ID

44907

Description

https://clinicaltrials.gov/show/NCT00989664 Eligibility check Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Link

https://clinicaltrials.gov/show/NCT00989664

Keywords

Versions (2)
  1. 5/18/18 5/18/18 - Halim Ugurlu
  2. 4/6/22 4/6/22 - Martin Dugas
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

April 6, 2022

DOI

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License

Creative Commons BY-NC 4.0
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Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy

English

Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7

1 forms  
  1. StudyEvent: Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy
    1. Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Site Number:
Description

Site Number

Data type

integer

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

Patient Number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Laboratory Results Baseline
Description

Laboratory Results Baseline

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Hematology Date
Description

Hematology Date

Data type

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0011008
Lab # (Worksheet B)
Description

Lab Nr.

Data type

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0022877
WBC
Description

WBC

Data type

float

Alias
UMLS CUI [1]
C0023508
RBC
Description

RBC

Data type

float

Alias
UMLS CUI [1]
C0014772
Hemoglobin
Description

Hemoglobin

Data type

float

Alias
UMLS CUI [1]
C0019046
Hematocrit
Description

Hematocrit

Data type

float

Alias
UMLS CUI [1]
C0518014
Platelets
Description

Platelets

Data type

float

Alias
UMLS CUI [1]
C0005821
Neutrophils
Description

Neutrophils

Data type

float

Alias
UMLS CUI [1]
C0200633
Lymphocytes
Description

Lymphocytes

Data type

float

Alias
UMLS CUI [1]
C0200635
Monocytes
Description

Monocytes

Data type

float

Alias
UMLS CUI [1]
C0200637
Eosinophils
Description

Eosinophils

Data type

float

Alias
UMLS CUI [1]
C0200638
Basophils
Description

Basophils

Data type

float

Alias
UMLS CUI [1]
C0200641
Other Differential
Description

Other Differential

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0205394
Absolute Neutrophile Count-ANC (10³/mm³)
Description

ANC-Absolute Neutrophile Count

Data type

float

Measurement units
  • 10³/mm³
Alias
UMLS CUI [1]
C0948762
10³/mm³
Laboratory Tests-Blood Chemistry
Description

Laboratory Tests-Blood Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0005774
Chemistry Date
Description

Chemistry Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005774
Lab # (Worksheet B)
Description

Lab Nr.

Data type

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0022877
Sodium
Description

Sodium

Data type

float

Alias
UMLS CUI [1]
C0337443
Potassium
Description

Potassium

Data type

float

Alias
UMLS CUI [1]
C0202194
Chloride
Description

Chloride

Data type

float

Alias
UMLS CUI [1]
C0201952
BUN
Description

BUN

Data type

float

Alias
UMLS CUI [1]
C0005845
Creatinine
Description

Creatinine

Data type

float

Alias
UMLS CUI [1]
C0201976
AST (SGOT)
Description

AST (SGOT)

Data type

float

Alias
UMLS CUI [1]
C0201899
ALT (SGPT)
Description

ALT (SGPT)

Data type

float

Alias
UMLS CUI [1]
C0201836
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Alias
UMLS CUI [1]
C0201850
LDH
Description

LDH

Data type

float

Alias
UMLS CUI [1]
C0202113
Total Bilirubin
Description

Total Bilirubin

Data type

float

Alias
UMLS CUI [1]
C0201913
TSH
Description

TSH

Data type

float

Alias
UMLS CUI [1]
C0202230
Total T3
Description

Thyroid Tests may also be: T3U=T3 Uptake T3F=Free T3 T4T=Total T4

Data type

float

Alias
UMLS CUI [1]
C0428419
Free T4
Description

Thyroid Tests may also be: T3U=T3 Uptake T3F=Free T3 T4T=Total T4

Data type

float

Alias
UMLS CUI [1]
C0202225
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
N/A
Description

N/A

Data type

boolean

Alias
UMLS CUI [1,1]
C1272460
UMLS CUI [1,2]
C0032976
Date
Description

Must be obtained within 7 days of study entry

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032976
Sample
Description

Sample

Data type

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0032976
Result
Description

Result

Data type

integer

Alias
UMLS CUI [1]
C0427777
Beta-2 Microglobulin (Serum)
Description

Beta-2 Microglobulin (Serum)

Alias
UMLS CUI-1
C0005149
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0005149
Result
Description

Result

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0005149
Infusion Record Dosimetric Dose - Day 0 and Day 7
Description

Infusion Record Dosimetric Dose - Day 0 and Day 7

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C2094191
Date Administered
Description

Date Administered

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Baseline HAMA (human antimurine antibody)
Description

Baseline HAMA (human antimurine antibody)

Alias
UMLS CUI-1
C1291910
UMLS CUI-2
C1442488
Baseline HAMA date
Description

Baseline HAMA date

Data type

date

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0011008
Baseline HAMA Result
Description

Baseline HAMA Result

Data type

integer

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C1291910
UMLS CUI [1,3]
C1274040
Dosimetric Dose
Description

Dosimetric Dose

Alias
UMLS CUI-1
C2094191
Time Started (24 hour clock) (cold)
Description

Time Started (cold)

Data type

time

Alias
UMLS CUI [1]
C1301880
Time Finished (24 hour clock) (cold)
Description

Time Finished (24 hour clock) (cold)

Data type

time

Alias
UMLS CUI [1]
C1522314
Time Started (24 hour clock) (cold flush)
Description

Time Started (24 hour clock) (cold flush)

Data type

time

Alias
UMLS CUI [1]
C1301880
Time Finished (24 hour clock) (cold flush)
Description

Time Finished (24 hour clock) (cold flush)

Data type

time

Alias
UMLS CUI [1]
C1522314
Time Started (24 hour clock) (hot)
Description

Time Started (24 hour clock) (hot)

Data type

time

Alias
UMLS CUI [1]
C1301880
Time Finished (24 hour clock) (hot)
Description

Time Finished (24 hour clock) (hot)

Data type

time

Alias
UMLS CUI [1]
C1522314
Time Started (24 hour clock) (hot flush)
Description

Time Started (24 hour clock) (hot flush)

Data type

time

Alias
UMLS CUI [1]
C1301880
Time Finished (24 hour clock) (hot flush)
Description

Time Finished (24 hour clock) (hot flush)

Data type

time

Alias
UMLS CUI [1]
C1522314
Anti-B1 Dose
Description

Anti-B1 Dose

Alias
UMLS CUI-1
C0768182
UMLS CUI-2
C3174092
Anti-B1 Dose (cold dose)
Description

Anti-B1 Dose (cold dose)

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C3174092
mg
Lot number of Anti-B1 (cold)
Description

Lot number of Anti-B1 (cold)

Data type

text

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

Anti-B1 Dose (hot dose)

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C3174092
mg
Lot number of Anti-B1 (hot)
Description

Lot number of Anti-B1 (hot)

Data type

text

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

Iodine-131 Anti-B1 (prescribed)

Data type

text

Alias
UMLS CUI [1]
C0768182
Lot Number (Nordion)
Description

Lot Number (Nordion)

Data type

text

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C3854006
Infusion Rate
Description

Infusion Rate

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

Infusion rate need to be adjusted?

Data type

boolean

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

If yes, was infusion rate

Data type

integer

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C2826232
If the infusion rate was adjusted, was it for (check all that apply)
Description

If the infusion rate was adjusted, was it for (check all that apply)

Data type

integer

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C2826232
Vital Signs
Description

Vital Signs

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

Time (24 hr)

Data type

time

Alias
UMLS CUI [1]
C0040223
Blood Pressure (mmhg)
Description

BP

Data type

text

Alias
UMLS CUI [1]
C0005823
Pulse
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temp. (C)
Description

Temp

Data type

float

Alias
UMLS CUI [1]
C0005903
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Adverse Experiences
Description

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Did the patient have any adverse experiences? (If yes, please record on AE page)
Description

If yes, please record on AE page

Data type

boolean

Alias
UMLS CUI [1]
C0877248
(Note; only Day 7) Was patient compliant with SSKI, Lugol`s solution or Potassium iodide as described in protocol?
Description

(Note; only Day 7) Compliance with SSKI, Lugol`s solution or Potassium iodide

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0032831
UMLS CUI [1,3]
C0065234
(Note; only Day 7) If No to previous question please explain
Description

(Note; only Day 7) If No to previous question please explain

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0681841
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Similar models

Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7

1 forms
  1. StudyEvent: Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy
    1. Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number:
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Laboratory Results Baseline
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Hematology Date
Item
Hematology Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Lab Nr.
Item
Lab # (Worksheet B)
text
C1300638 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
WBC
Item
WBC
float
C0023508 (UMLS CUI [1])
RBC
Item
RBC
float
C0014772 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0200637 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Other Differential
Item
Other Differential
text
C0022885 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ANC-Absolute Neutrophile Count
Item
Absolute Neutrophile Count-ANC (10³/mm³)
float
C0948762 (UMLS CUI [1])
Item Group
Laboratory Tests-Blood Chemistry
C1254595 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
Chemistry Date
Item
Chemistry Date
date
C0011008 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
Lab Nr.
Item
Lab # (Worksheet B)
text
C1300638 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
TSH
Item
TSH
float
C0202230 (UMLS CUI [1])
Total T3
Item
Total T3
float
C0428419 (UMLS CUI [1])
Free T4
Item
Free T4
float
C0202225 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
N/A
Item
N/A
boolean
C1272460 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
Sample
integer
C0200345 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Sample
Code List
Sample
CL Item
Urine (1)
CL Item
Serum (2)
Item
Result
integer
C0427777 (UMLS CUI [1])
Result
Code List
Result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Beta-2 Microglobulin (Serum)
C0005149 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0005149 (UMLS CUI [1,3])
Result
Item
Result
text
C1274040 (UMLS CUI [1,1])
C0005149 (UMLS CUI [1,2])
Item Group
Infusion Record Dosimetric Dose - Day 0 and Day 7
C0574032 (UMLS CUI-1)
C2094191 (UMLS CUI-2)
Date Administered
Item
Date Administered
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Baseline HAMA (human antimurine antibody)
C1291910 (UMLS CUI-1)
C1442488 (UMLS CUI-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
integer
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 (1)
CL Item
Negative (2)
Item Group
Dosimetric Dose
C2094191 (UMLS CUI-1)
Time Started (cold)
Item
Time Started (24 hour clock) (cold)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (cold)
Item
Time Finished (24 hour clock) (cold)
time
C1522314 (UMLS CUI [1])
Time Started (24 hour clock) (cold flush)
Item
Time Started (24 hour clock) (cold flush)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (cold flush)
Item
Time Finished (24 hour clock) (cold flush)
time
C1522314 (UMLS CUI [1])
Time Started (24 hour clock) (hot)
Item
Time Started (24 hour clock) (hot)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (hot)
Item
Time Finished (24 hour clock) (hot)
time
C1522314 (UMLS CUI [1])
Time Started (24 hour clock) (hot flush)
Item
Time Started (24 hour clock) (hot flush)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (hot flush)
Item
Time Finished (24 hour clock) (hot flush)
time
C1522314 (UMLS CUI [1])
Item Group
Anti-B1 Dose
C0768182 (UMLS CUI-1)
C3174092 (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])
Lot number of Anti-B1 (cold)
Item
Lot number of Anti-B1 (cold)
text
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
Anti-B1 Dose (hot dose)
Item
Anti-B1 Dose (hot dose)
float
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Lot number of Anti-B1 (hot)
Item
Lot number of Anti-B1 (hot)
text
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
Iodine-131 Anti-B1 (prescribed)
Item
Iodine-131 Anti-B1 (prescribed)
text
C0768182 (UMLS CUI [1])
Lot Number (Nordion)
Item
Lot Number (Nordion)
text
C1115660 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Item Group
Infusion Rate
C2964135 (UMLS CUI-1)
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, was infusion rate
integer
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
If yes, was infusion rate
Code List
If yes, was infusion rate
CL Item
Decreased by 1/2 (1)
CL Item
discontinued (2)
CL Item
other (3)
Item
If the infusion rate was adjusted, was it for (check all that apply)
integer
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
If the infusion rate was adjusted, was it for (check all that apply)
Code List
If the infusion rate was adjusted, was it for (check all that apply)
CL Item
low SBP (1)
CL Item
rigors (2)
CL Item
fever (3)
CL Item
mucosal congestion/edema (4)
CL Item
other (5)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Time (24 hr)
Item
Time (24 hr)
time
C0040223 (UMLS CUI [1])
BP
Item
Blood Pressure (mmhg)
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temp
Item
Temp. (C)
float
C0005903 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Did the patient have any adverse experiences?
Item
Did the patient have any adverse experiences? (If yes, please record on AE page)
boolean
C0877248 (UMLS CUI [1])
(Note; only Day 7) Compliance with SSKI, Lugol`s solution or Potassium iodide
Item
(Note; only Day 7) Was patient compliant with SSKI, Lugol`s solution or Potassium iodide as described in protocol?
boolean
C1321605 (UMLS CUI [1,1])
C0032831 (UMLS CUI [1,2])
C0065234 (UMLS CUI [1,3])
(Note; only Day 7) If No to previous question please explain
Item
(Note; only Day 7) If No to previous question please explain
text
C0947611 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
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