Informações:
Falhas:
ID
41375
Descrição
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
Palavras-chave
Versões (1)
- 16/09/2020 16/09/2020 -
Titular dos direitos
GlaxoSmithKline
Transferido a
16 de setembro de 2020
DOI
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Licença
Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162
Similar models
Unscheduled Visit
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
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])
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])
C1274040 (UMLS CUI [1,2])
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])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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)
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)
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])
C0220825 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
Has the tumor assessment been performed?
Item
Has the tumor assessment been performed?
boolean
C0027651 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
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)
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)
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
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 distal (7)
CL Item
Lung (9)
CL Item
Brain (10)
CL Item
Other (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
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
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)
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])
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])
C0011008 (UMLS CUI [1,2])
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])
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])
C0205250 (UMLS CUI [1,2])