Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Day 1 Visit Date
Item
Day 1 Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Course Delay (Regimen 1, Regimen 2)
C0750729 (UMLS CUI-1)
C1299700 (UMLS CUI-2)
Was course delayed?
Item
Was course delayed?
boolean
C0750729 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
Item
Reason for Delay
integer
C1298642 (UMLS CUI [1])
Code List
Reason for Delay
CL Item
Non-Haematology AE (2)
CL Item
Other, specify (3)
Specify other reason for delay
Item
Specify other reason for delay
text
C1298642 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Weight/Body Surface Area (Regimen 1, Regimen 2)
C0005910 (UMLS CUI-1)
C0005902 (UMLS CUI-2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Weight in kg or ibs
integer
C0005910 (UMLS CUI [1])
Code List
Weight in kg or ibs
Body Surface Area
Item
Body Surface Area
float
C0005902 (UMLS CUI [1])
Item Group
Topotecan Study Medication Record (Regimen 1, Regimen 2)
C0146224 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
Day (Topotecan)
Item
Day (Topotecan)
integer
C0439228 (UMLS CUI [1])
C0146224 (UMLS CUI [2])
Scheduled Daily Dose for this Infusion (Topotecan)
Item
Scheduled Daily Dose for this Infusion (Topotecan)
float
C2348070 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0574032 (UMLS CUI [2])
C0146224 (UMLS CUI [3])
Total Daily Dose for this Infusion (Topotecan)
Item
Total Daily Dose for this Infusion (Topotecan)
float
C2348070 (UMLS CUI [1])
C0574032 (UMLS CUI [2])
C0146224 (UMLS CUI [3])
Infusion Start Date (Topotecan)
Item
Infusion Start Date (Topotecan)
date
C0574032 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Infusion Start Time (Topotecan)
Item
Infusion Start Time (Topotecan)
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Infusion Stop Date (Topotecan)
Item
Infusion Stop Date (Topotecan)
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Infusion Stop Time (Topotecan)
Item
Infusion Stop Time (Topotecan)
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Item Group
Topotecan Study Medication Record (Regimen 1, Regimen 2)
C0146224 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
Was topotecan dose reduced compared to previous course?
Item
Was topotecan dose reduced compared to previous course?
boolean
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
Item
Reason for dose reduced
integer
C0146224 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Code List
Reason for dose reduced
CL Item
Non-Haematology AE (Record in the Adverse Experience section at the back of the previous module) (2)
CL Item
Other, specify (3)
Specify other reason for dose reduced
Item
Specify other reason for dose reduced
text
C0146224 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Day 5 Pre-Cisplatin Hydration Record (Regimen 1)
C0008838 (UMLS CUI-1)
C1321013 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Hydration regimen (Pre-Cisplatin)
Item
Hydration regimen (Pre-Cisplatin)
text
C1321013 (UMLS CUI [1,1])
C1276413 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Date of Infusion (Pre-Cisplatin)
Item
Date of Infusion (Pre-Cisplatin)
date
C0574032 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Time Infusion Started (Pre-Cisplatin)
Item
Time Infusion Started (Pre-Cisplatin)
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Total Administered (Pre-Cisplatin)
Item
Total Administered (Pre-Cisplatin)
float
C1533734 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Time Infusion Ended (Pre-Cisplatin)
Item
Time Infusion Ended (Pre-Cisplatin)
time
C0574032 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Item Group
Day 5 Cisplatin Study Medication Record (Regimen 1)
C0008838 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C2734539 (UMLS CUI-3)
Scheduled Dose For This Infusion (Cisplatin)
Item
Scheduled Dose For This Infusion (Cisplatin)
float
C0574032 (UMLS CUI [1])
C3174092 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0008838 (UMLS CUI [3])
Date Infusion Started (Cisplatin)
Item
Date Infusion Started (Cisplatin)
date
C3173309 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
Time Infusion Started (Cisplatin)
Item
Time Infusion Started (Cisplatin)
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
Total Administered (Cisplatin)
Item
Total Administered (Cisplatin)
float
C1521801 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
Date Infusion Ended (Cisplatin)
Item
Date Infusion Ended (Cisplatin)
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
Time Infusion Ended (Cisplatin)
Item
Time Infusion Ended (Cisplatin)
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
Item Group
Cisplatin Study Medication Record
C0008838 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
Was cisplatin dose reduced compared to previous course?
Item
Was cisplatin dose reduced compared to previous course?
boolean
C0008838 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
Item
Reason for dose reduced
integer
C0008838 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Code List
Reason for dose reduced
CL Item
Non-Haematology AE (Record in the Adverse Experience section at the back of the previous module) (2)
CL Item
Other, specify (3)
Specify other reason for dose reduced
Item
Specify other reason for dose reduced
text
C0008838 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Day 5 Post-Cisplatin Hydration Record (Regimen 1)
C0008838 (UMLS CUI-1)
C1321013 (UMLS CUI-2)
C0231290 (UMLS CUI-3)
Hydration regimen (Post-Cisplatin)
Item
Hydration regimen (Post-Cisplatin)
text
C1321013 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Date of Infusion (Post-Cisplatin)
Item
Date of Infusion (Post-Cisplatin)
date
C0574032 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Time Infusion Started (Post-Cisplatin)
Item
Time Infusion Started (Post-Cisplatin)
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Total Administered (Post-Cisplatin)
Item
Total Administered (Post-Cisplatin)
float
C1521801 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Time Infusion Ended (Post-Cisplatin)
Item
Time Infusion Ended (Post-Cisplatin)
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Item Group
Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1)
C0518766 (UMLS CUI-1)
C0008838 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date and time vital signs performed (Post-Cisplatin)
Item
Date and time vital signs performed (Post-Cisplatin)
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Temperature (Post-Cisplatin)
Item
Temperature (Post-Cisplatin)
float
C0005903 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Item
Temperature (Post-Cisplatin)
integer
C0005903 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Code List
Temperature (Post-Cisplatin)
Item
Temperature measurement site (Post-Cisplatin)
integer
C0489453 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Code List
Temperature measurement site (Post-Cisplatin)
Sitting Systolic Blood Pressure (Post-Cisplatin)
Item
Sitting Systolic Blood Pressure (Post-Cisplatin)
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Diastolic Sitting Blood Pressure (Post-Cisplatin)
Item
Diastolic Sitting Blood Pressure (Post-Cisplatin)
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Pulse (Post-Cisplatin)
Item
Pulse (Post-Cisplatin)
integer
C0232117 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Item Group
Etoposide Study Medication Record (Regimen 2)
C0015133 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C2734539 (UMLS CUI-3)
Day (Etoposide)
Item
Day (Etoposide)
integer
C0439228 (UMLS CUI [1])
C0015133 (UMLS CUI [2])
Scheduled Daily Dose for this Infusion (Etoposide)
Item
Scheduled Daily Dose for this Infusion (Etoposide)
float
C2348070 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0574032 (UMLS CUI [2])
C0015133 (UMLS CUI [3])
Total Daily Dose for this Infusion (Etoposide)
Item
Total Daily Dose for this Infusion (Etoposide)
float
C2348070 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
Infusion Start Date (Etoposide)
Item
Infusion Start Date (Etoposide)
date
C0574032 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
Infusion Start Time (Etoposide)
Item
Infusion Start Time (Etoposide)
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
Infusion Stop Date (Etoposide)
Item
Infusion Stop Date (Etoposide)
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
Infusion Stop Time (Etoposide)
Item
Infusion Stop Time (Etoposide)
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
Item Group
Etoposide Study Medication Record
C0015133 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
Was etoposide dose reduced compared to previous course?
Item
Was etoposide dose reduced compared to previous course?
boolean
C0015133 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
Item
Reason for dose reduced
integer
C0015133 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Code List
Reason for dose reduced
CL Item
Non-Haematology AE (Record in the Adverse Experience section at the back of the previous module) (2)
CL Item
Other, specify (3)
Specify other reason for dose reduced
Item
Specify other reason for dose reduced
text
C0015133 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)
C0015133 (UMLS CUI-1)
C0008838 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date and time vital signs performed (Post-Etoposide)
Item
Date and time vital signs performed (Post-Etoposide)
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Temperature (Post-Etoposide)
Item
Temperature (Post-Etoposide)
float
C0005903 (UMLS CUI [1])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Item
Temperature (Post-Etoposide)
integer
C0005903 (UMLS CUI [1])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Code List
Temperature (Post-Etoposide)
Item
Temperature site (Post-Etoposide)
integer
C0489453 (UMLS CUI [1])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Code List
Temperature site (Post-Etoposide)
Sitting Systolic Blood Pressure (Post-Etoposide)
Item
Sitting Systolic Blood Pressure (Post-Etoposide)
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Diastolic Sitting Blood Pressure (Post-Etoposide)
Item
Diastolic Sitting Blood Pressure (Post-Etoposide)
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Pulse (Post-Etoposide)
Item
Pulse (Post-Etoposide)
integer
C0232117 (UMLS CUI [1])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])