Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Identification Numbers
C1300638 (UMLS CUI-1)
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Topotecan and Ara-C Study Medication Record
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0146224 (UMLS CUI-3)
C0733521 (UMLS CUI-4)
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
Body Surface Area
Item
Body Surface Area
float
C0005902 (UMLS CUI [1])
Ideal Weight
Item
Ideal Weight
text
C0421272 (UMLS CUI [1])
Ideal Weight Was Used
Item
Ideal Weight Was Used
boolean
C0421272 (UMLS CUI [1])
Item Group
Topotecan Administration
C3469597 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Totally Daily Dose for this Infusion
Item
Totally Daily Dose for this Infusion
float
C2348070 (UMLS CUI [1])
Infusion start date
Item
Infusion start date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start time
Item
Infusion Start time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop date
Item
Infusion Stop date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop time
Item
Infusion Stop time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Ara-C Administration
C0733521 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Totally Daily Dose for this Infusion
Item
Totally Daily Dose for this Infusion
float
C2348070 (UMLS CUI [1])
Infusion start date
Item
Infusion start date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start time
Item
Infusion Start time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop date
Item
Infusion Stop date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop time
Item
Infusion Stop time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Idarubicin and Ara-C Study Medication Record
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0020789 (UMLS CUI-3)
C0020789 (UMLS CUI-4)
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
Body Surface Area
Item
Body Surface Area
float
C0005902 (UMLS CUI [1])
Ideal Weight
Item
Ideal Weight
text
C0421272 (UMLS CUI [1])
Ideal Weight Was Used
Item
Ideal Weight Was Used
boolean
C0421272 (UMLS CUI [1])
Item Group
Idarubicin Administration
C0013153 (UMLS CUI-1)
C0020789 (UMLS CUI-2)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Totally Daily Dose for this Infusion
Item
Totally Daily Dose for this Infusion
float
C2348070 (UMLS CUI [1])
Infusion start date
Item
Infusion start date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start time
Item
Infusion Start time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop date
Item
Infusion Stop date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop time
Item
Infusion Stop time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Ara-C Administration
C0733521 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Totally Daily Dose for this Infusion
Item
Totally Daily Dose for this Infusion
float
C2348070 (UMLS CUI [1])
Infusion start date
Item
Infusion start date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start time
Item
Infusion Start time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop date
Item
Infusion Stop date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop time
Item
Infusion Stop time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Dose Reduction
C0178602 (UMLS CUI-1)
C0547047 (UMLS CUI-2)
Dose Reduction
Item
Was the dose reduced compared to previous course?
boolean
C0178602 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Item
If Yes to Dose Reduction, reason, (if applicable, mark more than one box below)
text
C0178602 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Code List
If Yes to Dose Reduction, reason, (if applicable, mark more than one box below)
CL Item
Grade 3 or 4 non-hematologic toxicity ->Record in the Adverse Experience section (2)
CL Item
Consolidation (3)
CL Item
Other, specify:...................... (4)
Item Group
Retreatment Interval
C0376495 (UMLS CUI-1)
C1272706 (UMLS CUI-2)
Retreatment Interval
Item
Was the patient treated at 4 week (28 day) interval?
boolean
C0376495 (UMLS CUI [1,1])
C1272706 (UMLS CUI [1,2])
Item
If 'No' please indicate the retreatment interval below
text
C0376495 (UMLS CUI [1,1])
C1272706 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
Code List
If 'No' please indicate the retreatment interval below
CL Item
29-35 days (4-5 week interval) (1)
CL Item
36-42 days (5-6 week interval) (2)
CL Item
Other (> 42 Days or > 6 weeks), specify:............................... Specify reason=.............................. (3)
Approved by
Item
Approved by
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of Approve
Item
Date of Approve
date
C0011008 (UMLS CUI [1])
Item Group
G-CSF Study Medication Record
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0079459 (UMLS CUI-3)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1,1])
C0079459 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0079459 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item Group
Vital Signs-TAG Regiment only
C0518766 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
C0733521 (UMLS CUI-3)
C0079459 (UMLS CUI-4)
C0013227 (UMLS CUI-5)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
text
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1,1])
C0237400 (UMLS CUI [1,2])
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
Item
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
Item
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Pulse After 5 Minutes Sitting
Item
Pulse After 5 Minutes Sitting
integer
C0232117 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Vital Signs-IDAG Regiment only-Vital signs are to be performed on Days 1, 2, and 3 prior to idarubicin infusion and post ara-C infusion. On Days 4 and 5, vital signs are to be performed prior and post ara-C infusion
C0518766 (UMLS CUI-1)
C0020789 (UMLS CUI-2)
C0733521 (UMLS CUI-3)
C0079459 (UMLS CUI-4)
C0013227 (UMLS CUI-5)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
text
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1,1])
C0237400 (UMLS CUI [1,2])
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
Item
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
Item
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Pulse After 5 Minutes Sitting
Item
Pulse After 5 Minutes Sitting
integer
C0232117 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])