Information:
Fel:
ID
22292
Beskrivning
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"
Nyckelord
Versioner (1)
- 2017-05-29 2017-05-29 -
Rättsinnehavare
Roche
Uppladdad den
29 maj 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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DIAGNOSIS Roche H0650g Breast Cancer
Similar models
DIAGNOSIS
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
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])
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])
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])
bone
Item
METASTATIC SITE(S) -1. Bone
boolean
C0262950 (UMLS CUI [1])
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])
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])
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])
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])
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])
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])
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])
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)