ID

22292

Description

Study part: Diagnosis. 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"

Keywords

Versions (1)
  1. 5/29/17 5/29/17 -
Copyright Holder

Roche

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May 29, 2017

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Creative Commons BY-NC 3.0
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DIAGNOSIS Roche H0650g Breast Cancer

English

DIAGNOSIS

1 forms  
  1. StudyEvent: ODM
    1. DIAGNOSIS
PRIMARY DIAGNOSIS
Description

PRIMARY DIAGNOSIS

Alias
UMLS CUI-1
C0332137
PATIENT INT.
Description

Patient initial

Data type

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Description

Patient id

Data type

integer

Alias
UMLS CUI [1]
C2348585
PRIMARY SITE
Description

PRIMARY SITE

Data type

integer

Alias
UMLS CUI [1]
C0475447
DATE OF PRIMARY DIAGNOSIS
Description

DATE OF DIAGNOSIS

Data type

date

Alias
UMLS CUI [1]
C2316983
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-0. NONE
Description

METASTATIC SITE

Data type

boolean

Alias
UMLS CUI [1]
C0280457
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-1. Bone
Description

bone

Data type

boolean

Alias
UMLS CUI [1]
C0262950
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-2. LIVER
Description

Liver

Data type

boolean

Alias
UMLS CUI [1]
C0023884
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-3. LUNG
Description

Lung

Data type

boolean

Alias
UMLS CUI [1]
C0024109
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-4. DISTAL LYMPH NODES
Description

LYMPH NODES

Data type

boolean

Alias
UMLS CUI [1]
C0024204
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-6. CHEST WALL
Description

CHEST WALL

Data type

boolean

Alias
UMLS CUI [1]
C0205076
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-7. ABDOMEN (excl. Liver)
Description

ABDOMEN

Data type

boolean

Alias
UMLS CUI [1]
C0000726
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-8. MEDIASTINUM
Description

MEDIASTINUM

Data type

boolean

Alias
UMLS CUI [1]
C0025066
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-10. OTHER (SPECIFY):
Description

other

Data type

text

Alias
UMLS CUI [1]
C0205394
METASTATIC DIAGNOSIS
Description

METASTATIC DIAGNOSIS

Alias
UMLS CUI-1
C0011900
UMLS CUI-2
C0027627
DATE OF FIRST DIAGNOSIS OF METASTATIC DISEASE AND SITE(S) OF METASTASES NOTED
Description

date of diagnosis metastasis

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0027627
METASTATIC SITE(S) -1. Bone
Description

bone

Data type

boolean

Alias
UMLS CUI [1]
C0262950
METASTATIC SITE(S) -2. LIVER
Description

Liver

Data type

boolean

Alias
UMLS CUI [1]
C0023884
METASTATIC SITE(S) -3. LUNG
Description

Lung

Data type

boolean

Alias
UMLS CUI [1]
C0024109
METASTATIC SITE(S) -4. DISTAL LYMPH NODES
Description

LYMPH NODES

Data type

boolean

Alias
UMLS CUI [1]
C0024204
METASTATIC SITE(S)-6. CHEST WALL
Description

CHEST WALL

Data type

boolean

Alias
UMLS CUI [1]
C0205076
METASTATIC SITE(S) -7. ABDOMEN (excl. Liver)
Description

ABDOMEN

Data type

boolean

Alias
UMLS CUI [1]
C0000726
METASTATIC SITE(S)-8. MEDIASTINUM
Description

MEDIASTINUM

Data type

boolean

Alias
UMLS CUI [1]
C0025066
METASTATIC SITE(S)-10. OTHER (SPECIFY):
Description

other

Data type

text

Alias
UMLS CUI [1]
C0205394
AT TIME OF STUDY
Description

AT TIME OF STUDY

Alias
UMLS CUI-1
C2598110
METASTATIC SITE(S) -1. Bone
Description

bone

Data type

boolean

Alias
UMLS CUI [1]
C0262950
METHOD OF ASSESSMENT
Description

method of assessment

Data type

integer

Alias
UMLS CUI [1]
C2598110
IF OTHER, DESCRIBE:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
METASTATIC SITE(S) -2. LIVER
Description

Liver

Data type

boolean

Alias
UMLS CUI [1]
C0023884
METHOD OF ASSESSMENT
Description

method of assessment

Data type

integer

Alias
UMLS CUI [1]
C2598110
IF OTHER, DESCRIBE:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
METASTATIC SITE(S) -3. LUNG
Description

Lung

Data type

boolean

Alias
UMLS CUI [1]
C0024109
METHOD OF ASSESSMENT
Description

method of assessment

Data type

integer

Alias
UMLS CUI [1]
C2598110
IF OTHER, DESCRIBE:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
METASTATIC SITE(S) -4. DISTAL LYMPH NODES
Description

LYMPH NODES

Data type

boolean

Alias
UMLS CUI [1]
C0024204
METHOD OF ASSESSMENT
Description

method of assessment

Data type

integer

Alias
UMLS CUI [1]
C2598110
IF OTHER, DESCRIBE:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
METASTATIC SITE(S)-6. CHEST WALL
Description

CHEST WALL

Data type

boolean

Alias
UMLS CUI [1]
C0205076
METHOD OF ASSESSMENT
Description

method of assessment

Data type

integer

Alias
UMLS CUI [1]
C2598110
IF OTHER, DESCRIBE:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
METASTATIC SITE(S) -7. ABDOMEN (excl. Liver)
Description

ABDOMEN

Data type

boolean

Alias
UMLS CUI [1]
C0000726
METHOD OF ASSESSMENT
Description

method of assessment

Data type

integer

Alias
UMLS CUI [1]
C2598110
IF OTHER, DESCRIBE:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
METASTATIC SITE(S)-8. MEDIASTINUM
Description

MEDIASTINUM

Data type

boolean

Alias
UMLS CUI [1]
C0025066
METHOD OF ASSESSMENT
Description

method of assessment

Data type

integer

Alias
UMLS CUI [1]
C2598110
IF OTHER, DESCRIBE:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
METASTATIC SITE(S)-10. OTHER (SPECIFY):
Description

other

Data type

text

Alias
UMLS CUI [1]
C0205394
METHOD OF ASSESSMENT
Description

method of assessment

Data type

integer

Alias
UMLS CUI [1]
C2598110
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Similar models

DIAGNOSIS

1 forms
  1. StudyEvent: ODM
    1. DIAGNOSIS
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PRIMARY DIAGNOSIS
C0332137 (UMLS CUI-1)
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
Item
PRIMARY SITE
integer
C0475447 (UMLS CUI [1])
PRIMARY SITE
Code List
PRIMARY SITE
CL Item
Left Breast (1)
CL Item
Right Breast (2)
CL Item
Both Breasts (3)
DATE OF DIAGNOSIS
Item
DATE OF PRIMARY DIAGNOSIS
date
C2316983 (UMLS CUI [1])
METASTATIC SITE
Item
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-0. NONE
boolean
C0280457 (UMLS CUI [1])
bone
Item
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-1. Bone
boolean
C0262950 (UMLS CUI [1])
Liver
Item
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-2. LIVER
boolean
C0023884 (UMLS CUI [1])
Lung
Item
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-3. LUNG
boolean
C0024109 (UMLS CUI [1])
LYMPH NODES
Item
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-4. DISTAL LYMPH NODES
boolean
C0024204 (UMLS CUI [1])
CHEST WALL
Item
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-6. CHEST WALL
boolean
C0205076 (UMLS CUI [1])
ABDOMEN
Item
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-7. ABDOMEN (excl. Liver)
boolean
C0000726 (UMLS CUI [1])
MEDIASTINUM
Item
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-8. MEDIASTINUM
boolean
C0025066 (UMLS CUI [1])
other
Item
METASTATIC SITE(S) AT PRIMARY DIAGNOSIS-10. OTHER (SPECIFY):
text
C0205394 (UMLS CUI [1])
Item Group
METASTATIC DIAGNOSIS
C0011900 (UMLS CUI-1)
C0027627 (UMLS CUI-2)
date of diagnosis metastasis
Item
DATE OF FIRST DIAGNOSIS OF METASTATIC DISEASE AND SITE(S) OF METASTASES NOTED
date
C2316983 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
bone
Item
METASTATIC SITE(S) -1. Bone
boolean
C0262950 (UMLS CUI [1])
Liver
Item
METASTATIC SITE(S) -2. LIVER
boolean
C0023884 (UMLS CUI [1])
Lung
Item
METASTATIC SITE(S) -3. LUNG
boolean
C0024109 (UMLS CUI [1])
LYMPH NODES
Item
METASTATIC SITE(S) -4. DISTAL LYMPH NODES
boolean
C0024204 (UMLS CUI [1])
CHEST WALL
Item
METASTATIC SITE(S)-6. CHEST WALL
boolean
C0205076 (UMLS CUI [1])
ABDOMEN
Item
METASTATIC SITE(S) -7. ABDOMEN (excl. Liver)
boolean
C0000726 (UMLS CUI [1])
MEDIASTINUM
Item
METASTATIC SITE(S)-8. MEDIASTINUM
boolean
C0025066 (UMLS CUI [1])
other
Item
METASTATIC SITE(S)-10. OTHER (SPECIFY):
text
C0205394 (UMLS CUI [1])
Item Group
AT TIME OF STUDY
C2598110 (UMLS CUI-1)
bone
Item
METASTATIC SITE(S) -1. Bone
boolean
C0262950 (UMLS CUI [1])
Item
METHOD OF ASSESSMENT
integer
C2598110 (UMLS CUI [1])
undefined item
Code List
METHOD OF ASSESSMENT
CL Item
1 X-ray  (1)
CL Item
2 CTChest  (2)
CL Item
3 CT Abdomen  (3)
CL Item
4 MRI  (4)
CL Item
5 Ultrasound (5 )
CL Item
6 Photograph (6)
CL Item
Physical Examination (7)
CL Item
10 Other (describe) (8)
Other
Item
IF OTHER, DESCRIBE:
text
C0205394 (UMLS CUI [1])
Liver
Item
METASTATIC SITE(S) -2. LIVER
boolean
C0023884 (UMLS CUI [1])
Item
METHOD OF ASSESSMENT
integer
C2598110 (UMLS CUI [1])
undefined item
Code List
METHOD OF ASSESSMENT
CL Item
1 X-ray  (1)
CL Item
2 CTChest  (2)
CL Item
3 CT Abdomen  (3)
CL Item
4 MRI  (4)
CL Item
5 Ultrasound (5 )
CL Item
6 Photograph (6)
CL Item
Physical Examination (7)
CL Item
10 Other (describe) (8)
Other
Item
IF OTHER, DESCRIBE:
text
C0205394 (UMLS CUI [1])
Lung
Item
METASTATIC SITE(S) -3. LUNG
boolean
C0024109 (UMLS CUI [1])
Item
METHOD OF ASSESSMENT
integer
C2598110 (UMLS CUI [1])
undefined item
Code List
METHOD OF ASSESSMENT
CL Item
1 X-ray  (1)
CL Item
2 CTChest  (2)
CL Item
3 CT Abdomen  (3)
CL Item
4 MRI  (4)
CL Item
5 Ultrasound (5 )
CL Item
6 Photograph (6)
CL Item
Physical Examination (7)
CL Item
10 Other (describe) (8)
Other
Item
IF OTHER, DESCRIBE:
text
C0205394 (UMLS CUI [1])
LYMPH NODES
Item
METASTATIC SITE(S) -4. DISTAL LYMPH NODES
boolean
C0024204 (UMLS CUI [1])
Item
METHOD OF ASSESSMENT
integer
C2598110 (UMLS CUI [1])
undefined item
Code List
METHOD OF ASSESSMENT
CL Item
1 X-ray  (1)
CL Item
2 CTChest  (2)
CL Item
3 CT Abdomen  (3)
CL Item
4 MRI  (4)
CL Item
5 Ultrasound (5 )
CL Item
6 Photograph (6)
CL Item
Physical Examination (7)
CL Item
10 Other (describe) (8)
Other
Item
IF OTHER, DESCRIBE:
text
C0205394 (UMLS CUI [1])
CHEST WALL
Item
METASTATIC SITE(S)-6. CHEST WALL
boolean
C0205076 (UMLS CUI [1])
Item
METHOD OF ASSESSMENT
integer
C2598110 (UMLS CUI [1])
undefined item
Code List
METHOD OF ASSESSMENT
CL Item
1 X-ray  (1)
CL Item
2 CTChest  (2)
CL Item
3 CT Abdomen  (3)
CL Item
4 MRI  (4)
CL Item
5 Ultrasound (5 )
CL Item
6 Photograph (6)
CL Item
Physical Examination (7)
CL Item
10 Other (describe) (8)
Other
Item
IF OTHER, DESCRIBE:
text
C0205394 (UMLS CUI [1])
ABDOMEN
Item
METASTATIC SITE(S) -7. ABDOMEN (excl. Liver)
boolean
C0000726 (UMLS CUI [1])
Item
METHOD OF ASSESSMENT
integer
C2598110 (UMLS CUI [1])
undefined item
Code List
METHOD OF ASSESSMENT
CL Item
1 X-ray  (1)
CL Item
2 CTChest  (2)
CL Item
3 CT Abdomen  (3)
CL Item
4 MRI  (4)
CL Item
5 Ultrasound (5 )
CL Item
6 Photograph (6)
CL Item
Physical Examination (7)
CL Item
10 Other (describe) (8)
Other
Item
IF OTHER, DESCRIBE:
text
C0205394 (UMLS CUI [1])
MEDIASTINUM
Item
METASTATIC SITE(S)-8. MEDIASTINUM
boolean
C0025066 (UMLS CUI [1])
Item
METHOD OF ASSESSMENT
integer
C2598110 (UMLS CUI [1])
undefined item
Code List
METHOD OF ASSESSMENT
CL Item
1 X-ray  (1)
CL Item
2 CTChest  (2)
CL Item
3 CT Abdomen  (3)
CL Item
4 MRI  (4)
CL Item
5 Ultrasound (5 )
CL Item
6 Photograph (6)
CL Item
Physical Examination (7)
CL Item
10 Other (describe) (8)
Other
Item
IF OTHER, DESCRIBE:
text
C0205394 (UMLS CUI [1])
other
Item
METASTATIC SITE(S)-10. OTHER (SPECIFY):
text
C0205394 (UMLS CUI [1])
Item
METHOD OF ASSESSMENT
integer
C2598110 (UMLS CUI [1])
undefined item
Code List
METHOD OF ASSESSMENT
CL Item
1 X-ray  (1)
CL Item
2 CTChest  (2)
CL Item
3 CT Abdomen  (3)
CL Item
4 MRI  (4)
CL Item
5 Ultrasound (5 )
CL Item
6 Photograph (6)
CL Item
Physical Examination (7)
CL Item
10 Other (describe) (8)
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