ID

41375

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

Keywords

Versions (1)
  1. 9/16/20 9/16/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 16, 2020

DOI

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License

Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

English

Unscheduled Visit

1 forms  
  1. StudyEvent: ODM
    1. Unscheduled Visit
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Unscheduled Visit
Description

Unscheduled Visit

Alias
UMLS CUI-1
C0545082
UMLS CUI-2
C3854240
Has the patient been seen at a time not specified in the protocol?
Description

Has the patient been seen at a time not specified in the protocol?

Data type

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
Physical Examination (Unscheduled Visit)
Description

Physical Examination (Unscheduled Visit)

Alias
UMLS CUI-1
C0031809
Has a complete physical examination been performed?
Description

Has a complete physical examination been performed?

Data type

boolean

Alias
UMLS CUI [1]
C0031809
If a complete physical examination has been performed, record result
Description

Tick all that apply. At least one box must be ticked.

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1274040
If other physical examination result, specify
Description

If other physical examination result, specify

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
Weight (Unscheduled Visit)
Description

Weight (Unscheduled Visit)

Alias
UMLS CUI-1
C0005910
Has the weight been recorded?
Description

Has the weight been recorded?

Data type

boolean

Alias
UMLS CUI [1]
C0005910
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Conclusion of unscheduled visit
Description

Conclusion of unscheduled visit

Alias
UMLS CUI-1
C0545082
UMLS CUI-2
C3854240
UMLS CUI-3
C1707478
Has the patient progressed?
Description

Yes → Please schedule the concluding visit or the first Yearly Follow-up Contact. No → Please schedule the next planned visit.

Data type

boolean

Alias
UMLS CUI [1]
C1280477
Unscheduled Tumor Assessment
Description

Unscheduled Tumor Assessment

Alias
UMLS CUI-1
C0027651
UMLS CUI-2
C0220825
UMLS CUI-3
C3854240
Has any tumor assessment been performed at a time not specified in the protocol?
Description

Has any tumor assessment been performed at a time not specified in the protocol?

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C3854240
Tumor Assessment
Description

Tumor Assessment

Alias
UMLS CUI-1
C0027651
UMLS CUI-2
C0220825
Has the tumor assessment been performed?
Description

Yes → Please specify if any of the following assessment have been performed.

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0220825
Tumor Assessment
Description

Tumor Assessment

Alias
UMLS CUI-1
C0027651
UMLS CUI-2
C0220825
Examination
Description

Examination

Data type

integer

Alias
UMLS CUI [1]
C0582103
Test Done
Description

Test Done

Data type

boolean

Alias
UMLS CUI [1]
C0039593
Test Date
Description

Test Date

Data type

date

Alias
UMLS CUI [1]
C2826247
Site evaluation for non-target lesion(s) and new lesions
Description

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
Date of evaluation
Description

Date of evaluation

Data type

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
Site evaluation for non-target lesion(s) and new lesions
Description

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
Site
Description

Site

Data type

integer

Alias
UMLS CUI [1]
C1515974
Method of evaluation
Description

Method of evaluation

Data type

integer

Alias
UMLS CUI [1]
C2911685
Other method of evaluation
Description

Other method of evaluation

Data type

text

Alias
UMLS CUI [1,1]
C2911685
UMLS CUI [1,2]
C0205394
Response of Non-target lesion
Description

Response of Non-target lesion

Data type

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1518389
UMLS CUI [2]
C0521982
New lesion since previous assessment
Description

New lesion since previous assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205314
UMLS CUI [2,1]
C0220825
UMLS CUI [2,2]
C0205156
Target lesion(s) evaluation
Description

Target lesion(s) evaluation

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C1521840
UMLS CUI-3
C0220825
Lesion No
Description

Lesion No

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0221198
Site Target Lesion
Description

Site Target Lesion

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1521840
Other Site Target Lesion
Description

Other Site Target Lesion

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C0205394
Method of Evaluation
Description

Method of Evaluation

Data type

integer

Alias
UMLS CUI [1]
C2911685
Other Method of Evaluation
Description

Other Method of Evaluation

Data type

text

Alias
UMLS CUI [1,1]
C2911685
UMLS CUI [1,2]
C0205394
Longest Diameter
Description

Longest Diameter

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1301886
UMLS CUI [1,2]
C1522425
mm
Response Assessment
Description

Response Assessment

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0220825
What is the response for target lesion?
Description

* For patients with all target lesions < 20 mm only (< 10 mm with spiral CT-scan) ** NE = Non Evaluable

Data type

integer

Alias
UMLS CUI [1]
C0521982
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1521840
What is the response for non target lesion?
Description

* For patients with all target lesions < 20 mm only (< 10 mm with spiral CT-scan) ** NE = Non Evaluable

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1518389
UMLS CUI [2]
C0521982
What is the overall response at this visit?
Description

What is the overall response at this visit?

Data type

integer

Alias
UMLS CUI [1,1]
C1561607
UMLS CUI [1,2]
C0871261
Response date:
Description

Response date:

Data type

date

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0011008
If overall response is PD, are the criteria for SPD met?
Description

If overall response is PD, are the criteria for SPD met?

Data type

boolean

Alias
UMLS CUI [1]
C3272903
UMLS CUI [2]
C0243161
If response SD, SD / PR, PD, has the patient shown a mixed response?
Description

If response SD, SD / PR, PD, has the patient shown a mixed response?

Data type

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0205430
If the patient has shown a mixed response, specify
Description

If the patient has shown a mixed response, specify

Data type

integer

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0205430
UMLS CUI [1,3]
C2348235
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has an unscheduled blood sample been taken and found abnormal (outside normal range) that is clinical significant?
Description

Has an unscheduled blood sample been taken and found abnormal (outside normal range) that is clinical significant?

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C3854240
UMLS CUI [2]
C0205161
UMLS CUI [3]
C0086715
Please complete blood sample date
Description

Please complete blood sample date

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Laboratory Tests
Description

Laboratory Tests

Data type

text

Alias
UMLS CUI [1]
C0022885
Test Result
Description

Test Result

Data type

text

Alias
UMLS CUI [1]
C0587081
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Range - Low Ref Value
Description

Range - Low Ref Value

Data type

integer

Alias
UMLS CUI [1,1]
C1514721
UMLS CUI [1,2]
C0205251
Range - High Ref Value
Description

Range - High Ref Value

Data type

integer

Alias
UMLS CUI [1,1]
C1514721
UMLS CUI [1,2]
C0205250
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Similar models

Unscheduled Visit

1 forms
  1. StudyEvent: ODM
    1. Unscheduled Visit
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Unscheduled Visit
C0545082 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Has the patient been seen at a time not specified in the protocol?
Item
Has the patient been seen at a time not specified in the protocol?
boolean
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Item Group
Physical Examination (Unscheduled Visit)
C0031809 (UMLS CUI-1)
Has a complete physical examination been performed?
Item
Has a complete physical examination been performed?
boolean
C0031809 (UMLS CUI [1])
Item
If a complete physical examination has been performed, record result
integer
C0031809 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
If a complete physical examination has been performed, record result
Code List
If a complete physical examination has been performed, record result
CL Item
Normal  (1)
CL Item
Abnormal  (2)
CL Item
Adverse event / SAE (Record in AE / SAE section.)  (3)
CL Item
Suspicion of progression (Complete the Unscheduled Tumor Assessment section.)  (4)
CL Item
No changes since previous physical examination (5)
CL Item
Other, specify (6)
If other physical examination result, specify
Item
If other physical examination result, specify
text
C0031809 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Weight (Unscheduled Visit)
C0005910 (UMLS CUI-1)
Has the weight been recorded?
Item
Has the weight been recorded?
boolean
C0005910 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Conclusion of unscheduled visit
C0545082 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C1707478 (UMLS CUI-3)
Has the patient progressed?
Item
Has the patient progressed?
boolean
C1280477 (UMLS CUI [1])
Item Group
Unscheduled Tumor Assessment
C0027651 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
Has any tumor assessment been performed at a time not specified in the protocol?
Item
Has any tumor assessment been performed at a time not specified in the protocol?
boolean
C0027651 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
Item Group
Tumor Assessment
C0027651 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Has the tumor assessment been performed?
Item
Has the tumor assessment been performed?
boolean
C0027651 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Item Group
Tumor Assessment
C0027651 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Item
Examination
integer
C0582103 (UMLS CUI [1])
Examination
Code List
Examination
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)
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
C0221198 (UMLS CUI-1)
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])
Item Group
Site evaluation for non-target lesion(s) and new lesions
C0221198 (UMLS CUI-1)
C1518389 (UMLS CUI-2)
C1515974 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0221198 (UMLS CUI-5)
C0205314 (UMLS CUI-6)
Item
Site
integer
C1515974 (UMLS CUI [1])
Site
Code List
Site
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 distal (7)
CL Item
Lung (9)
CL Item
Brain (10)
CL Item
Other (99)
Item
Method of evaluation
integer
C2911685 (UMLS CUI [1])
Method of evaluation
Code List
Method of evaluation
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])
Item
Response of Non-target lesion
text
C0221198 (UMLS CUI [1,1])
C1518389 (UMLS CUI [1,2])
C0521982 (UMLS CUI [2])
Response of Non-target lesion
Code List
Response of Non-target lesion
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])
Item Group
Target lesion(s) evaluation
C0221198 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Lesion No
Item
Lesion No
integer
C0237753 (UMLS CUI [1,1])
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])
Site Target Lesion
Code List
Site Target Lesion
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])
Item
Method of Evaluation
integer
C2911685 (UMLS CUI [1])
Method of Evaluation
Code List
Method of Evaluation
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])
Longest Diameter
Item
Longest Diameter
integer
C1301886 (UMLS CUI [1,1])
C1522425 (UMLS CUI [1,2])
Item Group
Response Assessment
C0521982 (UMLS CUI-1)
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])
What is the response for target lesion?
Code List
What is the response for target lesion?
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])
What is the response for non target lesion?
Code List
What is the response for non target lesion?
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])
What is the overall response at this visit?
Code List
What is the overall response at this visit?
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])
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])
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])
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])
If the patient has shown a mixed response, specify
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)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has an unscheduled blood sample been taken and found abnormal (outside normal range) that is clinical significant?
Item
Has an unscheduled blood sample been taken and found abnormal (outside normal range) that is clinical significant?
boolean
C1277698 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C0205161 (UMLS CUI [2])
C0086715 (UMLS CUI [3])
Please complete blood sample date
Item
Please complete blood sample date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Laboratory Tests
Item
Laboratory Tests
text
C0022885 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Range - Low Ref Value
Item
Range - Low Ref Value
integer
C1514721 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Range - High Ref Value
Item
Range - High Ref Value
integer
C1514721 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
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