ID

41330

Beschreibung

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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Versionen (1)
  1. 26.08.20 26.08.20 -
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GlaxoSmithKline

Hochgeladen am

26. August 2020

DOI

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Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

Englisch

Screening - Screen Conclusion

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Screening Conclusion
Beschreibung

Screening Conclusion

Alias
UMLS CUI-1
C1710477
UMLS CUI-2
C1707478
Did the patient experience any Serious Adverse Event during screening?
Beschreibung

(only SAEs related to study participation or to a concurrent GSK medication need to be considered and reported).

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Specify total number of SAEs:
Beschreibung

Specify total number of SAEs:

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Is the patient a screening failure?
Beschreibung

(Was the patient withdrawn prior to treatment number allocation?)

Datentyp

boolean

Alias
UMLS CUI [1]
C1710476
Major reason for screening failure.
Beschreibung

(Tick one box only)

Datentyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
If major reason for screening failure is SAE, please specify SAE No.
Beschreibung

If major reason for screening failure is SAE, please specify SAE No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C2348235
If other reason for screening failure, specify
Beschreibung

If other reason for screening failure, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C2348235
Who made the decision:
Beschreibung

Who made the decision:

Datentyp

text

Alias
UMLS CUI [1]
C0679006
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 these screening forms for this patient. 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
Investigator's Signature Date
Beschreibung

Investigator's Signature Date

Datentyp

date

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

Screening - Screen Conclusion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Screening Conclusion
C1710477 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Did the patient experience any Serious Adverse Event during screening?
Item
Did the patient experience any Serious Adverse Event during screening?
boolean
C1519255 (UMLS CUI [1])
Specify total number of SAEs:
Item
Specify total number of SAEs:
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is the patient a screening failure?
Item
Is the patient a screening failure?
boolean
C1710476 (UMLS CUI [1])
Item
Major reason for screening failure.
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Major reason for screening failure.
Code List
Major reason for screening failure.
CL Item
Death (any cause)  (DEA)
CL Item
Eligibility criteria not fulfilled (inclusion and exclusion criteria). Please tick failing criteria on Eligibility form.  (ELI)
CL Item
Serious adverse event: Please complete and submit SAE report. (SAE)
CL Item
Consent withdrawal not due to a serious adverse event.  (CWS)
CL Item
Migrated / moved from the study area.  (MIG)
CL Item
Other, please specify (OTH)
If major reason for screening failure is SAE, please specify SAE No.
Item
If major reason for screening failure is SAE, please specify SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
If other reason for screening failure, specify
Item
If other reason for screening failure, specify
text
C1710476 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Who made the decision:
text
C0679006 (UMLS CUI [1])
Who made the decision:
Code List
Who made the decision:
CL Item
Investigator (I)
CL Item
Patient (S)
CL Item
Both (B)
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])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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