ID

18376

Beschreibung

Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00359190

Link

https://clinicaltrials.gov/show/NCT00359190

Stichworte

  1. 02.11.16 02.11.16 -
Hochgeladen am

2. November 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Neoplasms, Breast NCT00359190

Eligibility Neoplasms, Breast NCT00359190

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical labs are within acceptable ranges.
Beschreibung

Laboratory Results Acceptable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1879533
a histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
Beschreibung

Therapy naive Breast Carcinoma | Tumor size | Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0475440
UMLS CUI [3]
C0005558
at least 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
females must meet certain criteria specified in protocol.
Beschreibung

Gender | Inclusion criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C2348563
ability to swallow and retain oral medication.
Beschreibung

Able to swallow oral medication | oral medication Retain Ability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0085732
ability to follow and understand directions.
Beschreibung

Follow directions Ability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1720622
UMLS CUI [1,2]
C0085732
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is pregnant or lactating.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
medically unfit by the doctor as a result of the medical interview or physicals.
Beschreibung

Medically unfit | patient interview | Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C3841806
UMLS CUI [2]
C0683518
UMLS CUI [3]
C0031809
received treatment of an investigational drug within 4 weeks of study start.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
currently receiving treatment with prohibited meds listed in protocol.
Beschreibung

Illicit drug use Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C2348563
had major surgery in previous 2 weeks.
Beschreibung

major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
had prior radiation therapy to the chest to treat this incidence of breast cancer.
Beschreibung

History of radiation therapy to chest Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4038799
UMLS CUI [1,2]
C0678222
hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
Beschreibung

Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs | Idiosyncrasy Pharmaceutical Preparations Related Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0231191
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0013230
has a malabsorption syndrome.
Beschreibung

Malabsorption Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0024523

Ähnliche Modelle

Eligibility Neoplasms, Breast NCT00359190

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Laboratory Results Acceptable
Item
clinical labs are within acceptable ranges.
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Therapy naive Breast Carcinoma | Tumor size | Biopsy
Item
a histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
boolean
C0919936 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2])
C0005558 (UMLS CUI [3])
Age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Gender | Inclusion criteria Study Protocol
Item
females must meet certain criteria specified in protocol.
boolean
C0079399 (UMLS CUI [1])
C1512693 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Able to swallow oral medication | oral medication Retain Ability
Item
ability to swallow and retain oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Follow directions Ability
Item
ability to follow and understand directions.
boolean
C1720622 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
female who is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medically unfit | patient interview | Physical Examination
Item
medically unfit by the doctor as a result of the medical interview or physicals.
boolean
C3841806 (UMLS CUI [1])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Investigational New Drugs
Item
received treatment of an investigational drug within 4 weeks of study start.
boolean
C0013230 (UMLS CUI [1])
Illicit drug use Study Protocol
Item
currently receiving treatment with prohibited meds listed in protocol.
boolean
C0281875 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
major surgery
Item
had major surgery in previous 2 weeks.
boolean
C0679637 (UMLS CUI [1])
History of radiation therapy to chest Breast Carcinoma
Item
had prior radiation therapy to the chest to treat this incidence of breast cancer.
boolean
C4038799 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs | Idiosyncrasy Pharmaceutical Preparations Related Investigational New Drugs
Item
hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0231191 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Malabsorption Syndrome
Item
has a malabsorption syndrome.
boolean
C0024523 (UMLS CUI [1])

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