ID

15933

Beskrivning

Phase I Study of Oral PQR309 in Patients With Relapsed or Refractory Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02249429

Länk

https://clinicaltrials.gov/show/NCT02249429

Nyckelord

Versioner (1)
  1. 2016-06-19 2016-06-19 -
Uppladdad den

19 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Relapsed or Refractory Lymphomas DRKS00010139 NCT02249429

Engelsk

Eligibility Relapsed or Refractory Lymphomas NCT02249429

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of relapsed or refractory lymphoma and received at least one prior line of therapy.
Beskrivning

Non-Hodgkin's lymphoma recurrent | Non-Hodgkin's lymphoma refractory | Prior Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0854866
UMLS CUI [2]
C0854867
UMLS CUI [3]
C1514463
age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
use of adequate contraceptive measures for male patients.
Beskrivning

Male Contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0086580
eastern cooperative oncology group (ecog) performance score of 0-1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
signed informed consent.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous allogeneic hematopoietic stem cell transplant (hsct transplant).
Beskrivning

Allogeneic Hematopoietic Stem Cell Transplantation Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705576
UMLS CUI [1,2]
C0205156
autologous stem cell transplant within the last 6 months.
Beskrivning

Transplantation of autologous hematopoietic stem cell

Datatyp

boolean

Alias
UMLS CUI [1]
C1831743
concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors).
Beskrivning

cancer treatment Simultaneous | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Biological Response Modifiers | Signal Transduction Inhibitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0521115
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0005525
UMLS CUI [7]
C1519313
patients with a history of myocardial infarction or coronary artery bypass within the last 3 years.
Beskrivning

Myocardial Infarction | Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure nyha class 3 or 4, hypertension bp>150/100mmhg.
Beskrivning

Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral arterial bypass | Symptomatic congestive heart failure | New York Heart Association Classification | Hypertensive disease | Blood pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0190961
UMLS CUI [5]
C0742758
UMLS CUI [6]
C1275491
UMLS CUI [7]
C0020538
UMLS CUI [8]
C1271104
pre-diagnosed diabetes mellitus.
Beskrivning

Diabetes Mellitus | Diagnosis Pre

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0332152
fasting glucose > 7.0 mmol/l or hba1c > 6.4%.
Beskrivning

Glucose measurement, fasting | Glycosylated hemoglobin A

Datatyp

boolean

Alias
UMLS CUI [1]
C0202045
UMLS CUI [2]
C0019018
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Similar models

Eligibility Relapsed or Refractory Lymphomas NCT02249429

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Hodgkin's lymphoma recurrent | Non-Hodgkin's lymphoma refractory | Prior Therapy
Item
histologically confirmed diagnosis of relapsed or refractory lymphoma and received at least one prior line of therapy.
boolean
C0854866 (UMLS CUI [1])
C0854867 (UMLS CUI [2])
C1514463 (UMLS CUI [3])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Male Contraception
Item
use of adequate contraceptive measures for male patients.
boolean
C0086580 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance score of 0-1.
boolean
C1520224 (UMLS CUI [1])
Informed consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allogeneic Hematopoietic Stem Cell Transplantation Previous
Item
previous allogeneic hematopoietic stem cell transplant (hsct transplant).
boolean
C1705576 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Transplantation of autologous hematopoietic stem cell
Item
autologous stem cell transplant within the last 6 months.
boolean
C1831743 (UMLS CUI [1])
cancer treatment Simultaneous | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Biological Response Modifiers | Signal Transduction Inhibitor
Item
concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors).
boolean
C0920425 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0005525 (UMLS CUI [6])
C1519313 (UMLS CUI [7])
Myocardial Infarction | Coronary Artery Bypass Surgery
Item
patients with a history of myocardial infarction or coronary artery bypass within the last 3 years.
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral arterial bypass | Symptomatic congestive heart failure | New York Heart Association Classification | Hypertensive disease | Blood pressure
Item
patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure nyha class 3 or 4, hypertension bp>150/100mmhg.
boolean
C0002962 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0190961 (UMLS CUI [4])
C0742758 (UMLS CUI [5])
C1275491 (UMLS CUI [6])
C0020538 (UMLS CUI [7])
C1271104 (UMLS CUI [8])
Diabetes Mellitus | Diagnosis Pre
Item
pre-diagnosed diabetes mellitus.
boolean
C0011849 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Glucose measurement, fasting | Glycosylated hemoglobin A
Item
fasting glucose > 7.0 mmol/l or hba1c > 6.4%.
boolean
C0202045 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
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