ID
41385
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
Mots-clés
Versions (2)
- 23/09/2020 23/09/2020 -
- 02/11/2020 02/11/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
23 septembre 2020
DOI
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Licence
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
Description
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Description
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Description
AE No.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
Non-Serious Adverse Event Description
Type de données
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Description
Non-Serious Adverse Event site
Type de données
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1515974
Description
Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0004364
- UMLS CUI [1,2]
- C0746890
- UMLS CUI [2,1]
- C0012634
- UMLS CUI [2,2]
- C4330477
Description
Non-Serious Adverse Event Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Description
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Type de données
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Description
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Type de données
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
Description
Non-Serious Adverse Event Date stopped
Type de données
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Description
(CTC AE GRADING)
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Relationship to investigational products
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Non-Serious Adverse Event Outcome:
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Description
Death Form
Alias
- UMLS CUI-1
- C0011065
- UMLS CUI-2
- C1516308
Description
Did the patient die during the study?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
Date of death
Type de données
date
Alias
- UMLS CUI [1]
- C1148348
Description
Was an autopsy performed?
Type de données
text
Alias
- UMLS CUI [1]
- C0004398
Description
(tick only one box)
Type de données
text
Alias
- UMLS CUI [1]
- C0007465
Description
Specify comorbidity
Type de données
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C2348235
Description
Other cause of death, specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Study Conclusion - Pregnancy Information
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0032961
- UMLS CUI-4
- C1533716
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
Was the patient withdrawn from the study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
(tick one box only)
Type de données
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Description
Specify SAE No.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
Specify AE No.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
Specify protocol viaolation
Type de données
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Description
Specify other reason for withdrawal
Type de données
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [2]
- C2348235
Description
Who made the decision
Type de données
text
Alias
- UMLS CUI [1]
- C0679006
Description
Date of last contact:
Type de données
date
Alias
- UMLS CUI [1]
- C0805839
Description
No → Please give details in Adverse Events section
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Description
Study Conclusion - Investigator's Siganture
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C2346576
- UMLS CUI-4
- C0011008
Description
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.
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's Siganture Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Printed Investigator's name:
Type de données
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])