Informações:
Falhas:
ID
17711
Descrição
Study part: Dose-Limiting Toxicity 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.
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Versões (1)
- 28/09/2016 28/09/2016 -
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28 de setembro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Dose-Limiting Toxicity LeMLAR-Studie Lymphoma NCT01788189
Dose-Limiting Toxicity (only cycle 1 and 2)
- StudyEvent: ODM
Similar models
Dose-Limiting Toxicity (only cycle 1 and 2)
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
dose-limiting Toxicity
Item
Dose-limiting Toxicity DLT
boolean
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,2])
date dose-limiting Toxicity
Item
Datum der DLT:
date
C0011008 (UMLS CUI [1,1])
C1512043 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
C1512043 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
patient ID
Item
Patientenidentifikation
integer
C1269815 (UMLS CUI [1])
dosage Methotrexate
Item
Methotrexat:
float
C3174092 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,2])
dose Cytarabine
Item
Cytarabin:
float
C3174092 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,2])
dose-limiting Toxicity
Item
Dosis-limitierende Toxizität in Zyklus 1
boolean
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,2])
dose-limiting Toxicity
Item
Dosis-limitierende Toxizität in Zyklus 2
boolean
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,2])
therapy continued
Item
Unzureichende Voraussetzung für die Therapiefortsetzung an Tag 8 (+ ≤ 3 Tage)
boolean
C3494713 (UMLS CUI [1])
therapy continued
Item
Unzureichende Voraussetzung für die Therapiefortsetzung an Tag 15 (+ ≤ 6 Tage)
boolean
C3494713 (UMLS CUI [1])
therapy continued
Item
Unzureichende Voraussetzung für die Therapiefortsetzung an Tag 29 (+ ≤ 7 Tage)
boolean
C3494713 (UMLS CUI [1])
therapy continued granulocyte
Item
Unzureichende Voraussetzung für die Therapiefortsetzung wegen Granulozyten < 0.5/nl
boolean
C3494713 (UMLS CUI [1,1])
C0018183 (UMLS CUI [1,2])
C0018183 (UMLS CUI [1,2])
therapy continued Blood Platelets
Item
Unzureichende Voraussetzung für die Therapiefortsetzung wegen Thrombozyten < 25/nl
boolean
C3494713 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,2])
therapy continued Creatinine clearance measurement
Item
Unzureichende Voraussetzung für die Therapiefortsetzung wegen Kreatinin-Clearance < 60 ml/min
boolean
C3494713 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
C0373595 (UMLS CUI [1,2])
therapy continued Bilirubin
Item
Unzureichende Voraussetzung für die Therapiefortsetzung wegen Bilirubin ≥ 3.0 mg/dl
boolean
C3494713 (UMLS CUI [1,1])
C0005437 (UMLS CUI [1,2])
C0005437 (UMLS CUI [1,2])
therapy continued GOT
Item
Unzureichende Voraussetzung für die Therapiefortsetzung wegen GOT ≥ 6 x obere Normgrenze
boolean
C3494713 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,2])
therapy continued GPT
Item
Unzureichende Voraussetzung für die Therapiefortsetzung wegen GPT ≥ 6 x obere Normgrenze
boolean
C3494713 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,2])
therapy continued mucositis
Item
Unzureichende Voraussetzung für die Therapiefortsetzung wegen Mukositis Grad 3 oder 4
boolean
C3494713 (UMLS CUI [1,1])
C0333355 (UMLS CUI [1,2])
C0333355 (UMLS CUI [1,2])
Dosage Reduction Methotrexate
Item
Dosisreduktion von Methotrexat erforderlich
boolean
C0178602 (UMLS CUI [1,1])
C0441610 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,3])
C0441610 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,3])
dosage Methotrexate
Item
Verabreichte Dosis
float
C3174092 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,2])
day dosage Methotrexate
Item
An Tag
integer
C0439228 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,3])
Dosage Reduction Cytarabine
Item
Dosisreduktion von Cytarabin erforderlich
boolean
C0178602 (UMLS CUI [1,1])
C0441610 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,3])
C0441610 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,3])
dosage Cytarabine
Item
Verabreichte Dosis
float
C3174092 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,2])
day dosage Cytarabine
Item
An Tag
integer
C0439228 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,3])
Therapy Lenalidomide
Item
Lenalidomid-Therapie < 21 Tage pro Zyklus
boolean
C0087111 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
C1144149 (UMLS CUI [1,2])
toxicity Therapy cessation
Item
Anderweitige Toxizität, die die protokollgerechte Therapiefortführung verbietet
boolean
C0013221 (UMLS CUI [1,1])
C1699848 (UMLS CUI [1,2])
C1699848 (UMLS CUI [1,2])
toxicity
Item
Beschreibung der Toxizität:
text
C0013221 (UMLS CUI [1])
UE-Number
Item
UE-Nummer(n):
integer
comments
Item
Weitere Kommentare
text
C0947611 (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])