ID

31171

Description

Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 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. 7/25/18 7/25/18 -
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see clinicaltrials.gov

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July 25, 2018

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License

Creative Commons BY 4.0
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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

English

Physical Examination - Week 7

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Site number
Description

Site number

Data type

text

Alias
UMLS CUI [1,1]
C0018704 (Health care facility)
SNOMED
257622000
LOINC
LA30302-6
UMLS CUI [1,2]
C0600091 (Identifier)
SNOMED
118522005
LOINC
LP31795-5
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427 (undefined)
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440 (Person Initials)
Date of physical examination
Description

Physical Examination Date

Data type

date

Alias
UMLS CUI [1]
C2826643 (Physical Examination Date)
B-symptoms
Description

B-symptoms

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

B-Symptoms current

Data type

boolean

Alias
UMLS CUI [1,1]
C1706867 (B-Symptoms)
UMLS CUI [1,2]
C0521116 (Current (present time))
SNOMED
15240007
If yes, please check current B-symptoms.
Description

B-Symptoms current

Data type

text

Alias
UMLS CUI [1,1]
C1706867 (B-Symptoms)
UMLS CUI [1,2]
C0521116 (Current (present time))
SNOMED
15240007
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910 (Body Weight)
SNOMED
27113001
kg
Karnofsky Status
Description

Karnofsky Performance Status

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0206065 (Karnofsky Performance Status)
SNOMED
273546003
LOINC
LP267177-6
%
Respirations
Description

Respiration

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0035203 (Respiration)
SNOMED
719983008
LOINC
LA25346-0
breaths/min
Blood Pressure
Description

Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823 (Blood Pressure)
SNOMED
75367002
mmHg
Pulse
Description

Pulse Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117 (Pulse Rate)
SNOMED
78564009
bpm
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476 (Temperature)
SNOMED
703421000
LOINC
MTHU009008
°C
Physical Examination Body Systems
Description

Physical Examination Body Systems

Alias
UMLS CUI-1
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI-2
C0678852 (body system or organ function)
Organ System
Description

Organ System

Data type

text

Alias
UMLS CUI [1]
C0678852 (body system or organ function)
Not done
Description

Not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696 (Not Done)
SNOMED
385660001
Normal
Description

Normal

Data type

boolean

Alias
UMLS CUI [1]
C0205307 (Normal)
SNOMED
17621005
LOINC
LP15963-9
Abnormal
Description

Abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0205161 (Abnormal)
SNOMED
263654008
LOINC
LP28764-6
If abnormal, specify
Description

Abnormality specification

Data type

text

Alias
UMLS CUI [1,1]
C1704258 (Abnormality)
UMLS CUI [1,2]
C2348235 (Specification)
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Similar models

Physical Examination - Week 7

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Site number
Item
Site number
text
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (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 current
Item
Does the patient currently have evidence of B-symptoms?
boolean
C1706867 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Item
If yes, please check current B-symptoms.
text
C1706867 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
B-Symptoms current
Code List
If yes, please check current B-symptoms.
CL Item
Night sweats (Night sweats)
CL Item
intermittent fevers (intermittent fevers)
CL Item
Weight loss (Weight loss)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Karnofsky Performance Status
Item
Karnofsky Status
integer
C0206065 (UMLS CUI [1])
Respiration
Item
Respirations
integer
C0035203 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
integer
C0005823 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item Group
Physical Examination Body Systems
C0031809 (UMLS CUI-1)
C0678852 (UMLS CUI-2)
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
Genitoutinary (9)
CL Item
Abdomen (10)
CL Item
Musculoskeletal (11)
CL Item
Other (12)
Not done
Item
Not done
boolean
C1272696 (UMLS CUI [1])
Normal
Item
Normal
boolean
C0205307 (UMLS CUI [1])
Abnormal
Item
Abnormal
boolean
C0205161 (UMLS CUI [1])
Abnormality specification
Item
If abnormal, specify
text
C1704258 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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