Eligibility Leukemia NCT00528450

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00528450
Criteria
Beschreibung

Criteria

morphologic diagnosis of acute promyelocytic leukemia (apl), confirmed by one of the following:
Beschreibung

ID.1

Datentyp

boolean

Alias
UMLS CUI [1]
C0023487
demonstration of t(15;17) using conventional cytogenetics or fluorescence in situ hybridization (fish)
Beschreibung

ID.2

Datentyp

boolean

Alias
UMLS CUI [1]
C4287946
positive pml-rarα transcript by reverse transcriptase-polymerase chain reaction (rt-pcr) assay
Beschreibung

ID.3

Datentyp

boolean

Alias
UMLS CUI [1]
C3475382
patients with cns involvement by apl are eligible
Beschreibung

ID.4

Datentyp

boolean

Alias
UMLS CUI [1]
C0085136
karnofsky performance status 60-100%
Beschreibung

ID.6

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
creatinine ≤ 2.0 mg/dl or creatinine clearance > 60 ml/min
Beschreibung

ID.7

Datentyp

boolean

Alias
UMLS CUI [1]
C0010294
bilirubin < 2.0 mg/dl (unless attributed to gilbert disease)
Beschreibung

ID.8

Datentyp

boolean

Alias
UMLS CUI [1]
C0005437
alkaline phosphatase ≤ 2.5 times the upper limit of normal (uln)
Beschreibung

ID.9

Datentyp

boolean

Alias
UMLS CUI [1]
C0002059
ast and alt ≤ 2.5 uln
Beschreibung

ID.10

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004002
UMLS CUI [1,2]
C0001899
lvef ≥ 50% on echocardiogram or muga scan
Beschreibung

ID.11

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
qtc ≤ 500 msec on baseline ecg
Beschreibung

ID.12

Datentyp

boolean

Alias
UMLS CUI [1]
C0860814
not pregnant or nursing
Beschreibung

ID.13

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
negative pregnancy test
Beschreibung

ID.14

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
fertile patients must use effective contraception during and for ≥ 4 months after the completion of study treatment
Beschreibung

ID.15

Datentyp

boolean

Alias
UMLS CUI [1]
C0009862
no active serious infections not controlled by antibiotics
Beschreibung

ID.16

Datentyp

boolean

Alias
UMLS CUI [1]
C3714514
no other concurrent active malignancy requiring immediate therapy
Beschreibung

ID.17

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
no clinically significant cardiac disease (new york heart association class iii or iv heart disease), including chronic arrhythmias
Beschreibung

ID.18

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
no pulmonary disease
Beschreibung

ID.19

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
no other serious or life-threatening condition deemed unacceptable by the principal investigator
Beschreibung

ID.20

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
prior concurrent therapy:
Beschreibung

ID.21

Datentyp

boolean

Alias
UMLS CUI [1]
C0009429
no prior treatment for apl
Beschreibung

ID.22

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023487
UMLS CUI [1,2]
C0087111

Ähnliche Modelle

Eligibility Leukemia NCT00528450

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00528450
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
ID.1
Item
morphologic diagnosis of acute promyelocytic leukemia (apl), confirmed by one of the following:
boolean
C0023487 (UMLS CUI [1])
ID.2
Item
demonstration of t(15;17) using conventional cytogenetics or fluorescence in situ hybridization (fish)
boolean
C4287946 (UMLS CUI [1])
ID.3
Item
positive pml-rarα transcript by reverse transcriptase-polymerase chain reaction (rt-pcr) assay
boolean
C3475382 (UMLS CUI [1])
ID.4
Item
patients with cns involvement by apl are eligible
boolean
C0085136 (UMLS CUI [1])
ID.6
Item
karnofsky performance status 60-100%
boolean
C0206065 (UMLS CUI [1])
ID.7
Item
creatinine ≤ 2.0 mg/dl or creatinine clearance > 60 ml/min
boolean
C0010294 (UMLS CUI [1])
ID.8
Item
bilirubin < 2.0 mg/dl (unless attributed to gilbert disease)
boolean
C0005437 (UMLS CUI [1])
ID.9
Item
alkaline phosphatase ≤ 2.5 times the upper limit of normal (uln)
boolean
C0002059 (UMLS CUI [1])
ID.10
Item
ast and alt ≤ 2.5 uln
boolean
C0004002 (UMLS CUI [1,1])
C0001899 (UMLS CUI [1,2])
ID.11
Item
lvef ≥ 50% on echocardiogram or muga scan
boolean
C0428772 (UMLS CUI [1])
ID.12
Item
qtc ≤ 500 msec on baseline ecg
boolean
C0860814 (UMLS CUI [1])
ID.13
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.14
Item
negative pregnancy test
boolean
C0032961 (UMLS CUI [1])
ID.15
Item
fertile patients must use effective contraception during and for ≥ 4 months after the completion of study treatment
boolean
C0009862 (UMLS CUI [1])
ID.16
Item
no active serious infections not controlled by antibiotics
boolean
C3714514 (UMLS CUI [1])
ID.17
Item
no other concurrent active malignancy requiring immediate therapy
boolean
C0006826 (UMLS CUI [1])
ID.18
Item
no clinically significant cardiac disease (new york heart association class iii or iv heart disease), including chronic arrhythmias
boolean
C0018799 (UMLS CUI [1])
ID.19
Item
no pulmonary disease
boolean
C0024115 (UMLS CUI [1])
ID.20
Item
no other serious or life-threatening condition deemed unacceptable by the principal investigator
boolean
C0012634 (UMLS CUI [1])
ID.21
Item
prior concurrent therapy:
boolean
C0009429 (UMLS CUI [1])
ID.22
Item
no prior treatment for apl
boolean
C0023487 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])