Has study treatment been administered?
Item
Has study treatment been administered?
boolean
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Date of administration
Item
Date of administration
date
C1533734 (UMLS CUI [1,1])
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])
Item
Injection Site
integer
C2700396 (UMLS CUI [1])
Item
Injection Side
text
C1272883 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Item
Injection Route
text
C0013153 (UMLS CUI [1,1])
C1272883 (UMLS CUI [1,2])
Code List
Injection Route
If relevant, comment on administration
Item
If relevant, comment on administration
text
C1533734 (UMLS CUI [1,1])
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])
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])
AE No. (no administration)
Item
AE No. (no administration)
integer
C1518404 (UMLS CUI [1,1])
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])
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])
Code List
Please tick who made the decision if no ASCI administration
Item
Reason for dose delayed
text
C1299700 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason for dose delayed
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])
AE No. (delay)
Item
AE No. (delay)
integer
C1518404 (UMLS CUI [1,1])
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])
Has study treatment been administered?
Item
Has study treatment been administered?
boolean
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Date of administration
Item
Date of administration
date
C1533734 (UMLS CUI [1,1])
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])
Item
Injection Site
integer
C2700396 (UMLS CUI [1])
Item
Injection Side
text
C1272883 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Item
Injection Route
text
C0013153 (UMLS CUI [1,1])
C1272883 (UMLS CUI [1,2])
Code List
Injection Route
If relevant, comment on administration
Item
If relevant, comment on administration
text
C1533734 (UMLS CUI [1,1])
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])
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])
AE No. (no administration)
Item
AE No. (no administration)
integer
C1518404 (UMLS CUI [1,1])
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])
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])
Code List
Please tick who made the decision if no ASCI administration
Item
Reason for dose delayed
text
C1299700 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason for dose delayed
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])
AE No. (delay)
Item
AE No. (delay)
integer
C1518404 (UMLS CUI [1,1])
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])
Has the tumor assessment been performed?
Item
Has the tumor assessment been performed?
boolean
C0006826 (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 distant (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)