ID

31276

Beschrijving

Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Trefwoorden

Versies (1)
  1. 06-08-18 06-08-18 -
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see clinicaltrials.gov

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6 augustus 2018

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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

Engels

Infusion Record - Therapy Dose - Day 7

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Site Number
Beschrijving

Site number

Datatype

text

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Administration Date
Beschrijving

Administration Date

Datatype

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Baseline HAMA date
Beschrijving

Baseline HAMA date

Datatype

date

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0011008
Baseline HAMA result
Beschrijving

Baseline HAMA result

Datatype

text

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C1291910
UMLS CUI [1,3]
C1274040
Infusion
Beschrijving

Infusion

Alias
UMLS CUI-1
C0574032
Time started (cold)
Beschrijving

Infusion; cold, start time

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0009264
UMLS CUI [1,3]
C1301880
Time started (cold flush)
Beschrijving

Infusion; cold flush, start time

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1696091
UMLS CUI [1,3]
C0009264
UMLS CUI [1,4]
C1301880
Time started (hot)
Beschrijving

Infusion; hot, start time

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2350229
UMLS CUI [1,3]
C1301880
Time started (hot flush)
Beschrijving

Infusion; hot flush, start time

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1696091
UMLS CUI [1,3]
C2350229
UMLS CUI [1,4]
C1301880
Time finished (cold)
Beschrijving

Infusion; cold, end time

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0009264
UMLS CUI [1,3]
C1522314
Time finished (cold flush)
Beschrijving

Infusion; cold flush, end time

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1696091
UMLS CUI [1,3]
C0009264
UMLS CUI [1,4]
C1522314
Time finished (hot)
Beschrijving

Infusion; hot, end time

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2350229
UMLS CUI [1,3]
C1522314
Time finished (hot flush)
Beschrijving

Infusion; hot flush, end time

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1696091
UMLS CUI [1,3]
C2350229
UMLS CUI [1,4]
C1522314
Anti-B1 dose (cold dose)
Beschrijving

Infusion; Anti-B1 dose (cold dose)

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0768182
UMLS CUI [1,3]
C0009264
UMLS CUI [1,4]
C3174092
mg
Lot number of Anti-B1
Beschrijving

Infusion; Anti-B1; Lot number (cold dose)

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0768182
UMLS CUI [1,3]
C0009264
UMLS CUI [1,4]
C1115660
Anti-B1 dose (hot dose)
Beschrijving

Infusion; Anti-B1 dose (hot dose)

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0768182
UMLS CUI [1,3]
C2350229
UMLS CUI [1,4]
C3174092
mg
Lot number of Anti-B1
Beschrijving

Infusion; Anti-B1; Lot number (hot dose)

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0768182
UMLS CUI [1,3]
C2350229
UMLS CUI [1,4]
C1115660
Iodine-131 Anti-B1 (prescribed)
Beschrijving

Infusion; Anti-B1; Iodine-131; prescribed

Datatype

float

Maateenheden
  • mCi
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0768182
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C0278329
mCi
Lot number (Nordion)
Beschrijving

Infusion; Iodine-131; Lot number

Datatype

text

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0768182
UMLS CUI [1,3]
C3854006
UMLS CUI [1,4]
C1115660
Whole body dose (prescribed)
Beschrijving

Infusion; whole body dose

Datatype

float

Maateenheden
  • cGy
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0444584
cGy
Was dose attenuated for obesity?
Beschrijving

Infusion; Dose; Attenuation for obesity

Datatype

boolean

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

Infusion rate; Adjustment

Datatype

boolean

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C2826232
If yes, was infusion rate
Beschrijving

Infusion rate; type of adjustment

Datatype

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
If infusion rate was adjusted, was it for
Beschrijving

Infusion rate; reason for adjustment

Datatype

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C2826286
Vital signs [every 15 minutes during both (cold and hot) infusions]
Beschrijving

Vital signs [every 15 minutes during both (cold and hot) infusions]

Alias
UMLS CUI-1
C0518766
Time (24 hr)
Beschrijving

Vital signs; Time

Datatype

text

Alias
UMLS CUI [1]
C2826762
BP
Beschrijving

Vital signs; Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0005823
mmHg
Pulse
Beschrijving

Vital signs; Pulse rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0232117
bpm
Temperature
Beschrijving

Vital signs; Body Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0005903
°C
Comments
Beschrijving

Vital signs; Comments

Datatype

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0947611
Adverse Experiences
Beschrijving

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Did patient experience any adverse experiences?
Beschrijving

Adverse Events

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Infusion; Patient compliance
Beschrijving

Infusion; Patient compliance

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C1321605
UMLS CUI-3
C0013227
Was patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?
Beschrijving

SSKI, Compliance behavior; Potassium Iodide, Compliance behavior; Lugol's solution, Compliance behavior

Datatype

text

Alias
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]
C1321605
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Similar models

Infusion Record - Therapy Dose - Day 7

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Site number
Item
Site Number
text
C0018704 (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])
Administration Date
Item
Administration Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Baseline HAMA date
Item
Baseline HAMA date
date
C1291910 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Baseline HAMA result
text
C1442488 (UMLS CUI [1,1])
C1291910 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Baseline HAMA result
Code List
Baseline HAMA result
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Infusion
C0574032 (UMLS CUI-1)
Infusion; cold, start time
Item
Time started (cold)
text
C0574032 (UMLS CUI [1,1])
C0009264 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Infusion; cold flush, start time
Item
Time started (cold flush)
text
C0574032 (UMLS CUI [1,1])
C1696091 (UMLS CUI [1,2])
C0009264 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
Infusion; hot, start time
Item
Time started (hot)
text
C0574032 (UMLS CUI [1,1])
C2350229 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Infusion; hot flush, start time
Item
Time started (hot flush)
text
C0574032 (UMLS CUI [1,1])
C1696091 (UMLS CUI [1,2])
C2350229 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
Infusion; cold, end time
Item
Time finished (cold)
text
C0574032 (UMLS CUI [1,1])
C0009264 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Infusion; cold flush, end time
Item
Time finished (cold flush)
text
C0574032 (UMLS CUI [1,1])
C1696091 (UMLS CUI [1,2])
C0009264 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
Infusion; hot, end time
Item
Time finished (hot)
text
C0574032 (UMLS CUI [1,1])
C2350229 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Infusion; hot flush, end time
Item
Time finished (hot flush)
text
C0574032 (UMLS CUI [1,1])
C1696091 (UMLS CUI [1,2])
C2350229 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
Infusion; Anti-B1 dose (cold dose)
Item
Anti-B1 dose (cold dose)
float
C0574032 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
C0009264 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,4])
Infusion; Anti-B1; Lot number (cold dose)
Item
Lot number of Anti-B1
text
C0574032 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
C0009264 (UMLS CUI [1,3])
C1115660 (UMLS CUI [1,4])
Infusion; Anti-B1 dose (hot dose)
Item
Anti-B1 dose (hot dose)
float
C0574032 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
C2350229 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,4])
Infusion; Anti-B1; Lot number (hot dose)
Item
Lot number of Anti-B1
text
C0574032 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
C2350229 (UMLS CUI [1,3])
C1115660 (UMLS CUI [1,4])
Infusion; Anti-B1; Iodine-131; prescribed
Item
Iodine-131 Anti-B1 (prescribed)
float
C0574032 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0278329 (UMLS CUI [1,4])
Infusion; Iodine-131; Lot number
Item
Lot number (Nordion)
text
C0574032 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,3])
C1115660 (UMLS CUI [1,4])
Infusion; whole body dose
Item
Whole body dose (prescribed)
float
C0574032 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0444584 (UMLS CUI [1,3])
Infusion; Dose; Attenuation for obesity
Item
Was dose attenuated for obesity?
boolean
C0574032 (UMLS CUI [1,1])
C1707811 (UMLS CUI [1,2])
C0028754 (UMLS CUI [1,3])
Infusion rate; Adjustment
Item
Did infusion rate need to be adjusted?
boolean
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
Item
If yes, was infusion rate
text
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
Infusion rate; type of adjustment
Code List
If yes, was infusion rate
CL Item
decreased by 1/2 (decreased by 1/2)
CL Item
discontinued (discontinued)
CL Item
other (other)
Item
If infusion rate was adjusted, was it for
text
C2964135 (UMLS CUI [1,1])
C2826286 (UMLS CUI [1,2])
Infusion rate; type of adjustment
Code List
If infusion rate was adjusted, was it for
CL Item
other (other)
CL Item
lower SBP (lower SBP)
CL Item
rigors (rigors)
CL Item
fever (fever)
CL Item
mucosal congestion/edema (mucosal congestion/edema)
Item Group
Vital signs [every 15 minutes during both (cold and hot) infusions]
C0518766 (UMLS CUI-1)
Vital signs; Time
Item
Time (24 hr)
text
C2826762 (UMLS CUI [1])
Vital signs; Blood Pressure
Item
BP
integer
C0518766 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
Vital signs; Pulse rate
Item
Pulse
integer
C0518766 (UMLS CUI [1,1])
C0232117 (UMLS CUI [1,2])
Vital signs; Body Temperature
Item
Temperature
float
C0518766 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])
Vital signs; Comments
Item
Comments
text
C0518766 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Adverse Events
Item
Did patient experience any adverse experiences?
boolean
C0877248 (UMLS CUI [1])
Item Group
Infusion; Patient compliance
C0574032 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
Item
Was patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?
text
C1564085 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0032831 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0065234 (UMLS CUI [3,1])
C1321605 (UMLS CUI [3,2])
SSKI compliance
Code List
Was patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?
CL Item
Yes (Yes)
CL Item
No (Please explain) (No (Please explain))
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