ID

44907

Beschrijving

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

Trefwoorden

Versies (2)
  1. 18-05-18 18-05-18 - Halim Ugurlu
  2. 06-04-22 06-04-22 - Martin Dugas
Houder van rechten

GlaxoSmithKline (GSK)

Geüploaded op

6 april 2022

DOI

Voor een aanvraag inloggen.

Licentie

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

Engels

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

1 Formulieren  
  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
Beschrijving

Administration

Alias
UMLS CUI-1
C1320722
Site Number:
Beschrijving

Site Number

Datatype

integer

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

Patient Number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Laboratory Results Baseline
Beschrijving

Laboratory Results Baseline

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

Hematology Date

Datatype

date

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

Lab Nr.

Datatype

text

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

WBC

Datatype

float

Alias
UMLS CUI [1]
C0023508
RBC
Beschrijving

RBC

Datatype

float

Alias
UMLS CUI [1]
C0014772
Hemoglobin
Beschrijving

Hemoglobin

Datatype

float

Alias
UMLS CUI [1]
C0019046
Hematocrit
Beschrijving

Hematocrit

Datatype

float

Alias
UMLS CUI [1]
C0518014
Platelets
Beschrijving

Platelets

Datatype

float

Alias
UMLS CUI [1]
C0005821
Neutrophils
Beschrijving

Neutrophils

Datatype

float

Alias
UMLS CUI [1]
C0200633
Lymphocytes
Beschrijving

Lymphocytes

Datatype

float

Alias
UMLS CUI [1]
C0200635
Monocytes
Beschrijving

Monocytes

Datatype

float

Alias
UMLS CUI [1]
C0200637
Eosinophils
Beschrijving

Eosinophils

Datatype

float

Alias
UMLS CUI [1]
C0200638
Basophils
Beschrijving

Basophils

Datatype

float

Alias
UMLS CUI [1]
C0200641
Other Differential
Beschrijving

Other Differential

Datatype

text

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

ANC-Absolute Neutrophile Count

Datatype

float

Maateenheden
  • 10³/mm³
Alias
UMLS CUI [1]
C0948762
10³/mm³
Laboratory Tests-Blood Chemistry
Beschrijving

Laboratory Tests-Blood Chemistry

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

Chemistry Date

Datatype

date

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

Lab Nr.

Datatype

text

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

Sodium

Datatype

float

Alias
UMLS CUI [1]
C0337443
Potassium
Beschrijving

Potassium

Datatype

float

Alias
UMLS CUI [1]
C0202194
Chloride
Beschrijving

Chloride

Datatype

float

Alias
UMLS CUI [1]
C0201952
BUN
Beschrijving

BUN

Datatype

float

Alias
UMLS CUI [1]
C0005845
Creatinine
Beschrijving

Creatinine

Datatype

float

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

AST (SGOT)

Datatype

float

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

ALT (SGPT)

Datatype

float

Alias
UMLS CUI [1]
C0201836
Alkaline Phosphatase
Beschrijving

Alkaline Phosphatase

Datatype

float

Alias
UMLS CUI [1]
C0201850
LDH
Beschrijving

LDH

Datatype

float

Alias
UMLS CUI [1]
C0202113
Total Bilirubin
Beschrijving

Total Bilirubin

Datatype

float

Alias
UMLS CUI [1]
C0201913
TSH
Beschrijving

TSH

Datatype

float

Alias
UMLS CUI [1]
C0202230
Total T3
Beschrijving

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

Datatype

float

Alias
UMLS CUI [1]
C0428419
Free T4
Beschrijving

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

Datatype

float

Alias
UMLS CUI [1]
C0202225
Pregnancy Test
Beschrijving

Pregnancy Test

Alias
UMLS CUI-1
C0032976
N/A
Beschrijving

N/A

Datatype

boolean

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

Must be obtained within 7 days of study entry

Datatype

date

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

Sample

Datatype

integer

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

Result

Datatype

integer

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

Beta-2 Microglobulin (Serum)

Alias
UMLS CUI-1
C0005149
Date
Beschrijving

Date

Datatype

date

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

Result

Datatype

text

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

Infusion Record Dosimetric Dose - Day 0 and Day 7

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

Date Administered

Datatype

date

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

Baseline HAMA (human antimurine antibody)

Alias
UMLS CUI-1
C1291910
UMLS CUI-2
C1442488
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

integer

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

Dosimetric Dose

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

Time Started (cold)

Datatype

time

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

Time Finished (24 hour clock) (cold)

Datatype

time

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

Time Started (24 hour clock) (cold flush)

Datatype

time

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

Time Finished (24 hour clock) (cold flush)

Datatype

time

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

Time Started (24 hour clock) (hot)

Datatype

time

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

Time Finished (24 hour clock) (hot)

Datatype

time

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

Time Started (24 hour clock) (hot flush)

Datatype

time

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

Time Finished (24 hour clock) (hot flush)

Datatype

time

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

Anti-B1 Dose

Alias
UMLS CUI-1
C0768182
UMLS CUI-2
C3174092
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
mg
Lot number of Anti-B1 (cold)
Beschrijving

Lot number of Anti-B1 (cold)

Datatype

text

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

Anti-B1 Dose (hot dose)

Datatype

float

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

Lot number of Anti-B1 (hot)

Datatype

text

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

Iodine-131 Anti-B1 (prescribed)

Datatype

text

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

Lot Number (Nordion)

Datatype

text

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

Infusion Rate

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

Infusion rate need to be adjusted?

Datatype

boolean

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

If yes, was infusion rate

Datatype

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)
Beschrijving

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

Datatype

integer

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

Vital Signs

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

Time (24 hr)

Datatype

time

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

BP

Datatype

text

Alias
UMLS CUI [1]
C0005823
Pulse
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temp. (C)
Beschrijving

Temp

Datatype

float

Alias
UMLS CUI [1]
C0005903
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Adverse Experiences
Beschrijving

Adverse Experiences

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

If yes, please record on AE page

Datatype

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?
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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 Formulieren
  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)
Datatype
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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