ID

30258

Beschreibung

https://clinicaltrials.gov/show/NCT00989664 HAMA Results and Follow up - Physical Examination, Laboratory tests and Post-Treatment Response 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

Stichworte

Versionen (1)
  1. 25.05.18 25.05.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

25. Mai 2018

DOI

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Lizenz

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

Englisch

HAMA Results and Follow up - Physical Examination, Laboratory tests and Post-Treatment Response

1 Formulare  
HAMA Results
Beschreibung

HAMA Results

Alias
UMLS CUI-1
C1291910
UMLS CUI-2
C1254595
Sample Date
Beschreibung

Sample Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C1291910
Visit
Beschreibung

Visit - Week

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0439230
Visit
Beschreibung

Visit - other Week

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C0205394
Result
Beschreibung

Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1274040
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Please check the appropriate visit week:
Beschreibung

Visit week

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0439230
Visit - Other week
Beschreibung

Other Week

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0205394
Does the patient currently have evidence of "B" symptoms?
Beschreibung

"B" Symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1706867
UMLS CUI [1,2]
C0521116
If yes, please check current "B" symptoms
Beschreibung

"B" symptoms

Datentyp

integer

Alias
UMLS CUI [1,1]
C1706867
UMLS CUI [1,2]
C0521116
Date of physical examination
Beschreibung

Date of physical examination

Datentyp

date

Alias
UMLS CUI [1]
C2826643
Height
Beschreibung

Height

Datentyp

integer

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

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Karnofsky Status
Beschreibung

Karnofsky Status

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0206065
%
Respirations
Beschreibung

Respirations

Datentyp

integer

Maßeinheiten
  • breaths/minute
Alias
UMLS CUI [1]
C0035203
breaths/minute
Blood Pressure
Beschreibung

Blood Pressure

Datentyp

integer

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

Pulse

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Organ system
Beschreibung

Organ system

Datentyp

integer

Alias
UMLS CUI [1]
C0678852
Examination finding
Beschreibung

Examination finding

Datentyp

integer

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

If abnormal, specify:

Datentyp

text

Alias
UMLS CUI [1,1]
C2826279
UMLS CUI [1,2]
C2348235
Laboratory Results - Hematology/Chemistry
Beschreibung

Laboratory Results - Hematology/Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0005774
UMLS CUI-4
C1254595
UMLS CUI-5
C0018943
Hematology Date
Beschreibung

Hematology Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0011008
Lab # (Worksheet B)
Beschreibung

Lab # (Worksheet B)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Hematologic tests
Beschreibung

Hematologic tests

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Hematologic test results
Beschreibung

Hematologic test results

Datentyp

float

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205488
Chemistry Date
Beschreibung

Chemistry Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
Lab # (Worksheet B)
Beschreibung

Lab # (Worksheet B)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Chemistry tests
Beschreibung

Chemistry tests

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0022885
Chemistry test results
Beschreibung

Chemistry test results

Datentyp

float

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0005774
CT or other Radiological Imaging Results
Beschreibung

CT or other Radiological Imaging Results

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C1274040
Anatomic site
Beschreibung

Anatomic site

Datentyp

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0011923
Not done?
Beschreibung

Not done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1272696
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0011008
Radiological Imaging Method
Beschreibung

Radiological Imaging Method

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1275506
Specify other Imaging:
Beschreibung

Other Imaging

Datentyp

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0079595
UMLS CUI [1,3]
C0205394
Imaging Findings
Beschreibung

Imaging Findings

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0243095
Specify Abnormal Finding
Beschreibung

Abnormal Finding

Datentyp

text

Alias
UMLS CUI [1,1]
C2826279
UMLS CUI [1,2]
C0011923
Bone Marrow Biopsy
Beschreibung

Bone Marrow Biopsy

Alias
UMLS CUI-1
C0005954
Date of biopsy
Beschreibung

Date of biopsy

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005954
Marrow cellularity
Beschreibung

Marrow cellularity

Datentyp

integer

Alias
UMLS CUI [1]
C1561532
Tumor involvement
Beschreibung

Tumor involvement

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C1517677
%
Side
Beschreibung

Side

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0475445
Bone Marrow Biopsie not done/indicated?
Beschreibung

Bone Marrow Biopsie not done/indicated

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005957
UMLS CUI [1,2]
C1272696
Measurable Lymphoma Disease
Beschreibung

Measurable Lymphoma Disease

Alias
UMLS CUI-1
C0024299
UMLS CUI-2
C1513041
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C1515974
Method of Determination
Beschreibung

Method of Determination

Datentyp

text

Alias
UMLS CUI [1]
C2911685
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1148554
Tumor Measurements
Beschreibung

Tumor Measurements

Datentyp

integer

Maßeinheiten
  • cm x cm = cm²
Alias
UMLS CUI [1,1]
C0205485
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1300072
cm x cm = cm²
Non-Measurable Dlsease
Beschreibung

Non-Measurable Dlsease

Alias
UMLS CUI-1
C1334988
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C1515974
Method of Determination
Beschreibung

Method of Determination

Datentyp

text

Alias
UMLS CUI [1]
C2911685
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1148554
Status of Non-Measurable Disease
Beschreibung

Status

Datentyp

text

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C1334988
Response
Beschreibung

Response

Alias
UMLS CUI-1
C0521982
Response (check one)
Beschreibung

Response

Datentyp

integer

Alias
UMLS CUI [1]
C0521982
Date of Response Evaluation
Beschreibung

Date of Response Evaluation

Datentyp

date

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0220825
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Administaration
Beschreibung

Administaration

Alias
UMLS CUI-1
C1320722
Signature of Investigator
Beschreibung

Signature of Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

HAMA Results and Follow up - Physical Examination, Laboratory tests and Post-Treatment Response

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
HAMA Results
C1291910 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1,1])
C1291910 (UMLS CUI [1,2])
Item
Visit
integer
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Visit - Week
Code List
Visit
CL Item
Week 7 (1)
CL Item
Week 13 (2)
CL Item
Week 25 (3)
Visit - other Week
Item
Visit
integer
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Result
integer
C1291910 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result
Code List
Result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Please check the appropriate visit week:
integer
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Visit week
Code List
Please check the appropriate visit week:
CL Item
Week 52 (1 year) (1)
CL Item
Week 78 (1,5 years) (2)
CL Item
Week 104 (2 years) (3)
CL Item
other Week (4)
Other Week
Item
Visit - Other week
integer
C0439230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
"B" Symptoms
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
integer
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)
Date of physical examination
Item
Date of physical examination
date
C2826643 (UMLS CUI [1])
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)
If abnormal, specify:
Item
If abnormal, specify:
text
C2826279 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Laboratory Results - Hematology/Chemistry
C1254595 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
C1254595 (UMLS CUI-4)
C0018943 (UMLS CUI-5)
Hematology Date
Item
Hematology Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Lab # (Worksheet B)
Item
Lab # (Worksheet B)
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Hematologic tests
integer
C0018941 (UMLS CUI [1])
Hematologic tests
Code List
Hematologic tests
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hemoglobin (3)
CL Item
Hematocrit (4)
CL Item
Platelets (5)
CL Item
Neutrophils (sears + bands) (6)
CL Item
Lymphocytes (7)
CL Item
Monocytes (8)
CL Item
Eosinophils (9)
CL Item
Basophils (10)
CL Item
Other differential (11)
CL Item
ANC (10³/mm³) (12)
Hematologic test results
Item
Hematologic test results
float
C1254595 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
Chemistry Date
Item
Chemistry Date
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Lab # (Worksheet B)
Item
Lab # (Worksheet B)
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Chemistry tests
integer
C0008000 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Chemistry tests
Code List
Chemistry tests
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
BUN (4)
CL Item
Creatinine (5)
CL Item
AST (SGOT) (6)
CL Item
Alkaline Phosphatase (7)
CL Item
LDH (8)
CL Item
Total Bilirubin (9)
CL Item
TSH (10)
CL Item
Total T3 (11)
CL Item
Free T4 (12)
Chemistry test results
Item
Chemistry test results
float
C1254595 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
Item Group
CT or other Radiological Imaging Results
C0011923 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Item
Anatomic site
integer
C1515974 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Anatomic site
Code List
Anatomic site
CL Item
Head/Neck (1)
CL Item
Chest (2)
CL Item
Abdomen (3)
CL Item
Pelvis (4)
CL Item
Other (5)
Not done
Item
Not done?
boolean
C0011923 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Radiological Imaging Method
integer
C0011923 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
Radiological Imaging Method
Code List
Radiological Imaging Method
CL Item
CT  (1)
CL Item
MRI  (2)
CL Item
X-Ray  (3)
CL Item
Other (4)
Other Imaging
Item
Specify other Imaging:
text
C0011923 (UMLS CUI [1,1])
C0079595 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Imaging Findings
integer
C0011923 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Imaging Findings
Code List
Imaging Findings
CL Item
Normal  (1)
CL Item
Abnormal (2)
Abnormal Finding
Item
Specify Abnormal Finding
text
C2826279 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Item Group
Bone Marrow Biopsy
C0005954 (UMLS CUI-1)
Date of biopsy
Item
Date of biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
Item
Marrow cellularity
integer
C1561532 (UMLS CUI [1])
Marrow cellularity
Code List
Marrow cellularity
CL Item
1 Normal  (1)
CL Item
1 Hypercellular (2)
CL Item
2 Hypocellular (3)
Tumor involvement
Item
Tumor involvement
integer
C1517677 (UMLS CUI [1])
Item
Side
integer
C0441987 (UMLS CUI [1,1])
C0475445 (UMLS CUI [1,2])
Side
Code List
Side
CL Item
Unilateral  (1)
CL Item
Bilateral (2)
Item
Bone Marrow Biopsie not done/indicated?
integer
C0005957 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Bone Marrow Biopsie not done/indicated
Code List
Bone Marrow Biopsie not done/indicated?
CL Item
Not done (1)
CL Item
Not indicated (BM not positive at baseline) (2)
CL Item
Not indicated (patient not in CR} (3)
Item Group
Measurable Lymphoma Disease
C0024299 (UMLS CUI-1)
C1513041 (UMLS CUI-2)
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1148554 (UMLS CUI [1,2])
Tumor Measurements
Item
Tumor Measurements
integer
C0205485 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1300072 (UMLS CUI [1,3])
Item Group
Non-Measurable Dlsease
C1334988 (UMLS CUI-1)
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1148554 (UMLS CUI [1,2])
Item
Status of Non-Measurable Disease
text
C0449438 (UMLS CUI [1,1])
C1334988 (UMLS CUI [1,2])
Status
Code List
Status of Non-Measurable Disease
CL Item
New  (1)
CL Item
Increased  (2)
CL Item
Stable  (3)
CL Item
Decreased (4)
Item Group
Response
C0521982 (UMLS CUI-1)
Item
Response (check one)
integer
C0521982 (UMLS CUI [1])
Response
Code List
Response (check one)
CL Item
CR (1)
CL Item
CCR (2)
CL Item
PR (3)
CL Item
SD (4)
CL Item
PD (5)
Date of Response Evaluation
Item
Date of Response Evaluation
date
C1704632 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Administaration
C1320722 (UMLS CUI-1)
Signature of Investigator
Item
Signature of Investigator
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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