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ID
41377
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
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
Study Treatment Administration; Tumor Assessment; Site evaluation for non-target lesion(s) and new lesions; Target lesion(s) evaluation; Response Assessment
Similar models
Study Treatment Administration; Tumor Assessment; Site evaluation for non-target lesion(s) and new lesions; Target lesion(s) evaluation; Response Assessment
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Study Treatment Administration (Visit 1)
C3469597 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
Has study treatment been administered?
Item
Has study treatment been administered?
boolean
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Date of administration
Item
Date of administration
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Dose delayed?
Item
Dose delayed?
boolean
C1299700 (UMLS CUI [1])
Administered Treatment Number
Item
Administered Treatment Number
integer
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
CL Item
Left (L)
CL Item
Right (R)
CL Item
I.M (IM)
CL Item
S.C (SC)
If relevant, comment on administration
Item
If relevant, comment on administration
text
C1533734 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item
If no ASCI, please tick the major reason for non administration
text
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
Code List
If no ASCI, please tick the major reason for non administration
CL Item
Serious adverse event (Please complete and submit SAE report, please specify SAE Case No.) (SAE)
CL Item
Non-Serious adverse event (Please complete Non-serious Adverse Event section, please specify AE No.) (AEX)
CL Item
Other, please specify (e.g.: consent eithdrawal, Protocol violation) (OTH)
SAE Case No. (no administration)
Item
SAE Case No. (no administration)
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
AE No. (no administration)
Item
AE No. (no administration)
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
Other reason for no administration
Item
Other reason for no administration
text
C3469597 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2826287 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Item
Please tick who made the decision if no ASCI administration
text
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0679006 (UMLS CUI [2])
C0304229 (UMLS CUI [1,2])
C0679006 (UMLS CUI [2])
Code List
Please tick who made the decision if no ASCI administration
CL Item
Investigator (I)
CL Item
Patient (S)
Item
Reason for dose delayed
text
C1299700 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Serious adverse event (Please complete and submit SAE report, please specify SAE CAse No. (SAE)
CL Item
Non-serious adverse event (Please complete Non-serious Adverse Event section, please specify AE No.) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal Protocol violation, ....) (OTH)
SAE Case No. (delay)
Item
SAE Case No. (delay)
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
AE No. (delay)
Item
AE No. (delay)
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
Other reason for dose delayed
Item
Other reason for dose delayed
text
C1299700 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Study Treatment Administration (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 27)
C3469597 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
Has study treatment been administered?
Item
Has study treatment been administered?
boolean
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Date of administration
Item
Date of administration
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Dose delayed?
Item
Dose delayed?
boolean
C1299700 (UMLS CUI [1])
Administered Treatment Number
Item
Administered Treatment Number
integer
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
CL Item
Left (L)
CL Item
Right (R)
CL Item
I.M (IM)
CL Item
S.C (SC)
If relevant, comment on administration
Item
If relevant, comment on administration
text
C1533734 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item
If no ASCI, please tick the major reason for non administration
text
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
Code List
If no ASCI, please tick the major reason for non administration
CL Item
Serious adverse event (Please complete and submit SAE report, please specify SAE Case No.) (SAE)
CL Item
Non-Serious adverse event (Please complete Non-serious Adverse Event section, please specify AE No.) (AEX)
CL Item
Other, please specify (OTH)
CL Item
Recurrence/ Progressive disease (PD)
SAE Case No. (no administration)
Item
SAE Case No. (no administration)
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
AE No. (no administration)
Item
AE No. (no administration)
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2])
Other reason for no administration
Item
Other reason for no administration
text
C3469597 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2826287 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Item
Please tick who made the decision if no ASCI administration
text
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0679006 (UMLS CUI [2])
C0304229 (UMLS CUI [1,2])
C0679006 (UMLS CUI [2])
Code List
Please tick who made the decision if no ASCI administration
CL Item
Investigator (I)
CL Item
Patient (S)
Item
Reason for dose delayed
text
C1299700 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Serious adverse event (Please complete and submit SAE report, please specify SAE CAse No. (SAE)
CL Item
Non-serious adverse event (Please complete Non-serious Adverse Event section, please specify AE No.) (AEX)
SAE Case No. (delay)
Item
SAE Case No. (delay)
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
AE No. (delay)
Item
AE No. (delay)
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1299700 (UMLS CUI [2])
Other reason for dose delayed
Item
Other reason for dose delayed
text
C1299700 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
C0006826 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
Has the tumor assessment been performed?
Item
Has the tumor assessment been performed?
boolean
C0006826 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
Item Group
Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
C0178874 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
CL Item
Clinical examination (1)
CL Item
Chest CT Scan (2)
CL Item
Complete Abdomen CT Scan (3)
CL Item
Contrast-Enhanced CT Scan of the brain (4)
CL Item
Brain MRI (5)
CL Item
Ultrasound of lymph node lesions (6)
CL Item
Ultrasound of subcutaneous lesions (7)
CL Item
Photography of superficial cutaneous lesions (with metrics notation) (8)
CL Item
Other, specify (9)
Test Done
Item
Test Done
boolean
C0039593 (UMLS CUI [1])
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Item Group
Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
C0221198 (UMLS CUI-1)
C1518389 (UMLS CUI-2)
C1515974 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0221198 (UMLS CUI-5)
C0205314 (UMLS CUI-6)
C1518389 (UMLS CUI-2)
C1515974 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0221198 (UMLS CUI-5)
C0205314 (UMLS CUI-6)
Date of evaluation
Item
Date of evaluation
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14 ,19, 21, 23 - 28, Follow-up)
C0221198 (UMLS CUI-1)
C1518389 (UMLS CUI-2)
C1515974 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0221198 (UMLS CUI-5)
C0205314 (UMLS CUI-6)
C1518389 (UMLS CUI-2)
C1515974 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0221198 (UMLS CUI-5)
C0205314 (UMLS CUI-6)
CL Item
Primary tumor/recurrence (1)
CL Item
Lymphnode regional (2)
CL Item
Lymphnode distant (3)
CL Item
Cutaneous/subcutaneous regional (4)
CL Item
Cutaneous/subcutaneous distant (5)
CL Item
Confluent skin lesions regional (6)
CL Item
Confluent skin lesions distant (7)
CL Item
Lung (9)
CL Item
Brain (10)
CL Item
Other site (99)
CL Item
Photography (1)
CL Item
X-ray (2)
CL Item
Ultrasound (3)
CL Item
Conventional CT-scan (4)
CL Item
Spiral CT-scan (5)
CL Item
MRI (6)
CL Item
Other (7)
CL Item
Clinical examination (8)
CL Item
Not done (9)
Other method of evaluation
Item
Other method of evaluation
text
C2911685 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item
Response of Non-target lesion
text
C0221198 (UMLS CUI [1,1])
C1518389 (UMLS CUI [1,2])
C0521982 (UMLS CUI [2])
C1518389 (UMLS CUI [1,2])
C0521982 (UMLS CUI [2])
CL Item
CR (CR)
CL Item
SD/PR (SP)
CL Item
PD (PD)
CL Item
NE (Non Evaluable) (NE)
CL Item
NA (Not Applicable) (NA)
New lesion since previous assessment
Item
New lesion since previous assessment
boolean
C0221198 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0220825 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0205314 (UMLS CUI [1,2])
C0220825 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Item Group
Target lesion(s) evaluation (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
C0221198 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C1521840 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Lesion No
Item
Lesion No
integer
C0237753 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
Item
Site Target Lesion
integer
C1515974 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
CL Item
Primary tumor/recurrence (1)
CL Item
Lymphnode regional (2)
CL Item
Lymphnode distant (3)
CL Item
Cutaneous/subcutaneous regional (4)
CL Item
Cutaneous/subcutaneous distant (5)
CL Item
Confluent skin lesions regional (6)
CL Item
Confluent skin lesions distant (7)
CL Item
Other site (99)
Other Site Target Lesion
Item
Other Site Target Lesion
text
C1515974 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
CL Item
Photography (1)
CL Item
X-ray (2)
CL Item
Ultrasound (3)
CL Item
Conventional CT-scan (4)
CL Item
Spiral CT-scan (5)
CL Item
MRI (6)
CL Item
Other (7)
CL Item
Clinical examination (8)
CL Item
Not done (9)
Other Method of Evaluation
Item
Other Method of Evaluation
text
C2911685 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Longest Diameter
Item
Longest Diameter
integer
C1301886 (UMLS CUI [1,1])
C1522425 (UMLS CUI [1,2])
C1522425 (UMLS CUI [1,2])
Item Group
Response Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
C0521982 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
Item
What is the response for target lesion?
integer
C0521982 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
CL Item
CR (1)
CL Item
P R (2)
CL Item
SD (3)
CL Item
SD / PR* (4)
CL Item
PD (5)
CL Item
NE** (6)
Item
What is the response for non target lesion?
integer
C0221198 (UMLS CUI [1,1])
C1518389 (UMLS CUI [1,2])
C0521982 (UMLS CUI [2])
C1518389 (UMLS CUI [1,2])
C0521982 (UMLS CUI [2])
CL Item
CR (1)
CL Item
S D / P R * (2)
CL Item
PD (3)
CL Item
NE** (4)
Item
What is the overall response at this visit?
integer
C1561607 (UMLS CUI [1,1])
C0871261 (UMLS CUI [1,2])
C0871261 (UMLS CUI [1,2])
CL Item
CR (1)
CL Item
PR (2)
CL Item
SD (3)
CL Item
SD/PR* (4)
CL Item
PD (5)
CL Item
NE** (6)
Response date:
Item
Response date:
date
C0521982 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
If overall response is PD, are the criteria for SPD met?
Item
If overall response is PD, are the criteria for SPD met?
boolean
C3272903 (UMLS CUI [1])
C0243161 (UMLS CUI [2])
C0243161 (UMLS CUI [2])
If response SD, SD / PR, PD, has the patient shown a mixed response?
Item
If response SD, SD / PR, PD, has the patient shown a mixed response?
boolean
C0521982 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,2])
Item
If the patient has shown a mixed response, specify
integer
C0521982 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205430 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Code List
If the patient has shown a mixed response, specify
CL Item
SD / PD with target lesion regression (1)
CL Item
PR / SD with new lesion (2)