ID

43681

Beschrijving

Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab; ODM derived from: https://clinicaltrials.gov/show/NCT02236806

Link

https://clinicaltrials.gov/show/NCT02236806

Trefwoorden

  1. 26-04-16 26-04-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT02236806

Eligibility Breast Cancer NCT02236806

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Beschrijving

Female

Datatype

boolean

Alias
UMLS CUI [1]
C0086287
age >18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
non-metastatic histologically confirmed primary invasive breast cancer
Beschrijving

Invasive breast carcinoma Histologic Confirmed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205462
UMLS CUI [1,3]
C0521093
scheduled to receive neoadjuvant and/or adjuvant anthracyclines with or without anti-her2 therapy
Beschrijving

Anthracycline Antibiotics Neoadjuvant Therapy | Anthracycline Antibiotics Adjuvant therapy | Human Epidermal Growth Factor Receptor 2 Measurement Monoclonal Antibodies Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003234
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C0003234
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C3810543
UMLS CUI [3,2]
C0003250
UMLS CUI [3,3]
C0087111
provided informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
able to swallow capsules
Beschrijving

Able to swallow capsule

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
lvef > 50%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
treatment with ace-inhibitors or beta blockers at diagnosis
Beschrijving

Treated with Angiotensin-Converting Enzyme Inhibitors | Treated with Adrenergic beta-Antagonists

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332293
UMLS CUI [1,2]
C0003015
UMLS CUI [2,1]
C0332293
UMLS CUI [2,2]
C0001645
history of nci common toxicity criteria for adverse effects (ctcae) (version 4.0) grade >2 symptomatic congestive heart failure (chf), previous myocardial infarction, significant symptoms (grade>2) relating to lvef dysfunction, valvular disease, cardiac arrhythmia (grade>3)
Beschrijving

Common Terminology Criteria for Adverse Events | Congestive heart failure | Myocardial infarction | Left ventricular ejection fraction Dysfunction | Valvular disease | Cardiac Arrhythmia

Datatype

boolean

Alias
UMLS CUI [1]
C1516728
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0428772
UMLS CUI [4,2]
C3887504
UMLS CUI [5]
C3258293
UMLS CUI [6]
C0003811

Similar models

Eligibility Breast Cancer NCT02236806

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Female
Item
female
boolean
C0086287 (UMLS CUI [1])
Age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
Invasive breast carcinoma Histologic Confirmed
Item
non-metastatic histologically confirmed primary invasive breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0521093 (UMLS CUI [1,3])
Anthracycline Antibiotics Neoadjuvant Therapy | Anthracycline Antibiotics Adjuvant therapy | Human Epidermal Growth Factor Receptor 2 Measurement Monoclonal Antibodies Therapeutic procedure
Item
scheduled to receive neoadjuvant and/or adjuvant anthracyclines with or without anti-her2 therapy
boolean
C0003234 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0003234 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C3810543 (UMLS CUI [3,1])
C0003250 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
Informed Consent
Item
provided informed consent
boolean
C0021430 (UMLS CUI [1])
Able to swallow capsule
Item
able to swallow capsules
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
lvef > 50%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Treated with Angiotensin-Converting Enzyme Inhibitors | Treated with Adrenergic beta-Antagonists
Item
treatment with ace-inhibitors or beta blockers at diagnosis
boolean
C0332293 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C0332293 (UMLS CUI [2,1])
C0001645 (UMLS CUI [2,2])
Common Terminology Criteria for Adverse Events | Congestive heart failure | Myocardial infarction | Left ventricular ejection fraction Dysfunction | Valvular disease | Cardiac Arrhythmia
Item
history of nci common toxicity criteria for adverse effects (ctcae) (version 4.0) grade >2 symptomatic congestive heart failure (chf), previous myocardial infarction, significant symptoms (grade>2) relating to lvef dysfunction, valvular disease, cardiac arrhythmia (grade>3)
boolean
C1516728 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0428772 (UMLS CUI [4,1])
C3887504 (UMLS CUI [4,2])
C3258293 (UMLS CUI [5])
C0003811 (UMLS CUI [6])

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