ID

30409

Description

Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry on a Cohort of Patients Receiving Plerixafor; ODM derived from: https://clinicaltrials.gov/show/NCT01362972

Link

https://clinicaltrials.gov/show/NCT01362972

Keywords

  1. 6/3/18 6/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 3, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Lymphoma NCT01362972

Eligibility Lymphoma NCT01362972

  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01362972
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for inclusion in the cohort analysis, patients must have data in the ebmt registry that meet the following criteria:
Description

Inclusion Cohort Analysis | Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0086027
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
adults diagnosed with lymphoma or multiple myeloma (mm)
Description

Adult | Lymphoma | Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0024299
UMLS CUI [3]
C0026764
received first autologous transplants of peripheral blood (pb) non ex-vivo manipulated stem cells in the time period listed above using cells mobilised with one of the following regimens:
Description

Autologous peripheral blood stem cell transplant First | Manipulation Stem cells

Data type

boolean

Alias
UMLS CUI [1,1]
C1960579
UMLS CUI [1,2]
C0205435
UMLS CUI [2,1]
C0947647
UMLS CUI [2,2]
C0038250
plerixafor plus granulocyte colony stimulating factor (g-csf)
Description

Plerixafor | G-CSF

Data type

boolean

Alias
UMLS CUI [1]
C1955474
UMLS CUI [2]
C0079459
plerixafor plus g-csf plus chemotherapy
Description

Plerixafor | G-CSF | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1955474
UMLS CUI [2]
C0079459
UMLS CUI [3]
C0392920
g-csf alone or
Description

G-CSF Alone

Data type

boolean

Alias
UMLS CUI [1,1]
C0079459
UMLS CUI [1,2]
C0205171
g-csf plus chemotherapy
Description

G-CSF | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0079459
UMLS CUI [2]
C0392920
note: patients included in the plerixafor groups will be those treated according to the label
Description

Plerixafor Group | Therapeutic procedure in accordance with Label

Data type

boolean

Alias
UMLS CUI [1,1]
C1955474
UMLS CUI [1,2]
C0441833
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C4281991
UMLS CUI [2,3]
C1705425
provision of informed consent (i.e., all patients with data in the ebmt registry will have signed consent at the time of transplantation for the potential use of their data for analysis)
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients treated with plerixafor not according to the european union (eu) label.
Description

Plerixafor | Agreement European Union Label Lacking

Data type

boolean

Alias
UMLS CUI [1]
C1955474
UMLS CUI [2,1]
C0680240
UMLS CUI [2,2]
C0015179
UMLS CUI [2,3]
C1705425
UMLS CUI [2,4]
C0332268
patients whose graft product underwent ex vivo manipulation will be excluded from analysis
Description

Graft material ex vivo Manipulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0181074
UMLS CUI [1,2]
C2348480
UMLS CUI [1,3]
C0947647

Similar models

Eligibility Lymphoma NCT01362972

  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01362972
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion Cohort Analysis | Criteria Fulfill
Item
for inclusion in the cohort analysis, patients must have data in the ebmt registry that meet the following criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0086027 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Adult | Lymphoma | Multiple Myeloma
Item
adults diagnosed with lymphoma or multiple myeloma (mm)
boolean
C0001675 (UMLS CUI [1])
C0024299 (UMLS CUI [2])
C0026764 (UMLS CUI [3])
Autologous peripheral blood stem cell transplant First | Manipulation Stem cells
Item
received first autologous transplants of peripheral blood (pb) non ex-vivo manipulated stem cells in the time period listed above using cells mobilised with one of the following regimens:
boolean
C1960579 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0947647 (UMLS CUI [2,1])
C0038250 (UMLS CUI [2,2])
Plerixafor | G-CSF
Item
plerixafor plus granulocyte colony stimulating factor (g-csf)
boolean
C1955474 (UMLS CUI [1])
C0079459 (UMLS CUI [2])
Plerixafor | G-CSF | Chemotherapy
Item
plerixafor plus g-csf plus chemotherapy
boolean
C1955474 (UMLS CUI [1])
C0079459 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
G-CSF Alone
Item
g-csf alone or
boolean
C0079459 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
G-CSF | Chemotherapy
Item
g-csf plus chemotherapy
boolean
C0079459 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Plerixafor Group | Therapeutic procedure in accordance with Label
Item
note: patients included in the plerixafor groups will be those treated according to the label
boolean
C1955474 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C4281991 (UMLS CUI [2,2])
C1705425 (UMLS CUI [2,3])
Informed Consent
Item
provision of informed consent (i.e., all patients with data in the ebmt registry will have signed consent at the time of transplantation for the potential use of their data for analysis)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Plerixafor | Agreement European Union Label Lacking
Item
patients treated with plerixafor not according to the european union (eu) label.
boolean
C1955474 (UMLS CUI [1])
C0680240 (UMLS CUI [2,1])
C0015179 (UMLS CUI [2,2])
C1705425 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
Graft material ex vivo Manipulation
Item
patients whose graft product underwent ex vivo manipulation will be excluded from analysis
boolean
C0181074 (UMLS CUI [1,1])
C2348480 (UMLS CUI [1,2])
C0947647 (UMLS CUI [1,3])

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