ID

31366

Description

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

Keywords

Versions (4)
  1. 7/9/18 7/9/18 -
  2. 7/21/18 7/21/18 -
  3. 8/18/18 8/18/18 -
  4. 2/18/22 2/18/22 - Martin Dugas
Copyright Holder

GlaxoSmithKline

Uploaded on

August 18, 2018

DOI

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License

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

English

Physical Examination, Laboratory Results Hematology/ Chemistry Week 7 (Visit 6)

1 forms  
Date of physical examination
Description

Date of physical examination

Alias
UMLS CUI-1
C2826643
Date of physical examination
Description

Physical Examination Date

Data type

date

Alias
UMLS CUI [1]
C2826643
B- Symptoms
Description

B- Symptoms

Alias
UMLS CUI-1
C1706867
Does the patient currently have evidence of "B" symptoms?
Description

B-Symptoms

Data type

boolean

Alias
UMLS CUI [1]
C1706867
If yes, please check current "B" symptoms
Description

B-Symptoms

Data type

text

Alias
UMLS CUI [1,1]
C1706867
UMLS CUI [1,2]
C0521116
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Height (cm)
Description

Body Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight (kg)
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005890
kg
Karnofsky Status (%)
Description

Karnofsky Performance Status

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0206065
%
Respirations (breaths/min)
Description

Respiration

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0035203
breaths/min
Blood Pressure (mmHg)
Description

Blood Pressure

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse (bpm)
Description

Pulse Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature (°C)
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Organ/ System
Description

Organ/ System

Alias
UMLS CUI-1
C0678852
Organ/ System
Description

Organ/ System

Data type

text

Alias
UMLS CUI [1]
C0678852
Finding
Description

Finding

Data type

text

Alias
UMLS CUI [1]
C0243095
If abnormal finding, please specify
Description

If abnormal, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2348235
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
hematology Date
Description

hematology Date

Data type

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0011008
Laboratory Number Hematology
Description

Worksheet B

Data type

text

Alias
UMLS CUI [1,1]
C2986056
UMLS CUI [1,2]
C0474523
WBC
Description

WBC

Data type

text

Alias
UMLS CUI [1]
C0023508
RBC
Description

RBC

Data type

text

Alias
UMLS CUI [1]
C0014772
Hemoglobin
Description

Hemoglobin

Data type

text

Alias
UMLS CUI [1]
C0019046
Hematocrit
Description

Hematocrit

Data type

text

Alias
UMLS CUI [1]
C0518014
Platelets
Description

Platelets

Data type

text

Alias
UMLS CUI [1]
C0005821
Neutrophils (segs + bands)
Description

Neutrophils

Data type

text

Alias
UMLS CUI [1]
C0200633
Lymphocytes
Description

Lymphocytes

Data type

text

Alias
UMLS CUI [1]
C0200635
Monocytes
Description

Monocytes

Data type

text

Alias
UMLS CUI [1]
C0200637
Eosinophils
Description

Eosinophils

Data type

text

Alias
UMLS CUI [1]
C0200638
Basophils
Description

Basophils

Data type

text

Alias
UMLS CUI [1]
C0200641
Other differential
Description

Other differential

Data type

text

Alias
UMLS CUI [1,1]
C0162401
UMLS CUI [1,2]
C0205394
ANC (10*3/mm3)
Description

ANC (10*3/mm3)

Data type

float

Measurement units
  • 10*3/mm3
Alias
UMLS CUI [1]
C0948762
10*3/mm3
Chemistry
Description

Chemistry

Alias
UMLS CUI-1
C0008000
Chemistry Date
Description

Chemistry Date

Data type

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0011008
Laboratory Number Chemistry
Description

Worksheet B

Data type

text

Alias
UMLS CUI [1,1]
C2986056
UMLS CUI [1,2]
C0008000
Sodium
Description

Sodium

Data type

text

Alias
UMLS CUI [1]
C0337443
Potassium
Description

Potassium

Data type

text

Alias
UMLS CUI [1]
C0202194
Chloride
Description

Chloride

Data type

text

Alias
UMLS CUI [1]
C0201952
BUN
Description

BUN

Data type

text

Alias
UMLS CUI [1]
C0005845
Creatinine
Description

Creatinine

Data type

text

Alias
UMLS CUI [1]
C0201975
AST (SGOT)
Description

AST (SGOT)

Data type

text

Alias
UMLS CUI [1]
C0201899
Alkaline phosphatase
Description

Alkaline phosphatase

Data type

text

Alias
UMLS CUI [1]
C0201850
LDH
Description

LDH

Data type

text

Alias
UMLS CUI [1]
C0202113
Total Bilirubin
Description

Total Bilirubin

Data type

text

Alias
UMLS CUI [1]
C0201913
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Similar models

Physical Examination, Laboratory Results Hematology/ Chemistry Week 7 (Visit 6)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of physical examination
C2826643 (UMLS CUI-1)
Physical Examination Date
Item
Date of physical examination
date
C2826643 (UMLS CUI [1])
Item Group
B- Symptoms
C1706867 (UMLS CUI-1)
B-Symptoms
Item
Does the patient currently have evidence of "B" symptoms?
boolean
C1706867 (UMLS CUI [1])
Item
If yes, please check current "B" symptoms
text
C1706867 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
B-Symptoms
Code List
If yes, please check current "B" symptoms
CL Item
Night sweats (1)
CL Item
Intermittent fevers (2)
CL Item
Weight loss (3)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Body Height
Item
Height (cm)
float
C0005890 (UMLS CUI [1])
Body weight
Item
Weight (kg)
float
C0005890 (UMLS CUI [1])
Karnofsky Performance Status
Item
Karnofsky Status (%)
float
C0206065 (UMLS CUI [1])
Respiration
Item
Respirations (breaths/min)
integer
C0035203 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure (mmHg)
text
C0005823 (UMLS CUI [1])
Pulse Rate
Item
Pulse (bpm)
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature (°C)
float
C0039476 (UMLS CUI [1])
Item Group
Organ/ System
C0678852 (UMLS CUI-1)
Item
Organ/ System
text
C0678852 (UMLS CUI [1])
Organ/ System
Code List
Organ/ System
CL Item
General Appearance (1)
CL Item
Skin (2)
CL Item
HEENT (3)
CL Item
Neck (4)
CL Item
Lymph Nodes (5)
CL Item
Lungs (6)
CL Item
Heart (7)
CL Item
Neurological (8)
CL Item
Genitourinary (9)
CL Item
Abdomen (10)
CL Item
Musculoskeletal (11)
CL Item
Other (12)
Item
Finding
text
C0243095 (UMLS CUI [1])
Not Done
Code List
Finding
CL Item
Normal (1)
CL Item
Not Done (0)
CL Item
Abnormal (2)
If abnormal, please specify
Item
If abnormal finding, please specify
text
C0243095 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Hematology
C0474523 (UMLS CUI-1)
hematology Date
Item
hematology Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Number Hematology
Item
Laboratory Number Hematology
text
C2986056 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
WBC
Item
WBC
text
C0023508 (UMLS CUI [1])
RBC
Item
RBC
text
C0014772 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
text
C0019046 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
text
C0518014 (UMLS CUI [1])
Platelets
Item
Platelets
text
C0005821 (UMLS CUI [1])
Neutrophils
Item
Neutrophils (segs + bands)
text
C0200633 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
text
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
text
C0200637 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
text
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
text
C0200641 (UMLS CUI [1])
Other differential
Item
Other differential
text
C0162401 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ANC (10*3/mm3)
Item
ANC (10*3/mm3)
float
C0948762 (UMLS CUI [1])
Item Group
Chemistry
C0008000 (UMLS CUI-1)
Chemistry Date
Item
Chemistry Date
date
C0008000 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Number Chemistry
Item
Laboratory Number Chemistry
text
C2986056 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Sodium
Item
Sodium
text
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
text
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
text
C0201952 (UMLS CUI [1])
BUN
Item
BUN
text
C0005845 (UMLS CUI [1])
Creatinine
Item
Creatinine
text
C0201975 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
text
C0201899 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
text
C0201850 (UMLS CUI [1])
LDH
Item
LDH
text
C0202113 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1])
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