ID

30148

Description

https://clinicaltrials.gov/show/NCT00989664 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

Link

https://clinicaltrials.gov/show/NCT00989664

Keywords

Versions (1)
  1. 5/15/18 5/15/18 - Halim Ugurlu
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 15, 2018

DOI

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License

Creative Commons BY-NC 3.0
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29959_Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy

English

General Medical History, Physical Examination Baseline

1 forms  
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Site Number:
Description

Site Number

Data type

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Medical History Date
Description

Medical History Date

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0011008
Medical History Date
Description

Medical History Date

Data type

date

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011008
Series Page
Description

Series Page

Data type

integer

Alias
UMLS CUI [1]
C0237753
Last page
Description

Last page

Data type

boolean

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C1704732
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Patient 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

text

Alias
UMLS CUI [1]
C0015031
Diagnosis/Condition
Description

Diagnosis/Condition

Alias
UMLS CUI-1
C0011900
UMLS CUI-2
C0012634
Disease/Condition
Description

Disease/Condition

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0012634
Date of Onset
Description

Date of Onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Status
Description

Status

Data type

integer

Alias
UMLS CUI [1]
C0449438
Physical Examination - Baseline
Description

Physical Examination - Baseline

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

B-Symptoms

Data type

integer

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

If Yes to B-Symptoms

Data type

text

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

Date of physical examination

Data type

date

Alias
UMLS CUI [1]
C2826643
Height
Description

Height

Data type

float

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 (breaths/min)
Description

Respirations

Data type

integer

Alias
UMLS CUI [1]
C0035203
Blood Pressure (mmHg)
Description

Blood Pressure

Data type

integer

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

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature (Celcius)
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
Result of Physical Examination
Description

Result of PE

Data type

integer

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0031809
If abnormal Physical Examination, specify
Description

If abnormal PE

Data type

text

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C0031809
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Similar models

General Medical History, Physical Examination Baseline

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number:
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Medical History Date
C0262926 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Medical History Date
Item
Medical History Date
date
C0262926 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Series Page
Item
Series Page
integer
C0237753 (UMLS CUI [1])
Last page
Item
Last page
boolean
C0237753 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Date of birth
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
M (1)
CL Item
F (2)
Item
Ethnic Origin
text
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
Diagnosis/Condition
C0011900 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Disease/Condition
Item
Disease/Condition
text
C0011900 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Item
Status
integer
C0449438 (UMLS CUI [1])
Status
Code List
Status
CL Item
Active (1)
CL Item
Inactive (2)
Item Group
Physical Examination - Baseline
C0031809 (UMLS CUI-1)
Item
Does the patient currently have evidence of "B" symptoms?
integer
C1706867 (UMLS CUI [1])
B-Symptoms
Code List
Does the patient currently have evidence of "B" symptoms?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (0)
Item
If yes, please check current "B" symptoms
text
C1706867 (UMLS CUI [1])
If Yes to 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)
Date of physical examination
Item
Date of physical examination
date
C2826643 (UMLS CUI [1])
Height
Item
Height
float
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 (breaths/min)
integer
C0035203 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure (mmHg)
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse (bpm)
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature (Celcius)
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
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
Result of Physical Examination
integer
C1274040 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Result of PE
Code List
Result of Physical Examination
CL Item
Not Done (1)
CL Item
Normal (2)
CL Item
Abnormal (3)
If abnormal PE
Item
If abnormal Physical Examination, specify
text
C0205161 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
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