ID

31074

Beschreibung

A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE); ODM derived from: https://clinicaltrials.gov/show/NCT00719472

Link

https://clinicaltrials.gov/show/NCT00719472

Stichworte

Versionen (1)
  1. 18.07.18 18.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. Juli 2018

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.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Non-Hodgkin's Lymphoma NCT00719472

Englisch

Eligibility Non-Hodgkin's Lymphoma NCT00719472

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with previously untreated diffuse large b-cell lymphoma (dlbcl) who are scheduled to receive rituximab 375 mg/m^2 plus chop (cyclophosphamide, hydroxydaunorubicin [also called doxorubicin or adriamycin], oncovin [vincristine], prednisone or prednisolone) chemotherapy, or previously untreated follicular non-hodgkin lymphoma (nhl) who are scheduled to receive rituximab 375 mg/m^2 plus cvp (cyclophosphamide, vincristine, prednisolone) chemotherapy
Beschreibung

Diffuse Large B-Cell Lymphoma untreated | Rituximab plus CHOP Scheduled | Doxorubicin | Adriamycin | Oncovin | Vincristine | Prednisone | Prednisolone | Follicular Lymphoma untreated | Rituximab plus CVP Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0393022
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0163868
UMLS CUI [2,4]
C0205539
UMLS CUI [3]
C0013089
UMLS CUI [4]
C0085752
UMLS CUI [5]
C0591904
UMLS CUI [6]
C0042679
UMLS CUI [7]
C0032952
UMLS CUI [8]
C0032950
UMLS CUI [9,1]
C0024301
UMLS CUI [9,2]
C0332155
UMLS CUI [10,1]
C0393022
UMLS CUI [10,2]
C0332287
UMLS CUI [10,3]
C0056633
UMLS CUI [10,4]
C0205539
eastern cooperative oncology group (ecog) performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
* clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), new york heart association (nyha) classification grade ii or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to day 1, or nyha grade ii or greater peripheral vascular disease on day 1 (first day of treatment)
Beschreibung

Cardiovascular Disease | Uncontrolled hypertension | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Ventricular arrhythmia Requirement Pharmaceutical Preparations | Peripheral Vascular Disease New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C1275491
UMLS CUI [6,1]
C0085612
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0013227
UMLS CUI [7,1]
C0085096
UMLS CUI [7,2]
C1275491
patients who meet any of the following criteria will be excluded from further study participation after cycle 1:
Beschreibung

Criteria Fulfill | Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332196
circulating lymphocyte count > 5,000/μl before the cycle 2 rituximab infusion
Beschreibung

Circulating Lymphocyte Count

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0175630
UMLS CUI [1,2]
C0200635
development of a serious and/or grade 3 or 4 adverse event during cycle 1 judged by the investigator to be related to the rituximab infusion
Beschreibung

Adverse event Serious | Adverse event CTCAE Grades | Relationship Rituximab Infusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0393022
UMLS CUI [3,3]
C0574032
prior premedication with additional corticosteroids other than the prednisone included in the chemotherapy regimens
Beschreibung

Premedication Adrenal Cortex Hormones Additional | Exception Prednisone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0032952
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Non-Hodgkin's Lymphoma NCT00719472

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma untreated | Rituximab plus CHOP Scheduled | Doxorubicin | Adriamycin | Oncovin | Vincristine | Prednisone | Prednisolone | Follicular Lymphoma untreated | Rituximab plus CVP Scheduled
Item
patients with previously untreated diffuse large b-cell lymphoma (dlbcl) who are scheduled to receive rituximab 375 mg/m^2 plus chop (cyclophosphamide, hydroxydaunorubicin [also called doxorubicin or adriamycin], oncovin [vincristine], prednisone or prednisolone) chemotherapy, or previously untreated follicular non-hodgkin lymphoma (nhl) who are scheduled to receive rituximab 375 mg/m^2 plus cvp (cyclophosphamide, vincristine, prednisolone) chemotherapy
boolean
C0079744 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0393022 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0163868 (UMLS CUI [2,3])
C0205539 (UMLS CUI [2,4])
C0013089 (UMLS CUI [3])
C0085752 (UMLS CUI [4])
C0591904 (UMLS CUI [5])
C0042679 (UMLS CUI [6])
C0032952 (UMLS CUI [7])
C0032950 (UMLS CUI [8])
C0024301 (UMLS CUI [9,1])
C0332155 (UMLS CUI [9,2])
C0393022 (UMLS CUI [10,1])
C0332287 (UMLS CUI [10,2])
C0056633 (UMLS CUI [10,3])
C0205539 (UMLS CUI [10,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Disease | Uncontrolled hypertension | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Ventricular arrhythmia Requirement Pharmaceutical Preparations | Peripheral Vascular Disease New York Heart Association Classification
Item
* clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), new york heart association (nyha) classification grade ii or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to day 1, or nyha grade ii or greater peripheral vascular disease on day 1 (first day of treatment)
boolean
C0007222 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0085612 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
C0085096 (UMLS CUI [7,1])
C1275491 (UMLS CUI [7,2])
Criteria Fulfill | Study Subject Participation Status Excluded
Item
patients who meet any of the following criteria will be excluded from further study participation after cycle 1:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Circulating Lymphocyte Count
Item
circulating lymphocyte count > 5,000/μl before the cycle 2 rituximab infusion
boolean
C0175630 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
Adverse event Serious | Adverse event CTCAE Grades | Relationship Rituximab Infusion
Item
development of a serious and/or grade 3 or 4 adverse event during cycle 1 judged by the investigator to be related to the rituximab infusion
boolean
C0877248 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0393022 (UMLS CUI [3,2])
C0574032 (UMLS CUI [3,3])
Premedication Adrenal Cortex Hormones Additional | Exception Prednisone
Item
prior premedication with additional corticosteroids other than the prednisone included in the chemotherapy regimens
boolean
C0033045 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video