ID
41377
Beschreibung
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
Stichworte
Versionen (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 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
16. September 2020
DOI
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Lizenz
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
Beschreibung
Study Treatment Administration (Visit 1)
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0304229
Beschreibung
No → Please give reason and complete Study Conclusion Yes → Date of administration
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
Beschreibung
Date of administration
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Beschreibung
Dose delayed?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1299700
Beschreibung
Administered Treatment Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0237753
Beschreibung
Injection Site
Datentyp
integer
Alias
- UMLS CUI [1]
- C2700396
Beschreibung
Injection Side
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1272883
- UMLS CUI [1,2]
- C0441987
Beschreibung
Injection Route
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C1272883
Beschreibung
If relevant, comment on administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0947611
Beschreibung
If no ASCI, please tick the major reason for non administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2826287
Beschreibung
SAE Case No. (no administration)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C3469597
Beschreibung
AE No. (no administration)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C3469597
Beschreibung
Other reason for no administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C2826287
- UMLS CUI [2]
- C0205394
Beschreibung
Please tick who made the decision if no ASCI administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0679006
Beschreibung
Please tick the major reason for non administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299700
- UMLS CUI [1,2]
- C0392360
Beschreibung
SAE Case No. (delay)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C1299700
Beschreibung
AE No. (delay)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C1299700
Beschreibung
Other reason for dose delayed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299700
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
Beschreibung
Study Treatment Administration (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 27)
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0304229
Beschreibung
No → Please give reason below. Yes → Date of administration
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
Beschreibung
Date of administration
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Beschreibung
Dose delayed?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1299700
Beschreibung
Administered Treatment Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0237753
Beschreibung
Injection Site
Datentyp
integer
Alias
- UMLS CUI [1]
- C2700396
Beschreibung
Injection Side
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1272883
- UMLS CUI [1,2]
- C0441987
Beschreibung
Injection Route
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C1272883
Beschreibung
If relevant, comment on administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0947611
Beschreibung
If no ASCI, please tick the major reason for non administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2826287
Beschreibung
SAE Case No. (no administration)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C3469597
Beschreibung
AE No. (no administration)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C3469597
Beschreibung
Other reason for no administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C2826287
- UMLS CUI [2]
- C0205394
Beschreibung
Please tick who made the decision if no ASCI administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0679006
Beschreibung
Please tick the major reason for non administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299700
- UMLS CUI [1,2]
- C0392360
Beschreibung
SAE Case No. (delay)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C1299700
Beschreibung
AE No. (delay)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C1299700
Beschreibung
Other reason for dose delayed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299700
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
Beschreibung
Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
Alias
- UMLS CUI-1
- C0006826
- UMLS CUI-2
- C0220825
Beschreibung
Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
Alias
- UMLS CUI-1
- C0178874
- UMLS CUI-2
- C0220825
Beschreibung
Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0582103
Beschreibung
Test Done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039593
Beschreibung
Test Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826247
Beschreibung
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
Beschreibung
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
Beschreibung
Site
Datentyp
integer
Alias
- UMLS CUI [1]
- C1515974
Beschreibung
Method of evaluation
Datentyp
integer
Alias
- UMLS CUI [1]
- C2911685
Beschreibung
Other method of evaluation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2911685
- UMLS CUI [1,2]
- C0205394
Beschreibung
Response of Non-target lesion
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1518389
- UMLS CUI [2]
- C0521982
Beschreibung
New lesion since previous assessment
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0205314
- UMLS CUI [2,1]
- C0220825
- UMLS CUI [2,2]
- C0205156
Beschreibung
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
Beschreibung
Lesion No
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0221198
Beschreibung
Site Target Lesion
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C1521840
Beschreibung
Other Site Target Lesion
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C1521840
- UMLS CUI [1,4]
- C0205394
Beschreibung
Method of Evaluation
Datentyp
integer
Alias
- UMLS CUI [1]
- C2911685
Beschreibung
Other Method of Evaluation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2911685
- UMLS CUI [1,2]
- C0205394
Beschreibung
Longest Diameter
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C1301886
- UMLS CUI [1,2]
- C1522425
Beschreibung
Response Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C0220825
Beschreibung
* For patients with all target lesions < 20 mm only (< 10 mm with spiral CT-scan) ** NE = Non Evaluable
Datentyp
integer
Alias
- UMLS CUI [1]
- C0521982
- UMLS CUI [2,1]
- C0221198
- UMLS CUI [2,2]
- C1521840
Beschreibung
* For patients with all target lesions < 20 mm only (< 10 mm with spiral CT-scan) ** NE = Non Evaluable
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1518389
- UMLS CUI [2]
- C0521982
Beschreibung
What is the overall response at this visit?
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1561607
- UMLS CUI [1,2]
- C0871261
Beschreibung
Response date:
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0011008
Beschreibung
If overall response is PD, are the criteria for SPD met?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3272903
- UMLS CUI [2]
- C0243161
Beschreibung
If response SD, SD / PR, PD, has the patient shown a mixed response?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0205430
Beschreibung
If the patient has shown a mixed response, specify
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0205430
- UMLS CUI [1,3]
- C2348235
Ähnliche Modelle
Study Treatment Administration; Tumor Assessment; Site evaluation for non-target lesion(s) and new lesions; Target lesion(s) evaluation; Response Assessment
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])