Informationen:
Fehler:
ID
39086
Beschreibung
Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01622439
Link
https://clinicaltrials.gov/show/NCT01622439
Stichworte
Versionen (1)
- 29.11.19 29.11.19 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
29. November 2019
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Diffuse Large B-cell Lymphoma NCT01622439
Eligibility Diffuse Large B-cell Lymphoma NCT01622439
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Diffuse Large B-cell Lymphoma NCT01622439
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age
Item
age 18-80 years
boolean
C0001779 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma WHO tumor classification
Item
histologically confirmed (according to the who classification) diffuse large b-cell lymphoma stage ii-iv
boolean
C0079744 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
C1301142 (UMLS CUI [1,2])
Prior Therapy Absent Lymphoma | Adrenal Cortex Hormones Mitigation Intent allowed
Item
no previous treatment for lymphoma. corticosteroids for alleviation of lymphoma associated symptoms are allowed
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C1706602 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0332197 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C1706602 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
HIV negative
Item
hiv negativity
boolean
C0481430 (UMLS CUI [1])
Hepatitis C virus Seronegative | Hepatitis B Surface Antigens Seronegative | Anti-HBc antibody Seronegative | Infection Uncontrolled Seronegative
Item
seronegativity for hcv, hbsag, anti-hbc, or other active infection uncontrolled by treatment
boolean
C0220847 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
C0948759 (UMLS CUI [3,1])
C0521144 (UMLS CUI [3,2])
C3714514 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0521144 (UMLS CUI [4,3])
C0521144 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
C0948759 (UMLS CUI [3,1])
C0521144 (UMLS CUI [3,2])
C3714514 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0521144 (UMLS CUI [4,3])
Mental disorders Absent | Interference Comprehension Study Protocol
Item
absence of psychiatric illness or condition which could interfere with the subjects ability understand the requirements of the study
boolean
C0004936 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
C0332197 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Nervous system disorder Absent | Neuropsychiatric syndrome Absent | Interference Protocol Compliance
Item
absence of neurological or neuropsychiatric disorder, interfering with the requirements of the study
boolean
C0027765 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3203509 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0332197 (UMLS CUI [1,2])
C3203509 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
Absence Hearing impairment CTCAE Grades
Item
absence of hearing impairment > grade 2
boolean
C0332197 (UMLS CUI [1,1])
C1384666 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C1384666 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Porphyria Absent
Item
absence of porphyria
boolean
C3463940 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Gender | Pregnancy Absent | Breast Feeding Absent
Item
in females: absence of pregnancy and lactation
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Blood Donation Absent
Item
all subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy
boolean
C0005794 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Medication Sharing Absent | Investigational New Drugs Unused Return to Research Personnel
Item
all subjects must agree not to share study medication with another person, and to return all unused study drug to investigators
boolean
C0013227 (UMLS CUI [1,1])
C0237876 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0445107 (UMLS CUI [2,2])
C0332156 (UMLS CUI [2,3])
C0035173 (UMLS CUI [2,4])
C0237876 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0445107 (UMLS CUI [2,2])
C0332156 (UMLS CUI [2,3])
C0035173 (UMLS CUI [2,4])
Informed Consent
Item
written informed concent according to ich/gcp and swedish regulations
boolean
C0021430 (UMLS CUI [1])