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])
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])
Code List
If a complete physical examination has been performed, record result
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])
Has the weight been recorded?
Item
Has the weight been recorded?
boolean
C0005910 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Has the patient progressed?
Item
Has the patient progressed?
boolean
C1280477 (UMLS CUI [1])
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])
Has the tumor assessment been performed?
Item
Has the tumor assessment been performed?
boolean
C0027651 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Date of evaluation
Item
Date of evaluation
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Site
integer
C1515974 (UMLS CUI [1])
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)
Item
Method of evaluation
integer
C2911685 (UMLS CUI [1])
Code List
Method of evaluation
CL Item
Conventional CT-scan (4)
CL Item
Spiral CT-scan (5)
CL Item
Clinical examination (8)
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])
Code List
Response of Non-target lesion
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])
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])
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)
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])
Code List
Method of Evaluation
CL Item
Conventional CT-scan (4)
CL Item
Spiral CT-scan (5)
CL Item
Clinical examination (8)
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
What is the response for target lesion?
integer
C0521982 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
Code List
What is the response for target lesion?
Item
What is the response for non target lesion?
integer
C0221198 (UMLS CUI [1,1])
C1518389 (UMLS CUI [1,2])
C0521982 (UMLS CUI [2])
Code List
What is the response for non target lesion?
Item
What is the overall response at this visit?
integer
C1561607 (UMLS CUI [1,1])
C0871261 (UMLS CUI [1,2])
Code List
What is the overall response at this visit?
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])
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])
Please complete blood sample date
Item
Please complete blood sample date
date
C0005834 (UMLS CUI [1,1])
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])
Range - High Ref Value
Item
Range - High Ref Value
integer
C1514721 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])