ID

22285

Description

Study part: Unscheduled 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. 29/05/2017 29/05/2017 -
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Roche

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29 mai 2017

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UNSCHEDULED TUMOR ASSESSMENT Roche H0650g Breast Cancer

Anglais

UNSCHEDULED TUMOR ASSESSMENT

1 Formulaires  
TUMOR ASSESSMENT
Description

TUMOR ASSESSMENT

Alias
UMLS CUI-1
C3889740
PATIENT INT.
Description

Patient initial

Type de données

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Description

Patient id

Type de données

integer

Alias
UMLS CUI [1]
C2348585
A. COMPLETE TUMOR ASSESSMENT WORKSHEET
Description

worksheet tumor assessment

Type de données

boolean

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

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

Type de données

date

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

X-ray

Type de données

boolean

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

CT chest

Type de données

boolean

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

CT Abdomen

Type de données

boolean

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

MRI

Type de données

boolean

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

ULTRASOUND

Type de données

boolean

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

PHOTOGRAPH

Type de données

boolean

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

PHYSICAL EXAMINATION

Type de données

boolean

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

other

Type de données

text

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

tumor response

Type de données

integer

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

Tumor site Tumor Progression bone

Type de données

boolean

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

Tumor site Tumor Progression Liver

Type de données

boolean

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

Tumor site Tumor Progression LUNG

Type de données

boolean

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

Tumor site Tumor Progression LYMPH NODES

Type de données

boolean

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

Tumor site Tumor Progression REGIONAL LYMPH NODES

Type de données

boolean

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

Tumor site Tumor Progression CHEST WALL

Type de données

boolean

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

Tumor site Tumor Progression abdomen

Type de données

boolean

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

Tumor site Tumor Progression Mediastinum

Type de données

boolean

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

Tumor site Tumor Progression CNS

Type de données

boolean

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

Tumor site Tumor Progression Other

Type de données

text

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C0205394
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Similar models

UNSCHEDULED TUMOR ASSESSMENT

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
TUMOR ASSESSMENT
C3889740 (UMLS CUI-1)
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (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])
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