ID

44901

Descripción

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

Palabras clave

Versiones (4)
  1. 22/7/18 22/7/18 -
  2. 22/7/18 22/7/18 -
  3. 18/8/18 18/8/18 -
  4. 1/4/22 1/4/22 - Martin Dugas
Titular de derechos de autor

GlaxoSmithKline

Subido en

1 de abril de 2022

DOI

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Licencia

Creative Commons BY-NC 4.0
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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

Inglés

Physical Examination, Laboratory Results Hematology/ Chemistry Week 13 (Visit 8)

1 formularios  
  1. StudyEvent: Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593
    1. Physical Examination, Laboratory Results Hematology/ Chemistry Week 13 (Visit 8)
Date of physical examination
Descripción

Date of physical examination

Alias
UMLS CUI-1
C2826643
Date of physical examination
Descripción

Physical Examination Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826643
B- Symptoms
Descripción

B- Symptoms

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

B-Symptoms

Tipo de datos

boolean

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

B-Symptoms

Tipo de datos

text

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

Physical Examination

Alias
UMLS CUI-1
C0031809
Weight
Descripción

Body weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005890
kg
Karnofsky Status
Descripción

Karnofsky Performance Status

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0206065
%
Respirations
Descripción

Respiration

Tipo de datos

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1]
C0035203
breaths/min
Blood Pressure
Descripción

Blood Pressure

Tipo de datos

text

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse
Descripción

Pulse Rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Organ/ System
Descripción

Organ/ System

Alias
UMLS CUI-1
C0678852
Organ/ System
Descripción

Organ/ System

Tipo de datos

text

Alias
UMLS CUI [1]
C0678852
Finding
Descripción

Finding

Tipo de datos

text

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

If abnormal, please specify

Tipo de datos

text

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

Hematology

Alias
UMLS CUI-1
C0474523
hematology Date
Descripción

hematology Date

Tipo de datos

date

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

Worksheet B

Tipo de datos

text

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

WBC

Tipo de datos

float

Alias
UMLS CUI [1]
C0023508
RBC
Descripción

RBC

Tipo de datos

float

Alias
UMLS CUI [1]
C0014772
Hemoglobin
Descripción

Hemoglobin

Tipo de datos

float

Unidades de medida
  • g/dl
Alias
UMLS CUI [1]
C0019046
g/dl
Hematocrit
Descripción

Hematocrit

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0518014
%
Platelets
Descripción

Platelets

Tipo de datos

float

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

Neutrophils

Tipo de datos

float

Alias
UMLS CUI [1]
C0200633
Lymphocytes
Descripción

Lymphocytes

Tipo de datos

float

Alias
UMLS CUI [1]
C0200635
Monocytes
Descripción

Monocytes

Tipo de datos

float

Alias
UMLS CUI [1]
C0200637
Eosinophils
Descripción

Eosinophils

Tipo de datos

float

Alias
UMLS CUI [1]
C0200638
Basophils
Descripción

Basophils

Tipo de datos

float

Alias
UMLS CUI [1]
C0200641
Other differential
Descripción

Other differential

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0162401
UMLS CUI [1,2]
C0205394
ANC
Descripción

ANC

Tipo de datos

float

Unidades de medida
  • 1000/mm3
Alias
UMLS CUI [1]
C0948762
1000/mm3
Chemistry
Descripción

Chemistry

Alias
UMLS CUI-1
C0008000
Chemistry Date
Descripción

Chemistry Date

Tipo de datos

date

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

Worksheet B

Tipo de datos

text

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

Sodium

Tipo de datos

float

Unidades de medida
  • mmol/l
Alias
UMLS CUI [1]
C0337443
mmol/l
Potassium
Descripción

Potassium

Tipo de datos

float

Unidades de medida
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Chloride
Descripción

Chloride

Tipo de datos

float

Alias
UMLS CUI [1]
C0201952
BUN
Descripción

BUN

Tipo de datos

float

Alias
UMLS CUI [1]
C0005845
Creatinine
Descripción

Creatinine

Tipo de datos

float

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

AST

Tipo de datos

float

Alias
UMLS CUI [1]
C0201899
Alkaline phosphatase
Descripción

AP

Tipo de datos

float

Alias
UMLS CUI [1]
C0201850
LDH
Descripción

LDH

Tipo de datos

float

Alias
UMLS CUI [1]
C0202113
Total Bilirubin
Descripción

Total Bilirubin

Tipo de datos

float

Alias
UMLS CUI [1]
C0201913
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Similar models

Physical Examination, Laboratory Results Hematology/ Chemistry Week 13 (Visit 8)

1 formularios
  1. StudyEvent: Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593
    1. Physical Examination, Laboratory Results Hematology/ Chemistry Week 13 (Visit 8)
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 weight
Item
Weight
float
C0005890 (UMLS CUI [1])
Karnofsky Performance Status
Item
Karnofsky Status
float
C0206065 (UMLS CUI [1])
Respiration
Item
Respirations
integer
C0035203 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
text
C0005823 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
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
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 (segs + bands)
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
C0162401 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ANC
Item
ANC
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
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
C0201975 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
AP
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])
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