ID

41365

Description

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

Keywords

Versions (2)
  1. 9/13/20 9/13/20 -
  2. 10/30/20 10/30/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 13, 2020

DOI

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License

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

English

Treatment Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Treatment Conclusion
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study treatment phase?
Description

Did the subject become pregnant during the study treatment phase?

Data type

integer

Alias
UMLS CUI [1]
C3828490
Was the patient withdrawn from investigational product or did the patient not attend concluding visit?
Description

Was the patient withdrawn from investigational product or did the patient not attend concluding visit?

Alias
UMLS CUI-1
C0422727
UMLS CUI-2
C1707478
UMLS CUI-3
C0545082
Was the patient withdrawn from investigational product or did the patient not attend concluding visit?
Description

No → Patient has completed Treatment Phase (including Concluding Visit). Please schedule a follow-up visit at Month 60 Yes → Enter reason Patient has been withdrawn from investigational product or did not attend Concluding Visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1707478
UMLS CUI [1,3]
C0545082
Patient has been withdrawn from investigational attend Concluding Visit due to:
Description

Patient has been withdrawn from investigational attend Concluding Visit due to:

Data type

text

Alias
UMLS CUI [1]
C0422727
UMLS CUI [2,1]
C1707478
UMLS CUI [2,2]
C0545082
UMLS CUI [3]
C0392360
SAE No.
Description

SAE No.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE No.
Description

AE No.

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Specify protocol violation
Description

Specify protocol violation

Data type

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
Other reason Patient has been withdrawn from investigational attend Concluding Visit
Description

Other reason Patient has been withdrawn from investigational attend Concluding Visit

Data type

text

Alias
UMLS CUI [1]
C0422727
UMLS CUI [2,1]
C1707478
UMLS CUI [2,2]
C0545082
UMLS CUI [3]
C3840932
Who made the decision:
Description

(tick only one)

Data type

text

Alias
UMLS CUI [1]
C0679006
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Similar models

Treatment Conclusion

1 forms
  1. StudyEvent: ODM
    1. Treatment Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study treatment phase?
integer
C3828490 (UMLS CUI [1])
Did the subject become pregnant during the study treatment phase?
Code List
Did the subject become pregnant during the study treatment phase?
CL Item
No (1)
CL Item
Yes (Complete the Pregnancy Notification form) (2)
CL Item
Not Apllicable (not of childbearing potential or male) (3)
Item Group
Was the patient withdrawn from investigational product or did the patient not attend concluding visit?
C0422727 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
C0545082 (UMLS CUI-3)
Was the patient withdrawn from investigational product or did the patient not attend concluding visit?
Item
Was the patient withdrawn from investigational product or did the patient not attend concluding visit?
boolean
C0422727 (UMLS CUI [1,1])
C1707478 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item
Patient has been withdrawn from investigational attend Concluding Visit due to:
text
C0422727 (UMLS CUI [1])
C1707478 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C0392360 (UMLS CUI [3])
Patient has been withdrawn from investigational attend Concluding Visit due to:
Code List
Patient has been withdrawn from investigational attend Concluding Visit due to:
CL Item
Death (any cause) → Please complete Death Form section.  (DEA)
CL Item
Serious adverse event: → Please complete and submit SAE report. Please specify SAE No. (SAE)
CL Item
Non-Serious adverse event: → Please complete Non-serious Adverse Event section. Please specify AE No. (AEX)
CL Item
Recurrence / Progressive disease → Please schedule a Yearly follow-up contact.  (PD)
CL Item
Symptomatic deterioration without evidence of progressive disease  (SYM)
CL Item
Consent withdrawal, not due to an adverse event  (CWL)
CL Item
Protocol violation → please specify (PTV)
CL Item
Migrated / moved from the study area  (MIG)
CL Item
Lost to follow-up  (LFU)
CL Item
Other → please specify (OTH)
SAE No.
Item
SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE No.
Item
AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify protocol violation
Item
Specify protocol violation
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other reason Patient has been withdrawn from investigational attend Concluding Visit
Item
Other reason Patient has been withdrawn from investigational attend Concluding Visit
text
C0422727 (UMLS CUI [1])
C1707478 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C3840932 (UMLS CUI [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)
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