ID

42088

Beschreibung

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Stichworte

Versionen (2)
  1. 25.03.21 25.03.21 -
  2. 30.03.21 30.03.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

30. März 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758

Englisch

Week 3 - 13 and 25 - Laboratory Results; Physical Examination; Post-Treatment Response

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site Number
Beschreibung

Site Number

Datentyp

text

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Laboratory Results (Week 3-13, 25) - Hematology
Beschreibung

Laboratory Results (Week 3-13, 25) - Hematology

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0018943
Hematology Date
Beschreibung

Hematology Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0011008
Performed at primary lab listed on 1572? (Hematology)
Beschreibung

Performed at primary lab listed on 1572? (Hematology)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0018943
Laboratory Results (Week 3-13, 25) - Hematology
Beschreibung

Laboratory Results (Week 3-13, 25) - Hematology

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0018943
Laboratory Test (Hematology)
Beschreibung

Laboratory Test (Hematology)

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Laboratory Test Result (Hematology)
Beschreibung

Laboratory Test Result (Hematology)

Datentyp

float

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0587081
Laboratory Results (Week 25) - Hematology
Beschreibung

Laboratory Results (Week 25) - Hematology

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0018943
HAMA Date
Beschreibung

HAMA Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C0011008
HAMA Result
Beschreibung

HAMA Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1274040
Laboratory Results (Week 3, 13, 25) - Chemistry
Beschreibung

Laboratory Results (Week 3, 13, 25) - Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0008000
Chemistry Date
Beschreibung

Chemistry Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0011008
Performed at primary lab listed on 1572? (Chemistry)
Beschreibung

Performed at primary lab listed on 1572? (Chemistry)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
Laboratory Results (Week 3 and 13) - Chemistry
Beschreibung

Laboratory Results (Week 3 and 13) - Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0008000
Laboratory Test (Chemistry)
Beschreibung

Laboratory Test (Chemistry)

Datentyp

integer

Alias
UMLS CUI [1]
C0525044
Laboratory Test Result (Chemistry)
Beschreibung

Laboratory Test Result (Chemistry)

Datentyp

float

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0008000
Laboratory Results (Week 7) - Chemistry
Beschreibung

Laboratory Results (Week 7) - Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0008000
Chemistry Date
Beschreibung

Chemistry Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0011008
Performed at primary lab listed on 1572? (Chemistry)
Beschreibung

Performed at primary lab listed on 1572? (Chemistry)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
Laboratory Results (Week 7) - Chemistry
Beschreibung

Laboratory Results (Week 7) - Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0008000
Laboratory Test (Chemistry)
Beschreibung

Laboratory Test (Chemistry)

Datentyp

text

Alias
UMLS CUI [1]
C0525044
HAMA Date
Beschreibung

HAMA Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C0011008
HAMA Result
Beschreibung

HAMA Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1274040
Laboratory Results (Week 25) - Chemistry
Beschreibung

Laboratory Results (Week 25) - Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0008000
Laboratory Test (Chemistry)
Beschreibung

Laboratory Test (Chemistry)

Datentyp

integer

Alias
UMLS CUI [1]
C0525044
Laboratory Test Result (Chemistry)
Beschreibung

Laboratory Test Result (Chemistry)

Datentyp

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0008000
Physical Examination (Week 7, 13, 25)
Beschreibung

Physical Examination (Week 7, 13, 25)

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

Does the patient currently have evidence of

Datentyp

text

Alias
UMLS CUI [1,1]
C1706867
UMLS CUI [1,2]
C0521116
Current "B" symptoms
Beschreibung

Current

Datentyp

integer

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

Date of physical examination

Datentyp

date

Alias
UMLS CUI [1]
C2826643
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/min
Alias
UMLS CUI [1]
C0035203
breaths/min
Systolic Blood Pressure
Beschreibung

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
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 (Week 7, 13, 25)
Beschreibung

Physical Examination (Week 7, 13, 25)

Alias
UMLS CUI-1
C0031809
Organ/ System
Beschreibung

Organ/ System

Datentyp

integer

Alias
UMLS CUI [1]
C0678852
Result
Beschreibung

Result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
If abnormal, specify
Beschreibung

If abnormal, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2348235
Post-Treatment Response (Week 7, 13, 25) - CT or other Radiological Imaging Results
Beschreibung

Post-Treatment Response (Week 7, 13, 25) - CT or other Radiological Imaging Results

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0040405
UMLS CUI-3
C0011923
UMLS CUI-4
C1274040
Organ/System
Beschreibung

Organ/System

Datentyp

integer

Alias
UMLS CUI [1]
C0678852
Imaging Date
Beschreibung

Imaging Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0011008
Imaging Not done
Beschreibung

Imaging Not done

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1272696
Radiological Imaging
Beschreibung

Radiological Imaging

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1275506
Specify other radiological imaging
Beschreibung

Specify other radiological imaging

Datentyp

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1275506
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Radiological Imaging Result
Beschreibung

Radiological Imaging Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1274040
Specify abnormal Imaging result
Beschreibung

Specify abnormal Imaging result

Datentyp

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C2348235
Post-Treatment Response (Week 7, 13, 25) - Bone Marrow Biopsy
Beschreibung

Post-Treatment Response (Week 7, 13, 25) - Bone Marrow Biopsy

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0699749
UMLS CUI-3
C0005954
Date of biopsy
Beschreibung

Date of biopsy

Datentyp

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
Bone Marrow Biopsy not done/not indicated
Beschreibung

Bone Marrow Biopsy not done/not indicated

Datentyp

integer

Alias
UMLS CUI [1]
C0005954
UMLS CUI [2]
C1272696
UMLS CUI [3]
C3146298
Marrow cellularity
Beschreibung

Marrow cellularity

Datentyp

integer

Alias
UMLS CUI [1]
C1561532
Tumor involvement
Beschreibung

Tumor involvement

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1314939
%
Tumor involvement
Beschreibung

Tumor involvement

Datentyp

integer

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1314939
Post-Treatment Response (Week 7 and 13) - Received medication/transfusion
Beschreibung

Post-Treatment Response (Week 7 and 13) - Received medication/transfusion

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0013227
UMLS CUI-3
C1879316
Has the patient received medication/transfusion?
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C1879316
Post-Treatment Response (Week 7, 13, 25) - Measurable Lymphoma Disease
Beschreibung

Post-Treatment Response (Week 7, 13, 25) - Measurable Lymphoma Disease

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0024299
UMLS CUI-3
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 of Measurement
Beschreibung

Date of Measurement

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0242485
Tumor Measurments - Diameter 1
Beschreibung

Tumor Measurments - Diameter 1

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1301886
cm
Tumor Measurments - Diameter 2
Beschreibung

Tumor Measurments - Diameter 2

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1301886
cm
Tumor Measurment Result
Beschreibung

Tumor Measurment Result

Datentyp

float

Maßeinheiten
  • cm^2
Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1274040
cm^2
Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease
Beschreibung

Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0024299
Non-Measurable Lymphoma Disease - Check if None
Beschreibung

Non-Measurable Lymphoma Disease - Check if None

Datentyp

integer

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1334988
Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease
Beschreibung

Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0024299
UMLS CUI-3
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 of Measurement
Beschreibung

Date of Measurement

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0242485
Disease Status
Beschreibung

Check one

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Post-Treatment Response (Week 7, 13, 25) - Response
Beschreibung

Post-Treatment Response (Week 7, 13, 25) - Response

Alias
UMLS CUI-1
C0521982
Response
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]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0011008
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Signature of Investigator
Beschreibung

Signature of Investigator

Alias
UMLS CUI-1
C2346576
Signature of Investigator
Beschreibung

Signature of Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Signature of Investigator Date
Beschreibung

Signature of Investigator Date

Datentyp

date

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

Week 3 - 13 and 25 - Laboratory Results; Physical Examination; Post-Treatment Response

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Laboratory Results (Week 3-13, 25) - Hematology
C1254595 (UMLS CUI-1)
C0018943 (UMLS CUI-2)
Hematology Date
Item
Hematology Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Performed at primary lab listed on 1572? (Hematology)
Item
Performed at primary lab listed on 1572? (Hematology)
boolean
C0022885 (UMLS CUI [1,1])
C0018943 (UMLS CUI [1,2])
Item Group
Laboratory Results (Week 3-13, 25) - Hematology
C1254595 (UMLS CUI-1)
C0018943 (UMLS CUI-2)
Item
Laboratory Test (Hematology)
integer
C0018941 (UMLS CUI [1])
Laboratory Test (Hematology)
Code List
Laboratory Test (Hematology)
CL Item
WBC (10^3/mm^3) (1)
CL Item
RBC (10^6/mm^3) (2)
CL Item
Hemoglobin (g/dL) (3)
CL Item
Hematocrit (%) (4)
CL Item
Platelet Count (10^3/mm^3) (5)
CL Item
Neutrophils (10^3/mm^3) (segs + bands) (6)
CL Item
Lymphocytes (10^3/mm^3) (7)
CL Item
Monocytes (10^3/mm^3) (8)
CL Item
Eosinophils (10^3/mm^3) (9)
CL Item
Basophils (10^3/mm^3) (10)
CL Item
Other Differential (10^3/mm^3) (11)
Laboratory Test Result (Hematology)
Item
Laboratory Test Result (Hematology)
float
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item Group
Laboratory Results (Week 25) - Hematology
C1254595 (UMLS CUI-1)
C0018943 (UMLS CUI-2)
HAMA Date
Item
HAMA Date
date
C1291910 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
HAMA Result
integer
C1291910 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
HAMA Result
Code List
HAMA Result
CL Item
Pos (1)
CL Item
Neg (2)
Item Group
Laboratory Results (Week 3, 13, 25) - Chemistry
C1254595 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Chemistry Date
Item
Chemistry Date
date
C0008000 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Performed at primary lab listed on 1572? (Chemistry)
Item
Performed at primary lab listed on 1572? (Chemistry)
boolean
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item Group
Laboratory Results (Week 3 and 13) - Chemistry
C1254595 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Laboratory Test (Chemistry)
integer
C0525044 (UMLS CUI [1])
Laboratory Test (Chemistry)
Code List
Laboratory Test (Chemistry)
CL Item
Sodium (mEq/L) (1)
CL Item
Potassium (mEq/L) (2)
CL Item
Chloride (mEq/L) (3)
CL Item
BUN (mg/dL) (4)
CL Item
Creatinine (mg/dL) (5)
CL Item
AST/GOT (IU/L) (6)
CL Item
Alkaline Phosphatase (IU/L) (7)
CL Item
LDH (IU/L) (8)
CL Item
Total Bilirubin (mg/dL) (9)
Laboratory Test Result (Chemistry)
Item
Laboratory Test Result (Chemistry)
float
C0587081 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item Group
Laboratory Results (Week 7) - Chemistry
C1254595 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Chemistry Date
Item
Chemistry Date
date
C0008000 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Performed at primary lab listed on 1572? (Chemistry)
Item
Performed at primary lab listed on 1572? (Chemistry)
boolean
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item Group
Laboratory Results (Week 7) - Chemistry
C1254595 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Laboratory Test (Chemistry)
text
C0525044 (UMLS CUI [1])
Laboratory Test (Chemistry)
Code List
Laboratory Test (Chemistry)
CL Item
Sodium (mEq/L) (1)
CL Item
Potassium (mEq/L) (2)
CL Item
Chloride (mEq/L) (3)
CL Item
BUN (mg/dL) (4)
CL Item
Creatinine (mg/dL) (5)
CL Item
AST/GOT (IU/L) (6)
CL Item
Alkaline Phosphatase (IU/L) (7)
CL Item
LDH (IU/L) (8)
CL Item
Total Bilirubin (mg/dL) (9)
CL Item
HAMA (10)
HAMA Date
Item
HAMA Date
date
C1291910 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
HAMA Result
integer
C1291910 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
HAMA Result
Code List
HAMA Result
CL Item
Pos  (1)
CL Item
Neg (2)
Item Group
Laboratory Results (Week 25) - Chemistry
C1254595 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Laboratory Test (Chemistry)
integer
C0525044 (UMLS CUI [1])
Laboratory Test (Chemistry)
Code List
Laboratory Test (Chemistry)
CL Item
Sodium (mEq/L) (1)
CL Item
Potassium (mEq/L) (2)
CL Item
Chloride (mEq/L) (3)
CL Item
BUN (mg/dL) (4)
CL Item
Creatinine (mg/dL) (5)
CL Item
AST/GOT (IU/L) (6)
CL Item
Alkaline Phosphatase (IU/L) (7)
CL Item
LDH (IU/L) (8)
CL Item
Total Bilirubin (mg/dL) (9)
CL Item
TSH (uU7mL) (10)
CL Item
Total T3 (mg/dL) (11)
CL Item
Free T4 (ug/dL) (12)
Laboratory Test Result (Chemistry)
Item
Laboratory Test Result (Chemistry)
text
C0587081 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item Group
Physical Examination (Week 7, 13, 25)
C0031809 (UMLS CUI-1)
Item
Does the patient currently have evidence of "B" symptoms?
text
C1706867 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Does the patient currently have evidence of "B" symptoms?
Code List
Does the patient currently have evidence of "B" symptoms?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Done (ND)
Item
Current "B" symptoms
integer
C1706867 (UMLS CUI [1])
Current "B" symptoms
Code List
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])
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])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Physical Examination (Week 7, 13, 25)
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
integer
C1274040 (UMLS CUI [1])
Result
Code List
Result
CL Item
Not Done (1)
CL Item
Normal (2)
CL Item
Abnormal (3)
If abnormal, specify
Item
If abnormal, specify
text
C0243095 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Post-Treatment Response (Week 7, 13, 25) - CT or other Radiological Imaging Results
C0521982 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C0011923 (UMLS CUI-3)
C1274040 (UMLS CUI-4)
Item
Organ/System
integer
C0678852 (UMLS CUI [1])
Organ/System
Code List
Organ/System
CL Item
Head/Neck  (1)
CL Item
Chest  (2)
CL Item
Abdomen  (3)
CL Item
Pelvis  (4)
CL Item
Other (5)
Imaging Date
Item
Imaging Date
date
C0011923 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Imaging Not done
integer
C0011923 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Imaging Not done
Code List
Imaging Not done
CL Item
Not Done (1)
Item
Radiological Imaging
integer
C0011923 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
Radiological Imaging
Code List
Radiological Imaging
CL Item
CT  (1)
CL Item
MRI  (2)
CL Item
X-ray  (3)
CL Item
Other (4)
Specify other radiological imaging
Item
Specify other radiological imaging
text
C0011923 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Radiological Imaging Result
integer
C0011923 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Radiological Imaging Result
Code List
Radiological Imaging Result
CL Item
Normal  (1)
CL Item
Abnormal (specify) (2)
Specify abnormal Imaging result
Item
Specify abnormal Imaging result
text
C0011923 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Post-Treatment Response (Week 7, 13, 25) - Bone Marrow Biopsy
C0521982 (UMLS CUI-1)
C0699749 (UMLS CUI-2)
C0005954 (UMLS CUI-3)
Date of biopsy
Item
Date of biopsy
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Bone Marrow Biopsy not done/not indicated
integer
C0005954 (UMLS CUI [1])
C1272696 (UMLS CUI [2])
C3146298 (UMLS CUI [3])
Bone Marrow Biopsy not done/not indicated
Code List
Bone Marrow Biopsy not done/not indicated
CL Item
Not done (1)
CL Item
Not indicated (patient not in CCR or CR) (2)
Item
Marrow cellularity
integer
C1561532 (UMLS CUI [1])
Marrow cellularity
Code List
Marrow cellularity
CL Item
Normal  (1)
CL Item
Hypocellular  (2)
CL Item
Hypercellular (3)
Tumor involvement
Item
Tumor involvement
float
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Item
Tumor involvement
integer
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Tumor involvement
Code List
Tumor involvement
CL Item
Unilateral  (1)
CL Item
Bilateral (2)
Item Group
Post-Treatment Response (Week 7 and 13) - Received medication/transfusion
C0521982 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C1879316 (UMLS CUI-3)
Item
Has the patient received medication/transfusion?
integer
C0013227 (UMLS CUI [1])
C1879316 (UMLS CUI [2])
Has the patient received medication/transfusion?
Code List
Has the patient received medication/transfusion?
CL Item
G-CSF/GM-CSF (1)
CL Item
Platelet transfusion (2)
CL Item
RBC transfusion (3)
CL Item
Erythropoitein (4)
CL Item
Thrombopoietin (5)
Item Group
Post-Treatment Response (Week 7, 13, 25) - Measurable Lymphoma Disease
C0521982 (UMLS CUI-1)
C0024299 (UMLS CUI-2)
C1513041 (UMLS CUI-3)
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date of Measurement
Item
Date of Measurement
date
C0011008 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Tumor Measurments - Diameter 1
Item
Tumor Measurments - Diameter 1
float
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Tumor Measurments - Diameter 2
Item
Tumor Measurments - Diameter 2
float
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Tumor Measurment Result
Item
Tumor Measurment Result
float
C0475440 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease
C0521982 (UMLS CUI-1)
C0024299 (UMLS CUI-2)
Item
Non-Measurable Lymphoma Disease - Check if None
integer
C0024299 (UMLS CUI [1,1])
C1334988 (UMLS CUI [1,2])
Non-Measurable Lymphoma Disease - Check if None
Code List
Non-Measurable Lymphoma Disease - Check if None
CL Item
None (1)
Item Group
Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease
C0521982 (UMLS CUI-1)
C0024299 (UMLS CUI-2)
C1334988 (UMLS CUI-3)
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date of Measurement
Item
Date of Measurement
date
C0011008 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item
Disease Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Disease Status
Code List
Disease Status
CL Item
New (1)
CL Item
Increased (2)
CL Item
Stable (3)
CL Item
Decreased (4)
Item Group
Post-Treatment Response (Week 7, 13, 25) - Response
C0521982 (UMLS CUI-1)
Item
Response
integer
C0521982 (UMLS CUI [1])
Response
Code List
Response
CL Item
PD (1)
CL Item
SD (2)
CL Item
PR (3)
CL Item
CCR (4)
CL Item
CR (5)
Date of Response Evaluation
Item
Date of Response Evaluation
date
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Signature of Investigator
C2346576 (UMLS CUI-1)
Signature of Investigator
Item
Signature of Investigator
text
C2346576 (UMLS CUI [1])
Signature of Investigator Date
Item
Signature of Investigator Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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