ID

30223

Description

General Medical History and Physical Examination 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

Keywords

Versions (1)
  1. 5/22/18 5/22/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 22, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

English

General Medical History and Physical Examination

1 forms  
Medical history
Description

Medical history

Alias
UMLS CUI-1
C0262926
Medical history date
Description

Medical history date

Data type

date

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011008
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Ethnic Origin
Description

Ethnic Origin

Data type

integer

Alias
UMLS CUI [1]
C0015031
Diagnoses/Condition
Description

Diagnoses/Condition

Alias
UMLS CUI-1
C0011900
Diagnoses/Condition
Description

Diagnoses/Condition

Data type

text

Alias
UMLS CUI [1]
C0011900
Day of Onset
Description

Month/Year

Data type

partialDate

Alias
UMLS CUI [1]
C0574845
Status
Description

Status

Data type

integer

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0012634
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Does the patient currently have evidence of "B" symptoms?
Description

"B" symptoms

Data type

boolean

Alias
UMLS CUI [1]
C1706867
Date of physical examination
Description

Date of physical examination

Data type

date

Alias
UMLS CUI [1]
C2826643
If yes, please check current "B" symptoms:
Description

Current "B" symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C1706867
UMLS CUI [1,2]
C0521116
Height
Description

Height

Data type

integer

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

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Karnofsky Status
Description

Karnofsky Status

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0206065
%
Respirations
Description

Respirations

Data type

integer

Measurement units
  • breaths/minute
Alias
UMLS CUI [1]
C0035203
breaths/minute
Blood Pressure
Description

Blood Pressure

Data type

integer

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

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Organ/System
Description

Organ/System

Data type

integer

Alias
UMLS CUI [1]
C0678852
Examination finding
Description

Examination finding

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
If abnormal, specify:
Description

Abnormal finding Specification

Data type

text

Alias
UMLS CUI [1,1]
C2826279
UMLS CUI [1,2]
C2348235
If abnormal, specify:
Description

Abnormal finding Specification

Data type

text

Alias
UMLS CUI [1,1]
C2826279
UMLS CUI [1,2]
C2348235
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Similar models

General Medical History and Physical Examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Medical history
C0262926 (UMLS CUI-1)
Medical history date
Item
Medical history date
date
C0262926 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Ethnic Origin
integer
C0015031 (UMLS CUI [1])
Ethnic Origin
Code List
Ethnic Origin
CL Item
White (1)
CL Item
Hispanic (2)
CL Item
Asian (3)
CL Item
Black (4)
CL Item
Native American (5)
CL Item
Other (6)
Item Group
Diagnoses/Condition
C0011900 (UMLS CUI-1)
Diagnoses/Condition
Item
Diagnoses/Condition
text
C0011900 (UMLS CUI [1])
Day of Onset
Item
Day of Onset
partialDate
C0574845 (UMLS CUI [1])
Item
Status
integer
C0449438 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Status
Code List
Status
CL Item
Active (1)
CL Item
Inactive (2)
Item Group
Physical examination
C0031809 (UMLS CUI-1)
"B" symptoms
Item
Does the patient currently have evidence of "B" symptoms?
boolean
C1706867 (UMLS CUI [1])
Date of physical examination
Item
Date of physical examination
date
C2826643 (UMLS CUI [1])
Item
If yes, please check current "B" symptoms:
integer
C1706867 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Current "B" symptoms
Code List
If yes, please check current "B" symptoms:
CL Item
Night sweats (1)
CL Item
lntermittent fevers (2)
CL Item
Weight loss (3)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Karnofsky Status
Item
Karnofsky Status
integer
C0206065 (UMLS CUI [1])
Respirations
Item
Respirations
integer
C0035203 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Organ/System
integer
C0678852 (UMLS CUI [1])
Organ/System
Code List
Organ/System
CL Item
1. General Appearance (1)
CL Item
2. Skin (2)
CL Item
3. HEENT (3)
CL Item
4. Neck (4)
CL Item
5. Lymph Nodes (5)
CL Item
6. Lungs (6)
CL Item
7. Heart (7)
CL Item
8. Neurological (8)
CL Item
9. Genitourinary (9)
CL Item
10. Abdomen (10)
CL Item
11. Musculoskeletal (11)
CL Item
12. Other (12)
Item
Examination finding
integer
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Examination finding
Code List
Examination finding
CL Item
Not Done (1)
CL Item
Normal (2)
CL Item
Abnormal (3)
Abnormal finding Specification
Item
If abnormal, specify:
text
C2826279 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Abnormal finding Specification
Item
If abnormal, specify:
text
C2826279 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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