ID

44287

Descrição

Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02392039

Link

https://clinicaltrials.gov/show/NCT02392039

Palavras-chave

Versões (3)
  1. 30/04/2019 30/04/2019 -
  2. 30/04/2019 30/04/2019 -
  3. 20/09/2021 20/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma NCT02392039

Inglês

Eligibility Lymphoma NCT02392039

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02392039
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have newly diagnosed, previously untreated diffuse large b-cell lymphoma, mantle cell lymphoma, grade 3b follicular lymphoma, burkitt lymphoma, peripheral t cell lymphoma nos, nk/t cell lymphoma, or transformed lymphoma.
Descrição

Diffuse Large B-Cell Lymphoma Untreated | Mantle cell lymphoma Untreated | Follicular Lymphoma Grade Untreated | Burkitt Lymphoma Untreated | Peripheral T-Cell Lymphoma Untreated | NK/T-cell lymphoma Untreated | Lymphoma transformation Untreated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0334634
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0024301
UMLS CUI [3,2]
C0441800
UMLS CUI [3,3]
C0332155
UMLS CUI [4,1]
C0006413
UMLS CUI [4,2]
C0332155
UMLS CUI [5,1]
C0079774
UMLS CUI [5,2]
C0332155
UMLS CUI [6,1]
C0558916
UMLS CUI [6,2]
C0332155
UMLS CUI [7,1]
C0024299
UMLS CUI [7,2]
C0040682
UMLS CUI [7,3]
C0332155
2. planned to receive chemotherapy for 6 cycles which the treating physician plans to utilize for pegfilgrastim to minimize risk for neutropenic fever, including but not limited to r-chop, r-epoch, and r-hypercvad, chop, and smile.
Descrição

Chemotherapy cycle Quantity Planned | pegfilgrastim | Risk Febrile Neutropenia Diminishing | R-CHOP chemotherapy regimen | R-EPOCH Regimen | Other Coding | CHOP regimen | Other Coding

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1301732
UMLS CUI [2]
C1136535
UMLS CUI [3,1]
C0035647
UMLS CUI [3,2]
C0746883
UMLS CUI [3,3]
C0205216
UMLS CUI [4]
C4302501
UMLS CUI [5]
C1882521
UMLS CUI [6]
C3846158
UMLS CUI [7]
C0163868
UMLS CUI [8]
C3846158
3. age >= 18 years old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status 0-3.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
5. ability to provide informed consent for participation.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. existing chronic bone pain prior to pegfilgrastim usage.
Descrição

Bone pain chronic | Status pre- Use of Pegfilgrastim

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0151825
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C1136535
2. creatinine clearance of <50ml/minute by cockcroft gault equation.
Descrição

Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2711451
3. allergy to filgrastim, pegfilgrastim, or loratadine.
Descrição

Filgrastim allergy | Hypersensitivity Pegfilgrastim | Loratadine allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0570660
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1136535
UMLS CUI [3]
C0571031
4. chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication.
Descrição

Antihistamines Used daily chronic | Pharmaceutical Preparations Alternative Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019590
UMLS CUI [1,2]
C3845591
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1523987
UMLS CUI [2,3]
C0332268
5. inability to swallow medications.
Descrição

Lacking Able to swallow Oral medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
6. inability to complete the survey instrumentation accurately.
Descrição

Survey Completion Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038951
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Lymphoma NCT02392039

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02392039
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma Untreated | Mantle cell lymphoma Untreated | Follicular Lymphoma Grade Untreated | Burkitt Lymphoma Untreated | Peripheral T-Cell Lymphoma Untreated | NK/T-cell lymphoma Untreated | Lymphoma transformation Untreated
Item
1. patients must have newly diagnosed, previously untreated diffuse large b-cell lymphoma, mantle cell lymphoma, grade 3b follicular lymphoma, burkitt lymphoma, peripheral t cell lymphoma nos, nk/t cell lymphoma, or transformed lymphoma.
boolean
C0079744 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0334634 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0024301 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C0332155 (UMLS CUI [3,3])
C0006413 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0079774 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
C0558916 (UMLS CUI [6,1])
C0332155 (UMLS CUI [6,2])
C0024299 (UMLS CUI [7,1])
C0040682 (UMLS CUI [7,2])
C0332155 (UMLS CUI [7,3])
Chemotherapy cycle Quantity Planned | pegfilgrastim | Risk Febrile Neutropenia Diminishing | R-CHOP chemotherapy regimen | R-EPOCH Regimen | Other Coding | CHOP regimen | Other Coding
Item
2. planned to receive chemotherapy for 6 cycles which the treating physician plans to utilize for pegfilgrastim to minimize risk for neutropenic fever, including but not limited to r-chop, r-epoch, and r-hypercvad, chop, and smile.
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1136535 (UMLS CUI [2])
C0035647 (UMLS CUI [3,1])
C0746883 (UMLS CUI [3,2])
C0205216 (UMLS CUI [3,3])
C4302501 (UMLS CUI [4])
C1882521 (UMLS CUI [5])
C3846158 (UMLS CUI [6])
C0163868 (UMLS CUI [7])
C3846158 (UMLS CUI [8])
Age
Item
3. age >= 18 years old.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status 0-3.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
5. ability to provide informed consent for participation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bone pain chronic | Status pre- Use of Pegfilgrastim
Item
1. existing chronic bone pain prior to pegfilgrastim usage.
boolean
C0151825 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C1136535 (UMLS CUI [2,3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
2. creatinine clearance of <50ml/minute by cockcroft gault equation.
boolean
C2711451 (UMLS CUI [1])
Filgrastim allergy | Hypersensitivity Pegfilgrastim | Loratadine allergy
Item
3. allergy to filgrastim, pegfilgrastim, or loratadine.
boolean
C0570660 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1136535 (UMLS CUI [2,2])
C0571031 (UMLS CUI [3])
Antihistamines Used daily chronic | Pharmaceutical Preparations Alternative Lacking
Item
4. chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication.
boolean
C0019590 (UMLS CUI [1,1])
C3845591 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1523987 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Lacking Able to swallow Oral medication
Item
5. inability to swallow medications.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
Survey Completion Unable
Item
6. inability to complete the survey instrumentation accurately.
boolean
C0038951 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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