ID

42012

Description

Study part: Prior treatment for breast cancer (Adjuvant setting). 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 (2)
  1. 5/16/17 5/16/17 -
  2. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder

Roche

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March 15, 2021

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Creative Commons BY-NC 3.0
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PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING) Roche H0650g Breast Cancer

English

PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING)

1 forms  
REGIMEN 1
Description

REGIMEN 1

Alias
UMLS CUI-1
C0392920
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
CHEMOTHERAPY?
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
START DATE OF FIRST AGENT
Description

therapy start date

Data type

date

Alias
UMLS CUI [1]
C3173309
STOP DATE OF LAST AGENT
Description

therapy stop date

Data type

date

Alias
UMLS CUI [1]
C1531784
AGENT(S)
Description

Pharmaceutical Preparations

Data type

text

Alias
UMLS CUI [1]
C0013227
CUMULATIVE DOSE RC'D (Units)
Description

CUMULATIVE DOSE

Data type

text

Alias
UMLS CUI [1]
C2986497
NUMBER OF CYCLES
Description

NUMBER OF CYCLES

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1302181
REGIMEN 2
Description

REGIMEN 2

Alias
UMLS CUI-1
C1276413
START DATE OF FIRST AGENT
Description

therapy start date

Data type

date

Alias
UMLS CUI [1]
C3173309
STOP DATE OF LAST AGENT
Description

therapy stop date

Data type

date

Alias
UMLS CUI [1]
C1531784
AGENT(S)
Description

Pharmaceutical Preparations

Data type

text

Alias
UMLS CUI [1]
C0013227
CUMULATIVE DOSE RC'D (Units)
Description

CUMULATIVE DOSE

Data type

text

Alias
UMLS CUI [1]
C2986497
NUMBER OF CYCLES
Description

NUMBER OF CYCLES

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1302181
ADJUVANT THERAPY
Description

ADJUVANT THERAPY

Alias
UMLS CUI-1
C0677850
WAS A HIGH-DOSE CONSOLIDATION THERAPY GIVEN?
Description

CONSOLIDATION THERAPY

Data type

boolean

Alias
UMLS CUI [1]
C1511484
DID THE PATIENT RECEIVE A BONE MARROW OR STEM CELL- TRANSPLANT?
Description

Bone marrow transplantation; stem cell transplantation

Data type

boolean

Alias
UMLS CUI [1]
C1504389
DID PATIENT PROGRESS WITHIN 12 MONTHS FOLLOWING THE ADJUVANT CHEMOTHERAPY?
Description

Disease progression

Data type

boolean

Alias
UMLS CUI [1]
C0242656
WHAT WAS THE TOTAL DOSE OF DOXORUBICIN IN AN ADJUVANT SETTING?
Description

Total dose Doxorubicin

Data type

float

Measurement units
  • mg/m^2
Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0013089
UMLS CUI [1,3]
C0014582
mg/m^2
WHAT WAS THE TOTAL DOSE OF EPIRUBICIN USED IN AN ADJUVANT SETTING?
Description

Total dose Epirubicin

Data type

float

Measurement units
  • mg/m^2
Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0014582
mg/m^2
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Similar models

PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
REGIMEN 1
C0392920 (UMLS CUI-1)
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
Chemotherapy
Item
CHEMOTHERAPY?
boolean
C0392920 (UMLS CUI [1])
therapy start date
Item
START DATE OF FIRST AGENT
date
C3173309 (UMLS CUI [1])
therapy stop date
Item
STOP DATE OF LAST AGENT
date
C1531784 (UMLS CUI [1])
Pharmaceutical Preparations
Item
AGENT(S)
text
C0013227 (UMLS CUI [1])
CUMULATIVE DOSE
Item
CUMULATIVE DOSE RC'D (Units)
text
C2986497 (UMLS CUI [1])
NUMBER OF CYCLES
Item
NUMBER OF CYCLES
integer
C0449788 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
Item Group
REGIMEN 2
C1276413 (UMLS CUI-1)
therapy start date
Item
START DATE OF FIRST AGENT
date
C3173309 (UMLS CUI [1])
therapy stop date
Item
STOP DATE OF LAST AGENT
date
C1531784 (UMLS CUI [1])
Pharmaceutical Preparations
Item
AGENT(S)
text
C0013227 (UMLS CUI [1])
CUMULATIVE DOSE
Item
CUMULATIVE DOSE RC'D (Units)
text
C2986497 (UMLS CUI [1])
NUMBER OF CYCLES
Item
NUMBER OF CYCLES
integer
C0449788 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
Item Group
ADJUVANT THERAPY
C0677850 (UMLS CUI-1)
CONSOLIDATION THERAPY
Item
WAS A HIGH-DOSE CONSOLIDATION THERAPY GIVEN?
boolean
C1511484 (UMLS CUI [1])
Bone marrow transplantation; stem cell transplantation
Item
DID THE PATIENT RECEIVE A BONE MARROW OR STEM CELL- TRANSPLANT?
boolean
C1504389 (UMLS CUI [1])
Disease progression
Item
DID PATIENT PROGRESS WITHIN 12 MONTHS FOLLOWING THE ADJUVANT CHEMOTHERAPY?
boolean
C0242656 (UMLS CUI [1])
Total dose Doxorubicin
Item
WHAT WAS THE TOTAL DOSE OF DOXORUBICIN IN AN ADJUVANT SETTING?
float
C2986497 (UMLS CUI [1,1])
C0013089 (UMLS CUI [1,2])
C0014582 (UMLS CUI [1,3])
Total dose Epirubicin
Item
WHAT WAS THE TOTAL DOSE OF EPIRUBICIN USED IN AN ADJUVANT SETTING?
float
C2986497 (UMLS CUI [1,1])
C0014582 (UMLS CUI [1,2])
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