ID
41504
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 (5)
- 09-09-20 09-09-20 -
- 09-09-20 09-09-20 -
- 14-09-20 14-09-20 -
- 16-09-20 16-09-20 -
- 29-10-20 29-10-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
29 oktober 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
Study Treatment Administration; Tumor Assessment; Site evaluation for non-target lesion(s) and new lesions; Target lesion(s) evaluation; Response Assessment (Report Final and Annex Report 2 Final)
Beschrijving
Study Treatment Administration (Visit 1)
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0304229
Beschrijving
No → Please give reason and complete Study Conclusion Yes → Date of administration
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
Beschrijving
Date of administration
Datatype
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Beschrijving
Dose delayed?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1299700
Beschrijving
Administered Treatment Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0237753
Beschrijving
Injection Site
Datatype
integer
Alias
- UMLS CUI [1]
- C2700396
Beschrijving
Injection Side
Datatype
text
Alias
- UMLS CUI [1,1]
- C1272883
- UMLS CUI [1,2]
- C0441987
Beschrijving
Injection Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C1272883
Beschrijving
If relevant, comment on administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0947611
Beschrijving
If no ASCI, please tick the major reason for non administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2826287
Beschrijving
SAE Case No. (no administration)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C3469597
Beschrijving
AE No. (no administration)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C3469597
Beschrijving
Other reason for no administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C2826287
- UMLS CUI [2]
- C0205394
Beschrijving
Please tick who made the decision if no ASCI administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0679006
Beschrijving
Please tick the major reason for non administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299700
- UMLS CUI [1,2]
- C0392360
Beschrijving
SAE Case No. (delay)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C1299700
Beschrijving
AE No. (delay)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C1299700
Beschrijving
Other reason for dose delayed
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299700
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
Beschrijving
Study Treatment Administration (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 27)
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0304229
Beschrijving
No → Please give reason below. Yes → Date of administration
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
Beschrijving
Date of administration
Datatype
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Beschrijving
Dose delayed?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1299700
Beschrijving
Administered Treatment Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0237753
Beschrijving
Injection Site
Datatype
integer
Alias
- UMLS CUI [1]
- C2700396
Beschrijving
Injection Side
Datatype
text
Alias
- UMLS CUI [1,1]
- C1272883
- UMLS CUI [1,2]
- C0441987
Beschrijving
Injection Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C1272883
Beschrijving
If relevant, comment on administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0947611
Beschrijving
If no ASCI, please tick the major reason for non administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2826287
Beschrijving
SAE Case No. (no administration)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C3469597
Beschrijving
AE No. (no administration)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C3469597
Beschrijving
Other reason for no administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C2826287
- UMLS CUI [2]
- C0205394
Beschrijving
Please tick who made the decision if no ASCI administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0679006
Beschrijving
Please tick the major reason for non administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299700
- UMLS CUI [1,2]
- C0392360
Beschrijving
SAE Case No. (delay)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C1299700
Beschrijving
AE No. (delay)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C1299700
Beschrijving
Other reason for dose delayed
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299700
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
Beschrijving
Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
Alias
- UMLS CUI-1
- C0006826
- UMLS CUI-2
- C0220825
Beschrijving
Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
Alias
- UMLS CUI-1
- C0178874
- 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 (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
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 (Visit 7, 11, 14 ,19, 21, 23 - 28, Follow-up)
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 (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
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 (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
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
Similar models
Study Treatment Administration; Tumor Assessment; Site evaluation for non-target lesion(s) and new lesions; Target lesion(s) evaluation; Response Assessment (Report Final and Annex Report 2 Final)
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
C2826287 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0304229 (UMLS CUI [1,2])
C0679006 (UMLS CUI [2])
C0392360 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
C2826287 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0304229 (UMLS CUI [1,2])
C0679006 (UMLS CUI [2])
C0392360 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI [1,2])
C0220825 (UMLS CUI-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])
C0220825 (UMLS CUI-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])