ID

31363

Beschrijving

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

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Versies (3)
  1. 09-07-18 09-07-18 -
  2. 21-07-18 21-07-18 -
  3. 18-08-18 18-08-18 -
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GlaxoSmithKline

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18 augustus 2018

DOI

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Creative Commons BY-NC 3.0
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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

Engels

Infusion Record Dosimetric Dose - Day 0 (Visit 2)

1 Formulieren  
Date administered
Beschrijving

Date administered

Alias
UMLS CUI-1
C1533734
UMLS CUI-2
C0011008
Date administered
Beschrijving

Date administered

Datatype

date

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

HAMA

Alias
UMLS CUI-1
C1291910
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
HAMA Result
Beschrijving

Result

Datatype

text

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1274040
Infusion Time started (24 hour clock)
Beschrijving

Infusion Time started (24 hour clock)

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C1301880
Start time Infusion (cold)
Beschrijving

(cold)

Datatype

time

Alias
UMLS CUI [1,1]
C1142540
UMLS CUI [1,2]
C1301880
Start time Infusion (cold flush)
Beschrijving

(cold flush)

Datatype

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0016382
UMLS CUI [1,3]
C0009264
UMLS CUI [1,4]
C1301880
Start time Infusion (hot)
Beschrijving

(hot)

Datatype

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2350229
UMLS CUI [1,3]
C1301880
Start time Infusion (hot flush)
Beschrijving

(hot flush)

Datatype

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0600142
UMLS CUI [1,3]
C1301880
Infusion Time finished (24 hour clock)
Beschrijving

Infusion Time finished (24 hour clock)

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C1522314
Infusion Time finished (cold)
Beschrijving

(cold)

Datatype

time

Alias
UMLS CUI [1,1]
C1142540
UMLS CUI [1,2]
C1522314
Infusion Time finished (cold flush)
Beschrijving

(cold flush)

Datatype

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0016382
UMLS CUI [1,3]
C0009264
UMLS CUI [1,4]
C1522314
Infusion Time finished (hot)
Beschrijving

(hot)

Datatype

time

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

(hot flush)

Datatype

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0600142
UMLS CUI [1,3]
C1522314
Doses
Beschrijving

Doses

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C0750480
Anti- B1 dose (cold dose)
Beschrijving

Anti- B1 dose (cold dose)

Datatype

float

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

Lot number of Anti- B1

Datatype

text

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

Anti- B1 (hot dose)

Datatype

float

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

Lot number of Anti- B1

Datatype

text

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

Iodine- 131 Anti- B1 (prescribed)

Datatype

float

Maateenheden
  • mCi
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C0678766
UMLS CUI [1,3]
C0278329
mCi
Lot number (Nordion)
Beschrijving

Lot number (Nordion)

Datatype

text

Alias
UMLS CUI [1]
C1115660
Whole body dose (presribed)
Beschrijving

Medication dose; Whole body; prescribed

Datatype

float

Maateenheden
  • cGy
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0444584
UMLS CUI [1,3]
C0278329
cGy
Infusion rate
Beschrijving

Infusion rate

Alias
UMLS CUI-1
C2964135
Did infusion rate need to be adjusted?
Beschrijving

Infusion Rate; Adjustment Action

Datatype

boolean

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C3146298
If infusion rate had to be adjusted, specify adjustment
Beschrijving

Adjustment; Specification

Datatype

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C2348235
If other adjustment of infusion rate, specify
Beschrijving

Other; Specification

Datatype

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, for which reason?
Beschrijving

Infusion Rate; Adjustment Action; Indication of (contextual qualifier)

Datatype

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0456081
UMLS CUI [1,3]
C3146298
UMLS CUI [1,4]
C2348235
If other reason for adjustment of infusion rate, specify
Beschrijving

Indication; Other; Specification

Datatype

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
Was dose attenuated for obesity?
Beschrijving

Obesity; Medication dose; Attenuation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0599946
Record Vital Signs [every 15 minutes during both (cold and hot) infusions]
Beschrijving

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

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

Time

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
BP (mmHg)
Beschrijving

BP

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse (bpm)
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature (C°)
Beschrijving

Temperature

Datatype

float

Maateenheden
  • C°
Alias
UMLS CUI [1]
C0039476
C°
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Adverse Experience
Beschrijving

Adverse Experience

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

Averse event

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Compliance
Beschrijving

Compliance

Alias
UMLS CUI-1
C0525058
Was the patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1564085
UMLS CUI [1,3]
C0032831
UMLS CUI [1,4]
C0065234
If not compliant, please explain
Beschrijving

Explanation

Datatype

text

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0681841
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Similar models

Infusion Record Dosimetric Dose - Day 0 (Visit 2)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Date administered
C1533734 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Date administered
Item
Date administered
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
HAMA
C1291910 (UMLS CUI-1)
Baseline HAMA date
Item
Baseline HAMA date
date
C1291910 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
HAMA Result
text
C1291910 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result
Code List
HAMA Result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Infusion Time started (24 hour clock)
C0574032 (UMLS CUI-1)
C1301880 (UMLS CUI-2)
(cold)
Item
Start time Infusion (cold)
time
C1142540 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
(cold flush)
Item
Start time Infusion (cold flush)
time
C0574032 (UMLS CUI [1,1])
C0016382 (UMLS CUI [1,2])
C0009264 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
(hot)
Item
Start time Infusion (hot)
time
C0574032 (UMLS CUI [1,1])
C2350229 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
(hot flush)
Item
Start time Infusion (hot flush)
time
C0574032 (UMLS CUI [1,1])
C0600142 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item Group
Infusion Time finished (24 hour clock)
C0574032 (UMLS CUI-1)
C1522314 (UMLS CUI-2)
(cold)
Item
Infusion Time finished (cold)
time
C1142540 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
(cold flush)
Item
Infusion Time finished (cold flush)
time
C0574032 (UMLS CUI [1,1])
C0016382 (UMLS CUI [1,2])
C0009264 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
(hot)
Item
Infusion Time finished (hot)
time
C0574032 (UMLS CUI [1,1])
C2350229 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
(hot flush)
Item
Infusion Time finished (hot flush)
time
C0574032 (UMLS CUI [1,1])
C0600142 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item Group
Doses
C0178602 (UMLS CUI-1)
C0750480 (UMLS CUI-2)
Anti- B1 dose (cold dose)
Item
Anti- B1 dose (cold dose)
float
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0009264 (UMLS CUI [1,3])
Lot number of Anti- B1
Item
Lot number of Anti- B1 (cold)
text
C0768182 (UMLS CUI [1,1])
C1115660 (UMLS CUI [1,2])
C0009264 (UMLS CUI [1,3])
Anti- B1 (hot dose)
Item
Anti- B1 (hot dose)
float
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C2350229 (UMLS CUI [1,3])
Lot number of Anti- B1
Item
Lot number of Anti- B1 (hot)
text
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
C2350229 (UMLS CUI [1,3])
Iodine- 131 Anti- B1 (prescribed)
Item
Iodine- 131 Anti- B1 (prescribed)
float
C0768182 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,3])
Lot number (Nordion)
Item
Lot number (Nordion)
text
C1115660 (UMLS CUI [1])
Medication dose; Whole body; prescribed
Item
Whole body dose (presribed)
float
C3174092 (UMLS CUI [1,1])
C0444584 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,3])
Item Group
Infusion rate
C2964135 (UMLS CUI-1)
Infusion Rate; Adjustment Action
Item
Did infusion rate need to be adjusted?
boolean
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Item
If infusion rate had to be adjusted, specify adjustment
text
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Specification
Code List
If infusion rate had to be adjusted, specify adjustment
CL Item
decreased by 1/2 (1)
CL Item
discontinued (2)
CL Item
other (3)
Other; Specification
Item
If other adjustment of infusion rate, specify
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, for which reason?
text
C2964135 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
undefined item
Code List
If infusion rate was adjusted, for which reason?
CL Item
SBP down (1)
CL Item
rigors (2)
CL Item
fever (3)
CL Item
mucosal congestion/ edema (4)
CL Item
other (5)
Indication; Other; Specification
Item
If other reason for adjustment of infusion rate, specify
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])
Obesity; Medication dose; Attenuation
Item
Was dose attenuated for obesity?
boolean
C0028754 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0599946 (UMLS CUI [1,3])
Item Group
Record Vital Signs [every 15 minutes during both (cold and hot) infusions]
C0518766 (UMLS CUI-1)
Time
Item
Vital Signs Time (24hr)
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
BP
Item
BP (mmHg)
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse (bpm)
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature (C°)
float
C0039476 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Adverse Experience
C0877248 (UMLS CUI-1)
Averse event
Item
Did the patient have any adverse experiences?
boolean
C0877248 (UMLS CUI [1])
Item Group
Compliance
C0525058 (UMLS CUI-1)
Compliance behavior; SSKI; Potassium Iodide; Lugol's solution
Item
Was the 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])
C0032831 (UMLS CUI [1,3])
C0065234 (UMLS CUI [1,4])
Explanation
Item
If not compliant, please explain
text
C1321605 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
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