ID
41385
Beschrijving
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
Trefwoorden
Versies (2)
- 23-09-20 23-09-20 -
- 02-11-20 02-11-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 september 2020
DOI
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Licentie
Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162
Non-Serious Adverse Events; Study Conclusion
- StudyEvent: ODM
Beschrijving
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beschrijving
AE No.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Non-Serious Adverse Event Description
Datatype
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Beschrijving
Non-Serious Adverse Event site
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1515974
Beschrijving
Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0004364
- UMLS CUI [1,2]
- C0746890
- UMLS CUI [2,1]
- C0012634
- UMLS CUI [2,2]
- C4330477
Beschrijving
Non-Serious Adverse Event Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beschrijving
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beschrijving
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3469597
- UMLS CUI [2,2]
- C0687676
- UMLS CUI [2,3]
- C0347984
Beschrijving
Non-Serious Adverse Event Date stopped
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschrijving
(CTC AE GRADING)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
Relationship to investigational products
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Non-Serious Adverse Event Outcome:
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschrijving
Death Form
Alias
- UMLS CUI-1
- C0011065
- UMLS CUI-2
- C1516308
Beschrijving
Did the patient die during the study?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beschrijving
Date of death
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
Was an autopsy performed?
Datatype
text
Alias
- UMLS CUI [1]
- C0004398
Beschrijving
(tick only one box)
Datatype
text
Alias
- UMLS CUI [1]
- C0007465
Beschrijving
Specify comorbidity
Datatype
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C2348235
Beschrijving
Other cause of death, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Study Conclusion - Pregnancy Information
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0032961
- UMLS CUI-4
- C1533716
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschrijving
Was the patient withdrawn from the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
(tick one box only)
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Beschrijving
Specify SAE No.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschrijving
Specify AE No.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Specify protocol viaolation
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beschrijving
Specify other reason for withdrawal
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [2]
- C2348235
Beschrijving
Who made the decision
Datatype
text
Alias
- UMLS CUI [1]
- C0679006
Beschrijving
Date of last contact:
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
Beschrijving
No → Please give details in Adverse Events section
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beschrijving
Study Conclusion - Investigator's Siganture
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C2346576
- UMLS CUI-4
- C0011008
Beschrijving
I confirm that I have reviewed the data in this Case Report Form 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.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator's Siganture Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Printed Investigator's name:
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Non-Serious Adverse Events; Study Conclusion
- StudyEvent: ODM
C2348563 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
C0746890 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C4330477 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0008972 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
C0392360 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0681850 (UMLS CUI [1,2])
C0008972 (UMLS CUI-2)
C2346576 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
C0011008 (UMLS CUI [1,2])