Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1709561 (UMLS CUI [1])
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit not done
integer
C0545082 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
CL Item
Visit Not Done (1)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature Unit
integer
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Temperature Unit
Hematology - Sample Date
Item
Hematology - Sample Date
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haematology - Laboratory Name
Item
Haematology - Laboratory Name
text
C3258037 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Item
Hematology Test
integer
C0018941 (UMLS CUI [1])
Code List
Hematology Test
CL Item
Granulocytes (12)
Item
Hematology - No Result
integer
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Hematology - No Result
Hematology - Value
Item
Hematology - Value
text
C0474523 (UMLS CUI [1])
Item
Hematology - Value out of range and NOT clinically significant
integer
C0474523 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Code List
Hematology - Value out of range and NOT clinically significant
CL Item
Value out of range and NOT clinically significant (2)
Item
Hematology - Value out of range and clinically significant
integer
C0474523 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Code List
Hematology - Value out of range and clinically significant
CL Item
Value out of range and clinically significant (3)
Were the study medications administered at Day 15?
Item
Were the study medications administered at Day 15?
boolean
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
If study medication was not administered at Day 15, mark reason(s) why
integer
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [2])
Code List
If study medication was not administered at Day 15, mark reason(s) why
CL Item
Non-Hematology (2)
CL Item
Other, specify (3)
If other reason for medication not administered, specify
Item
If other reason for medication not administered, specify
text
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Was the topotecan dose reduced?
Item
Was the topotecan dose reduced?
boolean
C0146224 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Item
If topotecan dose was reduced, mark reason(s) dose was reduced
integer
C0146224 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Code List
If topotecan dose was reduced, mark reason(s) dose was reduced
CL Item
Non-Hematology, specify (2)
If other reason topotecan dose was reduced, specify
Item
If other reason topotecan dose was reduced, specify
text
C0146224 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Topotecan Dose Modification
integer
C1707811 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
Code List
Topotecan Dose Modification
CL Item
25% reduction (3)
CL Item
50% reduction (4)
CL Item
Other, specify (5)
CL Item
Re-escalation (1)
If other topotecan dose reduction, specify
Item
If other topotecan dose reduction, specify
integer
C1707814 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Topotecan scheduled dose
Item
Topotecan scheduled dose
float
C0146224 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Total mg to be given (Topotecan)
Item
Total mg to be given (Topotecan)
float
C0178602 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Date Administered (Topotecan)
Item
Date Administered (Topotecan)
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Start Time (Topotecan)
Item
Start Time (Topotecan)
time
C1301880 (UMLS CUI [1])
C0146224 (UMLS CUI [2])
Stop Time (Topotecan)
Item
Stop Time (Topotecan)
time
C1522314 (UMLS CUI [1])
C0146224 (UMLS CUI [2])
Was complete dose given? (Topotecan)
Item
Was complete dose given? (Topotecan)
boolean
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
If complete dose Topotecan was not given, provide actual mg given:
Item
If complete dose Topotecan was not given, provide actual mg given:
float
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Was the gemcitabine dose reduced?
Item
Was the gemcitabine dose reduced?
boolean
C0045093 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Item
If gemcitabine dose was reduced, mark reason(s) dose was reduced
integer
C0045093 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Code List
If gemcitabine dose was reduced, mark reason(s) dose was reduced
CL Item
Non-Hematology, specify (2)
If other reason gemcitabine dose was reduced, specify
Item
If other reason gemcitabine dose was reduced, specify
text
C0045093 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Gemcitabine Dose Modification
integer
C1707811 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
Code List
Gemcitabine Dose Modification
CL Item
25% reduction (3)
CL Item
50% reduction (4)
CL Item
Other, specify (5)
CL Item
Re-escalation (1)
If other gemcitabine dose reduction, specify
Item
If other gemcitabine dose reduction, specify
integer
C1707814 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Gemcitabine scheduled dose
Item
Gemcitabine scheduled dose
float
C0045093 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Total mg to be given (Gemicitabine)
Item
Total mg to be given (Gemicitabine)
float
C0178602 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
Date Administered (Gemicitabine)
Item
Date Administered (Gemicitabine)
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
Start Time (Gemicitabine)
Item
Start Time (Gemicitabine)
time
C1301880 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
Stop Time (Gemicitabine)
Item
Stop Time (Gemicitabine)
time
C1522314 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
Was complete dose given? (Gemicitabine)
Item
Was complete dose given? (Gemicitabine)
boolean
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
If complete dose Gemcitabine was not given, provide actual mg given:
Item
If complete dose Gemcitabine was not given, provide actual mg given:
float
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])