ID

46

Beschreibung

Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma Inclusion Criteria: - measurable disease as defined by the presence of at least one measurable lesion - prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study - life expectancy of at least 12 weeks - adequate bone marrow, liver and kidney function Exclusion Criteria: - excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation

Stichworte

Versionen (4)
  1. 11.11.11 11.11.11 -
  2. 11.11.11 11.11.11 -
  3. 21.03.14 21.03.14 - Martin Dugas
  4. 17.09.21 17.09.21 -
Hochgeladen am

11. November 2011

DOI

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NCT00044564 Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Beschreibung

Inclusion criteria

Advanced Renal Cell Carcinoma
Beschreibung

Advanced Renal Cell Carcinoma

Datentyp

boolean

Prior therapy
Beschreibung

Prior therapy

Datentyp

boolean

Life expectancy
Beschreibung

Life expectancy

Datentyp

boolean

Bone marrow, liver, kidney
Beschreibung

Bone marrow, liver, kidney

Datentyp

boolean

Exclusion criteria
Beschreibung

Exclusion criteria

excluded medical conditions
Beschreibung

excluded medical conditions

Datentyp

boolean

excluded therapies and medications
Beschreibung

excluded therapies and medications

Datentyp

boolean

other exclusion criteria
Beschreibung

other exclusion criteria

Datentyp

boolean

Medical concepts
Beschreibung

Medical concepts

Diagnosis
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Immunotherapy
Beschreibung

Immunotherapy

Datentyp

string

Alias
UMLS CUI
C0021083
SNOMED CT 2010_0731
146638005
Radiotherapy
Beschreibung

Radiotherapy

Datentyp

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
Life expectancy
Beschreibung

Life expectancy

Datentyp

string

Alias
UMLS CUI
C0023671
LOINC Version 232
LP75025-4
WBC
Beschreibung

WBC

Datentyp

string

Alias
SNOMED CT 2010_0731
767002
LOINC
6690-2
Platelet count
Beschreibung

Platelet count

Datentyp

string

Alias
SNOMED CT 2010_0731
365632008
UMLS CUI
C1287267
LOINC
777-3
Hemoglobin
Beschreibung

Hemoglobin

Datentyp

string

Alias
SNOMED CT 2010_0731
38082009
UMLS CUI
C0019046
MedDRA 13.1
10019481
LOINC
LP14449-0
INR
Beschreibung

INR

Datentyp

string

Alias
UMLS CUI
C0525032
SNOMED CT 2010_0731
165581004
MedDRA 13.1
10022400
LOINC
LP20762-8
Bilirubin
Beschreibung

Bilirubin

Datentyp

string

Alias
SNOMED CT 2010_0731
79706000
UMLS CUI
C0011221
MedDRA Version 13.1
10004683
LOINC
1975-2
Creatinine
Beschreibung

Creatinine

Datentyp

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
LOINC
38483-4
MedDRA 13.1
10011358
Neuropathy
Beschreibung

Neuropathy

Datentyp

string

Alias
UMLS CUI
C0442874
SNOMED CT 2010_0731
386033004
MedDRA 13.1
10029328
Cardiac disease
Beschreibung

Cardiac disease

Datentyp

string

Alias
UMLS CUI
C0018799
SNOMED CT 2010_0731
56265001
MedDRA 13.1
10061024
Infection
Beschreibung

Infection

Datentyp

string

Alias
UMLS CUI
C0021311
SNOMED CT 2010_0731
257551009
MedDRA Version 13.1
10021789
HIV negative
Beschreibung

HIV negative

Datentyp

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
MedDRA 13.1
10020179
Hepatitis
Beschreibung

Hepatitis

Datentyp

string

Alias
SNOMED CT 2010_0731
29001004
UMLS CUI
C0019158
MedDRA Version 13.1
10019717
LOINC
LP20771-9
Metastasis
Beschreibung

Metastasis

Datentyp

string

Alias
UMLS CUI
C0027627
SNOMED CT 2010_0731
128462008
MedDRA 13.1
10027449
LOINC Version 232
LP35033-7
Allergic reaction, due to correct medicinal substance properly administered
Beschreibung

Allergic reaction, due to correct medicinal substance properly administered

Datentyp

string

Alias
UMLS CUI
C0274302
SNOMED CT 2010_0731
57302007
Organ transplant
Beschreibung

Organ transplant

Datentyp

string

Alias
UMLS CUI
C0029216
MedDRA 13.1
10061890
LOINC Version 232
MTHU000173
Pharmaceutical Preparations
Beschreibung

Pharmaceutical Preparations

Datentyp

string

Alias
UMLS CUI
C0013227
Chemotherapy
Beschreibung

Chemotherapy

Datentyp

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Immunomodulatory or immunosuppressive therapy
Beschreibung

Immunomodulatory or immunosuppressive therapy

Datentyp

string

Alias
SNOMED CT 2010_0731
86553008
UMLS CUI
C1963758
MedDRA Version 13.1
10067473
Radiotherapy
Beschreibung

Radiotherapy

Datentyp

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
pregnant
Beschreibung

pregnant

Datentyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Lactation
Beschreibung

Lactation

Datentyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Contraception
Beschreibung

Contraception

Datentyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Drug abuse
Beschreibung

Drug abuse

Datentyp

string

Alias
UMLS CUI
C0013146
SNOMED CT 2010_0731
26416006
MedDRA 13.1
10013654
LOINC
LP36310-8
ICD-9-CM Version 2011
305.90
Compliance
Beschreibung

Compliance

Datentyp

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Advanced Renal Cell Carcinoma
Item
boolean
Prior therapy
Item
boolean
Life expectancy
Item
boolean
Bone marrow, liver, kidney
Item
boolean
excluded medical conditions
Item
boolean
excluded therapies and medications
Item
boolean
other exclusion criteria
Item
boolean
Diagnosis
Item
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
Immunotherapy
Item
string
C0021083 (UMLS CUI)
146638005 (SNOMED CT 2010_0731)
Radiotherapy
Item
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
Life expectancy
Item
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
WBC
Item
string
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC)
Platelet count
Item
string
365632008 (SNOMED CT 2010_0731)
C1287267 (UMLS CUI)
777-3 (LOINC)
Hemoglobin
Item
string
38082009 (SNOMED CT 2010_0731)
C0019046 (UMLS CUI)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC)
INR
Item
string
C0525032 (UMLS CUI)
165581004 (SNOMED CT 2010_0731)
10022400 (MedDRA 13.1)
LP20762-8 (LOINC)
Bilirubin
Item
string
79706000 (SNOMED CT 2010_0731)
C0011221 (UMLS CUI)
10004683 (MedDRA Version 13.1)
1975-2 (LOINC)
Creatinine
Item
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Neuropathy
Item
string
C0442874 (UMLS CUI)
386033004 (SNOMED CT 2010_0731)
10029328 (MedDRA 13.1)
Cardiac disease
Item
string
C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
Infection
Item
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA Version 13.1)
HIV negative
Item
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)
Hepatitis
Item
string
29001004 (SNOMED CT 2010_0731)
C0019158 (UMLS CUI)
10019717 (MedDRA Version 13.1)
LP20771-9 (LOINC)
Metastasis
Item
string
C0027627 (UMLS CUI)
128462008 (SNOMED CT 2010_0731)
10027449 (MedDRA 13.1)
LP35033-7 (LOINC Version 232)
Allergic reaction, due to correct medicinal substance properly administered
Item
string
C0274302 (UMLS CUI)
57302007 (SNOMED CT 2010_0731)
Organ transplant
Item
string
C0029216 (UMLS CUI)
10061890 (MedDRA 13.1)
MTHU000173 (LOINC Version 232)
Pharmaceutical Preparations
Item
string
C0013227 (UMLS CUI)
Chemotherapy
Item
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Immunomodulatory or immunosuppressive therapy
Item
string
86553008 (SNOMED CT 2010_0731)
C1963758 (UMLS CUI)
10067473 (MedDRA Version 13.1)
Radiotherapy
Item
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
pregnant
Item
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Drug abuse
Item
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC)
305.90 (ICD-9-CM Version 2011)
Compliance
Item
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)
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