ID

31569

Beskrivning

Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00659438

Länk

https://clinicaltrials.gov/show/NCT00659438

Nyckelord

Versioner (1)
  1. 2018-09-05 2018-09-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00659438

Engelsk

Eligibility Prostate Cancer NCT00659438

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
males presented with a confirmed histological diagnosis of adenocarcinoma of the prostate with evidence of metastases (including bone, lymph nodes, or other site) radiologically or histologically documented and despite a serum testosterone ≤1.73 nmol/l (50 ng/dl) proving castration, evidence of biochemical progression of prostate cancer, documented by a rise in psa .
Beskrivning

Adenocarcinoma of the prostate metastatic | BONE INVOLVEMENT | Lymph Node Involvement | Involvement with Site Other | Serum testosterone measurement Consistent with Male Castration | Progression Biochemical Prostate carcinoma | Raised prostate specific antigen

Datatyp

boolean

Alias
UMLS CUI [1]
C0862636
UMLS CUI [2]
C0741591
UMLS CUI [3]
C0806692
UMLS CUI [4,1]
C1314939
UMLS CUI [4,2]
C1515974
UMLS CUI [4,3]
C0205394
UMLS CUI [5,1]
C0428413
UMLS CUI [5,2]
C0332290
UMLS CUI [5,3]
C0007347
UMLS CUI [6,1]
C0449258
UMLS CUI [6,2]
C0205474
UMLS CUI [6,3]
C0600139
UMLS CUI [7]
C0178415
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiotherapy or surgery or antiandrogens (except lhrh analogue) or bilateral orchiectomy within the 30 days preceding visit 1. incompletely healed surgical incision.
Beskrivning

Therapeutic radiology procedure | Operative Surgical Procedures | Androgen Antagonists | Exception LH-RH Analogs | Bilateral orchiectomy | Surgical incision Healed Incomplete

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0002842
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1518041
UMLS CUI [5]
C0007347
UMLS CUI [6,1]
C0184898
UMLS CUI [6,2]
C0205249
UMLS CUI [6,3]
C0205257
concomitant anticancer therapy other than surgical castration or continuous medical castration.
Beskrivning

Cancer treatment concomitant | Exception Male Castration | Exception Medical Castration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0521115
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007347
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1513054
biology restriction.
Beskrivning

Restriction biological

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0443288
UMLS CUI [1,2]
C0205460
clinical significant cardiovascular event or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia.
Beskrivning

Cardiovascular event Increases Risk Ventricular arrhythmia | Heart Disease Increases Risk Ventricular arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0085612
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205217
UMLS CUI [2,3]
C0035647
UMLS CUI [2,4]
C0085612
history of arrhythmia which is symptomatic or requires treatment (ctcae grade 3), symptomatic despite treatment, or asymptomatic sustained ventricular tachycardia. subjects with atrial fibrillation controlled on medication are permitted.
Beskrivning

ARRHYTHMIA SYMPTOMATIC CTCAE Grades | Treatment required for Cardiac Arrhythmia CTCAE Grades | VENTRICULAR TACHYCARDIA SYMPTOMATIC | Sustained ventricular tachycardia Asymptomatic | Pharmacotherapy Atrial Fibrillation allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0741212
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0332121
UMLS CUI [2,2]
C0003811
UMLS CUI [2,3]
C1516728
UMLS CUI [3]
C0750198
UMLS CUI [4,1]
C0750197
UMLS CUI [4,2]
C0231221
UMLS CUI [5,1]
C0013216
UMLS CUI [5,2]
C0004238
UMLS CUI [5,3]
C0683607
hypertension not controlled by medical therapy
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
ecg /qtc prolongation
Beskrivning

ECG QTc interval prolonged

Datatyp

boolean

Alias
UMLS CUI [1]
C4272943
presence of left bundle branch block (lbbb).
Beskrivning

Left Bundle-Branch Block

Datatyp

boolean

Alias
UMLS CUI [1]
C0023211
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Similar models

Eligibility Prostate Cancer NCT00659438

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of the prostate metastatic | BONE INVOLVEMENT | Lymph Node Involvement | Involvement with Site Other | Serum testosterone measurement Consistent with Male Castration | Progression Biochemical Prostate carcinoma | Raised prostate specific antigen
Item
males presented with a confirmed histological diagnosis of adenocarcinoma of the prostate with evidence of metastases (including bone, lymph nodes, or other site) radiologically or histologically documented and despite a serum testosterone ≤1.73 nmol/l (50 ng/dl) proving castration, evidence of biochemical progression of prostate cancer, documented by a rise in psa .
boolean
C0862636 (UMLS CUI [1])
C0741591 (UMLS CUI [2])
C0806692 (UMLS CUI [3])
C1314939 (UMLS CUI [4,1])
C1515974 (UMLS CUI [4,2])
C0205394 (UMLS CUI [4,3])
C0428413 (UMLS CUI [5,1])
C0332290 (UMLS CUI [5,2])
C0007347 (UMLS CUI [5,3])
C0449258 (UMLS CUI [6,1])
C0205474 (UMLS CUI [6,2])
C0600139 (UMLS CUI [6,3])
C0178415 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Operative Surgical Procedures | Androgen Antagonists | Exception LH-RH Analogs | Bilateral orchiectomy | Surgical incision Healed Incomplete
Item
radiotherapy or surgery or antiandrogens (except lhrh analogue) or bilateral orchiectomy within the 30 days preceding visit 1. incompletely healed surgical incision.
boolean
C1522449 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0002842 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1518041 (UMLS CUI [4,2])
C0007347 (UMLS CUI [5])
C0184898 (UMLS CUI [6,1])
C0205249 (UMLS CUI [6,2])
C0205257 (UMLS CUI [6,3])
Cancer treatment concomitant | Exception Male Castration | Exception Medical Castration
Item
concomitant anticancer therapy other than surgical castration or continuous medical castration.
boolean
C0920425 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007347 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1513054 (UMLS CUI [3,2])
Restriction biological
Item
biology restriction.
boolean
C0443288 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
Cardiovascular event Increases Risk Ventricular arrhythmia | Heart Disease Increases Risk Ventricular arrhythmia
Item
clinical significant cardiovascular event or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia.
boolean
C1320716 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0085612 (UMLS CUI [1,4])
C0018799 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C0085612 (UMLS CUI [2,4])
ARRHYTHMIA SYMPTOMATIC CTCAE Grades | Treatment required for Cardiac Arrhythmia CTCAE Grades | VENTRICULAR TACHYCARDIA SYMPTOMATIC | Sustained ventricular tachycardia Asymptomatic | Pharmacotherapy Atrial Fibrillation allowed
Item
history of arrhythmia which is symptomatic or requires treatment (ctcae grade 3), symptomatic despite treatment, or asymptomatic sustained ventricular tachycardia. subjects with atrial fibrillation controlled on medication are permitted.
boolean
C0741212 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2,1])
C0003811 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C0750198 (UMLS CUI [3])
C0750197 (UMLS CUI [4,1])
C0231221 (UMLS CUI [4,2])
C0013216 (UMLS CUI [5,1])
C0004238 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
Uncontrolled hypertension
Item
hypertension not controlled by medical therapy
boolean
C1868885 (UMLS CUI [1])
ECG QTc interval prolonged
Item
ecg /qtc prolongation
boolean
C4272943 (UMLS CUI [1])
Left Bundle-Branch Block
Item
presence of left bundle branch block (lbbb).
boolean
C0023211 (UMLS CUI [1])
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