4pp Cell Therapy Registry 25CTR.pdf

Cell Therapy Registry – Med-A
Descripción

Cell Therapy Registry – Med-A

First report – 6 months after cell therapy
Descripción

First report – 6 months after cell therapy

Tipo de datos

text

CENTRE IDENTIFICATION
Descripción

CENTRE IDENTIFICATION

EBMT Code (CIC) Number
Descripción

OrganizationalUnit::EBMT(CIC)CodeNumber

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C0029246
Hospital
Descripción

Klinik

Tipo de datos

text

Alias
UMLS CUI [1]
C0019994
Unit
Descripción

Unit

Tipo de datos

text

Contact person
Descripción

Contact person

Tipo de datos

text

Phone
Descripción

ContactPersonTelephoneNumber

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0039457
UMLS CUI [1,4]
C0337611
Fax
Descripción

ContactPersonFaxNumber

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0337611
UMLS CUI [1,4]
C0085205
E-mail
Descripción

ContactPersonE-mailText

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1527021
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0013849
UMLS CUI [1,4]
C0337611
REPORT INFORMATION
Descripción

REPORT INFORMATION

Date of this report
Descripción

Date of this report

Tipo de datos

date

Unidades de medida
  • yyyy/mm/dd
Alias
UMLS CUI [1]
C1302584
yyyy/mm/dd
PATIENT IDENTIFICATION
Descripción

PATIENT IDENTIFICATION

Unique Patient Number or Code
Descripción

Unique Patient Number or Code

Tipo de datos

text

Initials
Descripción

(first name(s) _family name(s)

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Date of Birth
Descripción

Date of Birth

Tipo de datos

date

Gender:
Descripción

Gender

Tipo de datos

text

INDICATION FOR TREATMENT If Primary disease
Descripción

INDICATION FOR TREATMENT If Primary disease

Date of diagnosis
Descripción

Diagnose-Datum

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C1274082
Autoimmune disease, specify
Descripción

Autoimmune disease, specify

Tipo de datos

text

Neurologic disorder, specify
Descripción

Neurologic disorder, specify

Tipo de datos

text

Heart disease, specify
Descripción

Heart disease, specify

Tipo de datos

text

Haematologic, specify
Descripción

Haematologic, specify

Tipo de datos

text

Other, specify
Descripción

Other, specify

Tipo de datos

text

If Haematopoietic stem cell transplant related
Descripción

If Haematopoietic stem cell transplant related

Tipo de datos

text

CELL THERAPY TREATMENT
Descripción

CELL THERAPY TREATMENT

Date of first cell infusion
Descripción

Date of first cell infusion

Tipo de datos

date

Performance score (if alive)
Descripción

Performance score

Tipo de datos

integer

Alias
UMLS CUI [1]
C1518965
Score achived
Descripción

Score

Tipo de datos

text

Alias
UMLS CUI [1]
C1518965
Status at therapy
Descripción

Status at therapy

Tipo de datos

text

Cell origin
Descripción

Cell origin

Tipo de datos

text

Tissue cell source
Descripción

Tissue cell source

Tipo de datos

text

Tissue cell source, specify other
Descripción

Tissue cell source

Tipo de datos

text

Cell characteristic
Descripción

Cell characteristic

Tipo de datos

text

Cell characteristic, specify other
Descripción

Cell characteristic

Tipo de datos

text

Chronological no. of cell therapy for this patient
Descripción

f more than 6 months apart

Tipo de datos

integer

GRAFT MANIPULATION
Descripción

GRAFT MANIPULATION

Ex-vivo manipulation
Descripción

Ex-vivo manipulation

Tipo de datos

integer

Ex-vivo manipulation, Growth factor, specify
Descripción

Ex-vivo manipulation

Tipo de datos

text

Ex-vivo manipulation, other
Descripción

Ex-vivo manipulation

Tipo de datos

text

In-vivo manipulation, in the donor
Descripción

In-vivo manipulation

Tipo de datos

text

In-vivo manipulation In the donor, growth factor, specify
Descripción

In-vivo manipulation In the donor

Tipo de datos

text

In-vivo manipulation In the donor, other
Descripción

In-vivo manipulation In the donor

Tipo de datos

text

In-vivo manipulation, in the patient
Descripción

In-vivo manipulation

Tipo de datos

text

In-vivo manipulation in the patient, growth factor, specify
Descripción

In-vivo manipulation, in the patient

Tipo de datos

text

In-vivo manipulation in the patient, other
Descripción

In-vivo manipulation, in the patient

Tipo de datos

text

TREATMENT
Descripción

TREATMENT

Route of infusion
Descripción

Route of infusion

Tipo de datos

text

Route of infusion, Locally intra-arterially, specify artery
Descripción

Route of infusion

Tipo de datos

text

Route of infusion, pther route
Descripción

Route of infusion

Tipo de datos

text

Dose
Descripción

Dose

Tipo de datos

text

Dose, Total No of infusions
Descripción

Dose

Tipo de datos

integer

Dose, No of cells infused per infusion
Descripción

Dose

Tipo de datos

integer

Unidades de medida
  • x 106/kg
x 106/kg
Associated procedure
Descripción

Associated procedure

Tipo de datos

text

Associated procedure, Yes: specify
Descripción

Associated procedure

Tipo de datos

text

RESPONSE
Descripción

RESPONSE

Best clinical/biological response after cell therapy
Descripción

Best clinical/biological response after cell therapy

Tipo de datos

integer

Laboratory response
Descripción

Laboratory response

Tipo de datos

text

Laboratory response, Specify laboratory parameter
Descripción

Laboratory response

Tipo de datos

text

DATE OF LAST CONTACT
Descripción

DATE OF LAST CONTACT

Date of last follow up or death
Descripción

Date of last follow up or death

Tipo de datos

date

Survival Status
Descripción

Survival Status

Tipo de datos

text

Main Cause of Death
Descripción

Main Cause of Death

Tipo de datos

text

Main Cause of Death, HSCT related (if applicable
Descripción

Main Cause of Death

Tipo de datos

text

Main Cause of Death, Cell Therapy related:
Descripción

Main Cause of Death

Tipo de datos

text

Main Cause of Death, Other
Descripción

Main Cause of Death

Tipo de datos

text

CENTRE IDENTIFICATION
Descripción

CENTRE IDENTIFICATION

EBMT Code (CIC) Number
Descripción

OrganizationalUnit::EBMT(CIC)CodeNumber

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C0029246
Hospital
Descripción

Hospital

Tipo de datos

text

Unit
Descripción

Unit

Tipo de datos

text

Contact person
Descripción

Contact person

Tipo de datos

text

Phone
Descripción

ContactPersonTelephoneNumber

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0039457
UMLS CUI [1,4]
C0337611
Fax
Descripción

ContactPersonFaxNumber

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0337611
UMLS CUI [1,4]
C0085205
Contact Person E-Mail
Descripción

CentralLaboratoryContactPersonEmailAddressText

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0337611
UMLS CUI [1,4]
C1705961
UMLS CUI [1,5]
C0013849
REPORT INFORMATION
Descripción

REPORT INFORMATION

Date of this Report
Descripción

Date of this Report

Tipo de datos

date

PATIENT IDENTIFICATION
Descripción

PATIENT IDENTIFICATION

Unique Patient Number or Code
Descripción

Unique Patient Number or Code

Tipo de datos

integer

Initials, first name(s), family name(s)
Descripción

Compulsory, registrations will not be accepted without this item

Tipo de datos

text

Date of Birth
Descripción

PersonBirthDate

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0005615
Sex
Descripción

Sex

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
DATE OF LAST CONTACT
Descripción

DATE OF LAST CONTACT

Tipo de datos

date

DISEASE PRESENCE/DETECTION AT LAST CONTACT
Descripción

Was disease detected

Tipo de datos

text

PATIENT STATUS, Survival Status
Descripción

PATIENT STATUS

Tipo de datos

text

Main Cause of Death
Descripción

Main Cause of Death

Tipo de datos

text

Main Cause of Death, HSCT related (if applicable)
Descripción

Main Cause of Death

Tipo de datos

text

Main Cause of Death, Cell Therapy related
Descripción

Main Cause of Death

Tipo de datos

text

Main Cause of Death, Other
Descripción

Main Cause of Death

Tipo de datos

text

Similar models

4pp Cell Therapy Registry 25CTR.pdf

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Cell Therapy Registry – Med-A
First report – 6 months after cell therapy
Item
First report – 6 months after cell therapy
text
Item Group
CENTRE IDENTIFICATION
OrganizationalUnit::EBMT(CIC)CodeNumber
Item
EBMT Code (CIC) Number
float
C0237753 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0029246 (UMLS CUI [1,4])
Klinik
Item
Hospital
text
C0019994 (UMLS CUI [1])
Unit
Item
Unit
text
Contact person
Item
Contact person
text
ContactPersonTelephoneNumber
Item
Phone
text
C0237753 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
ContactPersonFaxNumber
Item
Fax
text
C0237753 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C0085205 (UMLS CUI [1,4])
ContactPersonE-mailText
Item
E-mail
text
C1527021 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
Item Group
REPORT INFORMATION
Date of this report
Item
Date of this report
date
C1302584 (UMLS CUI [1])
Item Group
PATIENT IDENTIFICATION
Unique Patient Number or Code
Item
Unique Patient Number or Code
text
Initialen
Item
Initials
text
C2986440 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
Item
Gender:
text
Code List
Gender:
CL Item
male  (1)
CL Item
female (2)
Item Group
INDICATION FOR TREATMENT If Primary disease
Diagnose-Datum
Item
Date of diagnosis
date
C2316983 (UMLS CUI [1,1])
C1274082 (UMLS CUI [1,2])
Autoimmune disease, specify
Item
Autoimmune disease, specify
text
Neurologic disorder, specify
Item
Neurologic disorder, specify
text
Heart disease, specify
Item
Heart disease, specify
text
Haematologic, specify
Item
Haematologic, specify
text
Other, specify
Item
Other, specify
text
Item
If Haematopoietic stem cell transplant related
text
Code List
If Haematopoietic stem cell transplant related
CL Item
GvHD prophylaxis (1)
CL Item
GvHD treatment (2)
CL Item
Prevention of rejection (3)
CL Item
Graft enhancement (4)
CL Item
Bone marrow failure (5)
Item Group
CELL THERAPY TREATMENT
Date of first cell infusion
Item
Date of first cell infusion
date
Item
Performance score (if alive)
integer
C1518965 (UMLS CUI [1])
Code List
Performance score (if alive)
CL Item
Karnofsky (1)
CL Item
Lansky (2)
Item
Score achived
text
C1518965 (UMLS CUI [1])
Code List
Score achived
CL Item
10 (1)
CL Item
20 (2)
CL Item
30 (3)
CL Item
40 (4)
CL Item
50 (5)
CL Item
60 (6)
CL Item
70 (7)
CL Item
80 (8)
CL Item
90 (9)
CL Item
100 (10)
Item
Status at therapy
text
Code List
Status at therapy
CL Item
Chronic (1)
CL Item
Acute (2)
CL Item
Acute exacerbation of chronic disease (3)
Item
Cell origin
text
Code List
Cell origin
CL Item
Allogeneic  (1)
CL Item
Autologous (2)
Item
Tissue cell source
text
Code List
Tissue cell source
CL Item
Bone Marrow VBMSC (1)
CL Item
Peripheral Blood VPBSC (2)
CL Item
Cord Blood VCBSC (3)
CL Item
Adipose ADIPCELL (4)
CL Item
Endothelial cell progenitor ENDOCELL (5)
CL Item
Other, specify (6)
Tissue cell source
Item
Tissue cell source, specify other
text
Item
Cell characteristic
text
Code List
Cell characteristic
CL Item
Mononuclear cells  (1)
CL Item
CD34+ CD34POS (2)
CL Item
Mesenchymal MESECHYM (3)
CL Item
Unseparated bone marrow (4)
CL Item
Other, specify (5)
Cell characteristic
Item
Cell characteristic, specify other
text
Chronological no. of cell therapy for this patient
Item
Chronological no. of cell therapy for this patient
integer
Item Group
GRAFT MANIPULATION
Item
Ex-vivo manipulation
integer
Code List
Ex-vivo manipulation
CL Item
no (1)
CL Item
yes (2)
CL Item
unknown (3)
CL Item
Growth factor, specify  (4)
CL Item
Other (5)
CL Item
Expansion (6)
Ex-vivo manipulation
Item
Ex-vivo manipulation, Growth factor, specify
text
Ex-vivo manipulation
Item
Ex-vivo manipulation, other
text
Item
In-vivo manipulation, in the donor
text
Code List
In-vivo manipulation, in the donor
CL Item
No  (1)
CL Item
Yes:  (2)
CL Item
Growth factor, specify  (3)
CL Item
Other (4)
CL Item
unknown (5)
In-vivo manipulation In the donor
Item
In-vivo manipulation In the donor, growth factor, specify
text
In-vivo manipulation In the donor
Item
In-vivo manipulation In the donor, other
text
Item
In-vivo manipulation, in the patient
text
Code List
In-vivo manipulation, in the patient
CL Item
No  (1)
CL Item
Yes (2)
CL Item
Growth factor, specify (3)
CL Item
Other  (4)
CL Item
Unknown (5)
In-vivo manipulation, in the patient
Item
In-vivo manipulation in the patient, growth factor, specify
text
In-vivo manipulation, in the patient
Item
In-vivo manipulation in the patient, other
text
Item Group
TREATMENT
Item
Route of infusion
text
Code List
Route of infusion
CL Item
Intravenous (1)
CL Item
Locally intra-arterially, specify artery (2)
CL Item
Locally into tissue (3)
CL Item
Intra bone (4)
CL Item
Other route (5)
CL Item
Intraperiteonally (6)
CL Item
ntrathecal (7)
Route of infusion
Item
Route of infusion, Locally intra-arterially, specify artery
text
Route of infusion
Item
Route of infusion, pther route
text
Item
Dose
text
Code List
Dose
CL Item
Total No of infusions (1)
CL Item
No of cells infused per infusion (2)
Dose
Item
Dose, Total No of infusions
integer
Dose
Item
Dose, No of cells infused per infusion
integer
Code List
Associated procedure
CL Item
no (1)
CL Item
yes (2)
CL Item
Prior to cell therapy (3)
CL Item
Simultaneous (4)
CL Item
Post cell therapy (5)
CL Item
unknown (6)
Associated procedure
Item
Associated procedure, Yes: specify
text
Item Group
RESPONSE
Item
Best clinical/biological response after cell therapy
integer
Code List
Best clinical/biological response after cell therapy
CL Item
Complete sustained remission (CR) (1)
CL Item
Partial sustained remission (PR) (2)
CL Item
Remission (CR or PR) followed by relapse or progression (3)
CL Item
Stable (4)
CL Item
Progression (5)
CL Item
Unknown (6)
Item
Laboratory response
text
Code List
Laboratory response
CL Item
Normalized (1)
CL Item
Improvement (2)
CL Item
Unchanged (3)
CL Item
Worsening (4)
CL Item
Specify laboratory parameter (5)
Laboratory response
Item
Laboratory response, Specify laboratory parameter
text
Item Group
DATE OF LAST CONTACT
Date of last follow up or death
Item
Date of last follow up or death
date
Item
Survival Status
text
Code List
Survival Status
CL Item
Alive (1)
CL Item
Dead (2)
CL Item
Check here if patient lost to follow up (3)
Item
Main Cause of Death
text
Code List
Main Cause of Death
CL Item
Relapse or Progression (if indication: primary disease) (1)
CL Item
HSCT related (if applicable) (2)
CL Item
Cell Therapy related (3)
CL Item
Other (4)
CL Item
Unknown (5)
Main Cause of Death
Item
Main Cause of Death, HSCT related (if applicable
text
Main Cause of Death
Item
Main Cause of Death, Cell Therapy related:
text
Main Cause of Death
Item
Main Cause of Death, Other
text
Item Group
CENTRE IDENTIFICATION
OrganizationalUnit::EBMT(CIC)CodeNumber
Item
EBMT Code (CIC) Number
float
C0237753 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0029246 (UMLS CUI [1,4])
Hospital
Item
Hospital
text
Unit
Item
Unit
text
Contact person
Item
Contact person
text
ContactPersonTelephoneNumber
Item
Phone
text
C0237753 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
ContactPersonFaxNumber
Item
Fax
text
C0237753 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C0085205 (UMLS CUI [1,4])
CentralLaboratoryContactPersonEmailAddressText
Item
Contact Person E-Mail
text
C0027361 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C1705961 (UMLS CUI [1,4])
C0013849 (UMLS CUI [1,5])
Item Group
REPORT INFORMATION
Date of this Report
Item
Date of this Report
date
Item Group
PATIENT IDENTIFICATION
Unique Patient Number or Code
Item
Unique Patient Number or Code
integer
Initials
Item
Initials, first name(s), family name(s)
text
PersonBirthDate
Item
Date of Birth
date
C0011008 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0005615 (UMLS CUI [1,3])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
DATE OF LAST CONTACT
Item
DATE OF LAST CONTACT
date
Item
DISEASE PRESENCE/DETECTION AT LAST CONTACT
text
Code List
DISEASE PRESENCE/DETECTION AT LAST CONTACT
CL Item
no (1)
CL Item
yes (2)
Item
PATIENT STATUS, Survival Status
text
Code List
PATIENT STATUS, Survival Status
CL Item
Alive (1)
CL Item
Dead (2)
CL Item
Check here if patient lost to follow up (3)
Item
Main Cause of Death
text
Code List
Main Cause of Death
CL Item
Relapse or Progression (1)
CL Item
Relapse or Progression (2)
CL Item
Cell Therapy related (3)
CL Item
Other (4)
CL Item
Unknown (5)
Main Cause of Death
Item
Main Cause of Death, HSCT related (if applicable)
text
Main Cause of Death
Item
Main Cause of Death, Cell Therapy related
text
Main Cause of Death
Item
Main Cause of Death, Other
text