ID

22280

Beschreibung

Study part: Tumor Assessment Worksheet & Tumor Assessment. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

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  1. 29.05.17 29.05.17 -
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29. Mai 2017

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TUMOR ASSESSMENT WORKSHEET & TUMOR ASSESSMENT Roche H0650g Breast Cancer

Englisch

TUMOR ASSESSMENT WORKSHEET & TUMOR ASSESSMENT

1 Formulare  
TUMOR LOCATION
Beschreibung

TUMOR LOCATION

Alias
UMLS CUI-1
C0872338
PATIENT INT.
Beschreibung

Patient initial

Datentyp

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Beschreibung

Patient id

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
CHEST WALL
Beschreibung

chest wall

Datentyp

text

Alias
UMLS CUI [1]
C0205076
ABDOMEN
Beschreibung

Abdomen

Datentyp

text

Alias
UMLS CUI [1]
C0000726
LIVER
Beschreibung

Liver

Datentyp

text

Alias
UMLS CUI [1]
C0023884
LUNGS
Beschreibung

Lungs

Datentyp

text

Alias
UMLS CUI [1]
C0024109
TUMOR ASSESSMENT
Beschreibung

TUMOR ASSESSMENT

Alias
UMLS CUI-1
C3889740
A. COMPLETE TUMOR ASSESSMENT WORKSHEET
Beschreibung

worksheet tumor assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349155
UMLS CUI [1,2]
C3889740
B. DATE OF ASSESSMENT WHICH DETERMINED OVERALL RESPONSE/PROGRESSION·
Beschreibung

IN THE CASE OF PROGRESSIVE DISEASE. USE THE EARLIEST DATE THE PROGRESSION WAS DIAGNOSED. IN ALL OTHER CASES. THE DATE OF THE LAST ASSESSMENT (1.e., CT. X-RAY, ETC.) PERFORMED SHOULD BE RECORDED.

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3889740
C. METHOD(S) OF ASSESSMENT USED: X-RAY
Beschreibung

X-ray

Datentyp

boolean

Alias
UMLS CUI [1]
C0043309
C. METHOD(S) OF ASSESSMENT USED: CT CHEST
Beschreibung

CT chest

Datentyp

boolean

Alias
UMLS CUI [1]
C0202823
C. METHOD(S) OF ASSESSMENT USED: CT ABDOMEN
Beschreibung

CT Abdomen

Datentyp

boolean

Alias
UMLS CUI [1]
C0412620
C. METHOD(S) OF ASSESSMENT USED: MRI
Beschreibung

MRI

Datentyp

boolean

Alias
UMLS CUI [1]
C0024485
C. METHOD(S) OF ASSESSMENT USED: ULTRASOUND
Beschreibung

ULTRASOUND

Datentyp

boolean

Alias
UMLS CUI [1]
C0041618
C. METHOD(S) OF ASSESSMENT USED: PHOTOGRAPH
Beschreibung

PHOTOGRAPH

Datentyp

boolean

Alias
UMLS CUI [1]
C0441468
C. METHOD(S) OF ASSESSMENT USED: PHYSICAL EXAMINATION
Beschreibung

PHYSICAL EXAMINATION

Datentyp

boolean

Alias
UMLS CUI [1]
C0031809
C. METHOD(S) OF ASSESSMENT USED: OTHER
Beschreibung

other

Datentyp

text

Alias
UMLS CUI [1]
C0205394
D INVESTIGATOR ASSESSMENT OF OVERALL RESPONSE (CHECK ONE):
Beschreibung

tumor response

Datentyp

integer

Alias
UMLS CUI [1]
C3539879
E. SITES OF PROGRESSION: BONE
Beschreibung

Tumor site Tumor Progression bone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C0262950
E. SITES OF PROGRESSION: LIVER
Beschreibung

Tumor site Tumor Progression Liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C0023884
E. SITES OF PROGRESSION: LUNG
Beschreibung

Tumor site Tumor Progression LUNG

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C0024109
E. SITES OF PROGRESSION: DISTAL LYMPH NODES
Beschreibung

Tumor site Tumor Progression LYMPH NODES

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C0024204
E. SITES OF PROGRESSION: REGIONAL LYMPH NODES
Beschreibung

Tumor site Tumor Progression REGIONAL LYMPH NODES

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C0807729
E. SITES OF PROGRESSION: CHEST WALL
Beschreibung

Tumor site Tumor Progression CHEST WALL

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C0205076
E. SITES OF PROGRESSION: ABDOMEN
Beschreibung

Tumor site Tumor Progression abdomen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C0000726
E. SITES OF PROGRESSION: MEDIASTINUM
Beschreibung

Tumor site Tumor Progression Mediastinum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C0025066
E. SITES OF PROGRESSION: CNS
Beschreibung

Tumor site Tumor Progression CNS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C3714787
E. SITES OF PROGRESSION: OTHER
Beschreibung

Tumor site Tumor Progression Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C0205394
TUMOR LOCATION
Beschreibung

TUMOR LOCATION

Alias
UMLS CUI-1
C0872338
LYMPH NODES
Beschreibung

LYMPH NODES

Datentyp

text

Alias
UMLS CUI [1]
C0024204
BONE
Beschreibung

BONE

Datentyp

text

Alias
UMLS CUI [1]
C0262950
ABDOMEN
Beschreibung

ABDOMEN

Datentyp

text

Alias
UMLS CUI [1]
C0000726
OTHER
Beschreibung

OTHER

Datentyp

text

Alias
UMLS CUI [1]
C0205394
TUMOR ASSESSMENT WORKSHEET
Beschreibung

TUMOR ASSESSMENT WORKSHEET

Alias
UMLS CUI-1
C2349155
UMLS CUI-2
C3889740
LESION NUMBER
Beschreibung

Lesion number

Datentyp

integer

Alias
UMLS CUI [1]
C0449791
SITE OF LESION
Beschreibung

tumor site

Datentyp

integer

Alias
UMLS CUI [1]
C0475445
IF "OTHER" SITE, DESCRIBE:
Beschreibung

other

Datentyp

text

Alias
UMLS CUI [1]
C0205394
DATE OF ASSESSMENT PROCEDURE:
Beschreibung

Date Tumor assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3889740
METHOD OF ASSESSMENT
Beschreibung

METHOD OF ASSESSMENT

Datentyp

integer

Alias
UMLS CUI [1]
C2598110
IF "OTHER" METHOD, DESCRIBE:
Beschreibung

other

Datentyp

text

Alias
UMLS CUI [1]
C0205394
SIZE OF LESION
Beschreibung

lesion size

Datentyp

text

Maßeinheiten
  • cm x cm
Alias
UMLS CUI [1]
C0449453
cm x cm
MEASURABLE?
Beschreibung

Lesion size Measurable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C1513040
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Ähnliche Modelle

TUMOR ASSESSMENT WORKSHEET & TUMOR ASSESSMENT

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
TUMOR LOCATION
C0872338 (UMLS CUI-1)
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
chest wall
Item
CHEST WALL
text
C0205076 (UMLS CUI [1])
Abdomen
Item
ABDOMEN
text
C0000726 (UMLS CUI [1])
Liver
Item
LIVER
text
C0023884 (UMLS CUI [1])
Lungs
Item
LUNGS
text
C0024109 (UMLS CUI [1])
Item Group
TUMOR ASSESSMENT
C3889740 (UMLS CUI-1)
worksheet tumor assessment
Item
A. COMPLETE TUMOR ASSESSMENT WORKSHEET
boolean
C2349155 (UMLS CUI [1,1])
C3889740 (UMLS CUI [1,2])
date Tumor assessment
Item
B. DATE OF ASSESSMENT WHICH DETERMINED OVERALL RESPONSE/PROGRESSION·
date
C0011008 (UMLS CUI [1,1])
C3889740 (UMLS CUI [1,2])
X-ray
Item
C. METHOD(S) OF ASSESSMENT USED: X-RAY
boolean
C0043309 (UMLS CUI [1])
CT chest
Item
C. METHOD(S) OF ASSESSMENT USED: CT CHEST
boolean
C0202823 (UMLS CUI [1])
CT Abdomen
Item
C. METHOD(S) OF ASSESSMENT USED: CT ABDOMEN
boolean
C0412620 (UMLS CUI [1])
MRI
Item
C. METHOD(S) OF ASSESSMENT USED: MRI
boolean
C0024485 (UMLS CUI [1])
ULTRASOUND
Item
C. METHOD(S) OF ASSESSMENT USED: ULTRASOUND
boolean
C0041618 (UMLS CUI [1])
PHOTOGRAPH
Item
C. METHOD(S) OF ASSESSMENT USED: PHOTOGRAPH
boolean
C0441468 (UMLS CUI [1])
PHYSICAL EXAMINATION
Item
C. METHOD(S) OF ASSESSMENT USED: PHYSICAL EXAMINATION
boolean
C0031809 (UMLS CUI [1])
other
Item
C. METHOD(S) OF ASSESSMENT USED: OTHER
text
C0205394 (UMLS CUI [1])
Item
D INVESTIGATOR ASSESSMENT OF OVERALL RESPONSE (CHECK ONE):
integer
C3539879 (UMLS CUI [1])
tumor response
Code List
D INVESTIGATOR ASSESSMENT OF OVERALL RESPONSE (CHECK ONE):
CL Item
COMPLETE RESPONSE: DISAPPEARANCE OF ALL RADIOGRAPHICALLY AND/OR VISUALLY APPARENT TUMOR. COMPLETE RESPONSE OF SKIN AND CHEST WALL MUST BE CONFIRMED BY BIOPSY.  (1)
CL Item
PARTIAL RESPONSE: REDUCTION OF AT LEAST 50% IN THE SUM OF THE PRODUCTS OF THE PERPENDICULAR DIAMETERS OF ALL MEASURABLE LESIONS. NO NEW LESIONS MAY HAVE APPEARED, NOR MAY ANY LESION HAVE PROGRESSED IN SIZE.  (2)
CL Item
MINOR RESPONSE: REDUCTION OF 25% TO 49% IN THE SUM OF THE PRODUCTS OF THE PERPENDICULAR DIAMETERS OF ALL MEASURABLE LESIONS. NO NEW LESIONS MAY HAVE APPEARED. NOR MAY ANY LESION HAVE PROGRESSED IN SIZE.  (3)
CL Item
STABLE DISEASE: NO CHANGE OF GREATER THAN 25% IN THE SIZE OF MEASURABLE LESIONS. NO NEW LESIONS MAY HAVE APPEARED. (4)
CL Item
PROGRESSIVE DISEASE: OBJECTIVE EVIDENCE OF AN INCREASE OF 25% OR MORE IN ANY MEASURABLE LESION OR THE APPEARANCE OF NEW LESIONS. IF PROGRESSION IS NOTED. COMPLETE QUESTION "E" (SITES OF PROGRESSION) AND STUDY TERMINATION SECTION OF THE CASE REPORT FORM. (5)
Tumor site Tumor Progression bone
Item
E. SITES OF PROGRESSION: BONE
boolean
C0475445 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0262950 (UMLS CUI [1,3])
Tumor site Tumor Progression Liver
Item
E. SITES OF PROGRESSION: LIVER
boolean
C0475445 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
Tumor site Tumor Progression LUNG
Item
E. SITES OF PROGRESSION: LUNG
boolean
C0475445 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0024109 (UMLS CUI [1,3])
Tumor site Tumor Progression LYMPH NODES
Item
E. SITES OF PROGRESSION: DISTAL LYMPH NODES
boolean
C0475445 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])
Tumor site Tumor Progression REGIONAL LYMPH NODES
Item
E. SITES OF PROGRESSION: REGIONAL LYMPH NODES
boolean
C0475445 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0807729 (UMLS CUI [1,3])
Tumor site Tumor Progression CHEST WALL
Item
E. SITES OF PROGRESSION: CHEST WALL
boolean
C0475445 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0205076 (UMLS CUI [1,3])
Tumor site Tumor Progression abdomen
Item
E. SITES OF PROGRESSION: ABDOMEN
boolean
C0475445 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,3])
Tumor site Tumor Progression Mediastinum
Item
E. SITES OF PROGRESSION: MEDIASTINUM
boolean
C0475445 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0025066 (UMLS CUI [1,3])
Tumor site Tumor Progression CNS
Item
E. SITES OF PROGRESSION: CNS
boolean
C0475445 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
Tumor site Tumor Progression Other
Item
E. SITES OF PROGRESSION: OTHER
text
C0475445 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
TUMOR LOCATION
C0872338 (UMLS CUI-1)
LYMPH NODES
Item
LYMPH NODES
text
C0024204 (UMLS CUI [1])
BONE
Item
BONE
text
C0262950 (UMLS CUI [1])
ABDOMEN
Item
ABDOMEN
text
C0000726 (UMLS CUI [1])
OTHER
Item
OTHER
text
C0205394 (UMLS CUI [1])
Item Group
TUMOR ASSESSMENT WORKSHEET
C2349155 (UMLS CUI-1)
C3889740 (UMLS CUI-2)
Lesion number
Item
LESION NUMBER
integer
C0449791 (UMLS CUI [1])
Item
SITE OF LESION
integer
C0475445 (UMLS CUI [1])
tumor site
Code List
SITE OF LESION
CL Item
BONE  (1)
CL Item
LIVER  (2)
CL Item
LUNG  (3)
CL Item
DISTAL LYMPH NODES  (4)
CL Item
REGIONAL LYMPH NODES  (5)
CL Item
CHEST WALL  (6)
CL Item
ABDOMEN. (EXCLUDING LIVER)  (7)
CL Item
MEDIASTINUM  (8)
CL Item
CNS  (9)
CL Item
OTHER (DESCRIBE) (10)
other
Item
IF "OTHER" SITE, DESCRIBE:
text
C0205394 (UMLS CUI [1])
Date Tumor assessment
Item
DATE OF ASSESSMENT PROCEDURE:
date
C0011008 (UMLS CUI [1,1])
C3889740 (UMLS CUI [1,2])
Item
METHOD OF ASSESSMENT
integer
C2598110 (UMLS CUI [1])
METHOD OF ASSESSMENT
Code List
METHOD OF ASSESSMENT
CL Item
X-RAY  (1)
CL Item
CT CHEST  (2)
CL Item
CT ABDOMEN  (3)
CL Item
MRI  (4)
CL Item
ULTRASOUND  (5)
CL Item
PHOTOGRAPH  (6)
CL Item
PHYSICAL EXAMINATION  (7)
CL Item
OTHER (DESCRIBE) (1O)
other
Item
IF "OTHER" METHOD, DESCRIBE:
text
C0205394 (UMLS CUI [1])
lesion size
Item
SIZE OF LESION
text
C0449453 (UMLS CUI [1])
Lesion size Measurable
Item
MEASURABLE?
boolean
C0449453 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
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