ID

29434

Beschreibung

Long term follow-up, Visit 6 Month 30, Serious adverse events Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

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  1. 24.03.18 24.03.18 -
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GlaxoSmithKline (GSK)

Hochgeladen am

24. März 2018

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GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915

Englisch

Long term follow-up, Visit 6 Month 30, Serious adverse events

1 Formulare  
Serious adverse events
Beschreibung

Serious adverse events

Alias
UMLS CUI-1
C1519255
Serious adverse events
Beschreibung

Serious adverse events

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Initials:
Beschreibung

Subject Demography

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

integer

Alias
UMLS CUI [1]
C0079399
Adverse Event (please print clearly) Diagnosis (or signs and symptoms if not known)
Beschreibung

Adverse event diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Date and time started: (Adverse event first symptoms)
Beschreibung

Start date/time

Datentyp

datetime

Alias
UMLS CUI [1]
C0808070
UMLS CUI [2]
C1301880
Date and time stopped: (If ongoing please leave blank)
Beschreibung

End date/time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Intensity: (maximum)
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
Specify criteria for considering this as a Serious Adverse Event. (mark all that apply).
Beschreibung

Serious adverse event criteria

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Autopsy?
Beschreibung

If SAE resulted in death, please send autopsy report when available

Datentyp

boolean

Alias
UMLS CUI [1]
C0004398
Hospitalization Admission date
Beschreibung

If SAE required hospitalization, please specify:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0019993
Hospitalization Discharge date
Beschreibung

If SAE required hospitalization, please specify:

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0019993
Prolongation of Hospitalization: Discharge date
Beschreibung

Prolongation of Hospitalization

Datentyp

date

Alias
UMLS CUI [1,1]
C0745041
UMLS CUI [1,2]
C2361123
Other events (not SAE) to be reported in the same way: Cancer
Beschreibung

Cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
In your opinion, did the vaccine possibly contribute to the SAE:
Beschreibung

Vaccine contribution

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0042210
Other possible contributors: (mark all that apply)
Beschreibung

Other possible contributors

Datentyp

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Outcome: (maximum)
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Action taken with respect to Study Vaccine
Beschreibung

Action taken

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Events after further vaccination
Beschreibung

Further vaccination events

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0700325
UMLS CUI [1,3]
C0877248
Was subject withdrawn due to this specific SAE?
Beschreibung

Subject withdrawal

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
UMLS CUI [2,1]
C1710677
UMLS CUI [2,2]
C1519255
Study vaccine information
Beschreibung

Study vaccine information

Alias
UMLS CUI-1
C0042210
Vaccine (specify mixed or separate)
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 [1,3]
C0042210
Lot No
Beschreibung

Lot No

Datentyp

integer

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

Route / Site

Datentyp

text

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

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
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
C1519255
Drug / vaccine
Beschreibung

Drug / vaccine

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Dosage
Beschreibung

Dosage

Datentyp

text

Alias
UMLS CUI [1]
C0178602
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]
C0808070
End date
Beschreibung

End date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Relevant intercurrent illness & medical history that could have contributed to this SAE (Including allergies)
Beschreibung

Relevant intercurrent illness & medical history that could have contributed to this SAE (Including allergies)

Alias
UMLS CUI-1
C3640977
Condition:
Beschreibung

Condition

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Still present?
Beschreibung

Presence of disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
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
Beschreibung

Drug

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Dosage
Beschreibung

Dosage

Datentyp

text

Alias
UMLS CUI [1]
C0178602
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End date
Beschreibung

End date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Surgical treatment for this SAE (please specify)
Beschreibung

Surgical treatment for SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1519255
SAE administative information
Beschreibung

SAE administative information

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0684224
Description (provide a brief narrative description of the SAE including relevant diagnostic findings, lab data & evolution of the events etc…)
Beschreibung

Description of SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
Comments (provide further comments concerning the case)
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Investigator signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Please PRINT name:
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Clinical Development Manager: Signature
Beschreibung

Clinical Development Manager: Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0681803
Clinical Development Manager: Please PRINT name
Beschreibung

Clinical Development Manager: Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0681803
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
AEGIS Number:
Beschreibung

AEGIS Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0679918
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Ähnliche Modelle

Long term follow-up, Visit 6 Month 30, Serious adverse events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Serious adverse events
C1519255 (UMLS CUI-1)
Item
Serious adverse events
integer
C1519255 (UMLS CUI [1])
Serious adverse events
Code List
Serious adverse events
CL Item
Initial report (1)
CL Item
Additional info (2)
CL Item
Additional info (3)
CL Item
Additional info (4)
Initials
Item
Initials:
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth:
date
C0421451 (UMLS CUI [1])
Item
Gender:
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender:
CL Item
Male (1)
CL Item
Female (2)
Adverse event diagnosis
Item
Adverse Event (please print clearly) Diagnosis (or signs and symptoms if not known)
text
C0877248 (UMLS CUI [1])
Start date/time
Item
Date and time started: (Adverse event first symptoms)
datetime
C0808070 (UMLS CUI [1])
C1301880 (UMLS CUI [2])
End date/time
Item
Date and time stopped: (If ongoing please leave blank)
datetime
C2826793 (UMLS CUI [1])
Item
Intensity: (maximum)
integer
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity: (maximum)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Specify criteria for considering this as a Serious Adverse Event. (mark all that apply).
integer
C1519255 (UMLS CUI [1])
Serious adverse event criteria
Code List
Specify criteria for considering this as a Serious Adverse Event. (mark all that apply).
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])
Hospitalization
Item
Hospitalization Admission date
boolean
C0011008 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Hospitalization
Item
Hospitalization Discharge date
date
C0011008 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Prolongation of Hospitalization
Item
Prolongation of Hospitalization: Discharge date
date
C0745041 (UMLS CUI [1,1])
C2361123 (UMLS CUI [1,2])
Cancer
Item
Other events (not SAE) to be reported in the same way: Cancer
boolean
C0006826 (UMLS CUI [1])
Vaccine contribution
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
Other possible contributors: (mark all that apply)
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other possible contributors
Code List
Other possible contributors: (mark all that apply)
CL Item
Medical history (record in section 15) (1)
(Comment:en)
CL Item
Other medication (record in section 14) (2)
(Comment:en)
CL Item
Protocol required procedure (3)
(Comment:en)
CL Item
Other procedure (4)
(Comment:en)
CL Item
Lack of efficacy (5)
(Comment:en)
CL Item
Erroneous administration (6)
(Comment:en)
CL Item
Other, specify: _________________ (record additional information in section 19) (7)
(Comment:en)
Item
Outcome: (maximum)
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome: (maximum)
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
C2826626 (UMLS CUI [1])
Action taken
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])
C0700325 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Further vaccination events
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)
Subject withdrawal
Item
Was subject withdrawn due to this specific SAE?
boolean
C0422727 (UMLS CUI [1])
C1710677 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Item Group
Study vaccine information
C0042210 (UMLS CUI-1)
Vaccine
Item
Vaccine (specify mixed or separate)
text
C0042210 (UMLS CUI [1])
Dose No
Item
Dose No
integer
C3174092 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Lot No
Item
Lot No
integer
C2826710 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route / Site
Item
Route / Site
text
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item Group
Concomitant medication / vaccination that could have contributed to this SAE
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Drug / vaccine
Item
Drug / vaccine
text
C2347852 (UMLS CUI [1])
Dosage
Item
Dosage
text
C0178602 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item Group
Relevant intercurrent illness & medical history that could have contributed to this SAE (Including allergies)
C3640977 (UMLS CUI-1)
Condition
Item
Condition:
text
C0012634 (UMLS CUI [1])
Presence of disease
Item
Still present?
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Item Group
Drug(s) used to treat this SAE
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Drug
Item
Drug
text
C2347852 (UMLS CUI [1])
Dosage
Item
Dosage
text
C0178602 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Surgical treatment for SAE
Item
Surgical treatment for this SAE (please specify)
text
C0543467 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SAE administative information
C1519255 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
Description of SAE
Item
Description (provide a brief narrative description of the SAE including relevant diagnostic findings, lab data & evolution of the events etc…)
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Comments
Item
Comments (provide further comments concerning the case)
text
C0947611 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator name
Item
Please PRINT name:
text
C2826892 (UMLS CUI [1])
Clinical Development Manager: Signature
Item
Clinical Development Manager: Signature
text
C1519316 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
Clinical Development Manager: Name
Item
Clinical Development Manager: Please PRINT name
text
C0027365 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
AEGIS Number
Item
AEGIS Number:
integer
C0600091 (UMLS CUI [1,1])
C0679918 (UMLS CUI [1,2])
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