ID

17709

Description

Study part: Basic documentation B2 LeMLAR-Studie. LeMLAR-Studie. Lenalidomide in conjunction with methotrexate, leucovorin, cytarabine and rituximab for the treatment of relapsed or refractory CD20-positive aggressive lymphomas: an open-label, multicenter phase I/II trial. Publication granted by Prof. Dührsen and provided by Claudia Ose, University clinic Essen, NCT01788189, Version 1.3-28.04.2013.doc.

Keywords

  1. 9/28/16 9/28/16 -
  2. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
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September 28, 2016

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License

Creative Commons BY-NC 3.0

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Basic documentation B2 LeMLAR-Studie Lymphoma NCT01788189

Basic documentation B2

  1. StudyEvent: ODM
    1. Basic documentation B2
Vorgeschichte
Description

Vorgeschichte

Alias
UMLS CUI-1
C0262926
Therapielinie
Description

Therapy

Data type

text

Alias
UMLS CUI [1]
C0087111
Therapie von:
Description

Date of start of treatment

Data type

partialDate

Alias
UMLS CUI [1]
C3173309
Therapie bis:
Description

Therapy End Date

Data type

partialDate

Alias
UMLS CUI [1,1]
C2584899
UMLS CUI [1,2]
C2711097
Protokoll, Anzahl Zyklen
Description

protocol

Data type

text

Alias
UMLS CUI [1]
C1507394
Therapieergebnis (CR, PR, SD, PD, NE)
Description

result therapy

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0087111
Geplanter Therapiebeginn (Datum):
Description

Therapy start date

Data type

date

Alias
UMLS CUI [1]
C1531783
Datum der Bearbeitung
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Name
Description

Name

Data type

text

Alias
UMLS CUI [1]
C0027365
Unterschrift
Description

signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Einschlusskriterien
Description

Einschlusskriterien

Alias
UMLS CUI-1
C1512693
Histologisch gesicherte Diagnose eines CD20-positiven aggressiven Non-Hodgkin-Lymphoms
Description

Lymphoma, Non-Hodgkin

Data type

boolean

Alias
UMLS CUI [1]
C0024305
Refraktärität oder Rezidiv
Description

recurrence

Data type

boolean

Alias
UMLS CUI [1]
C0035020
Allgemeinzustand ECOG 0 – 3
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Messbare Krankheitsmanifestationen
Description

disease manifestations

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1280464
Fehlende Eignung für eine Hochdosistherapie mit autologer Blutstammzelltransplantation
Description

Autologous peripheral hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C1142466
Fehlen von Ausschlusskriterien
Description

exclusion

Data type

boolean

Alias
UMLS CUI [1]
C2828389
Effektive Kontrazeption
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Fähigkeit, die Bedeutung der Studie zu erkennen und sich entsprechend zu verhalten
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Erfolgte Patientenaufklärung und Vorliegen der
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
schriftlichen Einwilligung (Datum):
Description

datum Informed Consent

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Ausschlusskriterien
Description

Ausschlusskriterien

Alias
UMLS CUI-1
C0680251
Zentralnervöse Rezidivmanifestation
Description

Recurrence Central Nervous System

Data type

boolean

Alias
UMLS CUI [1,1]
C2825055
UMLS CUI [1,2]
C3714787
Schwerwiegende, die geplante Therapie beeinträchtigende Organfunktionsstörungen, die nicht durch das Lymphom erklärt werden
Description

organ function disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0012634
Vorliegen von Umständen, aufgrund derer die Studienteilnahme zu risikoreich erscheint
Description

medical condition high risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332167
Vorliegen von Umständen, die die Interpretation der Studiendaten unmöglich machen
Description

medical condition compromise interpretation

Data type

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0420833
Aktive HBV- oder HCV-, jede HIV- oder ander- weitige unkontrollierte Infektion
Description

infection active Hepatitis B and hepatitis C HIV

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C2711110
UMLS CUI [1,4]
C0019682
Nicht lymphombedingte, inadäquate Organfunktionen (Neutrophile < 1.0/nl, Thrombozyten < 75/nl, Kreatinin-Clearance < 60 ml/min, Bilirubin ≥ 2.5 mg/dl, GOT/GPT ≥ 4 x obere Normgrenze)
Description

organ function Insufficiency neutrophil Blood Platelets Creatinine clearance Bilirubin GOT/GPT

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0231179
UMLS CUI [1,3]
C0027950
UMLS CUI [1,4]
C0005821
UMLS CUI [1,5]
C0373595
UMLS CUI [1,6]
C0005437
UMLS CUI [1,7]
C0364051
Schwangerschaft oder Stillzeit
Description

pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Basic documentation B2

  1. StudyEvent: ODM
    1. Basic documentation B2
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vorgeschichte
C0262926 (UMLS CUI-1)
Therapy
Item
Therapielinie
text
C0087111 (UMLS CUI [1])
Date of start of treatment
Item
Therapie von:
partialDate
C3173309 (UMLS CUI [1])
Therapy End Date
Item
Therapie bis:
partialDate
C2584899 (UMLS CUI [1,1])
C2711097 (UMLS CUI [1,2])
protocol
Item
Protokoll, Anzahl Zyklen
text
C1507394 (UMLS CUI [1])
result therapy
Item
Therapieergebnis (CR, PR, SD, PD, NE)
text
C1274040 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Therapy start date
Item
Geplanter Therapiebeginn (Datum):
date
C1531783 (UMLS CUI [1])
date
Item
Datum der Bearbeitung
date
C0011008 (UMLS CUI [1])
Name
Item
Name
text
C0027365 (UMLS CUI [1])
signature
Item
Unterschrift
text
C1519316 (UMLS CUI [1])
Item Group
Einschlusskriterien
C1512693 (UMLS CUI-1)
Lymphoma, Non-Hodgkin
Item
Histologisch gesicherte Diagnose eines CD20-positiven aggressiven Non-Hodgkin-Lymphoms
boolean
C0024305 (UMLS CUI [1])
recurrence
Item
Refraktärität oder Rezidiv
boolean
C0035020 (UMLS CUI [1])
ECOG
Item
Allgemeinzustand ECOG 0 – 3
boolean
C1520224 (UMLS CUI [1])
disease manifestations
Item
Messbare Krankheitsmanifestationen
boolean
C0012634 (UMLS CUI [1,1])
C1280464 (UMLS CUI [1,2])
Autologous peripheral hematopoietic stem cell transplant
Item
Fehlende Eignung für eine Hochdosistherapie mit autologer Blutstammzelltransplantation
boolean
C1142466 (UMLS CUI [1])
exclusion
Item
Fehlen von Ausschlusskriterien
boolean
C2828389 (UMLS CUI [1])
contraception
Item
Effektive Kontrazeption
boolean
C0700589 (UMLS CUI [1])
compliance
Item
Fähigkeit, die Bedeutung der Studie zu erkennen und sich entsprechend zu verhalten
boolean
C1321605 (UMLS CUI [1])
informed consent
Item
Erfolgte Patientenaufklärung und Vorliegen der
boolean
C0021430 (UMLS CUI [1])
datum Informed Consent
Item
schriftlichen Einwilligung (Datum):
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item Group
Ausschlusskriterien
C0680251 (UMLS CUI-1)
Recurrence Central Nervous System
Item
Zentralnervöse Rezidivmanifestation
boolean
C2825055 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
organ function disorder
Item
Schwerwiegende, die geplante Therapie beeinträchtigende Organfunktionsstörungen, die nicht durch das Lymphom erklärt werden
boolean
C0678852 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
medical condition high risk
Item
Vorliegen von Umständen, aufgrund derer die Studienteilnahme zu risikoreich erscheint
boolean
C0012634 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
medical condition compromise interpretation
Item
Vorliegen von Umständen, die die Interpretation der Studiendaten unmöglich machen
boolean
C1699700 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,3])
infection active Hepatitis B and hepatitis C HIV
Item
Aktive HBV- oder HCV-, jede HIV- oder ander- weitige unkontrollierte Infektion
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C2711110 (UMLS CUI [1,3])
C0019682 (UMLS CUI [1,4])
organ function Insufficiency neutrophil Blood Platelets Creatinine clearance Bilirubin GOT/GPT
Item
Nicht lymphombedingte, inadäquate Organfunktionen (Neutrophile < 1.0/nl, Thrombozyten < 75/nl, Kreatinin-Clearance < 60 ml/min, Bilirubin ≥ 2.5 mg/dl, GOT/GPT ≥ 4 x obere Normgrenze)
boolean
C0678852 (UMLS CUI [1,1])
C0231179 (UMLS CUI [1,2])
C0027950 (UMLS CUI [1,3])
C0005821 (UMLS CUI [1,4])
C0373595 (UMLS CUI [1,5])
C0005437 (UMLS CUI [1,6])
C0364051 (UMLS CUI [1,7])
pregnancy; lactating
Item
Schwangerschaft oder Stillzeit
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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