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

Keywords

  1. 6/7/16 6/7/16 -
Uploaded on

June 7, 2016

DOI

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License

Creative Commons BY-NC 3.0

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18pp EBMT Amyloidosis

18pp EBMT Amyloidosis

  1. StudyEvent: ODM
    1. 18pp EBMT Amyloidosis
GENERAL INFORMATION TEAM
Description

GENERAL INFORMATION TEAM

EBMT Centre Identification Code (CIC)
Description

EBMT Centre Identification Code (CIC)

Data type

text

Alias
UMLS CUI [1]
C2348585
Name of the hospital
Description

Hospital

Data type

text

Alias
UMLS CUI [1]
C0019994
Unit
Description

Unit

Data type

text

Name of contact person
Description

Contact person

Data type

text

Alias
UMLS CUI [1]
C0337611
Telephone number
Description

Telephone

Data type

integer

Alias
UMLS CUI [1]
C1515258
Fax
Description

Fax

Data type

text

Alias
UMLS CUI [1,1]
C1549619
UMLS CUI [1,2]
C0337611
UMLS CUI [1,3]
C0030664
E-Mail
Description

E-Mail

Data type

text

Alias
UMLS CUI [1,1]
C1705961
UMLS CUI [1,2]
C0337611
UMLS CUI [1,3]
C0030664
Date of this report
Description

Date of this report

Data type

date

Alias
UMLS CUI [1]
C1302584
Patient following national / international study / trial
Description

Patient in Trial

Data type

integer

Alias
UMLS CUI [1]
C1997894
Name of study / trial
Description

Name of study / trial

Data type

text

Alias
UMLS CUI [1]
C0008976
GENERAL INFORMATION PATIENT
Description

GENERAL INFORMATION PATIENT

To be entered only if patient previously reported
Description

Unique Identification Code (UIC)

Data type

text

Alias
UMLS CUI [1]
C2348585
Hospital Unique Patient Number or Code
Description

Hospital Unique Patient Number or Code

Data type

text

Alias
UMLS CUI [1]
C1827636
First name(s)_surname(s)
Description

Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
ABO Group
Description

ABO Group

Data type

text

Rh factor Donor a
Description

Rh factor

Data type

boolean

Alias
UMLS CUI [1,1]
C0035403
UMLS CUI [1,2]
C0013018
DISEASE
Description

DISEASE

Date of diagnosis
Description

Date of diagnosis

Data type

text

Alias
UMLS CUI [1]
C2316983
Check the disease for which this transplant was performed
Description

Primary Disease Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0277554
AL AMYLOIDOSIS INITIAL DIAGNOSIS
Description

AL AMYLOIDOSIS INITIAL DIAGNOSIS

Has the information requested in this section been submitted with a previous HSCT registration for this patient?
Description

SubmittedPreviously

Data type

integer

EVIDENCE OF UNDERLYING PLASMA CELL DISORDER
Description

EVIDENCE OF UNDERLYING PLASMA CELL DISORDER

Data type

boolean

if yes
Description

EVIDENCE OF UNDERLYING PLASMA CELL DISORDER

Data type

text

If Other B-cell malignancy, specify
Description

EVIDENCE OF UNDERLYING PLASMA CELL DISORDER

Data type

text

Select one as applicable
Description

EVIDENCE OF UNDERLYING PLASMA CELL DISORDER

Data type

integer

Select one as applicable
Description

EVIDENCE OF UNDERLYING PLASMA CELL DISORDER

Data type

integer

If Multiple myeloma
Description

Stage at diagnosis (Salmon and Durie) A

Data type

integer

If Multiple myeloma
Description

Stage at diagnosis (Salmon and Durie) B

Data type

boolean

DIAGNOSIS OF AMYLOIDOSIS
Description

Methods Hereditary Amyloidosis

Data type

integer

DIAGNOSIS OF AMYLOIDOSIS
Description

Methods Immunohistochemistry

Data type

text

Hb (g/dl) CLINICAL AND LABORATORY DATA
Description

HbLab

Data type

float

Hb (g/dl) CLINICAL AND LABORATORY DATA
Description

Hb (g/dL)

Data type

integer

CLINICAL AND LABORATORY DATA
Description

Serum creatinine

Data type

float

CLINICAL AND LABORATORY DATA Serum creatinine
Description

Serum creatinine

Data type

text

CLINICAL AND LABORATORY DATA Serum creatinine
Description

Serum creatinine

Data type

integer

CLINICAL AND LABORATORY DATA Creatinine clearance (mL/min)
Description

Creatinine clearance (mL/min)

Data type

float

Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
Description

Creatinine clearance (mL/min)

Data type

integer

Total urinary protein excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary protein excretion (mg/24 h)

Data type

float

CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
Description

Total urinary protein excretion (mg/24 h)

Data type

integer

Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary albumin excretion (mg/24 h)

Data type

float

Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary albumin excretion (mg/24 h)

Data type

integer

Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
Description

Serum calcium (mmol/L)

Data type

float

Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
Description

Serum calcium (mmol/L)

Data type

integer

Serum albumin (g/L) CLINICAL AND LABORATORY DATA
Description

Serum albumin (g/L)

Data type

float

Serum albumin (g/L) CLINICAL AND LABORATORY DATA
Description

Serum albumin (g/L)

Data type

integer

Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
Description

Serum alkaline phosphatase (IU/L)

Data type

float

Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
Description

Serum alkaline phosphatase (IU/L)

Data type

integer

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

integer

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

float

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

integer

Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
Description

Serum NT-pro-BNP (ng/L)

Data type

float

CLINICAL AND LABORATORY DATA Serum NT-pro-BNP (ng/L)
Description

Serum NT-pro-BNP (ng/L)

Data type

integer

Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
Description

Serum c-Troponin T (μg/L)

Data type

float

Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
Description

Serum c-Troponin T (μg/L)

Data type

integer

BM aspirate: % plasmacytosis
Description

BM aspirate

Data type

float

BM aspirate % plasmacytosis
Description

BM aspirate

Data type

integer

BM trephine % plasmacytosis
Description

BM trephine

Data type

float

BM trephine: % plasmacytosis
Description

BM trephine

Data type

integer

Monoclonal Ig in serum
Description

Monoclonal Ig in serum

Data type

float

Measurement units
  • g/L
g/L
Immunofixation of serum
Description

Immunofixation of serum

Data type

integer

Free light chains in serum Kappa light chains
Description

Kappa light chains

Data type

float

Measurement units
  • mg/L
mg/L
Kappa light chains Not evaluated
Description

Kappa light chains

Data type

boolean

Lambda light chains
Description

Lambda light chains

Data type

float

Measurement units
  • mg/L
mg/L
Lambda light chains Not evaluated
Description

Lambda light chains

Data type

boolean

Immunofixation of urine
Description

Immunofixation of urine

Data type

integer

Monoclonal light chains in urine
Description

Monoclonal light chains in urine

Data type

float

Measurement units
  • g/24h
g/24h
Serum Beta2 microglobulin
Description

Serum Beta2 microglobulin

Data type

float

Measurement units
  • mg/L
mg/L
Bone structure (X-ray)
Description

Bone structure (X-ray)

Data type

integer

Macroglossy Typical clinical symptoms
Description

Macroglossy

Data type

integer

Periorbital bleeding Typical clinical symptoms
Description

Periorbital bleeding

Data type

integer

Shoulder pad sign Typical clinical symptoms
Description

Shoulder pad sign

Data type

integer

ORGAN INVOLVEMENT AT DIAGNOSIS
Description

ORGAN INVOLVEMENT AT DIAGNOSIS

Soft Tissues
Description

Soft Tissues

Data type

text

Gastrointestinal Tract
Description

Gastrointestinal Tract

Data type

integer

Heart
Description

Heart

Data type

integer

Liver
Description

Liver

Data type

integer

Kidney
Description

Kidney

Data type

integer

Peripheral nerves
Description

Peripheral nerves

Data type

integer

Autonomic nerves
Description

Autonomic nerves

Data type

integer

if other, please specify
Description

ORGAN INVOLVEMENT AT DIAGNOSIS

Data type

text

Liver span in ultrasound or CT scan (cm craniocaudal diameter)
Description

Liver span in ultrasound or CT scan

Data type

float

Liver span in ultrasound or CT scan (cm craniocaudal diameter) Not evaluated
Description

Liver span in ultrasound or CT scan

Data type

boolean

NYHA class
Description

NYHA class

Data type

integer

Alias
UMLS CUI [1]
C1275491
Left Ventricular Ejection Fraction
Description

LVEF

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0428772
%
Left ventricular ejection fraction Not evaluated
Description

Left ventricular ejection fraction

Data type

boolean

Interventricular septal wall thickness (mean # mm in echocardiogram)
Description

Interventricular septal wall thickness

Data type

float

Interventricular septal wall thickness (mean # mm in echocardiogram) Not evaluated
Description

Interventricular septal wall thickness

Data type

boolean

Weight loss
Description

Weight loss

Data type

integer

Malabsorption
Description

Malabsorption

Data type

integer

GI bleeding
Description

GI Bleeding

Data type

integer

If other evidence of gastrointestinal involvement, please specify
Description

Other evidence of gastrointestinal involvement

Data type

text

Neurological exam
Description

Neurological exam

Data type

text

If abnormal: Specify abnormality
Description

Neurological exam

Data type

text

PNP severity
Description

PNP severity

Data type

integer

Orthostatic hypotension
Description

Orthostatic hypotension

Data type

integer

Intractable diarrhoea
Description

Intractable diarrhoea

Data type

integer

Inflexible pulse rate
Description

Inflexible pulse rate

Data type

integer

Clinical evidence for involvement of other sites
Description

Other sites

Data type

text

PRE-HSCT TREATMENT
Description

PRE-HSCT TREATMENT

WAS THE PATIENT TREATED BEFORE THE HSCT PROCEDURE?
Description

WAS THE PATIENT TREATED BEFORE THE HSCT PROCEDURE?

Data type

integer

Chemotherapy Modality
Description

Chemotherapy

Data type

boolean

Modality, if Chemotherapy
Description

Chemotherapy

Data type

text

If Other, please specify
Description

Modality

Data type

text

HSCT
Description

HSCT

DATE OF HSCT
Description

DATE OF HSCT

Data type

date

HSCT TYPE Allogeneic: proceed to “Status at Start of Conditioning” on page 4
Description

HSCT TYPE

Data type

boolean

Autologous: Date of 1st collection or pheresis
Description

Autologous: Date of 1st collection or pheresis

Data type

date

STATUS OF DISEASE AT COLLECTION (AUTOGRAFTS ONLY)
Description

STATUS OF DISEASE AT COLLECTION (AUTOGRAFTS ONLY)

Haematological status
Description

Haematological status

Data type

text

Organ status
Description

Organ status

Data type

integer

STATUS OF DISEASE AT START OF CONDITIONING FOR BMT
Description

STATUS OF DISEASE AT START OF CONDITIONING FOR BMT

Haematological status
Description

Haematological status

Data type

integer

Organ status
Description

Organ status

Data type

integer

Hb (g/dl) CLINICAL AND LABORATORY DATA
Description

HbLab

Data type

float

Hb (g/dl) CLINICAL AND LABORATORY DATA
Description

Hb (g/dL)

Data type

integer

CLINICAL AND LABORATORY DATA
Description

Serum creatinine

Data type

float

CLINICAL AND LABORATORY DATA Serum creatinine
Description

Serum creatinine

Data type

text

CLINICAL AND LABORATORY DATA Serum creatinine
Description

Serum creatinine

Data type

integer

CLINICAL AND LABORATORY DATA Creatinine clearance (mL/min)
Description

Creatinine clearance (mL/min)

Data type

float

Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
Description

Creatinine clearance (mL/min)

Data type

integer

Total urinary protein excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary protein excretion (mg/24 h)

Data type

float

CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
Description

Total urinary protein excretion (mg/24 h)

Data type

integer

Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary albumin excretion (mg/24 h)

Data type

float

Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary albumin excretion (mg/24 h)

Data type

integer

Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
Description

Serum calcium (mmol/L)

Data type

float

Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
Description

Serum calcium (mmol/L)

Data type

integer

Serum albumin (g/L) CLINICAL AND LABORATORY DATA
Description

Serum albumin (g/L)

Data type

float

Serum albumin (g/L) CLINICAL AND LABORATORY DATA
Description

Serum albumin (g/L)

Data type

integer

Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
Description

Serum alkaline phosphatase (IU/L)

Data type

float

Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
Description

Serum alkaline phosphatase (IU/L)

Data type

integer

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

integer

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

float

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

integer

Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
Description

Serum NT-pro-BNP (ng/L)

Data type

float

CLINICAL AND LABORATORY DATA Serum NT-pro-BNP (ng/L)
Description

Serum NT-pro-BNP (ng/L)

Data type

integer

Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
Description

Serum c-Troponin T (μg/L)

Data type

float

Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
Description

Serum c-Troponin T (μg/L)

Data type

integer

BM aspirate: % plasmacytosis
Description

BM aspirate

Data type

float

BM aspirate % plasmacytosis
Description

BM aspirate

Data type

integer

BM trephine % plasmacytosis
Description

BM trephine

Data type

float

BM trephine: % plasmacytosis
Description

BM trephine

Data type

integer

Monoclonal Ig in serum
Description

Monoclonal Ig in serum

Data type

float

Measurement units
  • g/L
g/L
Immunofixation of serum
Description

Immunofixation of serum

Data type

integer

Free light chains in serum Kappa light chains
Description

Kappa light chains

Data type

float

Measurement units
  • mg/L
mg/L
Kappa light chains Not evaluated
Description

Kappa light chains

Data type

boolean

Lambda light chains
Description

Lambda light chains

Data type

float

Measurement units
  • mg/L
mg/L
Lambda light chains Not evaluated
Description

Lambda light chains

Data type

boolean

Immunofixation of urine
Description

Immunofixation of urine

Data type

integer

Monoclonal light chains in urine
Description

Monoclonal light chains in urine

Data type

float

Measurement units
  • g/24h
g/24h
Serum Beta2 microglobulin
Description

Serum Beta2 microglobulin

Data type

float

Measurement units
  • mg/L
mg/L
Soft Tissues
Description

Soft Tissues

Data type

text

Gastrointestinal Tract
Description

Gastrointestinal Tract

Data type

integer

Heart
Description

Heart

Data type

integer

Liver
Description

Liver

Data type

integer

Kidney
Description

Kidney

Data type

integer

Peripheral nerves
Description

Peripheral nerves

Data type

integer

Autonomic nerves
Description

Autonomic nerves

Data type

integer

Liver span in ultrasound or CT scan (cm craniocaudal diameter)
Description

Liver span in ultrasound or CT scan

Data type

float

Liver span in ultrasound or CT scan (cm craniocaudal diameter) Not evaluated
Description

Liver span in ultrasound or CT scan

Data type

boolean

NYHA class
Description

NYHA class

Data type

integer

Alias
UMLS CUI [1]
C1275491
Left Ventricular Ejection Fraction
Description

LVEF

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0428772
%
Left ventricular ejection fraction Not evaluated
Description

Left ventricular ejection fraction

Data type

boolean

Interventricular septal wall thickness (mean # mm in echocardiogram)
Description

Interventricular septal wall thickness

Data type

float

Interventricular septal wall thickness (mean # mm in echocardiogram) Not evaluated
Description

Interventricular septal wall thickness

Data type

boolean

Weight loss
Description

Weight loss

Data type

integer

Malabsorption
Description

Malabsorption

Data type

integer

GI bleeding
Description

GI Bleeding

Data type

integer

If other evidence of gastrointestinal involvement, please specify
Description

Other evidence of gastrointestinal involvement

Data type

text

Neurological exam
Description

Neurological exam

Data type

text

If abnormal: Specify abnormality
Description

Neurological exam

Data type

text

PNP severity
Description

PNP severity

Data type

integer

Orthostatic hypotension
Description

Orthostatic hypotension

Data type

integer

Intractable diarrhoea
Description

Intractable diarrhoea

Data type

integer

Inflexible pulse rate
Description

Inflexible pulse rate

Data type

integer

Clinical evidence for involvement of other sites
Description

Other sites

Data type

text

STATUS OF DISEASE AT 100 DAYS AFTER HSCT
Description

STATUS OF DISEASE AT 100 DAYS AFTER HSCT

BEST HAEMATOLOGICAL RESPONSE TO HSCT AT 100 DAYS
Description

BEST HAEMATOLOGICAL RESPONSE TO HSCT AT 100 DAYS

Data type

text

DATE RESPONSE ACHIEVED OR ASSESSED
Description

DATE RESPONSE ACHIEVED OR ASSESSED

Data type

date

Hb (g/dl) CLINICAL AND LABORATORY DATA
Description

Hb (g/dL)

Data type

integer

CLINICAL AND LABORATORY DATA
Description

Serum creatinine

Data type

float

CLINICAL AND LABORATORY DATA Serum creatinine
Description

Serum creatinine

Data type

text

CLINICAL AND LABORATORY DATA Serum creatinine
Description

Serum creatinine

Data type

integer

CLINICAL AND LABORATORY DATA Creatinine clearance (mL/min)
Description

Creatinine clearance (mL/min)

Data type

float

Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
Description

Creatinine clearance (mL/min)

Data type

integer

Total urinary protein excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary protein excretion (mg/24 h)

Data type

float

CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
Description

Total urinary protein excretion (mg/24 h)

Data type

integer

Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary albumin excretion (mg/24 h)

Data type

float

Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary albumin excretion (mg/24 h)

Data type

integer

Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
Description

Serum calcium (mmol/L)

Data type

float

Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
Description

Serum calcium (mmol/L)

Data type

integer

Serum albumin (g/L) CLINICAL AND LABORATORY DATA
Description

Serum albumin (g/L)

Data type

float

Serum albumin (g/L) CLINICAL AND LABORATORY DATA
Description

Serum albumin (g/L)

Data type

integer

Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
Description

Serum alkaline phosphatase (IU/L)

Data type

float

Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
Description

Serum alkaline phosphatase (IU/L)

Data type

integer

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

integer

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

float

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

integer

Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
Description

Serum NT-pro-BNP (ng/L)

Data type

float

CLINICAL AND LABORATORY DATA Serum NT-pro-BNP (ng/L)
Description

Serum NT-pro-BNP (ng/L)

Data type

integer

Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
Description

Serum c-Troponin T (μg/L)

Data type

float

Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
Description

Serum c-Troponin T (μg/L)

Data type

integer

BM aspirate: % plasmacytosis
Description

BM aspirate

Data type

float

BM aspirate % plasmacytosis
Description

BM aspirate

Data type

integer

BM trephine % plasmacytosis
Description

BM trephine

Data type

float

BM trephine: % plasmacytosis
Description

BM trephine

Data type

integer

Monoclonal Ig in serum
Description

Monoclonal Ig in serum

Data type

float

Measurement units
  • g/L
g/L
Immunofixation of serum
Description

Immunofixation of serum

Data type

integer

Free light chains in serum Kappa light chains
Description

Kappa light chains

Data type

float

Measurement units
  • mg/L
mg/L
Kappa light chains Not evaluated
Description

Kappa light chains

Data type

boolean

Lambda light chains
Description

Lambda light chains

Data type

float

Measurement units
  • mg/L
mg/L
Lambda light chains Not evaluated
Description

Lambda light chains

Data type

boolean

Immunofixation of urine
Description

Immunofixation of urine

Data type

integer

Monoclonal light chains in urine
Description

Monoclonal light chains in urine

Data type

float

Measurement units
  • g/24h
g/24h
Serum Beta2 microglobulin
Description

Serum Beta2 microglobulin

Data type

float

Measurement units
  • mg/L
mg/L
ORGAN-SPECIFIC RESPONSES AT 100 DAYS AFTER HSCT
Description

ORGAN-SPECIFIC RESPONSES AT 100 DAYS AFTER HSCT

Kidney
Description

Renal response

Data type

integer

Liver Liver span in ultrasound or CT scan (cm craniocaudal diameter)
Description

Liver span in ultrasound or CT scan

Data type

float

Liver Not evaluated Liver span in ultrasound or CT scan (cm craniocaudal diameter)
Description

Liver span in ultrasound or CT scan

Data type

boolean

Hepatic response
Description

Hepatic response

Data type

integer

Heart NYHA class
Description

NYHA class

Data type

integer

Left ventricular ejection fraction
Description

Left ventricular ejection fraction

Data type

float

Measurement units
  • %
%
Left ventricular ejection fraction
Description

Left ventricular ejection fraction

Data type

integer

Interventricular septal wall thickness (mean # mm in echocardiogram)
Description

Interventricular septal wall thickness

Data type

float

Interventricular septal wall thickness (mean # mm in echocardiogram)
Description

Interventricular septal wall thickness

Data type

integer

Cardiac response
Description

Cardiac response

Data type

text

Weight loss
Description

Weight loss

Data type

integer

Malabsorption
Description

Malabsorption

Data type

integer

GI bleeding
Description

GI Bleeding

Data type

integer

GI response
Description

GI response

Data type

integer

Neurological exam Peripheral neuropathy (Compare current situation to situation before HSCT)
Description

Neurological exam

Data type

integer

PNP severity Peripheral neuropathy (Compare current situation to situation before HSCT)
Description

PNP severity

Data type

integer

PN response Peripheral neuropathy (Compare current situation to situation before HSCT)
Description

PN response

Data type

integer

AN response Autonomic neuropathy
Description

AN response

Data type

integer

Clinical evidence for involvement of new sites Evidence of new organ involvement
Description

Clinical evidence for involvement of new sites

Data type

text

KARNOFSKY
Description

KARNOFSKY

Data type

text

FORMS TO BE FILLED IN
Description

FORMS TO BE FILLED IN

Type of Transplant
Description

Type of Transplant

Data type

text

Alias
UMLS CUI [1,1]
C0559189
UMLS CUI [1,2]
C0040739
FOLLOW UP AL AMYLOIDOSIS
Description

FOLLOW UP AL AMYLOIDOSIS

Unique Identification Code (UIC) (if known)
Description

Unique Identification Code (UIC)

Data type

text

Alias
UMLS CUI [1]
C2348585
Hospital Unique Patient Number
Description

Hospital Unique Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Initials
Description

Initialen

Data type

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Date of HSCT
Description

Date of HSCT

Data type

date

Alias
UMLS CUI [1]
C2584899
PATIENT LAST SEEN
Description

PATIENT LAST SEEN

Date of Last Contact or Death
Description

Date last contact

Data type

date

Alias
UMLS CUI [1]
C0805839
Complete haematological remission obtained after the HSCT in the absence of additional disease treatment
Description

Complete haematological remission obtained after the HSCT in the absence of additional disease treatment

Data type

integer

GRAFT VERSUS HOST DISEASE (GvHD) SINCE LAST REPORT
Description

GRAFT VERSUS HOST DISEASE (GvHD) SINCE LAST REPORT

Maximum Grade of Acute GVHD
Description

AcuteGraftVersusHostDiseaseMaximumOverallGrade

Data type

integer

Alias
UMLS CUI [1,1]
C0856825
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0441800
UMLS CUI [1,4]
C1561607
UMLS CUI [1,5]
C0856825
UMLS CUI [1,6]
C0441800
If present
Description

Maximum grade

Data type

integer

Reason if present
Description

Maximum grade

Data type

text

Date onset of this episode (if new or recurrent)
Description

Date onset of this episode

Data type

date

Measurement units
  • yyyy/mm/dd
Alias
UMLS CUI [1]
C0574845
yyyy/mm/dd
Date onset of this episode Not applicable
Description

Date onset of this episode

Data type

boolean

Stage skin
Description

aGvHD Stage Skin

Data type

integer

Alias
UMLS CUI [1,1]
C0856825
UMLS CUI [1,2]
C1306673
UMLS CUI [1,3]
C1306673
Stage liver
Description

aGvHD Stage liver

Data type

integer

Alias
UMLS CUI [1,1]
C0856825
UMLS CUI [1,2]
C1306673
UMLS CUI [1,3]
C0023884
Stage gut
Description

aGvHD stage gut

Data type

integer

Alias
UMLS CUI [1,1]
C0856825
UMLS CUI [1,2]
C1306673
UMLS CUI [1,3]
C0021853
Resolution
Description

aGvHD Resolution

Data type

integer

Alias
UMLS CUI [1,1]
C0856825
UMLS CUI [1,2]
C1514893
Date of resolution
Description

aGvHD Date of resolution

Data type

date

Measurement units
  • yyyy/mm/dd
Alias
UMLS CUI [1,1]
C0856825
UMLS CUI [1,2]
C1514893
UMLS CUI [1,3]
C0011008
yyyy/mm/dd
Presence of cGvHD
Description

Chronic Graft versus Host Disease

Data type

text

Alias
UMLS CUI [1]
C0867389
Presence of cGVHD if yes
Description

Presence of cGVHD

Data type

integer

Date of onset
Description

cGvHD Date of onset

Data type

date

Measurement units
  • yyyy/mm/dd
Alias
UMLS CUI [1,1]
C0867389
UMLS CUI [1,2]
C0011008
yyyy/mm/dd
cGvHD grade
Description

cGvHD grade

Data type

integer

Alias
UMLS CUI [1,1]
C0867389
UMLS CUI [1,2]
C0441800
Organs affected
Description

Organs affected

Data type

integer

Alias
UMLS CUI [1]
C0449642
If resolved, specify the date of resolution:
Description

Date of Resolution

Data type

date

Alias
UMLS CUI [1,1]
C1514893
UMLS CUI [1,2]
C0011008
OTHER COMPLICATIONS SINCE LAST REPORT
Description

OTHER COMPLICATIONS SINCE LAST REPORT

Infection related complications
Description

Infection related complications

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0009566
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary
Description

Bacteraemia / fungemia / viremia / parasites

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

Bacteraemia / fungemia / viremia / parasites

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
Description

Septic shock

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

Septic shock

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
Description

ARDS

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

ARDS

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
Description

Multiorgan failure due to infection

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

Multiorgan failure due to infection

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
Description

Pneumonia

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

Pneumonia

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
Description

Hepatitis

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

Hepatitis

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
Description

CNS infection

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

CNS infection

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary
Description

Gut infection

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

Gut infection

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
Description

Skin infection

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

Skin infection

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
Description

Cystitis

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

Cystitis

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
Description

Retinitis

Data type

text

Date Provide different dates for different episodes of the same complication if applicable
Description

Retinitis

Data type

text

Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary
Description

Other

Data type

text

Date Provide different dates for different episodes of the same complication if applicable.
Description

Other

Data type

text

Non infection related complications
Description

Non infection related complications

Data type

boolean

Alias
UMLS CUI [1]
C0009566
CTC grade Cardiovascular
Description

CTC grade Cardiovascular

Data type

integer

Date Cardiovascular
Description

Date Cardiovascular

Data type

date

Comments
Description

Cardiovascular

Data type

text

CTC grade Dermatologic
Description

CTC grade Dermatologic

Data type

integer

Date Dermatologic
Description

Date Dermatologic

Data type

date

Comments
Description

Dermatologic

Data type

text

CTC grade Gastrointestinal
Description

CTC grade Gastrointestinal

Data type

integer

Date Gastrointestinal
Description

Date Gastrointestinal

Data type

date

Comments
Description

Gastrointestinal

Data type

text

CTC grade Haemorrhage
Description

CTC grade Haemorrhage

Data type

integer

Date Haemorrhage
Description

Date Haemorrhage

Data type

date

Haemorrhage Comments
Description

Haemorrhage Comments

Data type

text

CTC grade Hepatic
Description

CTC grade Hepatic

Data type

integer

Date Hepatic
Description

Date Hepatic

Data type

date

Comments
Description

Hepatic Comments

Data type

text

CTC grade Neurologic
Description

CTC grade Neurologic

Data type

integer

Date Neurologic
Description

Date Neurologic

Data type

date

Neurologic Comments
Description

Neurologic Comments

Data type

text

CTC grade Pulmonary
Description

CTC grade Pulmonary

Data type

integer

Pulmonary Date
Description

Pulmonary Date

Data type

date

Pulmonary Comments
Description

Pulmonary Comments

Data type

text

CTC grade Renal
Description

CTC grade Renal

Data type

integer

Renal Date
Description

Renal Date

Data type

date

Renal Comments
Description

Renal Comments

Data type

text

Other CTC grade
Description

Other CTC grade

Data type

integer

Date of other Typte
Description

Date of other Typte

Data type

date

Comments of Other type
Description

Comments of Other type

Data type

text

Graft loss
Description

Graft loss

Data type

text

Alias
UMLS CUI [1]
C0877042
Overall chimaerism
Description

Overall chimaerism

Data type

integer

GRAFT ASSESSMENT AND HAEMOPOIETIC CHIMAERISM
Description

GRAFT ASSESSMENT AND HAEMOPOIETIC CHIMAERISM

Date of Test
Description

Date of Test

Data type

date

Alias
UMLS CUI [1,1]
C0024671
UMLS CUI [1,2]
C0011008
Identification of donor or Cord Blood Unit given by the centre
Description

Identification

Data type

text

Alias
UMLS CUI [1]
C1718162
Number in the infusion order (if applicable)
Description

Number in the infusion order

Data type

text

Alias
UMLS CUI [1]
C0237753
Number in the infusion order
Description

Number in the infusion order

Data type

integer

Cell type on which test was performed (% Donor Cells): BM
Description

Bone marrow

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0005953
%
Cell type on which test was performed (% Donor cells): PB mononuclear cells (PBMC)
Description

PB mononuclear cells (PBMC)

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C1321301
%
Cell type on which test was performed (% Donor cells): T-Cells
Description

T-Cells

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0039194
%
Cell type on which test was performed (% Donor cells): B-Cells
Description

B-Cells

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0004561
%
Cell type on which test was performed (% Donor cells): Red blood cells
Description

Red blood cells

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0014772
%
Cell type on which test was performed (% Donor cells): Monocytes
Description

Monocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0026473
%
Cell type on which test was performed (% Donor cells): PMNs (neutrophils)
Description

PMNs (neutrophils)

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200633
%
Cell type on which test was performed (% Donor cells): Lymphocytes, NOS
Description

Lymphocytes, NOS

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0024264
%
Cell type on which test was performed (% Donor cells): Myeloid cells, NOS
Description

Myeloid cells, NOS

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0887899
%
Cell type on which test was performed (% Donor cells):
Description

Other

Data type

float

Measurement units
  • %
%
Test used:
Description

Laboratory tests

Data type

text

Alias
UMLS CUI [1]
C0022885
SECONDARY MALIGNANCY, LYMPHOPROLIFERATIVE OR MYELOPROLIFRATIVE DISORDER DIAGNOSED
Description

SECONDARY MALIGNANCY, LYMPHOPROLIFERATIVE OR MYELOPROLIFRATIVE DISORDER DIAGNOSED

Data type

integer

Date of diagnosis
Description

Diagnose-Datum

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C1274082
Diagnosis
Description

Diagnosis

Data type

integer

If other diagnosis, please specify
Description

Diagnosis

Data type

text

ADDITIONAL THERAPIES SINCE LAST FOLLOW UP
Description

ADDITIONAL THERAPIES SINCE LAST FOLLOW UP

Treatment given since last report
Description

Additional treatment

Data type

text

Alias
UMLS CUI [1]
C1706712
Date started
Description

Datestarted

Data type

date

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.
Description

ADDITIONAL TREATMENT

Data type

integer

Disease status before this cellular therapy
Description

Disease status before this cellular therapy

Data type

integer

If yes: Type of cells
Description

Type of cells

Data type

integer

Alias
UMLS CUI [1]
C0302189
If DLI, specify the number of cells infused by type: Nucleated cells
Description

Nucleated cells

Data type

text

Alias
UMLS CUI [1]
C1180059
Number of Nucleated cells infused (DLI only)
Description

Nucleated cells

Data type

text

Measurement units
  • 10^8/kg
Alias
UMLS CUI [1]
C1180059
10^8/kg
If DLI, specify the number of cells infused by type: CD 34+
Description

CD 34+

Data type

text

Alias
UMLS CUI [1]
C3538723
specify the number of cells infused by type: CD 34+
Description

CD 34+

Data type

text

Alias
UMLS CUI [1]
C3538723
If DLI, specify the number of cells infused by type: CD 3+
Description

CD 3+

Data type

text

Alias
UMLS CUI [1]
C3542405
specify the number of cells infused by type: CD 3+
Description

CD 3+

Data type

float

Alias
UMLS CUI [1]
C3542405
Total number of cells infused (non DLI only)
Description

All cells

Data type

float

Measurement units
  • x10^6/kg
Alias
UMLS CUI [1]
C0007584
x10^6/kg
All cells
Description

All cells

Data type

text

Alias
UMLS CUI [1]
C0007584
Chronological number of this cell therapy for this patient
Description

Chronological number

Data type

float

Alias
UMLS CUI [1]
C2348184
Indication (check all that apply)
Description

Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0302189
Number of infusions within 10 weeks (count only infusions that are part of same regimen and given for the same indication)
Description

Infusion count

Data type

float

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0750480
Maximum Grade of Acute GVHD
Description

AcuteGraftVersusHostDiseaseMaximumOverallGrade

Data type

text

Alias
UMLS CUI [1,1]
C0856825
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0441800
UMLS CUI [1,4]
C1561607
UMLS CUI [1,5]
C0856825
UMLS CUI [1,6]
C0441800
Disease treatment (apart from donor cell infusion or other type of cell therapy)
Description

Disease treatment

Data type

integer

Alias
UMLS CUI [1]
C0087111
FIRST EVIDENCE OF DISEASE WORSENING SINCE LAST HSCT
Description

FIRST EVIDENCE OF DISEASE WORSENING SINCE LAST HSCT

EVIDENCE OF DISEASE ACTIVITY
Description

EVIDENCE OF DISEASE ACTIVITY

Data type

text

If yes, date first noted
Description

EVIDENCE OF DISEASE ACTIVITY

Data type

date

LAST DISEASE AND PATIENT STATUS
Description

LAST DISEASE AND PATIENT STATUS

HAEMATOLOGICAL DISEASE STATUS
Description

HAEMATOLOGICAL DISEASE STATUS

Data type

integer

Organ Response
Description

ORGAN RESPONSE

Data type

integer

Hb (g/dl) CLINICAL AND LABORATORY DATA
Description

Hb (g/dL)

Data type

integer

CLINICAL AND LABORATORY DATA
Description

Serum creatinine

Data type

float

CLINICAL AND LABORATORY DATA Serum creatinine
Description

Serum creatinine

Data type

text

CLINICAL AND LABORATORY DATA Serum creatinine
Description

Serum creatinine

Data type

integer

CLINICAL AND LABORATORY DATA Creatinine clearance (mL/min)
Description

Creatinine clearance (mL/min)

Data type

float

Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
Description

Creatinine clearance (mL/min)

Data type

integer

Total urinary protein excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary protein excretion (mg/24 h)

Data type

float

CLINICAL AND LABORATORY DATA Total urinary protein excretion (mg/24 h)
Description

Total urinary protein excretion (mg/24 h)

Data type

integer

Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary albumin excretion (mg/24 h)

Data type

float

Total urinary albumin excretion (mg/24 h) CLINICAL AND LABORATORY DATA
Description

Total urinary albumin excretion (mg/24 h)

Data type

integer

Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
Description

Serum calcium (mmol/L)

Data type

float

Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
Description

Serum calcium (mmol/L)

Data type

integer

Serum albumin (g/L) CLINICAL AND LABORATORY DATA
Description

Serum albumin (g/L)

Data type

float

Serum albumin (g/L) CLINICAL AND LABORATORY DATA
Description

Serum albumin (g/L)

Data type

integer

Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
Description

Serum alkaline phosphatase (IU/L)

Data type

float

Serum alkaline phosphatase (IU/L) CLINICAL AND LABORATORY DATA
Description

Serum alkaline phosphatase (IU/L)

Data type

integer

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

integer

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

float

Serum bilirubin CLINICAL AND LABORATORY DATA
Description

Serum bilirubin

Data type

integer

Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
Description

Serum NT-pro-BNP (ng/L)

Data type

float

CLINICAL AND LABORATORY DATA Serum NT-pro-BNP (ng/L)
Description

Serum NT-pro-BNP (ng/L)

Data type

integer

Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
Description

Serum c-Troponin T (μg/L)

Data type

float

Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
Description

Serum c-Troponin T (μg/L)

Data type

integer

BM aspirate: % plasmacytosis
Description

BM aspirate

Data type

float

BM aspirate % plasmacytosis
Description

BM aspirate

Data type

integer

BM trephine % plasmacytosis
Description

BM trephine

Data type

float

BM trephine: % plasmacytosis
Description

BM trephine

Data type

integer

Monoclonal Ig in serum
Description

Monoclonal Ig in serum

Data type

float

Measurement units
  • g/L
g/L
Immunofixation of serum
Description

Immunofixation of serum

Data type

integer

Free light chains in serum Kappa light chains
Description

Kappa light chains

Data type

float

Measurement units
  • mg/L
mg/L
Kappa light chains Not evaluated
Description

Kappa light chains

Data type

boolean

Lambda light chains
Description

Lambda light chains

Data type

float

Measurement units
  • mg/L
mg/L
Lambda light chains Not evaluated
Description

Lambda light chains

Data type

boolean

Immunofixation of urine
Description

Immunofixation of urine

Data type

integer

Monoclonal light chains in urine
Description

Monoclonal light chains in urine

Data type

float

Measurement units
  • g/24h
g/24h
Serum Beta2 microglobulin
Description

Serum Beta2 microglobulin

Data type

float

Measurement units
  • mg/L
mg/L
Renal response ORGAN-SPECIFIC RESPONSES AT THIS FOLLOW UP
Description

Renal response

Data type

integer

Liver (cm craniocaudal diameter)
Description

Liver span in ultrasound or CT scan

Data type

float

Liver (cm craniocaudal diameter)
Description

Liver span in ultrasound or CT scan

Data type

integer

Hepatic response
Description

Hepatic response

Data type

text

NYHA class
Description

NYHA class

Data type

integer

Alias
UMLS CUI [1]
C1275491
Left Ventricular Ejection Fraction
Description

LVEF

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0428772
%
Left Ventricular Ejection Fraction
Description

LVEF

Data type

integer

Interventricular septal wall thickness (mean # mm in echocardiogram)
Description

Interventricular septal wall thickness

Data type

float

Interventricular septal wall thickness (mean # mm in echocardiogram)
Description

Interventricular septal wall thickness

Data type

integer

Cardiac response
Description

Cardiac response

Data type

integer

Weight loss
Description

Weight loss

Data type

integer

Malabsorption
Description

Malabsorption

Data type

integer

GI bleeding
Description

GI bleeding

Data type

integer

GI response
Description

GI response

Data type

integer

Neurological exam
Description

Neurological exam

Data type

integer

PNP severity
Description

PNP severity

Data type

integer

PN response
Description

PN response

Data type

integer

AN response
Description

AN response

Data type

integer

Evidence of new organ involvement Clinical evidence for involvement of new sites
Description

Evidence of new organ involvement

Data type

text

Has patient or partner become pregnant after this HSCT?
Description

Has patient or partner become pregnant after this HSCT?

Data type

integer

Survival Status
Description

Survival Status

Data type

integer

Alias
UMLS CUI [1]
C1148433
Type of score used PERFORMANCE SCORE (if alive)
Description

Type of score used

Data type

integer

Score
Description

Performance score

Data type

integer

Alias
UMLS CUI [1]
C1518965
CAUSE OF DEATH (check only one main cause)
Description

CAUSE OF DEATH

Data type

integer

cGvHD
Description

cGvHD cause

Data type

integer

Interstitial pneumonitis Cause
Description

Interstitial pneumonitis

Data type

integer

Pulmonary toxicity Cause
Description

Pulmonary toxicity

Data type

integer

Infection
Description

Infection

Data type

integer

Infection:
Description

Infection

Data type

integer

Rejection / poor graft function
Description

Rejection / poor graft function

Data type

integer

Veno-Occlusive disease (VOD)
Description

Veno-Occlusive disease (VOD)

Data type

integer

Haemorrhage
Description

Haemorrhage

Data type

integer

Cardiac toxicity
Description

Cardiac toxicity

Data type

integer

Central nervous system toxicity
Description

Central nervous system toxicity

Data type

integer

Gastro intestinal toxicity
Description

Gastro intestinal toxicity

Data type

integer

Skin toxicity
Description

Skin toxicity

Data type

integer

Renal failure
Description

Renal failure

Data type

integer

Multiple organ failure
Description

Multiple organ failure

Data type

integer

If other HSCT related cause, please specify
Description

Other

Data type

text

ADDITIONAL NOTES IF APPLICABLE
Description

ADDITIONAL NOTES IF APPLICABLE

Comments
Description

Comments

Data type

text

IDENTIFICATION & SIGNATURE
Description

IDENTIFICATION & SIGNATURE

Data type

text

Similar models

18pp EBMT Amyloidosis

  1. StudyEvent: ODM
    1. 18pp EBMT Amyloidosis
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
GENERAL INFORMATION TEAM
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])
E-Mail
Item
E-Mail
text
C1705961 (UMLS CUI [1,1])
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])
Code List
Patient following national / international study / trial
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])
Item Group
GENERAL INFORMATION PATIENT
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])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
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])
Item Group
DISEASE
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])
Code List
Check the disease for which this transplant was performed
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 Group
AL AMYLOIDOSIS INITIAL 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
Item
Select one as applicable
integer
Code List
Select one as applicable
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)
Item
Select one as applicable
integer
Code List
Select one as applicable
CL Item
Kappa (1)
CL Item
Lambda (2)
CL Item
Absent (3)
CL Item
Not evaluated (4)
Item
If Multiple myeloma
integer
Code List
If Multiple myeloma
CL Item
I (I)
CL Item
II (II)
CL Item
III (III)
Stage at diagnosis (Salmon and Durie) B
Item
If Multiple myeloma
boolean
Item
DIAGNOSIS OF AMYLOIDOSIS
integer
Code List
DIAGNOSIS OF AMYLOIDOSIS
CL Item
Excluded (1)
CL Item
Not evaluated (2)
Item
DIAGNOSIS OF AMYLOIDOSIS
text
Code List
DIAGNOSIS OF AMYLOIDOSIS
CL Item
Done (Done)
CL Item
Not evaluated (Not evaluated)
HbLab
Item
Hb (g/dl) CLINICAL AND LABORATORY DATA
float
Item
Hb (g/dl) CLINICAL AND LABORATORY DATA
integer
Code List
Hb (g/dl) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum creatinine
Item
CLINICAL AND LABORATORY DATA
float
Item
CLINICAL AND LABORATORY DATA Serum creatinine
text
Code List
CLINICAL AND LABORATORY DATA Serum creatinine
CL Item
μmol/L (μmol/L)
CL Item
mg/dL (mg/dL)
Item
CLINICAL AND LABORATORY DATA Serum creatinine
integer
Code List
CLINICAL AND LABORATORY DATA Serum creatinine
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
Code List
Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
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
Item
Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum albumin (g/L)
Item
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
float
Item
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
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)
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
integer
Code List
Serum bilirubin CLINICAL AND LABORATORY DATA
CL Item
μmol/L  (1)
CL Item
mg/dL (2)
Serum bilirubin
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
float
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
integer
Code List
Serum bilirubin CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum NT-pro-BNP (ng/L)
Item
Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
float
Item
CLINICAL AND LABORATORY DATA Serum NT-pro-BNP (ng/L)
integer
Code List
CLINICAL AND LABORATORY DATA Serum NT-pro-BNP (ng/L)
CL Item
Not evaluated (1)
Serum c-Troponin T (μg/L)
Item
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
float
Item
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
BM aspirate
Item
BM aspirate: % plasmacytosis
float
Item
BM aspirate % plasmacytosis
integer
Code List
BM aspirate % plasmacytosis
CL Item
Not evaluated (1)
BM trephine
Item
BM trephine % plasmacytosis
float
Item
BM trephine: % plasmacytosis
integer
Code List
BM trephine: % plasmacytosis
CL Item
Not evaluated (1)
Monoclonal Ig in serum
Item
Monoclonal Ig in serum
float
Item
Immunofixation of serum
integer
Code List
Immunofixation of serum
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
Item
Immunofixation of urine
integer
Code List
Immunofixation of urine
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
Bone structure (X-ray)
integer
Code List
Bone structure (X-ray)
CL Item
Normal  (1)
CL Item
Lytic lesion present  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
Macroglossy Typical clinical symptoms
integer
Code List
Macroglossy Typical clinical symptoms
CL Item
Absent  (1)
CL Item
Present  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
Periorbital bleeding Typical clinical symptoms
integer
Code List
Periorbital bleeding Typical clinical symptoms
CL Item
Absent  (1)
CL Item
Present  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
Shoulder pad sign Typical clinical symptoms
integer
Code List
Shoulder pad sign Typical clinical symptoms
CL Item
Absent  (1)
CL Item
Present  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item Group
ORGAN INVOLVEMENT AT DIAGNOSIS
Item
Soft Tissues
text
Code List
Soft Tissues
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)
Item
Gastrointestinal Tract
integer
Code List
Gastrointestinal Tract
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
Heart
integer
Code List
Heart
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
Liver
integer
Code List
Liver
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
Kidney
integer
Code List
Kidney
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
Peripheral nerves
integer
Code List
Peripheral nerves
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
Autonomic nerves
integer
Code List
Autonomic nerves
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
if other, please specify
text
Code List
if other, please specify
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
Item
NYHA class
integer
C1275491 (UMLS CUI [1])
Code List
NYHA class
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
Item
Weight loss
integer
Code List
Weight loss
CL Item
No  (1)
CL Item
Yes  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
Malabsorption
integer
Code List
Malabsorption
CL Item
No  (1)
CL Item
Yes  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
GI bleeding
integer
Code List
GI bleeding
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
Item
Neurological exam
text
Code List
Neurological exam
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
Item
PNP severity
integer
Code List
PNP severity
CL Item
grade I  (1)
CL Item
grade II  (2)
CL Item
grade III  (3)
CL Item
grade IV (4)
Item
Orthostatic hypotension
integer
Code List
Orthostatic hypotension
CL Item
Yes  (1)
CL Item
No  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
Intractable diarrhoea
integer
Code List
Intractable diarrhoea
CL Item
Yes  (1)
CL Item
No  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
Inflexible pulse rate
integer
Code List
Inflexible pulse rate
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 Group
PRE-HSCT TREATMENT
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
Item
Modality, if Chemotherapy
text
Code List
Modality, if Chemotherapy
CL Item
Chemotherapy regimen (Chemotherapy regimen)
CL Item
Number of cycles (Number of cycles)
Modality
Item
If Other, please specify
text
Item Group
HSCT
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)
Item
Haematological status
text
Code List
Haematological status
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)
Item
Organ status
integer
Code List
Organ status
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
Item
Haematological status
integer
Code List
Haematological status
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)
Item
Organ status
integer
Code List
Organ status
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
Item
Hb (g/dl) CLINICAL AND LABORATORY DATA
integer
Code List
Hb (g/dl) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum creatinine
Item
CLINICAL AND LABORATORY DATA
float
Item
CLINICAL AND LABORATORY DATA Serum creatinine
text
Code List
CLINICAL AND LABORATORY DATA Serum creatinine
CL Item
μmol/L (μmol/L)
CL Item
mg/dL (mg/dL)
Item
CLINICAL AND LABORATORY DATA Serum creatinine
integer
Code List
CLINICAL AND LABORATORY DATA Serum creatinine
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
Code List
Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
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
Item
Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum albumin (g/L)
Item
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
float
Item
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
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)
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
integer
Code List
Serum bilirubin CLINICAL AND LABORATORY DATA
CL Item
μmol/L  (1)
CL Item
mg/dL (2)
Serum bilirubin
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
float
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
integer
Code List
Serum bilirubin CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum NT-pro-BNP (ng/L)
Item
Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
float
Item
CLINICAL AND LABORATORY DATA Serum NT-pro-BNP (ng/L)
integer
Code List
CLINICAL AND LABORATORY DATA Serum NT-pro-BNP (ng/L)
CL Item
Not evaluated (1)
Serum c-Troponin T (μg/L)
Item
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
float
Item
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
BM aspirate
Item
BM aspirate: % plasmacytosis
float
Item
BM aspirate % plasmacytosis
integer
Code List
BM aspirate % plasmacytosis
CL Item
Not evaluated (1)
BM trephine
Item
BM trephine % plasmacytosis
float
Item
BM trephine: % plasmacytosis
integer
Code List
BM trephine: % plasmacytosis
CL Item
Not evaluated (1)
Monoclonal Ig in serum
Item
Monoclonal Ig in serum
float
Item
Immunofixation of serum
integer
Code List
Immunofixation of serum
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
Item
Immunofixation of urine
integer
Code List
Immunofixation of urine
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
Soft Tissues
text
Code List
Soft Tissues
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)
Item
Gastrointestinal Tract
integer
Code List
Gastrointestinal Tract
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
Heart
integer
Code List
Heart
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
Liver
integer
Code List
Liver
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
Kidney
integer
Code List
Kidney
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
Peripheral nerves
integer
Code List
Peripheral nerves
CL Item
Dominant organ(s) involved (1)
CL Item
Additional organ involvement (2)
CL Item
Biopsy (3)
CL Item
No involvement (4)
Item
Autonomic nerves
integer
Code List
Autonomic nerves
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
Item
NYHA class
integer
C1275491 (UMLS CUI [1])
Code List
NYHA class
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
Item
Weight loss
integer
Code List
Weight loss
CL Item
No  (1)
CL Item
Yes  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
Malabsorption
integer
Code List
Malabsorption
CL Item
No  (1)
CL Item
Yes  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
GI bleeding
integer
Code List
GI bleeding
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
Item
Neurological exam
text
Code List
Neurological exam
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
Item
PNP severity
integer
Code List
PNP severity
CL Item
grade I  (1)
CL Item
grade II  (2)
CL Item
grade III  (3)
CL Item
grade IV (4)
Item
Orthostatic hypotension
integer
Code List
Orthostatic hypotension
CL Item
Yes  (1)
CL Item
No  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
Intractable diarrhoea
integer
Code List
Intractable diarrhoea
CL Item
Yes  (1)
CL Item
No  (2)
CL Item
Not evaluated  (3)
CL Item
Unknown (4)
Item
Inflexible pulse rate
integer
Code List
Inflexible pulse rate
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 Group
STATUS OF DISEASE AT 100 DAYS AFTER HSCT
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
Item
Hb (g/dl) CLINICAL AND LABORATORY DATA
integer
Code List
Hb (g/dl) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum creatinine
Item
CLINICAL AND LABORATORY DATA
float
Item
CLINICAL AND LABORATORY DATA Serum creatinine
text
Code List
CLINICAL AND LABORATORY DATA Serum creatinine
CL Item
μmol/L (μmol/L)
CL Item
mg/dL (mg/dL)
Item
CLINICAL AND LABORATORY DATA Serum creatinine
integer
Code List
CLINICAL AND LABORATORY DATA Serum creatinine
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
Code List
Creatinine clearance (mL/min) CLINICAL AND LABORATORY DATA
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
Item
Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum calcium (mmol/L) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum albumin (g/L)
Item
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
float
Item
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum albumin (g/L) CLINICAL AND LABORATORY DATA
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)
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
integer
Code List
Serum bilirubin CLINICAL AND LABORATORY DATA
CL Item
μmol/L  (1)
CL Item
mg/dL (2)
Serum bilirubin
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
float
Item
Serum bilirubin CLINICAL AND LABORATORY DATA
integer
Code List
Serum bilirubin CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
Serum NT-pro-BNP (ng/L)
Item
Serum NT-pro-BNP (ng/L) CLINICAL AND LABORATORY DATA
float
Item
CLINICAL AND LABORATORY DATA Serum NT-pro-BNP (ng/L)
integer
Code List
CLINICAL AND LABORATORY DATA Serum NT-pro-BNP (ng/L)
CL Item
Not evaluated (1)
Serum c-Troponin T (μg/L)
Item
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
float
Item
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
integer
Code List
Serum c-Troponin T (μg/L) CLINICAL AND LABORATORY DATA
CL Item
Not evaluated (1)
BM aspirate
Item
BM aspirate: % plasmacytosis
float
Item
BM aspirate % plasmacytosis
integer
Code List
BM aspirate % plasmacytosis
CL Item
Not evaluated (1)
BM trephine
Item
BM trephine % plasmacytosis
float
Item
BM trephine: % plasmacytosis
integer
Code List
BM trephine: % plasmacytosis
CL Item
Not evaluated (1)
Monoclonal Ig in serum
Item
Monoclonal Ig in serum
float
Item
Immunofixation of serum
integer
Code List
Immunofixation of serum
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