ID

31366

Beschreibung

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

Stichworte

Versionen (4)
  1. 09.07.18 09.07.18 -
  2. 21.07.18 21.07.18 -
  3. 18.08.18 18.08.18 -
  4. 18.02.22 18.02.22 - Martin Dugas
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GlaxoSmithKline

Hochgeladen am

18. August 2018

DOI

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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

Englisch

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

1 Formulare  
Date of physical examination
Beschreibung

Date of physical examination

Alias
UMLS CUI-1
C2826643
Date of physical examination
Beschreibung

Physical Examination Date

Datentyp

date

Alias
UMLS CUI [1]
C2826643
B- Symptoms
Beschreibung

B- Symptoms

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

B-Symptoms

Datentyp

boolean

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

B-Symptoms

Datentyp

text

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

Physical Examination

Alias
UMLS CUI-1
C0031809
Height (cm)
Beschreibung

Body Height

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight (kg)
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005890
kg
Karnofsky Status (%)
Beschreibung

Karnofsky Performance Status

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0206065
%
Respirations (breaths/min)
Beschreibung

Respiration

Datentyp

integer

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

Blood Pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse (bpm)
Beschreibung

Pulse Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature (°C)
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Organ/ System
Beschreibung

Organ/ System

Alias
UMLS CUI-1
C0678852
Organ/ System
Beschreibung

Organ/ System

Datentyp

text

Alias
UMLS CUI [1]
C0678852
Finding
Beschreibung

Finding

Datentyp

text

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

If abnormal, please specify

Datentyp

text

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

Hematology

Alias
UMLS CUI-1
C0474523
hematology Date
Beschreibung

hematology Date

Datentyp

date

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

Worksheet B

Datentyp

text

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

WBC

Datentyp

text

Alias
UMLS CUI [1]
C0023508
RBC
Beschreibung

RBC

Datentyp

text

Alias
UMLS CUI [1]
C0014772
Hemoglobin
Beschreibung

Hemoglobin

Datentyp

text

Alias
UMLS CUI [1]
C0019046
Hematocrit
Beschreibung

Hematocrit

Datentyp

text

Alias
UMLS CUI [1]
C0518014
Platelets
Beschreibung

Platelets

Datentyp

text

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

Neutrophils

Datentyp

text

Alias
UMLS CUI [1]
C0200633
Lymphocytes
Beschreibung

Lymphocytes

Datentyp

text

Alias
UMLS CUI [1]
C0200635
Monocytes
Beschreibung

Monocytes

Datentyp

text

Alias
UMLS CUI [1]
C0200637
Eosinophils
Beschreibung

Eosinophils

Datentyp

text

Alias
UMLS CUI [1]
C0200638
Basophils
Beschreibung

Basophils

Datentyp

text

Alias
UMLS CUI [1]
C0200641
Other differential
Beschreibung

Other differential

Datentyp

text

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

ANC (10*3/mm3)

Datentyp

float

Maßeinheiten
  • 10*3/mm3
Alias
UMLS CUI [1]
C0948762
10*3/mm3
Chemistry
Beschreibung

Chemistry

Alias
UMLS CUI-1
C0008000
Chemistry Date
Beschreibung

Chemistry Date

Datentyp

date

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

Worksheet B

Datentyp

text

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

Sodium

Datentyp

text

Alias
UMLS CUI [1]
C0337443
Potassium
Beschreibung

Potassium

Datentyp

text

Alias
UMLS CUI [1]
C0202194
Chloride
Beschreibung

Chloride

Datentyp

text

Alias
UMLS CUI [1]
C0201952
BUN
Beschreibung

BUN

Datentyp

text

Alias
UMLS CUI [1]
C0005845
Creatinine
Beschreibung

Creatinine

Datentyp

text

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

AST (SGOT)

Datentyp

text

Alias
UMLS CUI [1]
C0201899
Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Datentyp

text

Alias
UMLS CUI [1]
C0201850
LDH
Beschreibung

LDH

Datentyp

text

Alias
UMLS CUI [1]
C0202113
Total Bilirubin
Beschreibung

Total Bilirubin

Datentyp

text

Alias
UMLS CUI [1]
C0201913
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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