ID

129

Description

ODM derived from http://clinicaltrials.gov/show/NCT00185393

Link

http://clinicaltrials.gov/show/NCT00185393

Keywords

  1. 12/9/11 12/9/11 -
  2. 6/4/17 6/4/17 - Martin Dugas
Uploaded on

December 9, 2011

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00185393 Lymphoma, Non-Hodgkin

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

18 Years and older
Description

Age

Data type

boolean

Non Hodgkin Lymphoma stage III or IV at timepoint of diagnosis
Description

NHL III/IV

Data type

boolean

Patients who have achieved a remission after first line chemotherapy
Description

remission after first line chemotherapy

Data type

boolean

No less than 6 weeks and no more than 12 weeks since last dose of chemotherapy
Description

6-12 weeks since last dose of chemotherapy

Data type

boolean

written informed consent
Description

consent

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Any other anticancer treatment for NHL except the preceding first line chemotherapy
Description

Any other anticancer treatment for NHL except the preceding first line chemotherapy

Data type

boolean

Prior radiation therapy
Description

Prior radiation therapy

Data type

boolean

Patients who have not recovered from the toxic effects of the first line chemotherapy
Description

no recovery from chemotherapy

Data type

boolean

Any other cancer or history of cancer less than 10 years ago
Description

other cancer

Data type

boolean

Patients with known HIV positivity
Description

HIV

Data type

boolean

patients with pleural effusion or ascites
Description

pleural effusion or ascites

Data type

boolean

female patients who are pregnant or breast feeding (women of childbearing potential must have a negative serum pregnancy test at study entry)
Description

pregnant or breast feeding

Data type

boolean

Adults not employing an effective method of birth control during study treatment and 12 months thereafter
Description

no contraception

Data type

boolean

Patients unable or unwilling to comply with protocol
Description

non-compliance

Data type

boolean

Medical concepts
Description

Medical concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Lymphoma, Non-Hodgkin (Non-Hodgkins lymphoma)
Description

NHL

Data type

string

Alias
UMLS CUI
C0024305
SNOMED CT 2010_0731
118601006
MedDRA 13.1
10029547
ICD-10-CM Version 2010
C85.9
Diagnostic Neoplasm Staging
Description

Tumor Staging

Data type

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Disease remission
Description

Remission

Data type

string

Alias
UMLS CUI
C0544452
SNOMED CT 2010_0731
277022003
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Chemotherapy
Description

Chemotherapy

Data type

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
First-Line Treatment (primary treatment)
Description

First-Line Therapy (primary therapy)

Data type

string

Alias
UMLS CUI
C1708063
Radiotherapy
Description

Radiotherapy

Data type

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
Recovery - healing process
Description

Recovery

Data type

string

Alias
UMLS CUI
C2004454
Malignant Neoplasms
Description

Cancer

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
HIV negative
Description

HIV negative

Data type

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
MedDRA 13.1
10020179
Pleural effusion disorder
Description

Pleural effusion

Data type

string

Alias
UMLS CUI
C0032227
SNOMED CT 2010_0731
60046008
MedDRA 13.1
10035598
ICD-10-CM Version 2010
J90
ICD-9-CM Version 2011
511.9
CTCAE Version 4.03
E13486
Ascites
Description

Ascites

Data type

string

Alias
UMLS CUI
C0003962
SNOMED CT 2010_0731
389026000
MedDRA 13.1
10003445
ICD-10-CM Version 2010
R18
ICD-9-CM Version 2011
789.5
CTCAE Version 4.03
E10502
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding, Nursing
Description

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Serum pregnancy test (B-HCG)
Description

Serum pregnancy test

Data type

string

Alias
UMLS CUI
C0430060
SNOMED CT 2010_0731
166434005
Contraception
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Compliance
Description

Compliance

Data type

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
18 Years and older
boolean
NHL III/IV
Item
Non Hodgkin Lymphoma stage III or IV at timepoint of diagnosis
boolean
remission after first line chemotherapy
Item
Patients who have achieved a remission after first line chemotherapy
boolean
6-12 weeks since last dose of chemotherapy
Item
No less than 6 weeks and no more than 12 weeks since last dose of chemotherapy
boolean
consent
Item
written informed consent
boolean
Item Group
Exclusion Criteria
Any other anticancer treatment for NHL except the preceding first line chemotherapy
Item
Any other anticancer treatment for NHL except the preceding first line chemotherapy
boolean
Prior radiation therapy
Item
Prior radiation therapy
boolean
no recovery from chemotherapy
Item
Patients who have not recovered from the toxic effects of the first line chemotherapy
boolean
other cancer
Item
Any other cancer or history of cancer less than 10 years ago
boolean
HIV
Item
Patients with known HIV positivity
boolean
pleural effusion or ascites
Item
patients with pleural effusion or ascites
boolean
pregnant or breast feeding
Item
female patients who are pregnant or breast feeding (women of childbearing potential must have a negative serum pregnancy test at study entry)
boolean
no contraception
Item
Adults not employing an effective method of birth control during study treatment and 12 months thereafter
boolean
non-compliance
Item
Patients unable or unwilling to comply with protocol
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
NHL
Item
Lymphoma, Non-Hodgkin (Non-Hodgkins lymphoma)
string
C0024305 (UMLS CUI)
118601006 (SNOMED CT 2010_0731)
10029547 (MedDRA 13.1)
C85.9 (ICD-10-CM Version 2010)
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Remission
Item
Disease remission
string
C0544452 (UMLS CUI)
277022003 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
First-Line Therapy (primary therapy)
Item
First-Line Treatment (primary treatment)
string
C1708063 (UMLS CUI)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
Recovery
Item
Recovery - healing process
string
C2004454 (UMLS CUI)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)
Pleural effusion
Item
Pleural effusion disorder
string
C0032227 (UMLS CUI)
60046008 (SNOMED CT 2010_0731)
10035598 (MedDRA 13.1)
J90 (ICD-10-CM Version 2010)
511.9 (ICD-9-CM Version 2011)
E13486 (CTCAE Version 4.03)
Ascites
Item
Ascites
string
C0003962 (UMLS CUI)
389026000 (SNOMED CT 2010_0731)
10003445 (MedDRA 13.1)
R18 (ICD-10-CM Version 2010)
789.5 (ICD-9-CM Version 2011)
E10502 (CTCAE Version 4.03)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Serum pregnancy test
Item
Serum pregnancy test (B-HCG)
string
C0430060 (UMLS CUI)
166434005 (SNOMED CT 2010_0731)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Compliance
Item
Compliance
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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