ID

21490

Beskrivning

This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00517218

Länk

https://clinicaltrials.gov/show/NCT00517218

Nyckelord

Versioner (1)
  1. 2017-04-24 2017-04-24 -
Uppladdad den

24 april 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Lymphocytic Leukemia NCT00517218

Engelsk

Eligibility Lymphocytic Leukemia NCT00517218

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously untreated subjects with intermediate-or high-risk cll(modified rai stages i-iv)
Beskrivning

Study Subject untreated | Chronic Lymphocytic Leukemia Intermediate Rai Staging System | Chronic Lymphocytic Leukemia High risk Rai Staging System

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C0205103
UMLS CUI [2,3]
C1514715
UMLS CUI [3,1]
C0023434
UMLS CUI [3,2]
C0332167
UMLS CUI [3,3]
C1514715
measurable disease as primarily established by the national cancer institute-sponsored working group(nci-wg) guidelines for the diagnosis of cll
Beskrivning

Measurable Disease | Chronic Lymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0023434
requiring therapy for active disease, as primarily defined by the nci-wg guidelines
Beskrivning

Disease Requirement Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
eastern cooperative oncology group performance status < 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function determined , 14 days prior to the first dose of study medication
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
absolute lymphocyte count > 100,000/ul
Beskrivning

Absolute lymphocyte count

Datatyp

boolean

Alias
UMLS CUI [1]
C3544087
prior chemotherapy or other therapy for cll, including allogeneic transplant
Beskrivning

Chemotherapy Chronic Lymphocytic Leukemia | Therapeutic procedure Chronic Lymphocytic Leukemia | Transplantation, Homologous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0023434
UMLS CUI [3]
C0040739
less than 3 weeks from any prior major surgery at the time of informed consent
Beskrivning

major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
failure to recover from any serious adverse effect of surgery
Beskrivning

Operative Surgical Procedures Adverse effects Serious | Recovering failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0879626
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0521108
UMLS CUI [2,2]
C0231175
history of autoimmune hemolytic anemia or autoimmune thrombocytopenia
Beskrivning

Autoimmune hemolytic anemia | Autoimmune thrombocytopenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0002880
UMLS CUI [2]
C0242584
active serious infection requiring systemic anti-infective therapy
Beskrivning

Communicable Disease Serious | Anti-infective therapy Systemic Patient need for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1141958
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C0686904
Tillbaka till toppen

Similar models

Eligibility Lymphocytic Leukemia NCT00517218

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject untreated | Chronic Lymphocytic Leukemia Intermediate Rai Staging System | Chronic Lymphocytic Leukemia High risk Rai Staging System
Item
previously untreated subjects with intermediate-or high-risk cll(modified rai stages i-iv)
boolean
C0681850 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0023434 (UMLS CUI [2,1])
C0205103 (UMLS CUI [2,2])
C1514715 (UMLS CUI [2,3])
C0023434 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C1514715 (UMLS CUI [3,3])
Measurable Disease | Chronic Lymphocytic Leukemia
Item
measurable disease as primarily established by the national cancer institute-sponsored working group(nci-wg) guidelines for the diagnosis of cll
boolean
C1513041 (UMLS CUI [1])
C0023434 (UMLS CUI [2])
Disease Requirement Therapeutic procedure
Item
requiring therapy for active disease, as primarily defined by the nci-wg guidelines
boolean
C0012634 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group performance status < 2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function determined , 14 days prior to the first dose of study medication
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Absolute lymphocyte count
Item
absolute lymphocyte count > 100,000/ul
boolean
C3544087 (UMLS CUI [1])
Chemotherapy Chronic Lymphocytic Leukemia | Therapeutic procedure Chronic Lymphocytic Leukemia | Transplantation, Homologous
Item
prior chemotherapy or other therapy for cll, including allogeneic transplant
boolean
C0392920 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
C0040739 (UMLS CUI [3])
major surgery
Item
less than 3 weeks from any prior major surgery at the time of informed consent
boolean
C0679637 (UMLS CUI [1])
Operative Surgical Procedures Adverse effects Serious | Recovering failed
Item
failure to recover from any serious adverse effect of surgery
boolean
C0543467 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0521108 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Autoimmune hemolytic anemia | Autoimmune thrombocytopenia
Item
history of autoimmune hemolytic anemia or autoimmune thrombocytopenia
boolean
C0002880 (UMLS CUI [1])
C0242584 (UMLS CUI [2])
Communicable Disease Serious | Anti-infective therapy Systemic Patient need for
Item
active serious infection requiring systemic anti-infective therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1141958 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial