AE?
Item
In your opinion, did the vaccine possibly contribute to this AE?
boolean
C0304229 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
Item
Non-serious adverse event outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious adverse event outcome
Code List
Non-serious adverse event outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Serious adverse event
C1519255 (UMLS CUI-1)
Item
Serious adverse event
integer
C1519255 (UMLS CUI [1])
Serious adverse event
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 - Gender
text
C0011298 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Subject Demography - Gender
Code List
Subject Demography - Gender
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])
SAE - Intensity
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])
SAE - Other possible contributors
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])
SAE - Outcome
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])
SAE - Action taken with respect to Study Vaccine
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])
SAE - Events after further vaccination
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])
Specify criteria for considering this as a Serious Adverse Event
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
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])
Other events (not SAE) to be reported in the same way
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 - Study vaccine information
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-3)
C0042210 (UMLS CUI-4)
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 - Concomitant medication/ Vaccination that could have contributed to this SAE
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
C0042210 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
C0085978 (UMLS CUI-7)
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 - Relevant intercurrent illness & medical history that could have contributed to this SAE
C3640977 (UMLS CUI-1)
C1880177 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0262926 (UMLS CUI-4)
C1880177 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
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 - Drug(s) used to treat this SAE
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
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 - Surgical treatment for this SAE
C0543467 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
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
SAE- Description
C0678257 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
SAE- Description
Item
SAE- Description
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SAE - Comments
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
SAE - Comments
Item
SAE - Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
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])
Clinical Development Manager
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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