Informations:
Erreur:
ID
15657
Description
DOCUMENTED PATHOGENS (Use this table for guidance on the pathogens of interest) Bacteria: S. pneumoniae, Other gram positive (i.e.: other streptococci, staphylococci, listeria …),Haemophilus influenzae, Other gram negative (i.e.: E. coli klebsiella, proteus, serratia, pseudomonas …), Legionella sp, Mycobacteria sp, Other Fungi: Candida sp, Aspergillus sp, Pneumocystis carinii, Other Parasites: Toxoplasma gondii, Other Viruses: HSV, VZV, EBV, CMV, HHV-6, RSV. Other respiratory virus (influenza, parainfluenza, rhinovirus), Adenovirus, HBV, HCV, HIV,Papovavirus, Parvovirus, Other
Mots-clés
Versions (1)
- 07/06/2016 07/06/2016 -
Téléchargé le
7 de junho de 2016
DOI
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Creative Commons BY-NC 3.0
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18pp EBMT Amyloidosis
18pp EBMT Amyloidosis
- StudyEvent: ODM
Similar models
18pp EBMT Amyloidosis
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
EBMT Centre Identification Code (CIC)
Item
EBMT Centre Identification Code (CIC)
text
C2348585 (UMLS CUI [1])
Hospital
Item
Name of the hospital
text
C0019994 (UMLS CUI [1])
Unit
Item
Unit
text
Contact person
Item
Name of contact person
text
C0337611 (UMLS CUI [1])
Telephone
Item
Telephone number
integer
C1515258 (UMLS CUI [1])
Fax
Item
Fax
text
C1549619 (UMLS CUI [1,1])
C0337611 (UMLS CUI [1,2])
C0030664 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,2])
C0030664 (UMLS CUI [1,3])
E-Mail
Item
E-Mail
text
C1705961 (UMLS CUI [1,1])
C0337611 (UMLS CUI [1,2])
C0030664 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,2])
C0030664 (UMLS CUI [1,3])
Date of this report
Item
Date of this report
date
C1302584 (UMLS CUI [1])
Item
Patient following national / international study / trial
integer
C1997894 (UMLS CUI [1])
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Name of study / trial
Item
Name of study / trial
text
C0008976 (UMLS CUI [1])
Unique Identification Code (UIC)
Item
To be entered only if patient previously reported
text
C2348585 (UMLS CUI [1])
Hospital Unique Patient Number or Code
Item
Hospital Unique Patient Number or Code
text
C1827636 (UMLS CUI [1])
Initials
Item
First name(s)_surname(s)
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
ABO Group
Item
ABO Group
text
Rh factor
Item
Rh factor Donor a
boolean
C0035403 (UMLS CUI [1,1])
C0013018 (UMLS CUI [1,2])
C0013018 (UMLS CUI [1,2])
Date of diagnosis
Item
Date of diagnosis
text
C2316983 (UMLS CUI [1])
Item
Check the disease for which this transplant was performed
text
C0277554 (UMLS CUI [1])
CL Item
Acute Leukaemia (Acute Leukaemia)
CL Item
Acute Myelogenous Leukaemia (AML) (Acute Myelogenous Leukaemia (AML))
CL Item
Acute Lymphoblastic Leukaemia (ALL) (Acute Lymphoblastic Leukaemia (ALL))
CL Item
Secondary Acute Leukaemia (do not use if transformed from MDS/MPN) (Secondary Acute Leukaemia (do not use if transformed from MDS/MPN))
CL Item
Chronic Leukaemia (Chronic Leukaemia)
CL Item
Chronic Myeloid Leukaemia (CML) (Chronic Myeloid Leukaemia (CML))
CL Item
Chronic Lymphocytic Leukaemia (Chronic Lymphocytic Leukaemia)
CL Item
Lymphoma (Lymphoma)
CL Item
Non Hodgkin (Non Hodgkin)
CL Item
Hodgkin´s Disease (Hodgkin´s Disease)
CL Item
Myeloma/ Plasma cell disorder (Myeloma/ Plasma cell disorder)
CL Item
Solid Tumour (Solid Tumour)
CL Item
Myelodysplastic syndromes (Myelodysplastic syndromes)
CL Item
MDS (MDS)
CL Item
MD/ MPN (MD/ MPN)
CL Item
Myeloproliferative neoplasm (Myeloproliferative neoplasm)
CL Item
Bone marrow failure including Aplastic anaemia (Bone marrow failure including Aplastic anaemia)
CL Item
Inherited disorders (Inherited disorders)
CL Item
Primary immune deficiencies (Primary immune deficiencies)
CL Item
Metabolic disorders (Metabolic disorders)
CL Item
Histiocytic disorders (Histiocytic disorders)
CL Item
Autoimmune disease (Autoimmune disease)
CL Item
Juvenile Idiopathic Arthritis (Juvenile Idiopathic Arthritis)
CL Item
Multiple Sclerosis (Multiple Sclerosis)
CL Item
Systemic Lupus (Systemic Lupus)
CL Item
Systemic Sclerosis (Systemic Sclerosis)
CL Item
Haemoglobinopathiy (Haemoglobinopathiy)
CL Item
Other diagnosis (Other diagnosis)
Item
Has the information requested in this section been submitted with a previous HSCT registration for this patient?
integer
Code List
Has the information requested in this section been submitted with a previous HSCT registration for this patient?
CL Item
Yes: go to page 3, Pre-HSCT Treatment (1)
CL Item
No: proceed with this section (2)
EVIDENCE OF UNDERLYING PLASMA CELL DISORDER
Item
EVIDENCE OF UNDERLYING PLASMA CELL DISORDER
boolean
CL Item
Monoclonal Gammopathy (Monoclonal Gammopathy)
CL Item
Multiple Myeloma (Multiple Myeloma)
CL Item
Other B-cell malignancy (Other B-cell malignancy)
EVIDENCE OF UNDERLYING PLASMA CELL DISORDER
Item
If Other B-cell malignancy, specify
text
CL Item
IgG (1)
CL Item
IgA (2)
CL Item
IgD (3)
CL Item
IgE (4)
CL Item
IgM (5)
CL Item
Absent (6)
CL Item
Not evaluated (7)
CL Item
Kappa (1)
CL Item
Lambda (2)
CL Item
Absent (3)
CL Item
Not evaluated (4)
CL Item
I (I)
CL Item
II (II)
CL Item
III (III)
Stage at diagnosis (Salmon and Durie) B
Item
If Multiple myeloma
boolean
CL Item
Excluded (1)
CL Item
Not evaluated (2)
CL Item
Done (Done)
CL Item
Not evaluated (Not evaluated)
HbLab
Item
Hb (g/dl) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum creatinine
Item
CLINICAL AND LABORATORY DATA
float
CL Item
μmol/L (μmol/L)
CL Item
mg/dL (mg/dL)
CL Item
Not evaluated (1)
Creatinine clearance (mL/min)
Item
CLINICAL AND LABORATORY DATA Creatinine clearance (mL/min)
float
Item
Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
integer
CL Item
Not evaluated (1)
Total urinary protein excretion (mg/24 h)
Item
Total urinary protein excretion (mg/24 h) CLINICAL AND LABORATORY DATA
float
Item
CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
integer
Code List
CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
CL Item
Not evaluated (1)
Total urinary albumin excretion (mg/24 h)
Item
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
float
Item
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
integer
Code List
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum calcium (mmol/L)
Item
Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum albumin (g/L)
Item
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum alkaline phosphatase (IU/L)
Item
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
float
Item
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
CL Item
μmol/L (1)
CL Item
mg/dL (2)
Serum bilirubin
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum NT-pro-BNP (ng/L)
Item
Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum c-Troponin T (μg/L)
Item
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
BM aspirate
Item
BM aspirate: % plasmacytosis
float
CL Item
Not evaluated (1)
BM trephine
Item
BM trephine % plasmacytosis
float
CL Item
Not evaluated (1)
Monoclonal Ig in serum
Item
Monoclonal Ig in serum
float
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Kappa light chains
Item
Free light chains in serum Kappa light chains
float
Kappa light chains
Item
Kappa light chains Not evaluated
boolean
Lambda light chains
Item
Lambda light chains
float
Lambda light chains
Item
Lambda light chains Not evaluated
boolean
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Monoclonal light chains in urine
Item
Monoclonal light chains in urine
float
Serum Beta2 microglobulin
Item
Serum Beta2 microglobulin
float
CL Item
Normal (1)
CL Item
Lytic lesion present (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
Absent (1)
CL Item
Present (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
Absent (1)
CL Item
Present (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
Absent (1)
CL Item
Present (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
Dominant organ(s) involved (Dominant organ(s) involved)
CL Item
Additional organ involvement (Additional organ involvement)
CL Item
Biopsy (Biopsy)
CL Item
No involvement (No involvement)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Liver span in ultrasound or CT scan
Item
Liver span in ultrasound or CT scan (cm craniocaudal diameter)
float
Liver span in ultrasound or CT scan
Item
Liver span in ultrasound or CT scan (cm craniocaudal diameter) Not evaluated
boolean
CL Item
I (1)
CL Item
II (2)
CL Item
III (3)
CL Item
IV (4)
CL Item
not done (99)
LVEF
Item
Left Ventricular Ejection Fraction
float
C0428772 (UMLS CUI [1])
Left ventricular ejection fraction
Item
Left ventricular ejection fraction Not evaluated
boolean
Interventricular septal wall thickness
Item
Interventricular septal wall thickness (mean # mm in echocardiogram)
float
Interventricular septal wall thickness
Item
Interventricular septal wall thickness (mean # mm in echocardiogram) Not evaluated
boolean
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Other evidence of gastrointestinal involvement
Item
If other evidence of gastrointestinal involvement, please specify
text
CL Item
Normal (Normal )
CL Item
Abnormal ( Abnormal )
CL Item
Not evaluated or failed ( Not evaluated or failed )
CL Item
Unknown ( Unknown)
Neurological exam
Item
If abnormal: Specify abnormality
text
CL Item
grade I (1)
CL Item
grade II (2)
CL Item
grade III (3)
CL Item
grade IV (4)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Other sites
Item
Clinical evidence for involvement of other sites
text
Item
WAS THE PATIENT TREATED BEFORE THE HSCT PROCEDURE?
integer
Code List
WAS THE PATIENT TREATED BEFORE THE HSCT PROCEDURE?
CL Item
No (1)
CL Item
Yes, Date started (2)
Chemotherapy
Item
Chemotherapy Modality
boolean
CL Item
Chemotherapy regimen (Chemotherapy regimen)
CL Item
Number of cycles (Number of cycles)
Modality
Item
If Other, please specify
text
DATE OF HSCT
Item
DATE OF HSCT
date
HSCT TYPE
Item
HSCT TYPE Allogeneic: proceed to “Status at Start of Conditioning” on page 4
boolean
Autologous: Date of 1st collection or pheresis
Item
Autologous: Date of 1st collection or pheresis
date
Item Group
STATUS OF DISEASE AT COLLECTION (AUTOGRAFTS ONLY)
CL Item
At diagnosis (At diagnosis )
CL Item
CR1 ( CR1 )
CL Item
CR2 ( CR2 )
CL Item
>CR2 VNUMSTM ( >CR2 VNUMSTM)
CL Item
PR1 ( PR1 )
CL Item
PR2 (PR2 )
CL Item
>PR2 ( >PR2 )
CL Item
MR (MR)
CL Item
No change ( No change )
CL Item
Progression ( Progression )
CL Item
Unknown ( Unknown)
CL Item
At diagnosis (1)
CL Item
Response (2)
CL Item
No change (3)
CL Item
Progression (4)
CL Item
Unknown (5)
Item Group
STATUS OF DISEASE AT START OF CONDITIONING FOR BMT
CL Item
At diagnosis (At diagnosis )
CL Item
CR1 (CR1 )
CL Item
CR2 ( CR2 )
CL Item
>CR2 ( >CR2 )
CL Item
PR1 ( PR1 )
CL Item
PR2 ( PR2 )
CL Item
>PR2 ( >PR2 )
CL Item
MR ( MR)
CL Item
No change ( No change )
CL Item
Progression (Progression )
CL Item
Unknown (Unknown)
CL Item
At diagnosis (1)
CL Item
Response (2)
CL Item
No change (3)
CL Item
Progression (4)
CL Item
Unknown (5)
HbLab
Item
Hb (g/dl) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum creatinine
Item
CLINICAL AND LABORATORY DATA
float
CL Item
μmol/L (μmol/L)
CL Item
mg/dL (mg/dL)
CL Item
Not evaluated (1)
Creatinine clearance (mL/min)
Item
CLINICAL AND LABORATORY DATA Creatinine clearance (mL/min)
float
Item
Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
integer
CL Item
Not evaluated (1)
Total urinary protein excretion (mg/24 h)
Item
Total urinary protein excretion (mg/24 h) CLINICAL AND LABORATORY DATA
float
Item
CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
integer
Code List
CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
CL Item
Not evaluated (1)
Total urinary albumin excretion (mg/24 h)
Item
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
float
Item
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
integer
Code List
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum calcium (mmol/L)
Item
Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum albumin (g/L)
Item
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum alkaline phosphatase (IU/L)
Item
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
float
Item
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
CL Item
μmol/L (1)
CL Item
mg/dL (2)
Serum bilirubin
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum NT-pro-BNP (ng/L)
Item
Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum c-Troponin T (μg/L)
Item
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
BM aspirate
Item
BM aspirate: % plasmacytosis
float
CL Item
Not evaluated (1)
BM trephine
Item
BM trephine % plasmacytosis
float
CL Item
Not evaluated (1)
Monoclonal Ig in serum
Item
Monoclonal Ig in serum
float
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Kappa light chains
Item
Free light chains in serum Kappa light chains
float
Kappa light chains
Item
Kappa light chains Not evaluated
boolean
Lambda light chains
Item
Lambda light chains
float
Lambda light chains
Item
Lambda light chains Not evaluated
boolean
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Monoclonal light chains in urine
Item
Monoclonal light chains in urine
float
Serum Beta2 microglobulin
Item
Serum Beta2 microglobulin
float
CL Item
Dominant organ(s) involved (Dominant organ(s) involved)
CL Item
Additional organ involvement (Additional organ involvement)
CL Item
Biopsy (Biopsy)
CL Item
No involvement (No involvement)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Liver span in ultrasound or CT scan
Item
Liver span in ultrasound or CT scan (cm craniocaudal diameter)
float
Liver span in ultrasound or CT scan
Item
Liver span in ultrasound or CT scan (cm craniocaudal diameter) Not evaluated
boolean
CL Item
I (1)
CL Item
II (2)
CL Item
III (3)
CL Item
IV (4)
CL Item
not done (99)
LVEF
Item
Left Ventricular Ejection Fraction
float
C0428772 (UMLS CUI [1])
Left ventricular ejection fraction
Item
Left ventricular ejection fraction Not evaluated
boolean
Interventricular septal wall thickness
Item
Interventricular septal wall thickness (mean # mm in echocardiogram)
float
Interventricular septal wall thickness
Item
Interventricular septal wall thickness (mean # mm in echocardiogram) Not evaluated
boolean
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Other evidence of gastrointestinal involvement
Item
If other evidence of gastrointestinal involvement, please specify
text
CL Item
Normal (Normal )
CL Item
Abnormal ( Abnormal )
CL Item
Not evaluated or failed ( Not evaluated or failed )
CL Item
Unknown ( Unknown)
Neurological exam
Item
If abnormal: Specify abnormality
text
CL Item
grade I (1)
CL Item
grade II (2)
CL Item
grade III (3)
CL Item
grade IV (4)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Other sites
Item
Clinical evidence for involvement of other sites
text
Item
BEST HAEMATOLOGICAL RESPONSE TO HSCT AT 100 DAYS
text
Code List
BEST HAEMATOLOGICAL RESPONSE TO HSCT AT 100 DAYS
CL Item
CR1 (CR1 )
CL Item
CR2 ( CR2 )
CL Item
>CR2 ( >CR2)
CL Item
PR1 (PR1 )
CL Item
PR2 (PR2 )
CL Item
>PR2 ( >PR2 )
CL Item
MR ( MR)
CL Item
No change (No change )
CL Item
Progression ( Progression )
CL Item
Not evaluable (Not evaluable )
CL Item
Unknown ( Unknown)
DATE RESPONSE ACHIEVED OR ASSESSED
Item
DATE RESPONSE ACHIEVED OR ASSESSED
date
CL Item
Not evaluated (1)
Serum creatinine
Item
CLINICAL AND LABORATORY DATA
float
CL Item
μmol/L (μmol/L)
CL Item
mg/dL (mg/dL)
CL Item
Not evaluated (1)
Creatinine clearance (mL/min)
Item
CLINICAL AND LABORATORY DATA Creatinine clearance (mL/min)
float
Item
Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
integer
CL Item
Not evaluated (1)
Total urinary protein excretion (mg/24 h)
Item
Total urinary protein excretion (mg/24 h) CLINICAL AND LABORATORY DATA
float
Item
CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
integer
Code List
CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
CL Item
Not evaluated (1)
Total urinary albumin excretion (mg/24 h)
Item
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
float
Item
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
integer
Code List
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum calcium (mmol/L)
Item
Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum albumin (g/L)
Item
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum alkaline phosphatase (IU/L)
Item
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
float
Item
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
CL Item
μmol/L (1)
CL Item
mg/dL (2)
Serum bilirubin
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum NT-pro-BNP (ng/L)
Item
Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum c-Troponin T (μg/L)
Item
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
BM aspirate
Item
BM aspirate: % plasmacytosis
float
CL Item
Not evaluated (1)
BM trephine
Item
BM trephine % plasmacytosis
float
CL Item
Not evaluated (1)
Monoclonal Ig in serum
Item
Monoclonal Ig in serum
float
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Kappa light chains
Item
Free light chains in serum Kappa light chains
float
Kappa light chains
Item
Kappa light chains Not evaluated
boolean
Lambda light chains
Item
Lambda light chains
float
Lambda light chains
Item
Lambda light chains Not evaluated
boolean
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Monoclonal light chains in urine
Item
Monoclonal light chains in urine
float
Serum Beta2 microglobulin
Item
Serum Beta2 microglobulin
float
Item Group
ORGAN-SPECIFIC RESPONSES AT 100 DAYS AFTER HSCT
CL Item
Response (1)
CL Item
No response/stable disease (2)
CL Item
Progressive disease (3)
CL Item
Not evaluable (4)
CL Item
Not evaluated/not applicable (5)
CL Item
Unknown (6)
Liver span in ultrasound or CT scan
Item
Liver Liver span in ultrasound or CT scan (cm craniocaudal diameter)
float
Liver span in ultrasound or CT scan
Item
Liver Not evaluated Liver span in ultrasound or CT scan (cm craniocaudal diameter)
boolean
CL Item
Response (1)
CL Item
No response/stable disease (2)
CL Item
Progressive disease (3)
CL Item
Not evaluable (4)
CL Item
Not evaluated/not applicable (5)
CL Item
Unknown (6)
CL Item
I (I)
CL Item
II (II)
CL Item
III (III)
CL Item
IV (IV)
CL Item
Unknown (Unknown)
Left ventricular ejection fraction
Item
Left ventricular ejection fraction
float
CL Item
Not evaluated (1)
CL Item
evaluated (2)
Interventricular septal wall thickness
Item
Interventricular septal wall thickness (mean # mm in echocardiogram)
float
Item
Interventricular septal wall thickness (mean # mm in echocardiogram)
integer
Code List
Interventricular septal wall thickness (mean # mm in echocardiogram)
CL Item
Not evaluated (1)
CL Item
evaluated (2)
CL Item
Response (Response )
CL Item
No response/stable disease ( No response/stable disease )
CL Item
Progressive disease ( Progressive disease)
CL Item
Not evaluable ( Not evaluable )
CL Item
Not evaluated/not applicable ( Not evaluated/not applicable )
CL Item
Unknown ( Unknown)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
Response (1)
CL Item
No response/stable disease (2)
CL Item
Progressive disease (3)
CL Item
Not evaluable (4)
CL Item
Not evaluated/not applicable (5)
CL Item
Unknown (6)
Item
Neurological exam Peripheral neuropathy (Compare current situation to situation before HSCT)
integer
Code List
Neurological exam Peripheral neuropathy (Compare current situation to situation before HSCT)
CL Item
Improved (1)
CL Item
Worsened (2)
CL Item
Unchanged (3)
CL Item
Unknown (4)
Item
PNP severity Peripheral neuropathy (Compare current situation to situation before HSCT)
integer
Code List
PNP severity Peripheral neuropathy (Compare current situation to situation before HSCT)
CL Item
grade I (1)
CL Item
grade II (2)
CL Item
grade III (3)
CL Item
grade IV (4)
Item
PN response Peripheral neuropathy (Compare current situation to situation before HSCT)
integer
Code List
PN response Peripheral neuropathy (Compare current situation to situation before HSCT)
CL Item
Response (Response )
CL Item
Unknown (Unknown)
CL Item
No response/stable disease (No response/stable disease )
CL Item
Progressive disease (Progressive disease)
CL Item
Not evaluable (Not evaluable )
CL Item
Not evaluated/not applicable (Not evaluated/not applicable )
CL Item
Response (Response )
CL Item
No response/stable disease (No response/stable disease )
CL Item
Progressive disease (Progressive disease)
CL Item
Not evaluable (Not evaluable )
CL Item
Not evaluated/not applicable (Not evaluated/not applicable )
CL Item
Unknown (Unknown)
Clinical evidence for involvement of new sites
Item
Clinical evidence for involvement of new sites Evidence of new organ involvement
text
KARNOFSKY
Item
KARNOFSKY
text
CL Item
AUTOgraft (proceed to Autograft form) (AUTOgraft (proceed to Autograft form))
CL Item
ALLOgraft or Syngeneic graft (proceed to Allograft form) (ALLOgraft or Syngeneic graft (proceed to Allograft form))
CL Item
Other (contact the EBMT Central Registry for instructions) (Other (contact the EBMT Central Registry for instructions))
Unique Identification Code (UIC)
Item
Unique Identification Code (UIC) (if known)
text
C2348585 (UMLS CUI [1])
Hospital Unique Patient Number
Item
Hospital Unique Patient Number
text
C2348585 (UMLS CUI [1])
Initialen
Item
Initials
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Date of HSCT
Item
Date of HSCT
date
C2584899 (UMLS CUI [1])
Date last contact
Item
Date of Last Contact or Death
date
C0805839 (UMLS CUI [1])
Item
Complete haematological remission obtained after the HSCT in the absence of additional disease treatment
integer
Code List
Complete haematological remission obtained after the HSCT in the absence of additional disease treatment
CL Item
Previously reported (1)
CL Item
Yes, date (2)
CL Item
No (3)
CL Item
Unknown (4)
Item Group
GRAFT VERSUS HOST DISEASE (GvHD) SINCE LAST REPORT
Item
Maximum Grade of Acute GVHD
integer
C0856825 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C1561607 (UMLS CUI [1,4])
C0856825 (UMLS CUI [1,5])
C0441800 (UMLS CUI [1,6])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C1561607 (UMLS CUI [1,4])
C0856825 (UMLS CUI [1,5])
C0441800 (UMLS CUI [1,6])
CL Item
Agvhd Grade 0 (0)
CL Item
Agvhd Grade I (I)
CL Item
Agvhd Grade Ii (II)
CL Item
Agvhd Grade Iii (III)
CL Item
Agvhd Grade Iv (IV)
CL Item
Agvhd Present, Grade Unknown (Present, grade unknown)
CL Item
New onset (1)
CL Item
Recurrent (2)
CL Item
Persistent (3)
CL Item
Tapering (Tapering )
CL Item
DLI (DLI )
CL Item
Unexplained (Unexplained)
Date onset of this episode
Item
Date onset of this episode (if new or recurrent)
date
C0574845 (UMLS CUI [1])
Date onset of this episode
Item
Date onset of this episode Not applicable
boolean
Item
Stage skin
integer
C0856825 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C1306673 (UMLS CUI [1,3])
C1306673 (UMLS CUI [1,2])
C1306673 (UMLS CUI [1,3])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
Not evaluated (6)
CL Item
unknown (7)
Item
Stage liver
integer
C0856825 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1306673 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
Not evaluated (6)
CL Item
unknown (7)
Item
Stage gut
integer
C0856825 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0021853 (UMLS CUI [1,3])
C1306673 (UMLS CUI [1,2])
C0021853 (UMLS CUI [1,3])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
Not evaluated (6)
CL Item
unknown (7)
CL Item
No (1)
CL Item
Yes (2)
aGvHD Date of resolution
Item
Date of resolution
date
C0856825 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1514893 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Present continously since last reported episode (Present continously since last reported episode)
CL Item
Resolved (Resolved)
CL Item
First episode (1)
CL Item
Recurrence (2)
cGvHD Date of onset
Item
Date of onset
date
C0867389 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
limited (1)
CL Item
Extensive (2)
CL Item
Skin (1)
CL Item
Gut (2)
CL Item
Liver (3)
CL Item
Mouth (4)
CL Item
Eyes (5)
CL Item
Lung (6)
CL Item
Other, specify (7)
CL Item
Unknown (8)
Date of Resolution
Item
If resolved, specify the date of resolution:
date
C1514893 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Infection related complications
Item
Infection related complications
boolean
C0009450 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,2])
Bacteraemia / fungemia / viremia / parasites
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary
text
Bacteraemia / fungemia / viremia / parasites
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
Septic shock
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
text
Septic shock
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
ARDS
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
text
ARDS
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
Multiorgan failure due to infection
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
text
Multiorgan failure due to infection
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
Pneumonia
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
text
Pneumonia
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
Hepatitis
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
text
Hepatitis
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
CNS infection
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
text
CNS infection
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
Gut infection
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary
text
Gut infection
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
Skin infection
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
text
Skin infection
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
Cystitis
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
text
Cystitis
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
Retinitis
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
text
Retinitis
Item
Date Provide different dates for different episodes of the same complication if applicable
text
Other
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary
text
Other
Item
Date Provide different dates for different episodes of the same complication if applicable.
text
Non infection related complications
Item
Non infection related complications
boolean
C0009566 (UMLS CUI [1])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Date Cardiovascular
Item
Date Cardiovascular
date
Cardiovascular
Item
Comments
text
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Date Dermatologic
Item
Date Dermatologic
date
Dermatologic
Item
Comments
text
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Date Gastrointestinal
Item
Date Gastrointestinal
date
Gastrointestinal
Item
Comments
text
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Date Haemorrhage
Item
Date Haemorrhage
date
Haemorrhage Comments
Item
Haemorrhage Comments
text
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Date Hepatic
Item
Date Hepatic
date
Hepatic Comments
Item
Comments
text
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Date Neurologic
Item
Date Neurologic
date
Neurologic Comments
Item
Neurologic Comments
text
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Pulmonary Date
Item
Pulmonary Date
date
Pulmonary Comments
Item
Pulmonary Comments
text
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Renal Date
Item
Renal Date
date
Renal Comments
Item
Renal Comments
text
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Date of other Typte
Item
Date of other Typte
date
Comments of Other type
Item
Comments of Other type
text
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Not evaluated (Not evaluated)
CL Item
Full (donor >95 %) (1)
CL Item
Mixed (partial) (2)
CL Item
Autologous reconstitution (recipient >95 %) (3)
CL Item
Aplasia (4)
CL Item
Not evaluated (5)
Item Group
GRAFT ASSESSMENT AND HAEMOPOIETIC CHIMAERISM
Date of Test
Item
Date of Test
date
C0024671 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Identification
Item
Identification of donor or Cord Blood Unit given by the centre
text
C1718162 (UMLS CUI [1])
Number in the infusion order
Item
Number in the infusion order (if applicable)
text
C0237753 (UMLS CUI [1])
CL Item
N/A (1)
Bone marrow
Item
Cell type on which test was performed (% Donor Cells): BM
float
C0005953 (UMLS CUI [1])
PB mononuclear cells (PBMC)
Item
Cell type on which test was performed (% Donor cells): PB mononuclear cells (PBMC)
float
C1321301 (UMLS CUI [1])
T-Cells
Item
Cell type on which test was performed (% Donor cells): T-Cells
float
C0039194 (UMLS CUI [1])
B-Cells
Item
Cell type on which test was performed (% Donor cells): B-Cells
float
C0004561 (UMLS CUI [1])
Red blood cells
Item
Cell type on which test was performed (% Donor cells): Red blood cells
float
C0014772 (UMLS CUI [1])
Monocytes
Item
Cell type on which test was performed (% Donor cells): Monocytes
float
C0026473 (UMLS CUI [1])
PMNs (neutrophils)
Item
Cell type on which test was performed (% Donor cells): PMNs (neutrophils)
float
C0200633 (UMLS CUI [1])
Lymphocytes, NOS
Item
Cell type on which test was performed (% Donor cells): Lymphocytes, NOS
float
C0024264 (UMLS CUI [1])
Myeloid cells, NOS
Item
Cell type on which test was performed (% Donor cells): Myeloid cells, NOS
float
C0887899 (UMLS CUI [1])
Other
Item
Cell type on which test was performed (% Donor cells):
float
CL Item
FISH (FISH)
CL Item
Molecular (Molecular)
CL Item
Cytogenetic (Cytogenetic)
CL Item
ABO group (ABO group)
CL Item
Other (Other)
CL Item
unknown (unknown)
Item
SECONDARY MALIGNANCY, LYMPHOPROLIFERATIVE OR MYELOPROLIFRATIVE DISORDER DIAGNOSED
integer
Code List
SECONDARY MALIGNANCY, LYMPHOPROLIFERATIVE OR MYELOPROLIFRATIVE DISORDER DIAGNOSED
CL Item
Previously reported (1)
CL Item
Yes (2)
CL Item
No at date of this follow-up (3)
Diagnose-Datum
Item
Date of diagnosis
date
C2316983 (UMLS CUI [1,1])
C1274082 (UMLS CUI [1,2])
C1274082 (UMLS CUI [1,2])
CL Item
AML (1)
CL Item
MDS (2)
CL Item
Lymphoproliferative disorder (3)
CL Item
Other (4)
Diagnosis
Item
If other diagnosis, please specify
text
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Unknown (Unknown)
Datestarted
Item
Date started
date
Item
If yes: CELLULAR THERAPY One cell therapy regimen is defined as any number of infusions given within 10 weeks for the same indication. If more than one regimen of cell therapy has been given since last report, copy this section and complete it as many times as necessary.
integer
Code List
If yes: CELLULAR THERAPY One cell therapy regimen is defined as any number of infusions given within 10 weeks for the same indication. If more than one regimen of cell therapy has been given since last report, copy this section and complete it as many times as necessary.
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Disease status before this cellular therapy
integer
CL Item
CR (1)
CL Item
Not in CR (2)
CL Item
Not evaluated (3)
CL Item
Donor lymphocyte infusion (DLI) (1)
CL Item
Mesenchymal cells (2)
CL Item
Other (3)
CL Item
Unknown (4)
Item
If DLI, specify the number of cells infused by type: Nucleated cells
text
C1180059 (UMLS CUI [1])
CL Item
Evaluated (Evaluated)
CL Item
Not evaluated (Not evaluated)
CL Item
unknown (unknown)
Nucleated cells
Item
Number of Nucleated cells infused (DLI only)
text
C1180059 (UMLS CUI [1])
Item
If DLI, specify the number of cells infused by type: CD 34+
text
C3538723 (UMLS CUI [1])
CL Item
Evaluated (Evaluated)
CL Item
Not Evaluated (Not Evaluated)
CL Item
Unknown (Unknown)
CD 34+
Item
specify the number of cells infused by type: CD 34+
text
C3538723 (UMLS CUI [1])
CL Item
Evaluated (Evaluated )
CL Item
Not evaluated (Not evaluated)
CL Item
Unknown (Unknown)
CD 3+
Item
specify the number of cells infused by type: CD 3+
float
C3542405 (UMLS CUI [1])
All cells
Item
Total number of cells infused (non DLI only)
float
C0007584 (UMLS CUI [1])
CL Item
Evaluated (Evaluated)
CL Item
Not Evaluated (Not Evaluated)
CL Item
Unknown (Unknown)
Chronological number
Item
Chronological number of this cell therapy for this patient
float
C2348184 (UMLS CUI [1])
Item
Indication (check all that apply)
text
C3146298 (UMLS CUI [1,1])
C0302189 (UMLS CUI [1,2])
C0302189 (UMLS CUI [1,2])
CL Item
Planned/ protocol (Planned/ protocol)
CL Item
Treatment for disease (Treatment for disease)
CL Item
Prophylactic (Prophylactic)
CL Item
Mixed chimaerism (Mixed chimaerism)
CL Item
Treatment of GvHD (Treatment of GvHD)
CL Item
Treatment viral infection (Treatment viral infection)
CL Item
Loss/decreased chimaerism (Loss/decreased chimaerism)
CL Item
Treatment PTLD, EBV, lymphoma (Treatment PTLD, EBV, lymphoma)
CL Item
Other (Other)
Infusion count
Item
Number of infusions within 10 weeks (count only infusions that are part of same regimen and given for the same indication)
float
C0574032 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
Item
Maximum Grade of Acute GVHD
text
C0856825 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C1561607 (UMLS CUI [1,4])
C0856825 (UMLS CUI [1,5])
C0441800 (UMLS CUI [1,6])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C1561607 (UMLS CUI [1,4])
C0856825 (UMLS CUI [1,5])
C0441800 (UMLS CUI [1,6])
CL Item
Agvhd Grade 0 (0)
CL Item
Agvhd Grade I (I)
CL Item
Agvhd Grade Ii (II)
CL Item
Agvhd Grade Iii (III)
CL Item
Agvhd Grade Iv (IV)
CL Item
Agvhd Present, Grade Unknown (Present, grade unknown)
Item
Disease treatment (apart from donor cell infusion or other type of cell therapy)
integer
C0087111 (UMLS CUI [1])
Code List
Disease treatment (apart from donor cell infusion or other type of cell therapy)
CL Item
No (1)
CL Item
Yes: Planned (planned before HSCT took place) (2)
CL Item
Yes: Not planned (for relapse/progression or persistent disease) (3)
Item Group
FIRST EVIDENCE OF DISEASE WORSENING SINCE LAST HSCT
CL Item
Previously reported (Previously reported)
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Continuous worsening since HSCT (Continuous worsening since HSCT)
CL Item
Unknown (Unknown)
EVIDENCE OF DISEASE ACTIVITY
Item
If yes, date first noted
date
CL Item
Complete remission (Complete remission)
CL Item
Partial remission (Partial remission)
CL Item
Stable disease (Stable disease)
CL Item
Progression (Progression)
CL Item
Not evaluable (Not evaluable)
CL Item
Unknown (Unknown)
CL Item
Response (1)
CL Item
Non Response (2)
CL Item
Progression (3)
CL Item
Not evaluable (4)
CL Item
Unknown (5)
CL Item
Not evaluated (1)
Serum creatinine
Item
CLINICAL AND LABORATORY DATA
float
CL Item
μmol/L (μmol/L)
CL Item
mg/dL (mg/dL)
CL Item
Not evaluated (1)
Creatinine clearance (mL/min)
Item
CLINICAL AND LABORATORY DATA Creatinine clearance (mL/min)
float
Item
Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
integer
CL Item
Not evaluated (1)
Total urinary protein excretion (mg/24 h)
Item
Total urinary protein excretion (mg/24 h) CLINICAL AND LABORATORY DATA
float
Item
CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
integer
Code List
CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
CL Item
Not evaluated (1)
Total urinary albumin excretion (mg/24 h)
Item
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
float
Item
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
integer
Code List
Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum calcium (mmol/L)
Item
Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum albumin (g/L)
Item
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum alkaline phosphatase (IU/L)
Item
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
float
Item
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
CL Item
μmol/L (1)
CL Item
mg/dL (2)
Serum bilirubin
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum NT-pro-BNP (ng/L)
Item
Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
Serum c-Troponin T (μg/L)
Item
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
float
CL Item
Not evaluated (1)
BM aspirate
Item
BM aspirate: % plasmacytosis
float
CL Item
Not evaluated (1)
BM trephine
Item
BM trephine % plasmacytosis
float
CL Item
Not evaluated (1)
Monoclonal Ig in serum
Item
Monoclonal Ig in serum
float
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Kappa light chains
Item
Free light chains in serum Kappa light chains
float
Kappa light chains
Item
Kappa light chains Not evaluated
boolean
Lambda light chains
Item
Lambda light chains
float
Lambda light chains
Item
Lambda light chains Not evaluated
boolean
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
Monoclonal light chains in urine
Item
Monoclonal light chains in urine
float
Serum Beta2 microglobulin
Item
Serum Beta2 microglobulin
float
CL Item
Response (1)
CL Item
No response/stable disease (2)
CL Item
Progressive disease (3)
CL Item
Not evaluable (4)
CL Item
Not evaluated/not applicable (5)
CL Item
Unknown (6)
Liver span in ultrasound or CT scan
Item
Liver (cm craniocaudal diameter)
float
CL Item
Not evaluated (1)
CL Item
Response (Response)
CL Item
No response/stable disease (No response/stable disease)
CL Item
Progressive disease (Progressive disease)
CL Item
Not evaluable (Not evaluable)
CL Item
Not evaluated/not applicable (Not evaluated/not applicable)
CL Item
Unknown (Unknown)
CL Item
I (1)
CL Item
II (2)
CL Item
III (3)
CL Item
IV (4)
CL Item
unknown (5)
LVEF
Item
Left Ventricular Ejection Fraction
float
C0428772 (UMLS CUI [1])
CL Item
Not evaluated (1)
Interventricular septal wall thickness
Item
Interventricular septal wall thickness (mean # mm in echocardiogram)
float
Item
Interventricular septal wall thickness (mean # mm in echocardiogram)
integer
Code List
Interventricular septal wall thickness (mean # mm in echocardiogram)
CL Item
Not evaluated (1)
CL Item
Response (1)
CL Item
No response/stable disease (2)
CL Item
Progressive disease (3)
CL Item
Not evaluable (4)
CL Item
Not evaluated/not applicable (5)
CL Item
Unknown (6)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not evaluated (3)
CL Item
Unknown (4)
CL Item
Response (1)
CL Item
No response/stable disease (2)
CL Item
Progressive disease (3)
CL Item
Not evaluable (4)
CL Item
Not evaluated/not applicable (5)
CL Item
Unknown (6)
CL Item
Improved (1)
CL Item
Worsened (2)
CL Item
Unchanged (3)
CL Item
Unknown (4)
CL Item
grade I (1)
CL Item
grade II (2)
CL Item
grade III (3)
CL Item
grade IV (4)
CL Item
Response (1)
CL Item
No response/stable disease (2)
CL Item
Progressive disease (3)
CL Item
Not evaluable (4)
CL Item
Not evaluated/not applicable (5)
CL Item
Unknown (6)
CL Item
Response (1)
CL Item
No response/stable disease (2)
CL Item
Progressive disease (3)
CL Item
Not evaluable (4)
CL Item
Not evaluated/not applicable (5)
CL Item
Unknown (6)
Evidence of new organ involvement
Item
Evidence of new organ involvement Clinical evidence for involvement of new sites
text
Item
Has patient or partner become pregnant after this HSCT?
integer
Code List
Has patient or partner become pregnant after this HSCT?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
alive (0)
CL Item
dead (1)
CL Item
Karnofsky (1)
CL Item
Lansky (2)
CL Item
100 (Normal, NED) (1)
CL Item
90 (Normal activity) (2)
CL Item
80 (Normal with effort) (3)
CL Item
70 (Cares for self) (4)
CL Item
60 (Requires occasional assistance) (5)
CL Item
50 (Requires assistance) (6)
CL Item
40 (Disabled) (7)
CL Item
30 (Severely disabled) (8)
CL Item
20 (Very sick) (9)
CL Item
10 (Moribund) (10)
CL Item
Not evaluated (11)
CL Item
Unknown (12)
CL Item
Due to amyloidosis (progression of disease) (1)
CL Item
Secondary malignancy (including lymphoproliferative disease) (2)
CL Item
HSCT related cause (3)
CL Item
unknown (4)
CL Item
other (5)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
bacterial (1)
CL Item
viral (2)
CL Item
fungal (3)
CL Item
parasitic (4)
CL Item
unknown (5)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Other
Item
If other HSCT related cause, please specify
text
Comments
Item
Comments
text
IDENTIFICATION & SIGNATURE
Item
IDENTIFICATION & SIGNATURE
text
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