ID

42077

Beskrivning

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Nyckelord

Versioner (1)
  1. 2021-03-23 2021-03-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 mars 2021

DOI

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Licens

Creative Commons BY 4.0
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Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758

Engelsk

Infusion Record

1 Formulär  
  1. StudyEvent: ODM
    1. Infusion Record
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Site Number
Beskrivning

Site Number

Datatyp

text

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Infusion Record - Dosimetric Dose
Beskrivning

Infusion Record - Dosimetric Dose

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C2094191
Date administered (Dosimetric Dose)
Beskrivning

Date administered (Dosimetric Dose)

Datatyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C4019308
Time Started (Dosimetric Dose) - Cold
Beskrivning

Time Started (Dosimetric Dose) - Cold

Datatyp

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2]
C4019308
UMLS CUI [3]
C0009264
Time Started (Dosimetric Dose) - Cold Flush
Beskrivning

Time Started (Dosimetric Dose) - Cold Flush

Datatyp

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2]
C4019308
UMLS CUI [3,1]
C1696091
UMLS CUI [3,2]
C0009264
Time Started (Dosimetric Dose) - Hot
Beskrivning

Time Started (Dosimetric Dose) - Hot

Datatyp

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2]
C4019308
UMLS CUI [3]
C2350229
Time Started (Dosimetric Dose) - Hot Flush
Beskrivning

Time Started (Dosimetric Dose) - Hot Flush

Datatyp

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2]
C4019308
UMLS CUI [3,1]
C1696091
UMLS CUI [3,2]
C2350229
Time Finished (Dosimetric Dose) - Cold
Beskrivning

Time Finished (Dosimetric Dose) - Cold

Datatyp

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2]
C4019308
UMLS CUI [3]
C0009264
Time Finished (Dosimetric Dose) - Cold Flush
Beskrivning

Time Finished (Dosimetric Dose) - Cold Flush

Datatyp

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2]
C4019308
UMLS CUI [3,1]
C1696091
UMLS CUI [3,2]
C0009264
Time Finished (Dosimetric Dose) - Hot
Beskrivning

Time Finished (Dosimetric Dose) - Hot

Datatyp

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2]
C4019308
UMLS CUI [3]
C2350229
Time Finished (Dosimetric Dose) - Hot Flush
Beskrivning

Time Finished (Dosimetric Dose) - Hot Flush

Datatyp

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2]
C4019308
UMLS CUI [3,1]
C1696091
UMLS CUI [3,2]
C2350229
Anti-B1 dose (cold dose)
Beskrivning

Anti-B1 dose (cold dose)

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1]
C0768182
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C0009264
mg
Lot number of Anti-B1
Beskrivning

Lot number of Anti-B1

Datatyp

text

Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C1115660
Anti-B1 dose (hot dose)
Beskrivning

Anti-B1 dose (hot dose)

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1]
C0768182
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C2350229
mg
Lot number of Anti-B1
Beskrivning

Lot number of Anti-B1

Datatyp

text

Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C1115660
Iodine-131 Anti-B1 (prescripted)
Beskrivning

Iodine-131 Anti-B1 (prescripted)

Datatyp

float

Måttenheter
  • mCi
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C0278329
mCi
Lot number (Nordion)
Beskrivning

Lot number (Nordion)

Datatyp

text

Alias
UMLS CUI [1]
C1115660
Did infusion rate need to be adjusted?
Beskrivning

Did infusion rate need to be adjusted?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C2826232
If yes, specify adjustment of infusion rate
Beskrivning

If yes, specify adjustment of infusion rate

Datatyp

integer

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C2348235
Specify other adjustment of infusion rate
Beskrivning

Specify other adjustment of infusion rate

Datatyp

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
If infusion rate was adjusted, specify reason
Beskrivning

Check all that apply

Datatyp

integer

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C3146298
UMLS CUI [1,4]
C2348235
Specify other reason for adjustment
Beskrivning

Specify other reason for adjustment

Datatyp

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C3146298
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Did the patient have any adverse experiences?
Beskrivning

If yes, please record on AE page.

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
Infusion Record - Vital Signs (Dosimetric Dose)
Beskrivning

Infusion Record - Vital Signs (Dosimetric Dose)

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C0518766
UMLS CUI-3
C2094191
Time
Beskrivning

24 hr

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Beskrivning

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Pulse
Beskrivning

Pulse

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Infusion Record - Therapeutic Dose
Beskrivning

Infusion Record - Therapeutic Dose

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C0178602
UMLS CUI-3
C0302350
Date administered (Therapeutic Dose)
Beskrivning

Date administered (Therapeutic Dose)

Datatyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0302350
Time Started (Therapeutic Dose) - Cold
Beskrivning

Time Started (Therapeutic Dose) - Cold

Datatyp

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0302350
UMLS CUI [3]
C0009264
Time Started (Therapeutic Dose) - Cold Flush
Beskrivning

Time Started (Therapeutic Dose) - Cold Flush

Datatyp

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0302350
UMLS CUI [3,1]
C1696091
UMLS CUI [3,2]
C0009264
Time Started (Therapeutic Dose) - Hot
Beskrivning

Time Started (Therapeutic Dose) - Hot

Datatyp

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0302350
UMLS CUI [3]
C2350229
Time Started (Therapeutic Dose) - Hot Flush
Beskrivning

Time Started (Therapeutic Dose) - Hot Flush

Datatyp

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0302350
UMLS CUI [3,1]
C1696091
UMLS CUI [3,2]
C2350229
Time Finished (Therapeutic Dose) - Cold
Beskrivning

Time Finished (Therapeutic Dose) - Cold

Datatyp

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0302350
UMLS CUI [3]
C0009264
Time Finished (Therapeutic Dose) - Cold Flush
Beskrivning

Time Finished (Therapeutic Dose) - Cold Flush

Datatyp

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0302350
UMLS CUI [3,1]
C1696091
UMLS CUI [3,2]
C0009264
Time Finished (Therapeutic Dose) - Hot
Beskrivning

Time Finished (Therapeutic Dose) - Hot

Datatyp

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0302350
UMLS CUI [3]
C2350229
Time Finished (Therapeutic Dose) - Hot Flush
Beskrivning

Time Finished (Therapeutic Dose) - Hot Flush

Datatyp

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0302350
UMLS CUI [3,1]
C1696091
UMLS CUI [3,2]
C2350229
Anti-B1 dose (cold dose)
Beskrivning

Anti-B1 dose (cold dose)

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1]
C0768182
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C0009264
mg
Lot number of Anti-B1
Beskrivning

Lot number of Anti-B1

Datatyp

text

Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C1115660
Anti-B1 dose (hot dose)
Beskrivning

Anti-B1 dose (hot dose)

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1]
C0768182
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C2350229
mg
Lot number of Anti-B1
Beskrivning

Lot number of Anti-B1

Datatyp

text

Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C1115660
Iodine-131 Anti-B1 (prescripted)
Beskrivning

Iodine-131 Anti-B1 (prescripted)

Datatyp

float

Måttenheter
  • mCi
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C0278329
mCi
Lot number (Nordion)
Beskrivning

Lot number (Nordion)

Datatyp

text

Alias
UMLS CUI [1]
C1115660
Whole body dose (prescribed)
Beskrivning

Whole body dose (prescribed)

Datatyp

float

Måttenheter
  • cGy
Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0278329
UMLS CUI [1,3]
C0444584
cGy
Was dose attenuated for obesity?
Beskrivning

Was dose attenuated for obesity?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1707811
UMLS CUI [1,3]
C0028754
Did infusion rate need to be adjusted?
Beskrivning

Did infusion rate need to be adjusted?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C2826232
Specify adjustment of infusion
Beskrivning

Specify adjustment of infusion

Datatyp

integer

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C2348235
Specify other adjustment of infusion
Beskrivning

Specify other adjustment of infusion

Datatyp

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
If infusion rate was adjusted, specify reason
Beskrivning

Check all that apply

Datatyp

integer

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C3146298
UMLS CUI [1,4]
C2348235
Specify other reason for adjustment
Beskrivning

Specify other reason for adjustment

Datatyp

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C3146298
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Did the patient have any adverse experiences?
Beskrivning

If yes, please record on AE page.

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
Was patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?
Beskrivning

Was patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1564085
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0032831
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0065234
If patient was not compliant, please explain
Beskrivning

If patient was not compliant, please explain

Datatyp

text

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0681841
Infusion Record - Vital Signs (Therapeutic Dose)
Beskrivning

Infusion Record - Vital Signs (Therapeutic Dose)

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C0518766
UMLS CUI-3
C0178602
UMLS CUI-4
C0302350
Time
Beskrivning

24 hr

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Beskrivning

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Pulse
Beskrivning

Pulse

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Tillbaka till toppen

Similar models

Infusion Record

1 Formulär
  1. StudyEvent: ODM
    1. Infusion Record
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Infusion Record - Dosimetric Dose
C0574032 (UMLS CUI-1)
C2094191 (UMLS CUI-2)
Date administered (Dosimetric Dose)
Item
Date administered (Dosimetric Dose)
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C4019308 (UMLS CUI [2])
Time Started (Dosimetric Dose) - Cold
Item
Time Started (Dosimetric Dose) - Cold
time
C1301880 (UMLS CUI [1])
C4019308 (UMLS CUI [2])
C0009264 (UMLS CUI [3])
Time Started (Dosimetric Dose) - Cold Flush
Item
Time Started (Dosimetric Dose) - Cold Flush
time
C1301880 (UMLS CUI [1])
C4019308 (UMLS CUI [2])
C1696091 (UMLS CUI [3,1])
C0009264 (UMLS CUI [3,2])
Time Started (Dosimetric Dose) - Hot
Item
Time Started (Dosimetric Dose) - Hot
time
C1301880 (UMLS CUI [1])
C4019308 (UMLS CUI [2])
C2350229 (UMLS CUI [3])
Time Started (Dosimetric Dose) - Hot Flush
Item
Time Started (Dosimetric Dose) - Hot Flush
time
C1301880 (UMLS CUI [1])
C4019308 (UMLS CUI [2])
C1696091 (UMLS CUI [3,1])
C2350229 (UMLS CUI [3,2])
Time Finished (Dosimetric Dose) - Cold
Item
Time Finished (Dosimetric Dose) - Cold
time
C1522314 (UMLS CUI [1])
C4019308 (UMLS CUI [2])
C0009264 (UMLS CUI [3])
Time Finished (Dosimetric Dose) - Cold Flush
Item
Time Finished (Dosimetric Dose) - Cold Flush
time
C1522314 (UMLS CUI [1])
C4019308 (UMLS CUI [2])
C1696091 (UMLS CUI [3,1])
C0009264 (UMLS CUI [3,2])
Time Finished (Dosimetric Dose) - Hot
Item
Time Finished (Dosimetric Dose) - Hot
time
C1522314 (UMLS CUI [1])
C4019308 (UMLS CUI [2])
C2350229 (UMLS CUI [3])
Time Finished (Dosimetric Dose) - Hot Flush
Item
Time Finished (Dosimetric Dose) - Hot Flush
time
C1522314 (UMLS CUI [1])
C4019308 (UMLS CUI [2])
C1696091 (UMLS CUI [3,1])
C2350229 (UMLS CUI [3,2])
Anti-B1 dose (cold dose)
Item
Anti-B1 dose (cold dose)
float
C0768182 (UMLS CUI [1])
C3174092 (UMLS CUI [2,1])
C0009264 (UMLS CUI [2,2])
Lot number of Anti-B1
Item
Lot number of Anti-B1
text
C0768182 (UMLS CUI [1,1])
C1115660 (UMLS CUI [1,2])
Anti-B1 dose (hot dose)
Item
Anti-B1 dose (hot dose)
float
C0768182 (UMLS CUI [1])
C3174092 (UMLS CUI [2,1])
C2350229 (UMLS CUI [2,2])
Lot number of Anti-B1
Item
Lot number of Anti-B1
text
C0768182 (UMLS CUI [1,1])
C1115660 (UMLS CUI [1,2])
Iodine-131 Anti-B1 (prescripted)
Item
Iodine-131 Anti-B1 (prescripted)
float
C0768182 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
Lot number (Nordion)
Item
Lot number (Nordion)
text
C1115660 (UMLS CUI [1])
Did infusion rate need to be adjusted?
Item
Did infusion rate need to be adjusted?
boolean
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
Item
If yes, specify adjustment of infusion rate
integer
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
If yes, specify adjustment of infusion rate
Code List
If yes, specify adjustment of infusion rate
CL Item
Decreased by 1/2 (1)
CL Item
Discontinued (2)
CL Item
Other (3)
Specify other adjustment of infusion rate
Item
Specify other adjustment of infusion rate
text
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
If infusion rate was adjusted, specify reason
integer
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
If infusion rate was adjusted, specify reason
Code List
If infusion rate was adjusted, specify reason
CL Item
Decreased SBP (1)
CL Item
Rigors (2)
CL Item
Fever (3)
CL Item
Mucosal congestion/Edema (4)
CL Item
Other (5)
Specify other reason for adjustment
Item
Specify other reason for adjustment
text
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Did the patient have any adverse experiences?
Item
Did the patient have any adverse experiences?
boolean
C0877248 (UMLS CUI [1])
Item Group
Infusion Record - Vital Signs (Dosimetric Dose)
C0574032 (UMLS CUI-1)
C0518766 (UMLS CUI-2)
C2094191 (UMLS CUI-3)
Time
Item
Time
time
C0040223 (UMLS CUI [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])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Infusion Record - Therapeutic Dose
C0574032 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0302350 (UMLS CUI-3)
Date administered (Therapeutic Dose)
Item
Date administered (Therapeutic Dose)
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
Time Started (Therapeutic Dose) - Cold
Item
Time Started (Therapeutic Dose) - Cold
time
C1301880 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C0009264 (UMLS CUI [3])
Time Started (Therapeutic Dose) - Cold Flush
Item
Time Started (Therapeutic Dose) - Cold Flush
time
C1301880 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C1696091 (UMLS CUI [3,1])
C0009264 (UMLS CUI [3,2])
Time Started (Therapeutic Dose) - Hot
Item
Time Started (Therapeutic Dose) - Hot
time
C1301880 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C2350229 (UMLS CUI [3])
Time Started (Therapeutic Dose) - Hot Flush
Item
Time Started (Therapeutic Dose) - Hot Flush
time
C1301880 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C1696091 (UMLS CUI [3,1])
C2350229 (UMLS CUI [3,2])
Time Finished (Therapeutic Dose) - Cold
Item
Time Finished (Therapeutic Dose) - Cold
time
C1522314 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C0009264 (UMLS CUI [3])
Time Finished (Therapeutic Dose) - Cold Flush
Item
Time Finished (Therapeutic Dose) - Cold Flush
time
C1522314 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C1696091 (UMLS CUI [3,1])
C0009264 (UMLS CUI [3,2])
Time Finished (Therapeutic Dose) - Hot
Item
Time Finished (Therapeutic Dose) - Hot
time
C1522314 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C2350229 (UMLS CUI [3])
Time Finished (Therapeutic Dose) - Hot Flush
Item
Time Finished (Therapeutic Dose) - Hot Flush
time
C1522314 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C1696091 (UMLS CUI [3,1])
C2350229 (UMLS CUI [3,2])
Anti-B1 dose (cold dose)
Item
Anti-B1 dose (cold dose)
float
C0768182 (UMLS CUI [1])
C3174092 (UMLS CUI [2,1])
C0009264 (UMLS CUI [2,2])
Lot number of Anti-B1
Item
Lot number of Anti-B1
text
C0768182 (UMLS CUI [1,1])
C1115660 (UMLS CUI [1,2])
Anti-B1 dose (hot dose)
Item
Anti-B1 dose (hot dose)
float
C0768182 (UMLS CUI [1])
C3174092 (UMLS CUI [2,1])
C2350229 (UMLS CUI [2,2])
Lot number of Anti-B1
Item
Lot number of Anti-B1
text
C0768182 (UMLS CUI [1,1])
C1115660 (UMLS CUI [1,2])
Iodine-131 Anti-B1 (prescripted)
Item
Iodine-131 Anti-B1 (prescripted)
float
C0768182 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
Lot number (Nordion)
Item
Lot number (Nordion)
text
C1115660 (UMLS CUI [1])
Whole body dose (prescribed)
Item
Whole body dose (prescribed)
float
C0678766 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0444584 (UMLS CUI [1,3])
Was dose attenuated for obesity?
Item
Was dose attenuated for obesity?
boolean
C0574032 (UMLS CUI [1,1])
C1707811 (UMLS CUI [1,2])
C0028754 (UMLS CUI [1,3])
Did infusion rate need to be adjusted?
Item
Did infusion rate need to be adjusted?
boolean
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
Item
Specify adjustment of infusion
integer
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Specify adjustment o f infusion
Code List
Specify adjustment of infusion
CL Item
Decreased by 1/2 (1)
CL Item
Discontinued (2)
CL Item
Other (3)
Specify other adjustment of infusion
Item
Specify other adjustment of infusion
text
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
If infusion rate was adjusted, specify reason
integer
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
If infusion rate was adjusted, specify reason
Code List
If infusion rate was adjusted, specify reason
CL Item
Decreased SBP  (1)
CL Item
Rigors  (2)
CL Item
Fever  (3)
CL Item
Mucosal congestion/Edema  (4)
CL Item
Other (5)
Specify other reason for adjustment
Item
Specify other reason for adjustment
text
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Did the patient have any adverse experiences?
Item
Did the patient have any adverse experiences?
boolean
C0877248 (UMLS CUI [1])
Was patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?
Item
Was patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?
boolean
C1321605 (UMLS CUI [1,1])
C1564085 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0032831 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0065234 (UMLS CUI [3,2])
If patient was not compliant, please explain
Item
If patient was not compliant, please explain
text
C1321605 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
Item Group
Infusion Record - Vital Signs (Therapeutic Dose)
C0574032 (UMLS CUI-1)
C0518766 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0302350 (UMLS CUI-4)
Time
Item
Time
time
C0040223 (UMLS CUI [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])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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