ID

26121

Beschreibung

Study ID: 111029 Clinical Study ID: 111029 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A Documentation part: Serious Adverse Event

Link

https://clinicaltrials.gov/ct2/show/NCT00289757

Stichworte

Versionen (1)
  1. 09.10.17 09.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. Oktober 2017

DOI

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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Serious Adverse Event 111029

Englisch

Serious Adverse Event Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029

1 Formulare  
Serious Adverse Event
Beschreibung

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0170300
Serious Adverse Event
Beschreibung

Serious Adverse Event

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Initials
Beschreibung

Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Serious adverse events: Diagnosis only (if known) or signs / symptoms
Beschreibung

Diagnosis Serious adverse events

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Specify criteria for considering this as a Serious Adverse Event.
Beschreibung

Serious Adverse Event

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Autopsy
Beschreibung

If "Result in death"=Yes, please specify Send autopsy report when available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Admission date
Beschreibung

If "Requires in-patient hospitalization"=Yes, please specify

Datentyp

date

Alias
UMLS CUI [1]
C1302393
UMLS CUI [2]
C1519255
Discharge date
Beschreibung

If "Requires in-patient hospitalization"=Yes, please specify

Datentyp

date

Alias
UMLS CUI [1]
C2361123
UMLS CUI [2]
C1519255
Discharge date
Beschreibung

If "Prolongation of existing hospitalization"=Yes, please specify

Datentyp

date

Alias
UMLS CUI [1]
C2361123
UMLS CUI [2]
C1519255
Medically important event
Beschreibung

If "Medically important event"=Yes, please specify

Datentyp

text

Alias
UMLS CUI [1]
C2826307
Other events (not SAE) to be reported in the same way
Beschreibung

=Cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C2826307
Start Date
Beschreibung

Start Date

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Time started
Beschreibung

Time started

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1519255
End Date
Beschreibung

(If ongoing please leave blank)

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Time stopped
Beschreibung

(If ongoing please leave blank)

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1519255
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
In your opinion, did the vaccine possibly contribute to the SAE :
Beschreibung

Relationship to vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0170300
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C1519255
Other possible contributors:
Beschreibung

Cause of SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Please specify cause of SAE if Other
Beschreibung

Cause of SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Action taken with respect to study vaccine
Beschreibung

Action taken with respect to study vaccine

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0170300
UMLS CUI [1,3]
C1519255
Events after further vaccination
Beschreibung

Events after further vaccination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1519255
Was subject withdrawn due to this specific SAE ?
Beschreibung

Withdrawal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Relevant intercurrent illness & medical history that could have contributed to this SAE
Beschreibung

Relevant Medical Conditions

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1519255
Condition still present?
Beschreibung

Condition still present

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C1519255
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
Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Study vaccine information
Beschreibung

Study vaccine information

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C0170300
UMLS CUI-3
C0304229
Vaccine
Beschreibung

Vaccine

Datentyp

text

Alias
UMLS CUI [1]
C0042210
Dose No
Beschreibung

Dose No

Datentyp

integer

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

Lot Number

Datentyp

integer

Alias
UMLS CUI [1]
C2826710
UMLS CUI [2]
C0042210
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0011008
Concomitant medication / vaccination that could have contributed to this SAE
Beschreibung

Concomitant medication / vaccination that could have contributed to this SAE

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0042210
Relevant Concomitant Medications: Drug/vaccine name
Beschreibung

Concomitant medication / vaccination that could have contributed to this SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Dosage
Beschreibung

Dosage

Datentyp

float

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Stop date
Beschreibung

Stop date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Drug(s) used to treat this SAE
Beschreibung

Drug(s) used to treat this SAE

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0087111
UMLS CUI-3
C1519255
Drug name
Beschreibung

Drug name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Dosage
Beschreibung

Dosage

Datentyp

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0013227
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Start Date
Beschreibung

Start Date

Datentyp

date

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

End date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Surgical treatment for this SAE, please specify
Beschreibung

Surgical treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1519255
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Ähnliche Modelle

Serious Adverse Event Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
C0170300 (UMLS CUI-2)
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)
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Diagnosis Serious adverse events
Item
Serious adverse events: Diagnosis only (if known) or signs / symptoms
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Specify criteria for considering this as a Serious Adverse Event.
integer
C1519255 (UMLS CUI [1])
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-patient hospitalization. (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 (7)
autopsy
Item
Autopsy
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Admission date
Item
Admission date
date
C1302393 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Discharge date
Item
Discharge date
date
C2361123 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
discharge date
Item
Discharge date
date
C2361123 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Medically important event
Item
Medically important event
text
C2826307 (UMLS CUI [1])
Other events
Item
Other events (not SAE) to be reported in the same way
boolean
C0006826 (UMLS CUI [1])
C2826307 (UMLS CUI [2])
Start Date
Item
Start Date
text
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Time started
Item
Time started
time
C0040223 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Time stopped
Item
Time stopped
time
C0040223 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Relationship to vaccine
Item
In your opinion, did the vaccine possibly contribute to the SAE :
boolean
C0304229 (UMLS CUI [1,1])
C0170300 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item
Other possible contributors:
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Cause of SAE
Code List
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 (7)
Cause of SAE
Item
Please specify cause of SAE if Other
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
Item
Action taken with respect to study vaccine
integer
C1704758 (UMLS CUI [1,1])
C0170300 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Action taken with respect to study vaccine
Code List
Action taken with respect to study vaccine
CL Item
None (1)
CL Item
Vaccination course postponed (2)
CL Item
Vaccination course stopped (3)
Item
Events after further vaccination
integer
C0042196 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Events after further vaccination
Code List
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)
Withdrawal
Item
Was subject withdrawn due to this specific SAE ?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relevant Medical Conditions
Item
Relevant intercurrent illness & medical history that could have contributed to this SAE
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Condition still present
Item
Condition still present?
boolean
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Description
Item
Description
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Item Group
Study vaccine information
C0042210 (UMLS CUI-1)
C0170300 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Vaccine
Item
Vaccine
text
C0042210 (UMLS CUI [1])
Dose No
Item
Dose No
integer
C3174092 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2])
Lot Number
Item
Lot No
integer
C2826710 (UMLS CUI [1])
C0042210 (UMLS CUI [2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Site
Item
Site
text
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Date
Item
Date
date
C0042210 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Concomitant medication / vaccination that could have contributed to this SAE
C2347852 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Drug or vaccine name
Item
Relevant Concomitant Medications: Drug/vaccine name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Dosage
Item
Relevant Concomitant Medications: Dosage
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Frequency
Item
Relevant Concomitant Medications: Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Route
Item
Relevant Concomitant Medications: Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Start Date
Item
Relevant Concomitant Medications: Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Stop date
Item
Relevant Concomitant Medications: Stop date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item Group
Drug(s) used to treat this SAE
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Dosage
Item
Dosage
text
C0178602 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Surgical treatment
Item
Surgical treatment for this SAE, please specify
text
C0543467 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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