Item
Please mark the appropriate box to indicate month of report
integer
C0439231 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
Code List
Please mark the appropriate box to indicate month of report
CL Item
Other, specify (9)
If other month of report, specify
Item
If other month of report, specify
integer
C0439231 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Disease status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
CL Item
Not Applicable (disease progression previously established) (1)
CL Item
Non-evaluable (2)
CL Item
Complete Response (3)
CL Item
Partial Response (4)
CL Item
Stable Disease (5)
CL Item
Disease Progression (6)
Date of Progression
Item
Date of Progression
date
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Lesion Evaluation or Clinical Assessment
text
C0221198 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C4534461 (UMLS CUI [2])
Code List
Lesion Evaluation or Clinical Assessment
CL Item
Lesion Evaluation (1)
CL Item
Clinical Assessment (2)
Has the patient died?
Item
Has the patient died?
boolean
C0011065 (UMLS CUI [1])
If patient did not die, Date of last contact
Item
If patient did not die, Date of last contact
date
C0805839 (UMLS CUI [1])
Was the patient lost to follow-up?
Item
Was the patient lost to follow-up?
boolean
C1302313 (UMLS CUI [1])
Item
Primary Cause of Death
integer
C0007465 (UMLS CUI [1])
Code List
Primary Cause of Death
CL Item
Progressive Disease, specify details (1)
CL Item
Toxicity, specify details (2)
CL Item
Other, specify (3)
If Progressive Disease, specify details
Item
If Progressive Disease, specify details
text
C1335499 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
If Toxicity, specify details
Item
If Toxicity, specify details
text
C0040539 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
If other cause of Death, specify
Item
If other cause of Death, specify
text
C0007465 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Was an Autopsy performed?
Item
Was an Autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
If Autopsy was performed, please summarize findings
Item
If Autopsy was performed, please summarize findings
text
C0004398 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Investigator's Signauture
Item
Investigator's Signauture
text
C2346576 (UMLS CUI [1])
Date of Investigator's Signature
Item
Date of Investigator's Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of last dose of study medication
Item
Date of last dose of study medication
date
C1762893 (UMLS CUI [1])
Date of last visit
Item
Date of last visit
date
C1320303 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Disease status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
CL Item
Non-evaluable (1)
CL Item
Complete Response (2)
CL Item
Partial Response (3)
CL Item
Stable Disease (4)
CL Item
Disease Progression (5)
Date of Progression
Item
Date of Progression
date
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Lesion Evaluation or Clinical Assessment
integer
C0221198 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C4534461 (UMLS CUI [2])
Code List
Lesion Evaluation or Clinical Assessment
CL Item
Lesion Evaluation (1)
CL Item
Clinical Assessment (2)
Item
Please indicate Best Overall Response
integer
C2986560 (UMLS CUI [1])
Code List
Please indicate Best Overall Response
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
CL Item
Non-evaluable for response (5)
Item
Mark the primary cause of study conclusion
integer
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Code List
Mark the primary cause of study conclusion
CL Item
Adverse Event (complete Adverse Event Case Report Form.) (1)
CL Item
Progressive Disease (ie Lack of Efficacy) (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Death - Please complete the Death Report form (Form D). (5)
CL Item
Patient withdrawn at her own request, for reasons other that those above. (6)
CL Item
Other, specify (7)
If other cause of study conclusion, specify
Item
If other cause of study conclusion, specify
text
C0008972 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature - Date Signed
Item
Investigator's Signature - Date Signed
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])