ID

25679

Beschreibung

Visit 4, Concomitant vaccination, medication and study conclusion- GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731 Study ID: 100382 Clinical Study ID: 100382 Study Title: Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals’ Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289731 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Stichworte

Versionen (1)
  1. 09.09.17 09.09.17 -
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glaxoSmithKline

Hochgeladen am

9. September 2017

DOI

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Visit 4, Concomitant vaccination, medication and study conclusion- GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731

Englisch

Visit 4, Concomitant vaccination, medication and study conclusion- GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731

1 Formulare  
Check for study continuation
Beschreibung

Check for study continuation

Alias
UMLS CUI-1
C2348568
Did the subject come at visit 4?
Beschreibung

study continuation status

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason.
Beschreibung

Reson for non continuation

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
Please specify SAE N°
Beschreibung

Number of SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Other, please specify
Beschreibung

e.g.: consent withdrawal, Protocol violation, ...

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Please tick who took the decision.
Beschreibung

Decision taker

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006
Blood sample
Beschreibung

Blood sample

Alias
UMLS CUI-1
C0005834
Has a blood sample been taken?
Beschreibung

Blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Date of Blood sample
Beschreibung

Please complete only if different from visit date.

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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

Concomitant vaccination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Concomitant vaccination
Beschreibung

Concomitant vaccination

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

Trade name

Datentyp

text

Alias
UMLS CUI [1,1]
C0592503
UMLS CUI [1,2]
C0042210
Route
Beschreibung

Route of vaccine administration

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
Administration date
Beschreibung

Date of vaccine administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Medication
Beschreibung

Medication

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

Concomitant medication

Datentyp

integer

Alias
UMLS CUI [1]
C2347852
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
Trade / Generic Name
Beschreibung

Trade / Generic Name of medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0592503
UMLS CUI [1,2]
C0013227
Medical Indication
Beschreibung

Medical Indication for medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Prophylactic
Beschreibung

Prophylactic medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0420172
Total daily dose
Beschreibung

Total daily dose of medication

Datentyp

float

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

Drug administration route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Start
Beschreibung

Start date of medication

Datentyp

date

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

End date of medication

Datentyp

date

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

Medication continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Medical status at study end (Month 7)
Beschreibung

Medical status at study end (Month 7)

Alias
UMLS CUI-1
C3899485
Is the medical condition of the subject now the same as it was at study entry?
Beschreibung

If 'no', please record below.

Datentyp

boolean

Alias
UMLS CUI [1]
C3899485
Disease
Beschreibung

Disease

Alias
UMLS CUI-1
C0012634
Name of disease
Beschreibung

Disease

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Start date
Beschreibung

Start date of disease

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0808070
Requiring medication?
Beschreibung

If 'yes', please complete the medication section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332121
Follow-up- Studies
Beschreibung

Follow-up- Studies

Alias
UMLS CUI-1
C0016441
UMLS CUI-2
C0042210
Would the subject be willing to participate in a follow-up study?
Beschreibung

If "No", please specify the most appropriate reason.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
Please specify the most appropriate reason.
Beschreibung

Reason for non participation in follow-up

Datentyp

integer

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0566251
Please specify Adverse Events, or Serious Adverse Events.
Beschreibung

specify Adverse Events

Datentyp

text

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C1521902
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1521902
Specify other reason
Beschreibung

Other reason for no follow-up

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Occurrence of serious adverse event
Beschreibung

Occurrence of serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event during the study period?
Beschreibung

Serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
If yes, please give the total number of SAE's.
Beschreibung

Number of SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Pregnancy information
Beschreibung

Pregnancy information

Alias
UMLS CUI-1
C0032961
Did the subject become pregnant during the study?
Beschreibung

If yes, please complete the Pregnancy Notification form.

Datentyp

integer

Alias
UMLS CUI [1]
C0032961
Elimination criteria
Beschreibung

Elimination criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable during the study?
Beschreibung

Elimination criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Please specify elimination criteria.
Beschreibung

specify elimination criteria

Datentyp

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Study conclusion
Beschreibung

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Was the subject withdrawn from study?
Beschreibung

Withdrawn from study

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Please tick the ONE most appropriate category for drop out.
Beschreibung

Reason for withdrawal from study

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392360
Please specify SAE N°
Beschreibung

Number of SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Please specify protocol violation.
Beschreibung

specify protocol violation

Datentyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
Please specify other reason
Beschreibung

specify other reason

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2348568
Tick who took the decision for study withdrawal.
Beschreibung

decision study participation

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006
Date of last contact
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Compared to subject's medical condition at the beginning of the study (Day 0), is the medical condition the same at Month 7?
Beschreibung

Medical status

Datentyp

integer

Alias
UMLS CUI [1]
C3899485
Investigator's signature
Beschreibung

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschreibung

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Beschreibung

Printed Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beschreibung

Date of investigator's signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Visit 4, Concomitant vaccination, medication and study conclusion- GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Check for study continuation
C2348568 (UMLS CUI-1)
Item
Did the subject come at visit 4?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
study continuation status
Code List
Did the subject come at visit 4?
CL Item
Yes, please complete the following pages. (1)
CL Item
No, please complete below. (2)
Item
Please tick the ONE most appropriate reason.
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reson for non continuation
Code List
Please tick the ONE most appropriate reason.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Other, please specify (OTH)
Number of SAE
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Other reason for non-participation
Item
Other, please specify
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Please tick who took the decision.
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision taker
Code List
Please tick who took the decision.
CL Item
Investigator’s decision  (1)
CL Item
Subject's decision (2)
Item Group
Blood sample
C0005834 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date of Blood sample
Item
Date of Blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Concomitant vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
integer
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant vaccination
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and / or generic name, route and vaccine administration date. (2)
Item Group
Concomitant vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade name
Item
Trade / (Generic) Name
text
C0592503 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route
text
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Route of vaccine administration
Code List
Route
CL Item
Intradermal (ID)
CL Item
Inhalation  (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Date of vaccine administration
Item
Administration date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item Group
Medication
C0013227 (UMLS CUI-1)
Item
Have any medications/treatments been administered during study period?
integer
C2347852 (UMLS CUI [1])
Concomitant medication
Code List
Have any medications/treatments been administered during study period?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade / Generic Name of medication
Item
Trade / Generic Name
text
C0592503 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication for medication
Item
Medical Indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Prophylactic medication
Item
Prophylactic
boolean
C0420172 (UMLS CUI [1])
Total daily dose of medication
Item
Total daily dose
float
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1])
Drug administration route
Code List
Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Start date of medication
Item
Start
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date of medication
Item
End
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuous
Item
Medication continuing at the end of the study?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Medical status at study end (Month 7)
C3899485 (UMLS CUI-1)
medical status
Item
Is the medical condition of the subject now the same as it was at study entry?
boolean
C3899485 (UMLS CUI [1])
Item Group
Disease
C0012634 (UMLS CUI-1)
Disease
Item
Name of disease
text
C0012634 (UMLS CUI [1])
Start date of disease
Item
Start date
date
C0012634 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Disease requires medication
Item
Requiring medication?
boolean
C0012634 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Item Group
Follow-up- Studies
C0016441 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
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
Please specify the most appropriate reason.
integer
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Reason for non participation in follow-up
Code List
Please specify the most appropriate reason.
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Others (2)
specify Adverse Events
Item
Please specify Adverse Events, or Serious Adverse Events.
text
C0559546 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
Other reason for no follow-up
Item
Specify other reason
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Occurrence of serious adverse event
C1519255 (UMLS CUI-1)
Serious adverse event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
Number of SAE
Item
If yes, please give the total number of SAE's.
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Item
Did the subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did the subject become pregnant during the study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (not of childbearing potential or male) (3)
Item Group
Elimination criteria
C0680251 (UMLS CUI-1)
Elimination criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
specify elimination criteria
Item
Please specify elimination criteria.
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Withdrawn from study
Item
Was the subject withdrawn from study?
boolean
C2348568 (UMLS CUI [1])
Item
Please tick the ONE most appropriate category for drop out.
text
C2348568 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for withdrawal from study
Code List
Please tick the ONE most appropriate category for drop out.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Protocol violation (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 (OTH)
Number of SAE
Item
Please specify SAE N°
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
specify protocol violation
Item
Please specify protocol violation.
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
specify other reason
Item
Please specify other reason
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Item
Tick who took the decision for study withdrawal.
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
decision study participation
Code List
Tick who took the decision for study withdrawal.
CL Item
Investigator’s decision (1)
CL Item
Subject's decision (2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Compared to subject's medical condition at the beginning of the study (Day 0), is the medical condition the same at Month 7?
integer
C3899485 (UMLS CUI [1])
Medical status
Code List
Compared to subject's medical condition at the beginning of the study (Day 0), is the medical condition the same at Month 7?
CL Item
Yes (1)
CL Item
No, please complete Medical Condition Questionnaire at Month 7. (2)
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of investigator's signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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