ID

43811

Description

Study part: Prognostic factors. 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. 16/05/2017 16/05/2017 -
  2. 20/09/2021 20/09/2021 -
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PROGNOSTIC FACTORS Roche H0650g Breast Cancer

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PROGNOSTIC FACTORS

1 Formulaires  
  1. StudyEvent: ODM
    1. PROGNOSTIC FACTORS
PROGNOSTIC FACTORS
Description

PROGNOSTIC FACTORS

Alias
UMLS CUI-1
C1514474
1. MENOPAUSAL STATUS AT TIME OF PRIMARY DIAGNOSIS:
Description

MENOPAUSAL STATUS; PRIMARY DIAGNOSIS

Type de données

integer

Alias
UMLS CUI [1]
C0455962
UMLS CUI [2]
C0332137
2. SIZE OF PRIMARY TUMOR FROM PATHOLOGY OR SURGERY REPORT:
Description

Primary tumor size; Pathology report; Surgery report

Type de données

text

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C1302656
UMLS CUI [2]
C0807321
UMLS CUI [3]
C4291713
cm
3. HISTOLOGY OF PRIMARY TUMOR: 1. INFILTRATING DUCTAL CARCINOMA
Description

histology primary tumor; Infiltrating duct and lobular carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0334384
3. HISTOLOGY OF PRIMARY TUMOR: 2. INFILTRATING LOBULAR CARCINOMA
Description

histology primary tumor; Infiltrating duct and lobular carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0334384
3. HISTOLOGY OF PRIMARY TUMOR: 3. MEDULLARY CARCINOMA
Description

histology primary tumor; Medullary carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0206693
3. HISTOLOGY OF PRIMARY TUMOR: 4. COLLOID CARCINOMA
Description

histology primary tumor; Colloid carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0007130
3. HISTOLOGY OF PRIMARY TUMOR: 5. INFILTRATING COMEDOCARCINOMA
Description

histology primary tumor; Comedocarcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0334370
3. HISTOLOGY OF PRIMARY TUMOR: 6. INFILTRATING BREAST CARCINOMA
Description

histology primary tumor; Invasive carcinoma of breast

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0853879
3.HISTOLOGY OF PRIMARY TUMOR: 7. PAGET'S DISEASE
Description

histology primary tumor; Paget Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C1368019
3. HISTOLOGY OF PRIMARY TUMOR:8. DUCTAL CARCINOMA IN SITU
Description

histology primary tumor; Ductal carcinoma in situ

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C1266028
3. HISTOLOGY OF PRIMARY TUMOR: 9. LOBULAR CARCINOMA IN SITU
Description

histology primary tumor; Lobular carcinoma in situ of breast

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0279563
3. HISTOLOGY OF PRIMARY TUMOR: 10. MUCINOUS CARCINOMA
Description

histology primary tumor; Mucinous carcinoma of breast

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C1334807
3. HISTOLOGY OF PRIMARY TUMOR: 11. INFLAMMATORY CARCINOMA
Description

histology primary tumor; Inflammatory carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0334385
3. HISTOLOGY OF PRIMARY TUMOR: 12. OTHER (SPECIFY):
Description

histology primary tumor; other

Type de données

text

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0205394
3. HISTOLOGY OF PRIMARY TUMOR: 13. NOT AVAILABLE
Description

histology primary tumor; not available

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0686905
4. ESTROGEN RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
Description

Status Estrogen Receptors; Primary diagnosis

Type de données

integer

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0034804
UMLS CUI [2]
C0332137
5. PROGESTERONE RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
Description

Progesterone Receptor Status; Primary diagnosis

Type de données

integer

Alias
UMLS CUI [1]
C1514471
UMLS CUI [2]
C0332137
6. AXILLARY NODES AT TIME OF PRIMARY DIAGNOSIS:
Description

Principal diagnosis

Type de données

integer

Alias
UMLS CUI [1]
C0729594
UMLS CUI [2]
C0332137
6. IF YES, NUMBER OF NODES EXAMINED
Description

Number of lymph nodes examined

Type de données

integer

Alias
UMLS CUI [1]
C2733494
6. IF YES, NUMBER OF EXAMINED NODES WHICH WERE POSITIVE
Description

Number of Lymph Nodes Positive

Type de données

integer

Alias
UMLS CUI [1]
C4086646
7. DO ANY IMMEDIATE FAMILY MEMBERS HAVE A HISTORY OF BREAST CANCER?
Description

family medical history breast cancer

Type de données

integer

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0006142
7. IF YES, GRANDMOTHER (MATERNAL)?
Description

family medical history breast cancer; Maternal grandmother

Type de données

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0006142
UMLS CUI [2]
C1273525
7. IF YES, GRANDMOTHER (PATERNAL)?
Description

family medical history breast cancer; Paternal grandmother

Type de données

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0006142
UMLS CUI [2]
C1273524
7. IF YES, MOTHER?
Description

family medical history breast cancer; Mother

Type de données

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0006142
UMLS CUI [2]
C0026591
7. IF YES, SISTER?
Description

family medical history breast cancer; Sister

Type de données

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0006142
UMLS CUI [2]
C0337514
7. IF YES, DAUGHTER?
Description

family medical history breast cancer; Daughter

Type de données

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0006142
UMLS CUI [2]
C0011011
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Similar models

PROGNOSTIC FACTORS

1 Formulaires
  1. StudyEvent: ODM
    1. PROGNOSTIC FACTORS
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
PROGNOSTIC FACTORS
C1514474 (UMLS CUI-1)
Item
1. MENOPAUSAL STATUS AT TIME OF PRIMARY DIAGNOSIS:
integer
C0455962 (UMLS CUI [1])
C0332137 (UMLS CUI [2])
MENOPAUSAL STATUS; PRIMARY DIAGNOSIS
Code List
1. MENOPAUSAL STATUS AT TIME OF PRIMARY DIAGNOSIS:
CL Item
PREMENOPAUSAL  (1)
CL Item
PERIMENOPAUSAL  (2)
CL Item
POSTMENOPAUSAL (3)
Primary tumor size; Pathology report; Surgery report
Item
2. SIZE OF PRIMARY TUMOR FROM PATHOLOGY OR SURGERY REPORT:
text
C1302656 (UMLS CUI [1])
C0807321 (UMLS CUI [2])
C4291713 (UMLS CUI [3])
histology primary tumor; Infiltrating duct and lobular carcinoma
Item
3. HISTOLOGY OF PRIMARY TUMOR: 1. INFILTRATING DUCTAL CARCINOMA
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0334384 (UMLS CUI [2])
histology primary tumor; Infiltrating duct and lobular carcinoma
Item
3. HISTOLOGY OF PRIMARY TUMOR: 2. INFILTRATING LOBULAR CARCINOMA
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0334384 (UMLS CUI [2])
histology primary tumor; Medullary carcinoma
Item
3. HISTOLOGY OF PRIMARY TUMOR: 3. MEDULLARY CARCINOMA
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0206693 (UMLS CUI [2])
histology primary tumor; Colloid carcinoma
Item
3. HISTOLOGY OF PRIMARY TUMOR: 4. COLLOID CARCINOMA
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0007130 (UMLS CUI [2])
histology primary tumor; Comedocarcinoma
Item
3. HISTOLOGY OF PRIMARY TUMOR: 5. INFILTRATING COMEDOCARCINOMA
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0334370 (UMLS CUI [2])
histology primary tumor; Invasive carcinoma of breast
Item
3. HISTOLOGY OF PRIMARY TUMOR: 6. INFILTRATING BREAST CARCINOMA
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2])
histology primary tumor; Paget Disease
Item
3.HISTOLOGY OF PRIMARY TUMOR: 7. PAGET'S DISEASE
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C1368019 (UMLS CUI [2])
histology primary tumor; Ductal carcinoma in situ
Item
3. HISTOLOGY OF PRIMARY TUMOR:8. DUCTAL CARCINOMA IN SITU
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C1266028 (UMLS CUI [2])
histology primary tumor; Lobular carcinoma in situ of breast
Item
3. HISTOLOGY OF PRIMARY TUMOR: 9. LOBULAR CARCINOMA IN SITU
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0279563 (UMLS CUI [2])
histology primary tumor; Mucinous carcinoma of breast
Item
3. HISTOLOGY OF PRIMARY TUMOR: 10. MUCINOUS CARCINOMA
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C1334807 (UMLS CUI [2])
histology primary tumor; Inflammatory carcinoma
Item
3. HISTOLOGY OF PRIMARY TUMOR: 11. INFLAMMATORY CARCINOMA
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0334385 (UMLS CUI [2])
histology primary tumor; other
Item
3. HISTOLOGY OF PRIMARY TUMOR: 12. OTHER (SPECIFY):
text
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
histology primary tumor; not available
Item
3. HISTOLOGY OF PRIMARY TUMOR: 13. NOT AVAILABLE
boolean
C0019638 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0686905 (UMLS CUI [2])
Item
4. ESTROGEN RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
integer
C0449438 (UMLS CUI [1,1])
C0034804 (UMLS CUI [1,2])
C0332137 (UMLS CUI [2])
Status Estrogen Receptors; Primary diagnosis
Code List
4. ESTROGEN RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
CL Item
POSITIVE (1)
CL Item
NEGATIVE (2)
CL Item
NOT AVAILABLE (3)
Item
5. PROGESTERONE RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
integer
C1514471 (UMLS CUI [1])
C0332137 (UMLS CUI [2])
Status Estrogen Receptors; Primary diagnosis
Code List
5. PROGESTERONE RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
CL Item
POSITIVE (1)
CL Item
NEGATIVE (2)
CL Item
NOT AVAILABLE (3)
Item
6. AXILLARY NODES AT TIME OF PRIMARY DIAGNOSIS:
integer
C0729594 (UMLS CUI [1])
C0332137 (UMLS CUI [2])
Status Estrogen Receptors; Primary diagnosis
Code List
6. AXILLARY NODES AT TIME OF PRIMARY DIAGNOSIS:
CL Item
POSITIVE (1)
CL Item
NEGATIVE (2)
CL Item
NOT AVAILABLE (3)
Number of lymph nodes examined
Item
6. IF YES, NUMBER OF NODES EXAMINED
integer
C2733494 (UMLS CUI [1])
Number of Lymph Nodes Positive
Item
6. IF YES, NUMBER OF EXAMINED NODES WHICH WERE POSITIVE
integer
C4086646 (UMLS CUI [1])
Item
7. DO ANY IMMEDIATE FAMILY MEMBERS HAVE A HISTORY OF BREAST CANCER?
integer
C0241889 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,3])
family medical history breast cancer
Code List
7. DO ANY IMMEDIATE FAMILY MEMBERS HAVE A HISTORY OF BREAST CANCER?
CL Item
YES (1)
CL Item
NO (2)
CL Item
UNKNOWN (3)
family medical history breast cancer; Maternal grandmother
Item
7. IF YES, GRANDMOTHER (MATERNAL)?
boolean
C0241889 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,3])
C1273525 (UMLS CUI [2])
family medical history breast cancer; Paternal grandmother
Item
7. IF YES, GRANDMOTHER (PATERNAL)?
boolean
C0241889 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,3])
C1273524 (UMLS CUI [2])
family medical history breast cancer; Mother
Item
7. IF YES, MOTHER?
boolean
C0241889 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,3])
C0026591 (UMLS CUI [2])
family medical history breast cancer; Sister
Item
7. IF YES, SISTER?
boolean
C0241889 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,3])
C0337514 (UMLS CUI [2])
family medical history breast cancer; Daughter
Item
7. IF YES, DAUGHTER?
boolean
C0241889 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,3])
C0011011 (UMLS CUI [2])
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