Informationen:
Fehler:
ID
28057
Beschreibung
Dose Escalation Study of Revlimid With Fludarabine-Rituximab for CLL/SLL; ODM derived from: https://clinicaltrials.gov/show/NCT00543114
Link
https://clinicaltrials.gov/show/NCT00543114
Stichworte
Versionen (1)
- 13.12.17 13.12.17 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
13. Dezember 2017
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Eligibility Chronic Lymphocytic Leukemia NCT00543114
Eligibility Chronic Lymphocytic Leukemia NCT00543114
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Chronic Lymphocytic Leukemia NCT00543114
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
CLL/SLL WHO classification
Item
diagnosed with b-cll/sll based on the standard histologic and immunophenotypic criteria described in the who classification
boolean
C1302547 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C4267671 (UMLS CUI [1,2])
Systemic therapy Absent CLL/SLL | Chemotherapy Absent | Antibody therapy Absent
Item
no prior systemic therapy for cll/sll, including chemotherapy or antibody therapy
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1302547 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0281176 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0332197 (UMLS CUI [1,2])
C1302547 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0281176 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Therapeutic procedure Patient need for
Item
currently needs therapy based on 1996 nci-wg criteria
boolean
C0087111 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,2])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Laboratory test finding Within Study Protocol Parameter
Item
laboratory test results within parameters outlined in protocol
boolean
C0587081 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0549193 (UMLS CUI [1,4])
C0332285 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0549193 (UMLS CUI [1,4])
Able to take Aspirin Daily | Anticoagulation Prophylactic
Item
able to take aspirin daily as prophylactic anticoagulation
boolean
C4075001 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0003281 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
C0004057 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0003281 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
Medical condition Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent
Item
any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Laboratory test result abnormal Study Subject Participation Status At risk Unacceptable
Item
any condition, including the presence of abnormal laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
boolean
C0438215 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1883420 (UMLS CUI [1,4])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1883420 (UMLS CUI [1,4])
Investigational New Drugs | Therapy, Investigational
Item
use of any other experimental drug or therapy within 28 days of baseline
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C0949266 (UMLS CUI [2])
Hypersensitivity Thalidomide
Item
known hypersensitivity to thalidomide
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0039736 (UMLS CUI [1,2])
Erythema Nodosum | Rash desquamating | Thalidomide | Intake Pharmaceutical Preparations Similar
Item
development of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
boolean
C0014743 (UMLS CUI [1])
C0542171 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C1512806 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
C0542171 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C1512806 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
Lenalidomide
Item
prior use of lenalidomide
boolean
C1144149 (UMLS CUI [1])
Antineoplastic Agents | Cancer treatment
Item
concurrent use of other anti-cancer agents or treatments
boolean
C0003392 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C0920425 (UMLS CUI [2])
HIV Seropositivity
Item
known positive for hiv
boolean
C0019699 (UMLS CUI [1])
Hepatitis B, Chronic | Lamivudine Prophylactic Absent
Item
chronic active hep b patients not on prophylactic lamivudine
boolean
C0524909 (UMLS CUI [1])
C0209738 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0209738 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Mantle cell lymphoma
Item
diagnosis of mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])