ID

31129

Beskrivning

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

Nyckelord

  1. 2018-07-09 2018-07-09 -
  2. 2018-07-21 2018-07-21 -
  3. 2018-08-18 2018-08-18 -
  4. 2022-02-18 2022-02-18 - Martin Dugas
Rättsinnehavare

see clinicaltrials.gov

Uppladdad den

21 juli 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

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

Date of physical examination
Beskrivning

Date of physical examination

Alias
UMLS CUI-1
C2826643
Date of physical examination
Beskrivning

Physical Examination Date

Datatyp

date

Alias
UMLS CUI [1]
C2826643
B- Symptoms
Beskrivning

B- Symptoms

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

B-Symptoms

Datatyp

boolean

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

B-Symptoms

Datatyp

text

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

Physical Examination

Alias
UMLS CUI-1
C0031809
Height (cm)
Beskrivning

Body Height

Datatyp

float

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight (kg)
Beskrivning

Body weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005890
kg
Karnofsky Status (%)
Beskrivning

Karnofsky Performance Status

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0206065
%
Respirations (breaths/min)
Beskrivning

Respiration

Datatyp

integer

Måttenheter
  • breaths/min
Alias
UMLS CUI [1]
C0035203
breaths/min
Blood Pressure (mmHg)
Beskrivning

Blood Pressure

Datatyp

text

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse (bpm)
Beskrivning

Pulse Rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature (°C)
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Organ/ System
Beskrivning

Organ/ System

Alias
UMLS CUI-1
C0678852
Organ/ System
Beskrivning

Organ/ System

Datatyp

text

Alias
UMLS CUI [1]
C0678852
Finding
Beskrivning

Finding

Datatyp

text

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

If abnormal, please specify

Datatyp

text

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

Hematology

Alias
UMLS CUI-1
C0474523
hematology Date
Beskrivning

hematology Date

Datatyp

date

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

Worksheet B

Datatyp

text

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

WBC

Datatyp

text

Alias
UMLS CUI [1]
C0023508
RBC
Beskrivning

RBC

Datatyp

text

Alias
UMLS CUI [1]
C0014772
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

text

Alias
UMLS CUI [1]
C0019046
Hematocrit
Beskrivning

Hematocrit

Datatyp

text

Alias
UMLS CUI [1]
C0518014
Platelets
Beskrivning

Platelets

Datatyp

text

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

Neutrophils

Datatyp

text

Alias
UMLS CUI [1]
C0200633
Lymphocytes
Beskrivning

Lymphocytes

Datatyp

text

Alias
UMLS CUI [1]
C0200635
Monocytes
Beskrivning

Monocytes

Datatyp

text

Alias
UMLS CUI [1]
C0200637
Eosinophils
Beskrivning

Eosinophils

Datatyp

text

Alias
UMLS CUI [1]
C0200638
Basophils
Beskrivning

Basophils

Datatyp

text

Alias
UMLS CUI [1]
C0200641
Other differential
Beskrivning

Other differential

Datatyp

text

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

ANC (10*3/mm3)

Datatyp

float

Måttenheter
  • 10*3/mm3
Alias
UMLS CUI [1]
C0948762
10*3/mm3
Chemistry
Beskrivning

Chemistry

Alias
UMLS CUI-1
C0008000
Chemistry Date
Beskrivning

Chemistry Date

Datatyp

date

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

Worksheet B

Datatyp

text

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

Sodium

Datatyp

text

Alias
UMLS CUI [1]
C0337443
Potassium
Beskrivning

Potassium

Datatyp

text

Alias
UMLS CUI [1]
C0202194
Chloride
Beskrivning

Chloride

Datatyp

text

Alias
UMLS CUI [1]
C0201952
BUN
Beskrivning

BUN

Datatyp

text

Alias
UMLS CUI [1]
C0005845
Creatinine
Beskrivning

Creatinine

Datatyp

text

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

AST (SGOT)

Datatyp

text

Alias
UMLS CUI [1]
C0201899
Alkaline phosphatase
Beskrivning

Alkaline phosphatase

Datatyp

text

Alias
UMLS CUI [1]
C0201850
LDH
Beskrivning

LDH

Datatyp

text

Alias
UMLS CUI [1]
C0202113
Total Bilirubin
Beskrivning

Total Bilirubin

Datatyp

text

Alias
UMLS CUI [1]
C0201913

Similar models

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

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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])
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])
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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