ID
41531
Beskrivning
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
Nyckelord
Versioner (2)
- 2020-09-23 2020-09-23 -
- 2020-11-02 2020-11-02 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
2 november 2020
DOI
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Licens
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 (Report Final and Annex Report 2 Final)
Beskrivning
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beskrivning
AE No.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beskrivning
Non-Serious Adverse Event Description
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Beskrivning
Non-Serious Adverse Event site
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1515974
Beskrivning
Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0004364
- UMLS CUI [1,2]
- C0746890
- UMLS CUI [2,1]
- C0012634
- UMLS CUI [2,2]
- C4330477
Beskrivning
Non-Serious Adverse Event Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beskrivning
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Datatyp
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
Beskrivning
Non-Serious Adverse Event Date stopped
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beskrivning
(CTC AE GRADING)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Relationship to investigational products
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
Non-Serious Adverse Event Outcome:
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beskrivning
Death Form
Alias
- UMLS CUI-1
- C0011065
- UMLS CUI-2
- C1516308
Beskrivning
Did the patient die during the study?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beskrivning
Date of death
Datatyp
date
Alias
- UMLS CUI [1]
- C1148348
Beskrivning
Was an autopsy performed?
Datatyp
text
Alias
- UMLS CUI [1]
- C0004398
Beskrivning
(tick only one box)
Datatyp
text
Alias
- UMLS CUI [1]
- C0007465
Beskrivning
Specify comorbidity
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C2348235
Beskrivning
Other cause of death, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Study Conclusion - Pregnancy Information
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0032961
- UMLS CUI-4
- C1533716
Beskrivning
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beskrivning
Was the patient withdrawn from the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
(tick one box only)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Beskrivning
Specify SAE No.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beskrivning
Specify AE No.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beskrivning
Specify protocol viaolation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beskrivning
Specify other reason for withdrawal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [2]
- C2348235
Beskrivning
Who made the decision
Datatyp
text
Alias
- UMLS CUI [1]
- C0679006
Beskrivning
Date of last contact:
Datatyp
date
Alias
- UMLS CUI [1]
- C0805839
Beskrivning
No → Please give details in Adverse Events section
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beskrivning
Study Conclusion - Investigator's Siganture
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C2346576
- UMLS CUI-4
- C0011008
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator's Siganture Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Printed Investigator's name:
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Non-Serious Adverse Events; Study Conclusion (Report Final and Annex Report 2 Final)
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])
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])