ID

35727

Beschreibung

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Stichworte

Versionen (2)
  1. 18.03.19 18.03.19 -
  2. 18.03.19 18.03.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

18. März 2019

DOI

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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

Englisch

Long-Term Follow-Up (Month 60) - Demographics; Laboratory Tests; Follow-Up Studies; Safety Follow-Up - Serious Adverse Events; Tracking Document

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Center
Beschreibung

Center

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
GSK Receipt Date
Beschreibung

GSK Receipt Date

Datentyp

date

Alias
UMLS CUI [1]
C2985846
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
Subject initials
Beschreibung

First Name, Family Name

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
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
Race
Beschreibung

Race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
If other Race, please specify
Beschreibung

If other Race, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Laboratory Tests
Beschreibung

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Beschreibung

Has a blood sample been taken?

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Follow-Up Studies
Beschreibung

Follow-Up Studies

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

Would the subject be willing to participate in a follow-up study?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0600109
If subject would not be willing to participate in a follow-up study, please specify the reason
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0600109
UMLS CUI [1,3]
C0392360
If Adverse Event or Serious Adverse Event, please specify
Beschreibung

If Adverse Event or Serious Adverse Event, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2348235
If other, please specify
Beschreibung

If other, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Investigator Signature
Beschreibung

Investigator Signature

Alias
UMLS CUI-1
C2346576
Date of Investigator Signauture
Beschreibung

Date of Investigator Signauture

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Serious Adverse Events
Beschreibung

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Serious Adverse Event (SAE)
Beschreibung

Serious Adverse Event (SAE)

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Subject Demography - Initials (1)
Beschreibung

First Name, Family Name

Datentyp

text

Alias
UMLS CUI [1]
C0011298
UMLS CUI [2,1]
C1997894
UMLS CUI [2,2]
C2986440
Subject Demography - Date of Birth (1)
Beschreibung

Date of Birth (1)

Datentyp

date

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

Subject Demography - Gender (1)

Datentyp

text

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

Adverse Event - Diagnosis (2)

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
For GSK - Date and Time started (3)
Beschreibung

(Adverse event first symptoms)

Datentyp

datetime

Alias
UMLS CUI [1]
C2826806
For GSK - Date and time stopped (4)
Beschreibung

(If ongoing please leave blank)

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
For GSK - Intensity of Adverse Event (5)
Beschreibung

For GSK - Intensity of Adverse Event (5)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
For GSK - In your opinion, did the vaccine possibly contribute to the SAE? (6)
Beschreibung

For GSK - In your opinion, did the vaccine possibly contribute to the SAE? (6)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0042196
For GSK - Other possible contributors (11)
Beschreibung

(mark all that apply)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0205394
Adverse Event Outcome (7)
Beschreibung

(maximum)

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Action taken with respect to Study Vaccine (8)
Beschreibung

Action taken with respect to Study Vaccine (8)

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0042210
Events after further vaccination (9)
Beschreibung

Events after further vaccination (9)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C1517331
Specify criteria for considering this as a Serious Adverse Event (10)
Beschreibung

(mark all that apply)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C2348235
If results in Death, Autopsy performed? (10)
Beschreibung

If yes, send autopsy report when available

Datentyp

boolean

Alias
UMLS CUI [1]
C0004398
If in-patient hospitalization required, enter Admission Date (10)
Beschreibung

If in-patient hospitalization required, enter Admission Date (10)

Datentyp

date

Alias
UMLS CUI [1]
C2826664
UMLS CUI [2]
C1302393
If in-patient hospitalization required, enter Discharge Date (10)
Beschreibung

If in-patient hospitalization required, enter Discharge Date (10)

Datentyp

date

Alias
UMLS CUI [1]
C2826664
UMLS CUI [2]
C2361123
If prolongation of exisiting hospitalization, enter discharge date (10)
Beschreibung

If prolongation of exisiting hospitalization, enter discharge date (10)

Datentyp

date

Alias
UMLS CUI [1]
C0745041
UMLS CUI [2]
C2361123
Was subject withdrawn due to this specific SAE? (12)
Beschreibung

Was subject withdrawn due to this specific SAE? (12)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
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
SAE - Study Vaccine Information (13)
Beschreibung

SAE - Study Vaccine Information (13)

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C0304229
UMLS CUI-3
C1533716
Vaccine
Beschreibung

(specify mixed or separate)

Datentyp

text

Alias
UMLS CUI [1]
C0042210
Dose No
Beschreibung

Dose No

Datentyp

integer

Alias
UMLS CUI [1]
C1115464
Lot No
Beschreibung

Lot No

Datentyp

integer

Alias
UMLS CUI [1]
C1115660
Route / Site
Beschreibung

Route / Site

Datentyp

text

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

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
SAE - Concomitant medication / vaccination that could have contributed to this SAE (14)
Beschreibung

SAE - Concomitant medication / vaccination that could have contributed to this SAE (14)

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1519255
UMLS CUI-3
C1880177
UMLS CUI-5
C0042196
UMLS CUI-6
C2347852
UMLS CUI-7
C1519255
UMLS CUI-8
C1880177
Drug / vaccine
Beschreibung

Drug / vaccine

Datentyp

text

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0042210
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
SAE - Relevant intercurrent illness & medical history that could have contributed to this SAE (15)
Beschreibung

SAE - Relevant intercurrent illness & medical history that could have contributed to this SAE (15)

Alias
UMLS CUI-1
C0221423
UMLS CUI-2
C1519255
UMLS CUI-3
C1880177
UMLS CUI-4
C0262926
UMLS CUI-5
C1519255
UMLS CUI-6
C1880177
Condition:
Beschreibung

Condition:

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Still present?
Beschreibung

Still present?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
Drug(s) used to treat this SAE (16)
Beschreibung

Drug(s) used to treat this SAE (16)

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

Drug

Datentyp

text

Alias
UMLS CUI [1]
C0013227
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
Surgical treatment for this SAE (17)
Beschreibung

Surgical treatment for this SAE (17)

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

Surgical treatment for this SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1519255
Description (18)
Beschreibung

Description (18)

Alias
UMLS CUI-1
C0678257
Description
Beschreibung

Description

Datentyp

text

Alias
UMLS CUI [1]
C0678257
SAE - Comments
Beschreibung

SAE - Comments

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

SAE - Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Tracking Document
Beschreibung

Tracking Document

Alias
UMLS CUI-1
C3889409
Subject number of previous study
Beschreibung

Subject number of previous study

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C2242969
Subject initials
Beschreibung

first name family name

Datentyp

text

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

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
Beschreibung

Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1517942
Reason for Subject not willing to participate
Beschreibung

Reason for Subject not willing to participate

Datentyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1136454
If other Reason for Subject not willing to participate, please specify
Beschreibung

If other Reason for Subject not willing to participate, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1136454
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Date of contact
Beschreibung

Date of contact

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Investigator signature
Beschreibung

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator Signature (1)
Beschreibung

Investigator Signature (1)

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date (1)
Beschreibung

Investigator Signature Date (1)

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator Signature (2)
Beschreibung

Investigator Signature (2)

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date (2)
Beschreibung

Investigator Signature Date (2)

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator Signature (3)
Beschreibung

Investigator Signature (3)

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date (3)
Beschreibung

Investigator Signature Date (3)

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator Signature (4)
Beschreibung

Investigator Signature (4)

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date (4)
Beschreibung

Investigator Signature Date (4)

Datentyp

date

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

Clinical Development Manager - Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C0681803
UMLS CUI [1,2]
C1519316
Clinical Development Manager - Signature Date
Beschreibung

Clinical Development Manager - Signature Date

Datentyp

date

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

AEGIS Number

Datentyp

integer

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

Long-Term Follow-Up (Month 60) - Demographics; Laboratory Tests; Follow-Up Studies; Safety Follow-Up - Serious Adverse Events; Tracking Document

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
GSK Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Item Group
Demographics
C1704791 (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
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (F)
CL Item
Male (M)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (WH)
CL Item
Black (BL)
CL Item
Oriental (OR)
CL Item
Other, please specify (OT)
If other Race, please specify
Item
If other Race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
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])
C0600109 (UMLS CUI [1,2])
Item
If subject would not be willing to participate in a follow-up study, please specify the reason
text
C0016441 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
If subject would not be willing to participate in a follow-up study, please specify the reason
Code List
If subject would not be willing to participate in a follow-up study, please specify the reason
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
If Adverse Event or Serious Adverse Event, please specify
Item
If Adverse Event or Serious Adverse Event, please specify
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If other, please specify
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Date of Investigator Signauture
Item
Date of Investigator Signauture
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Item
Serious Adverse Event (SAE)
integer
C1519255 (UMLS CUI [1])
Serious Adverse Event (SAE)
Code List
Serious Adverse Event (SAE)
CL Item
Initial report (1)
CL Item
Additional info (2)
CL Item
Additional info (3)
CL Item
Additional info (4)
Subject Demography - Initials (1)
Item
Subject Demography - Initials (1)
text
C0011298 (UMLS CUI [1])
C1997894 (UMLS CUI [2,1])
C2986440 (UMLS CUI [2,2])
Date of Birth (1)
Item
Subject Demography - Date of Birth (1)
date
C0011298 (UMLS CUI [1])
C0421451 (UMLS CUI [2])
Item
Subject Demography - Gender (1)
text
C0011298 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Subject Demography - Gender
Code List
Subject Demography - Gender (1)
CL Item
Female (F)
CL Item
Male (M)
Adverse Event - Diagnosis (2)
Item
Adverse Event - Diagnosis (2)
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
For GSK - Date and Time started (3)
Item
For GSK - Date and Time started (3)
datetime
C2826806 (UMLS CUI [1])
For GSK - Date and time stopped (4)
Item
For GSK - Date and time stopped (4)
datetime
C2826793 (UMLS CUI [1])
Item
For GSK - Intensity of Adverse Event (5)
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
For GSK - Intensity of Adverse Event
Code List
For GSK - Intensity of Adverse Event (5)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
For GSK - In your opinion, did the vaccine possibly contribute to the SAE? (6)
Item
For GSK - In your opinion, did the vaccine possibly contribute to the SAE? (6)
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Item
For GSK - Other possible contributors (11)
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
For GSK - Other possible contributors (6)
Code List
For GSK - Other possible contributors (11)
CL Item
Medical history (record in section 15) (1)
CL Item
Other medication (record in section 14) (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)
Item
Adverse Event Outcome (7)
integer
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Adverse Event Outcome (7)
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 (8)
integer
C2826626 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Action taken with respect to Study Vaccine (8)
Code List
Action taken with respect to Study Vaccine (8)
CL Item
None (1)
CL Item
Vaccination course postponed (2)
CL Item
Vaccination course stopped (3)
Item
Events after further vaccination (9)
integer
C0042196 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
Events after further vaccination
Code List
Events after further vaccination (9)
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 (10)
integer
C1519255 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Specify criteria for considering this as a Serious Adverse Event (10)
Code List
Specify criteria for considering this as a Serious Adverse Event (10)
CL Item
Results 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, specify (7)
If results in Death, Autopsy performed? (10)
Item
If results in Death, Autopsy performed? (10)
boolean
C0004398 (UMLS CUI [1])
If in-patient hospitalization required, enter Admission Date (10)
Item
If in-patient hospitalization required, enter Admission Date (10)
date
C2826664 (UMLS CUI [1])
C1302393 (UMLS CUI [2])
If in-patient hospitalization required, enter Discharge Date (10)
Item
If in-patient hospitalization required, enter Discharge Date (10)
date
C2826664 (UMLS CUI [1])
C2361123 (UMLS CUI [2])
If prolongation of exisiting hospitalization, enter discharge date (10)
Item
If prolongation of exisiting hospitalization, enter discharge date (10)
date
C0745041 (UMLS CUI [1])
C2361123 (UMLS CUI [2])
Was subject withdrawn due to this specific SAE? (12)
Item
Was subject withdrawn due to this specific SAE? (12)
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Other events (not SAE) to be reported in the same way
integer
C0441471 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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)
Item Group
SAE - Study Vaccine Information (13)
C0042210 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
Vaccine
Item
Vaccine
text
C0042210 (UMLS CUI [1])
Dose No
Item
Dose No
integer
C1115464 (UMLS CUI [1])
Lot No
Item
Lot No
integer
C1115660 (UMLS CUI [1])
Route / Site
Item
Route / Site
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
SAE - Concomitant medication / vaccination that could have contributed to this SAE (14)
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1880177 (UMLS CUI-3)
C0042196 (UMLS CUI-5)
C2347852 (UMLS CUI-6)
C1519255 (UMLS CUI-7)
C1880177 (UMLS CUI-8)
Drug / vaccine
Item
Drug / vaccine
text
C0013227 (UMLS CUI [1])
C0042210 (UMLS CUI [2])
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
SAE - Relevant intercurrent illness & medical history that could have contributed to this SAE (15)
C0221423 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1880177 (UMLS CUI-3)
C0262926 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
C1880177 (UMLS CUI-6)
Condition:
Item
Condition:
text
C0012634 (UMLS CUI [1])
Still present?
Item
Still present?
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Item Group
Drug(s) used to treat this SAE (16)
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Drug
Item
Drug
text
C0013227 (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
Surgical treatment for this SAE (17)
C0543467 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Surgical treatment for this SAE
Item
Surgical treatment for this SAE
text
C0543467 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Description (18)
C0678257 (UMLS CUI-1)
Description
Item
Description
text
C0678257 (UMLS CUI [1])
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
Tracking Document
C3889409 (UMLS CUI-1)
Subject number of previous study
Item
Subject number of previous study
integer
C2348585 (UMLS CUI [1,1])
C2242969 (UMLS CUI [1,2])
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
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
integer
C1512693 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
Code List
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
CL Item
Subject not eligible (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to adverse events, or serious adverse event or other (3)
CL Item
Subject eligible and agreed to participate in the (4)
CL Item
long-term follow-up study (5)
Item
Reason for Subject not willing to participate
integer
C0392360 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
Reason for Subject not willing to participate
Code List
Reason for Subject not willing to participate
CL Item
adverse events, or serious adverse event: (1)
CL Item
other (2)
If other Reason for Subject not willing to participate, please specify
Item
If other Reason for Subject not willing to participate, please specify
text
C0392360 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator Signature (1)
Item
Investigator Signature (1)
text
C2346576 (UMLS CUI [1])
Investigator Signature Date (1)
Item
Investigator Signature Date (1)
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Signature (2)
Item
Investigator Signature (2)
text
C2346576 (UMLS CUI [1])
Investigator Signature Date (2)
Item
Investigator Signature Date (2)
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Signature (3)
Item
Investigator Signature (3)
text
C2346576 (UMLS CUI [1])
Investigator Signature Date (3)
Item
Investigator Signature Date (3)
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Signature (4)
Item
Investigator Signature (4)
text
C2346576 (UMLS CUI [1])
Investigator Signature Date (4)
Item
Investigator Signature Date (4)
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Clinical Development Manager - Signature
Item
Clinical Development Manager - Signature
text
C0681803 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Clinical Development Manager - Signature Date
Item
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
integer
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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