ID
41375
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 (1)
- 16-09-20 16-09-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 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
Unscheduled Visit
- StudyEvent: ODM
Beschrijving
Unscheduled Visit
Alias
- UMLS CUI-1
- C0545082
- UMLS CUI-2
- C3854240
Beschrijving
Physical Examination (Unscheduled Visit)
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Has a complete physical examination been performed?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Tick all that apply. At least one box must be ticked.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1274040
Beschrijving
If other physical examination result, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Beschrijving
Weight (Unscheduled Visit)
Alias
- UMLS CUI-1
- C0005910
Beschrijving
Conclusion of unscheduled visit
Alias
- UMLS CUI-1
- C0545082
- UMLS CUI-2
- C3854240
- UMLS CUI-3
- C1707478
Beschrijving
Unscheduled Tumor Assessment
Alias
- UMLS CUI-1
- C0027651
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C3854240
Beschrijving
Tumor Assessment
Alias
- UMLS CUI-1
- C0027651
- UMLS CUI-2
- C0220825
Beschrijving
Tumor Assessment
Alias
- UMLS CUI-1
- C0027651
- UMLS CUI-2
- C0220825
Beschrijving
Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0582103
Beschrijving
Test Done
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039593
Beschrijving
Test Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826247
Beschrijving
Site evaluation for non-target lesion(s) and new lesions
Alias
- UMLS CUI-1
- C0221198
- UMLS CUI-2
- C1518389
- UMLS CUI-3
- C1515974
- UMLS CUI-4
- C0220825
- UMLS CUI-5
- C0221198
- UMLS CUI-6
- C0205314
Beschrijving
Site evaluation for non-target lesion(s) and new lesions
Alias
- UMLS CUI-1
- C0221198
- UMLS CUI-2
- C1518389
- UMLS CUI-3
- C1515974
- UMLS CUI-4
- C0220825
- UMLS CUI-5
- C0221198
- UMLS CUI-6
- C0205314
Beschrijving
Site
Datatype
integer
Alias
- UMLS CUI [1]
- C1515974
Beschrijving
Method of evaluation
Datatype
integer
Alias
- UMLS CUI [1]
- C2911685
Beschrijving
Other method of evaluation
Datatype
text
Alias
- UMLS CUI [1,1]
- C2911685
- UMLS CUI [1,2]
- C0205394
Beschrijving
Response of Non-target lesion
Datatype
text
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1518389
- UMLS CUI [2]
- C0521982
Beschrijving
New lesion since previous assessment
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0205314
- UMLS CUI [2,1]
- C0220825
- UMLS CUI [2,2]
- C0205156
Beschrijving
Target lesion(s) evaluation
Alias
- UMLS CUI-1
- C0221198
- UMLS CUI-2
- C1521840
- UMLS CUI-3
- C0220825
Beschrijving
Lesion No
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0221198
Beschrijving
Site Target Lesion
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C1521840
Beschrijving
Other Site Target Lesion
Datatype
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C1521840
- UMLS CUI [1,4]
- C0205394
Beschrijving
Method of Evaluation
Datatype
integer
Alias
- UMLS CUI [1]
- C2911685
Beschrijving
Other Method of Evaluation
Datatype
text
Alias
- UMLS CUI [1,1]
- C2911685
- UMLS CUI [1,2]
- C0205394
Beschrijving
Longest Diameter
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C1301886
- UMLS CUI [1,2]
- C1522425
Beschrijving
Response Assessment
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C0220825
Beschrijving
* For patients with all target lesions < 20 mm only (< 10 mm with spiral CT-scan) ** NE = Non Evaluable
Datatype
integer
Alias
- UMLS CUI [1]
- C0521982
- UMLS CUI [2,1]
- C0221198
- UMLS CUI [2,2]
- C1521840
Beschrijving
* For patients with all target lesions < 20 mm only (< 10 mm with spiral CT-scan) ** NE = Non Evaluable
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1518389
- UMLS CUI [2]
- C0521982
Beschrijving
What is the overall response at this visit?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1561607
- UMLS CUI [1,2]
- C0871261
Beschrijving
Response date:
Datatype
date
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0011008
Beschrijving
If overall response is PD, are the criteria for SPD met?
Datatype
boolean
Alias
- UMLS CUI [1]
- C3272903
- UMLS CUI [2]
- C0243161
Beschrijving
If response SD, SD / PR, PD, has the patient shown a mixed response?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0205430
Beschrijving
If the patient has shown a mixed response, specify
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0205430
- UMLS CUI [1,3]
- C2348235
Beschrijving
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Has an unscheduled blood sample been taken and found abnormal (outside normal range) that is clinical significant?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C3854240
- UMLS CUI [2]
- C0205161
- UMLS CUI [3]
- C0086715
Beschrijving
Please complete blood sample date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Laboratory Tests
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Test Result
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Range - Low Ref Value
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1514721
- UMLS CUI [1,2]
- C0205251
Beschrijving
Range - High Ref Value
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1514721
- UMLS CUI [1,2]
- C0205250
Similar models
Unscheduled Visit
- StudyEvent: ODM
C0681850 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3854240 (UMLS CUI-2)
C1707478 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
C0220825 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C1518389 (UMLS CUI-2)
C1515974 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0221198 (UMLS CUI-5)
C0205314 (UMLS CUI-6)
C0011008 (UMLS CUI [1,2])
C1518389 (UMLS CUI-2)
C1515974 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0221198 (UMLS CUI-5)
C0205314 (UMLS CUI-6)
C0205394 (UMLS CUI [1,2])
C1518389 (UMLS CUI [1,2])
C0521982 (UMLS CUI [2])
C0205314 (UMLS CUI [1,2])
C0220825 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1521840 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C1522425 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C1518389 (UMLS CUI [1,2])
C0521982 (UMLS CUI [2])
C0871261 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2])
C0205430 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C3854240 (UMLS CUI [1,2])
C0205161 (UMLS CUI [2])
C0086715 (UMLS CUI [3])
C0011008 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,2])