ID

22049

Beschreibung

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"

Stichworte

Versionen (2)
  1. 16.05.17 16.05.17 -
  2. 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
Rechteinhaber

Roche

Hochgeladen am

16. Mai 2017

DOI

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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

Englisch

PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING)

1 Formulare  
REGIMEN 1
Beschreibung

REGIMEN 1

Alias
UMLS CUI-1
C0392920
PATIENT INT.
Beschreibung

Patient initial

Datentyp

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Beschreibung

Patient id

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
CHEMOTHERAPY?
Beschreibung

Chemotherapy

Datentyp

boolean

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

therapy start date

Datentyp

date

Alias
UMLS CUI [1]
C1531783
STOP DATE OF LAST AGENT
Beschreibung

therapy stop date

Datentyp

date

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

Pharmaceutical Preparations

Datentyp

text

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

CUMULATIVE DOSE

Datentyp

text

Alias
UMLS CUI [1]
C2986497
NUMBER OF CYCLES
Beschreibung

NUMBER OF CYCLES

Datentyp

integer

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

REGIMEN 2

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

therapy start date

Datentyp

date

Alias
UMLS CUI [1]
C1531783
STOP DATE OF LAST AGENT
Beschreibung

therapy stop date

Datentyp

date

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

Pharmaceutical Preparations

Datentyp

text

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

CUMULATIVE DOSE

Datentyp

text

Alias
UMLS CUI [1]
C2986497
NUMBER OF CYCLES
Beschreibung

NUMBER OF CYCLES

Datentyp

integer

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

ADJUVANT THERAPY

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

CONSOLIDATION THERAPY

Datentyp

boolean

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

Bone marrow transplantation; stem cell transplantation

Datentyp

boolean

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

Disease progression

Datentyp

boolean

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

Total dose Doxorubicin

Datentyp

float

Maßeinheiten
  • 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?
Beschreibung

Total dose Epirubicin

Datentyp

float

Maßeinheiten
  • mg/m^2
Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0014582
mg/m^2
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Ähnliche Modelle

PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
C1531783 (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
C1531783 (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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