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ID
14439
Descripción
DOCUMENTED PATHOGENS (Use this table for guidance on the pathogens of interest) Type 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 Type Fungi: Candida sp, Aspergillus sp, Pneumocystis carinii, Other Type Parasites: Toxoplasma gondii, Other Type Viruses: HSV, VZV, EBV, CMV, HHV-6, RSV, Other respiratory virus (influenza, parainfluenza, rhinovirus), Adenovirus, HBV, HCV, HIV, Papovavirus, Parvovirus, Other
Palabras clave
Versiones (3)
- 27/9/17 27/9/17 -
- 17/7/16 17/7/16 -
- 20/6/17 20/6/17 - Martin Dugas
Subido en
27 de septiembre de 2017
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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MYELOPROLIFERATIVE NEOPLASM EBMT
Similar models
15ppMPN
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
EBMT Centre Identification Code
Item
EBMT Centre Identification Code (CIC)
text
C0802049 (UMLS CUI [1])
Klinik
Item
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 of contact person
text
C1515258 (UMLS CUI [1])
ContactPersonFaxNumber
Item
Fax
text
C0237753 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C0085205 (UMLS CUI [1,4])
C0027361 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C0085205 (UMLS CUI [1,4])
ContactPersonE-mailText
Item
E-mail
text
C1527021 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
C0027361 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
C0337611 (UMLS CUI [1,4])
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
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
C0683312 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,3])
CL Item
Male (Male)
CL Item
Female (Female)
ABO Group
Item
ABO Group
text
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Not evaluated (Not evaluated)
Date of Diagnosis
Item
Date of Diagnosis
date
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)
Primary Disease Diagnosis
Item
If other diagnosis, specify:
text
C0277554 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item Group
SPECIFICATIONS OF THE DISEASE MYELOPROLIFERATIVE NEOPLASM DIAGNOSIS
CL Item
Chronic idiopathic myelofibrosis or Primary myelofibrosis (1)
CL Item
Polycythaemia vera (2)
CL Item
Essential thrombocythemia (3)
CL Item
Hyper eosinophilic syndrome (HES) (4)
CL Item
Chronic eosinophilic leukaemia (CEL) (5)
CL Item
Chronic neutrophilic leukaemia (6)
CL Item
Stem cell leukemia-Lymphoma syndrome (8p11 syndrome) (7)
CL Item
Systemic mastocytosis (8)
CL Item
Mast cell leukaemia (9)
CL Item
Mast cell sarcoma (10)
Item
Chronic eosinophilic leukaemia (CEL) With blastic transformation
text
Code List
Chronic eosinophilic leukaemia (CEL) With blastic transformation
CL Item
no (no)
CL Item
yes (yes )
CL Item
unknown (unknown)
Cytogenetics Data
Item
Include all analysis before treatment; describe results of most recent complete analysis
text
C0010802 (UMLS CUI [1])
CL Item
Not Done or failed (Not Done or failed)
CL Item
Done: normal (Done: normal)
CL Item
Done: abnormal (Done: abnormal)
CL Item
Unknown (Unknown)
CL Item
no (no)
CL Item
yes (yes )
CL Item
unknown (unknown)
number of metaphases with abnormalites
Item
If done
integer
number of metaphases examined
Item
if done
integer
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Absent (Absent)
CL Item
Present (Present)
Other abnormalities
Item
Other abnormalities please specify
text
CL Item
Evaluated: Absent (1)
CL Item
Evaluated: Present (2)
CL Item
Not evaluated (3)
CL Item
unknown (4)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Not evaluated (Not evaluated)
CL Item
unknown (unknown)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Not evaluated (Not evaluated)
CL Item
unknown (unknown)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Not evaluated (Not evaluated)
CL Item
unknown (unknown)
CL Item
Hb (g/dL) (Hb (g/dL))
CL Item
Platelets (109/L) (Platelets (109/L))
CL Item
White Blood Cells (109/L) (White Blood Cells (109/L))
CL Item
% blasts (% blasts)
CL Item
% blasts (% blasts)
CL Item
% neutrophils (% neutrophils)
HbLab
Item
Hb (g/dl)
float
Platelets (109/L)
Item
Platelets (109/L)
float
White Blood Cells
Item
Peripheral Blood Analysis If evaluated: White Blood Cells (10^9/L)
float
C0005821 (UMLS CUI [1])
Blasts
Item
Blasts
float
C1982687 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
neutrophils
Item
Neutrophils
float
CL Item
not evaluated (1)
CL Item
not evaluated (1)
CL Item
Not evaluated (1)
CL Item
Not evaluated (Not evaluated)
CL Item
Not evaluated (Not evaluated)
CL Item
Not evaluated (Not evaluated)
Bone marrow Blasts
Item
Bone marrow Blasts
integer
CL Item
not evaluated (1)
CL Item
yes (yes)
CL Item
no (no )
CL Item
Not evaluated (Not evaluated)
CL Item
unknown (unknown)
CL Item
Low (Low)
CL Item
Intermediate (Intermediate)
CL Item
High (High)
CL Item
Unknown (Unknown)
CL Item
Low (Low)
CL Item
High (High)
CL Item
Unknown (Unknown)
CL Item
Cytology (Cytology)
CL Item
Histology (Histology)
CL Item
Not available (Not available)
CL Item
Acellular (Acellular)
CL Item
Hypocellular (Hypocellular)
CL Item
Normocellular (Normocellular)
CL Item
Hypercellular (Hypercellular)
CL Item
Focal cellularity (Focal cellularity)
CL Item
Unknown (Unknown)
CL Item
No (No)
CL Item
Mild (Grade 1) (Mild (Grade 1))
CL Item
Moderate (Grade 2) (Moderate (Grade 2))
CL Item
Severe (Grade 3) (Severe (Grade 3))
CL Item
Not evaluable (Not evaluable)
CL Item
Unknown (Unknown)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Not evaluated (Not evaluated)
CL Item
Unknown (Unknown)
physical examination
Item
Physical examination below costal margin
float
CL Item
Not evaluated (1)
Spleen span in ultrasound or CT scan
Item
Spleen span in ultrasound or CT scan maximum diameter
float
CL Item
Not evaluated (1)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
First Line Therapy
Item
First Line Therapy given (If No, proceed to `Subclassification & Status of Disease at HSCT` If Yes, specify start date)
boolean
C1708063 (UMLS CUI [1])
CL Item
MPN (as registered at diagnosis) (1)
CL Item
Transformed to myelofibrosis from Polycythaemia vera/ Essential thrombocythemia (2)
CL Item
Transformed to AML (3)
date of transformation
Item
If transformed into Myelofibrosis or AML
date
TREATMENT
Item
Chemo/drug/agent
boolean
C0013216 (UMLS CUI [1])
CL Item
Ara-C (Ara-C)
CL Item
Androgens (Androgens)
CL Item
Tyrosine kinase inhibitor (Tyrosine kinase inhibitor)
CL Item
Hydroxyurea (Hydroxyurea)
CL Item
AML like therapy (AML like therapy)
CL Item
Interferon (Interferon)
CL Item
Thalidomide (Thalidomide)
CL Item
Lenalidomide (Lenalidomide)
CL Item
Steroids (Steroids)
Chemo/drug/agent
Item
if other please specify
text
Radiotherapy
Item
Radiotherapy
boolean
C1522449 (UMLS CUI [1])
CL Item
no (1)
CL Item
yes (2)
CL Item
unknown (3)
Radiotherapy
Item
if other Radiotherapy, please specify
text
Item
If subsequent HSCT, indicate the date of the 1st CR after this treatment * CR must include all three conditions: 1. Resolution of disease –related symptoms and signs including palpable hepato-splenomegaly 2. Hb >11gr/dL, Platelet >100 x109/L and neutrophils >1 x 109/L. 3. normal bone marrow histology, and fibrosis grade no higher than 1
text
Code List
If subsequent HSCT, indicate the date of the 1st CR after this treatment * CR must include all three conditions: 1. Resolution of disease –related symptoms and signs including palpable hepato-splenomegaly 2. Hb >11gr/dL, Platelet >100 x109/L and neutrophils >1 x 109/L. 3. normal bone marrow histology, and fibrosis grade no higher than 1
CL Item
Complete remission(CR) (Complete remission(CR))
CL Item
Never in CR (Never in CR)
Item Group
SUBCLASSIFICATION & STATUS OF DISEASE AT HSCT
Date of HSCT
Item
Date of HSCT
date
C2584899 (UMLS CUI [1])
CL Item
no (no )
CL Item
yes (yes)
CL Item
No transfusions (1)
CL Item
With transfusions (2)
CL Item
Never transfused (3)
CL Item
MPN (as registered at diagnosis) (1)
CL Item
Transformed to myelofibrosis from Polycythaemia vera/ Essential thrombocythemia (2)
CL Item
Transformed to AML (3)
If transformed into Myelofibrosis or AML, date of transformation
Item
If transformed into Myelofibrosis or AML, date of transformation
date
CL Item
Primary refractory phase (no change) (1)
CL Item
Complete remission (CR) (2)
CL Item
Improvement but no CR (3)
CL Item
Relapse (after CR) (4)
CL Item
Progression/worse (5)
CL Item
Untreated (Supportive care or treatment without chemotherapy) (6)
CL Item
1st (1st)
CL Item
2nd (2nd)
CL Item
3rd or higher (3rd or higher)
Item
(Within 2 months of the preparative -conditioning- regimen) Chromosome analysis
integer
Code List
(Within 2 months of the preparative -conditioning- regimen) Chromosome analysis
CL Item
Not done or failed (1)
CL Item
Done: normal (2)
CL Item
Done: abnormal (3)
CL Item
Unknown (4)
Item
If abnormal: Are there 3 or more abnormalities (complex kariotype)?
integer
CL Item
no (1)
CL Item
yes (2)
CL Item
unknown (3)
CL Item
Absent (1)
CL Item
Present (2)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Absent (1)
CL Item
Present (2)
CL Item
Absent (1)
CL Item
Present (2)
CL Item
Absent (1)
CL Item
Present (2)
CL Item
Absent (1)
CL Item
Present (2)
CL Item
Absent (1)
CL Item
Present (2)
HAEMATOLOGICAL VALUES Peripheral blood
Item
Hb (g/dl)
float
HAEMATOLOGICAL VALUES Peripheral blood
Item
Platelets (109/L)
float
HAEMATOLOGICAL VALUES Peripheral blood
Item
White Blood Cells (109/L)
float
HAEMATOLOGICAL VALUES Peripheral blood
Item
% blasts
float
HAEMATOLOGICAL VALUES Peripheral blood
Item
% monocytes
float
HAEMATOLOGICAL VALUES Peripheral blood
Item
% neutrophils
float
CL Item
yes (1)
CL Item
not evaluated (2)
CL Item
yes (1)
CL Item
not evaluated (2)
CL Item
yes (1)
CL Item
not evaluated (2)
CL Item
yes (1)
CL Item
not evaluated (2)
CL Item
yes (1)
CL Item
not avaluated (2)
CL Item
yes (1)
CL Item
not evaluatd (2)
Bone marrow
Item
blasts
float
CL Item
yes (1)
CL Item
not evaluated (2)
CL Item
yes (yes)
CL Item
no (no)
CL Item
not evaluated (not evaluated)
CL Item
unknown (unknown)
CL Item
Low (1)
CL Item
Intermediate (2)
CL Item
High (3)
CL Item
Unknown (4)
CL Item
Low (1)
CL Item
High (2)
CL Item
Unknown (3)
Item
Within 2 months of the preparative -conditoning- regimen:
text
C0005957 (UMLS CUI [1])
CL Item
Cytology (Cytology)
CL Item
Histology (Histology)
CL Item
Not available (Not available)
Item
(at diagnosis; check one box in each column) CELLULARITY ON BM ASPIRATE / BM BIOPSY
integer
Code List
(at diagnosis; check one box in each column) CELLULARITY ON BM ASPIRATE / BM BIOPSY
CL Item
Acellular (1)
CL Item
Hypocellular (2)
CL Item
Normocellular (3)
CL Item
Hypercellular (4)
CL Item
Focal cellularity (5)
CL Item
Unknown (6)
CL Item
No (1)
CL Item
Mild (Grade 1) (2)
CL Item
Moderate (Grade 2) (3)
CL Item
Severe (Grade 3) (4)
CL Item
Not evaluable (5)
CL Item
Unknown (6)
Item
Night sweat Within 2 months of the preparative -conditioning- regimen
integer
Code List
Night sweat Within 2 months of the preparative -conditioning- regimen
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Not evaluated (Not evaluated)
CL Item
Unknown (Unknown)
CL Item
yes (1)
CL Item
not evaluated (2)
Physical examination
Item
(below costal margin)
float
Spleen span in ultrasound or CT scan
Item
Spleen span in ultrasound or CT scan
float
CL Item
yes (1)
CL Item
not evaluated (2)
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Unknown (Unknown)
CL Item
Planned (planned before HSCT took place) (1)
CL Item
Not planned (for relapse/progression or persistent disease) (2)
CL Item
CR (maintained or achieved) (1)
CL Item
Improvement but no CR (2)
CL Item
Unknown (3)
CL Item
Relapse / Progression (4)
CL Item
Not evaluable (5)
CL Item
AUTOgraft, proceed to Autograft form (1)
CL Item
ALLOgraft or Syngeneic graft, proceed to Allograft form (2)
CL Item
other (3)
Other TYPE OF TRANSPLANT
Item
if other, please specify and contact the EBMT Central Registry Office for instructions
text
Unique Identification Code (UIC)
Item
Unique Identification Code (UIC) (if known)
text
C2348585 (UMLS CUI [1])
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
Hospital Unique Patient Number
Item
Hospital Unique Patient Number
text
C2348585 (UMLS CUI [1])
Initials
Item
First name(s)_surname(s)
text
C2986440 (UMLS CUI [1])
PersonBirthDate
Item
Date of Birth
date
C0011008 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0005615 (UMLS CUI [1,3])
C0027361 (UMLS CUI [1,2])
C0005615 (UMLS CUI [1,3])
Date of last HSCT for this patient
Item
Date of last HSCT for this patient
date
C0472699 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Date last contact
Item
Date of Last Contact or Death
date
C0805839 (UMLS CUI [1])
Item Group
GRAFT VERSUS HOST DISEASE (GvHD) SINCE LAST REPORT
Item
Acute Graft versus Host Disease (aGvHD) - Grade
integer
C0856825 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
CL Item
grade 0 (Absent) (1)
CL Item
grade I (2)
CL Item
grade II (3)
CL Item
grade III (4)
CL Item
grade IV (5)
CL Item
Not evaluated (6)
CL Item
New onset (1)
CL Item
Recurrent (2)
CL Item
Persistent (3)
CL Item
Tapering (1)
CL Item
DLI (2)
CL Item
Unexplained (3)
Date onset of this episode
Item
Date onset of this episode (if new or recurrent)
date
C0574845 (UMLS CUI [1])
CL Item
yes (1)
CL Item
not applicacable (2)
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)
Resolution
Item
aGvHD Resolution
boolean
C0856825 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
C1514893 (UMLS CUI [1,2])
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 continuously since last reported episode (Present continuously since last reported episode)
CL Item
Resolved (Resolved)
CL Item
No (1)
CL Item
Yes, First Episode (2)
CL Item
Yes, Recurrence (3)
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
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)
Organs affected
Item
if other, please specify
text
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])
Infection related complications
Item
Infection related complications
boolean
C0009450 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,2])
Bacteremia / fungemia / viremia / parasites
Item
Pathogen Use the list of pathogens listed after this table for guidance. Use “unknown” if necessary.
text
Bacteremia / 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
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
CL Item
No complications (1)
CL Item
Yes (2)
Item
Specify: Idiopathic pneumonia syndrome
text
C1504431 (UMLS CUI [1])
CL Item
Yes (Yes)
CL Item
No (No )
CL Item
Unknown (Unknown)
CL Item
Yes (Yes)
CL Item
No (No )
CL Item
Unknown (Unknown)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item
Specify: Haemorrhagic cystitis, non infectious
text
C0085692 (UMLS CUI [1])
CL Item
Yes (Yes )
CL Item
No (No )
CL Item
Unknown (Unknown)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
yes (yes)
CL Item
no (no )
CL Item
unknown (unknown)
Item
Specify: HSCT-associated microangiopathy
text
C0155765 (UMLS CUI [1])
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item
Specify: Renal failure requiring dialysis
text
C0035078 (UMLS CUI [1])
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item
Specify: Haemolytic anaemia due to blood group
text
C0002878 (UMLS CUI [1])
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
yes (1)
Idiopathic pneumonia syndrome
Item
Idiopathic pneumonia syndrome
date
VOD
Item
VOD
date
Cataract
Item
Cataract
date
Haemorrhagic cystitis, non infectious
Item
Haemorrhagic cystitis, non infectious
date
ARDS, non infectious
Item
ARDS, non infectious
date
Multiorgan failure, non infectious
Item
Multiorgan failure, non infectious
date
HSCT-associated microangiopathy
Item
HSCT-associated microangiopathy
date
Renal failure requiring dialysis
Item
Renal failure requiring dialysis
date
Haemolytic anaemia due to blood group
Item
Haemolytic anaemia due to blood group
date
Aseptic bone necrosis
Item
Aseptic bone necrosis
date
Other type of complication
Item
Other type of complication
date
Item Group
GRAFT ASSESSMENT AND HAEMOPOIETIC CHIMAERISM
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Not evaluated (Not evaluated)
CL Item
95%) (Full (donor >)
CL Item
Mixed (partial) (Mixed (partial))
CL Item
95%) (Autologuos reconstitution (recipient >)
CL Item
Aplasia (Aplasia)
CL Item
Not evaluated (Not evaluated)
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])
Item
Number in the infusion order (if applicable)
integer
C2348184 (UMLS CUI [1])
CL Item
......... (1)
CL Item
N/A (2)
BM
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-cell
Item
Cell type on which test was performed (%Donor cells)
float
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)
Test used
Item
If other Test used
text
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)
SECONDARY MALIGNANCY, LYMPHOPROLIFERATIVE OR MYELOPROLIFRATIVE DISORDER DIAGNOSED
Item
if yes, please date of diagnosis
date
CL Item
AML (1)
CL Item
MDS (2)
CL Item
Lymphoproliferative disorder (3)
CL Item
Other (4)
Other diagnosis
Item
Diagnosis, other:
text
C0205394 (UMLS CUI [1])
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Unknown (Unknown)
ADDITIONAL TREATMENT
Item
if yes, 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
C0302189 (UMLS CUI [1])
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 (Mark disease status before this cellular therapy) (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)
Type of cells
Item
if other type of cells please specify
text
CL Item
Number (1)
CL Item
Not evaluated (2)
CL Item
Unknown (3)
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)
CL Item
Evaluated (Evaluated )
CL Item
Not evaluated (Not evaluated)
CL Item
Unknown (Unknown)
CL Item
Number (1)
CL Item
Not evaluated (2)
CL Item
Unknown (3)
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)
Other indication
Item
if other indication please specify
text
Number of Infusions
Item
Number of Infusions (within 10 weeks) (count only infusions that are part of same regimen and given for the same indication) (count only infusions that are part of same regimen and given for the same indication)
float
C2348184 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C1289919 (UMLS CUI [1,2])
Item
Acute Graft versus Host Disease (after this infusion but before any further infusion/ transplant) Maximum grade:
text
C0856825 (UMLS CUI [1])
Code List
Acute Graft versus Host Disease (after this infusion but before any further infusion/ transplant) Maximum grade:
CL Item
grade 0 (absent) (grade 0 (absent))
CL Item
grade 1 (grade 1)
CL Item
grade 2 (grade 2)
CL Item
grade 3 (grade 3)
CL Item
grade 4 (grade 4)
CL Item
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 RELAPSE OR PROGRESSION SINCE LAST HSCT
Item
Relapse or Progression
text
C0277556 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0242656 (UMLS CUI [1,2])
CL Item
Previously reported (Previously reported)
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Continous progression since transplant (Continous progression since transplant)
CL Item
Unknown (Unknown)
RELAPSE OR PROGRESSION
Item
if date diagnosed
date
Item
last disease status
text
C0332307 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
CL Item
Complete Remission (Complete Remission)
CL Item
Relapse (Relapse)
CL Item
Treatment failure/ progression (Treatment failure/ progression)
CL Item
no (1)
CL Item
Mild (Grade1) (2)
CL Item
Moderate (Grade 2) (3)
CL Item
Severe (Grade 3) (4)
CL Item
Not evaluable (5)
CL Item
Unknown (6)
Item
Has patient or partner become pregnant after this HSCT?
text
C0032961 (UMLS CUI [1])
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Unknown (Unknown)
CL Item
alive (0)
CL Item
dead (1)
CL Item
Karnofsky (Karnofsky)
CL Item
Lansky (Lansky)
CL Item
Not evaluated (Not evaluated)
CL Item
Unknown (Unknown)
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
Relapse or progression (Relapse or progression)
CL Item
Secondary malignancy (including lymphoproliferative disease) (Secondary malignancy (including lymphoproliferative disease))
CL Item
HSCT related cause (HSCT related cause )
CL Item
Unknown (Unknown )
CL Item
Other (Other)
CL Item
GvHD (1)
CL Item
Interstitial pneumonitis (2)
CL Item
Pulmonary toxicity (3)
CL Item
Infection bacterial (4)
CL Item
Infection viral (5)
CL Item
Infection fungal (6)
CL Item
Infection parasitic (7)
CL Item
Infection unknown (8)
CL Item
Rejection / poor graft function (9)
CL Item
Veno-occlusive disease (VOD) (10)
CL Item
Haemorrhage (11)
CL Item
Cardiac toxicity (12)
CL Item
Central nervous system toxicity (13)
CL Item
Gastro intestinal toxicity (14)
CL Item
Skin toxicity (15)
CL Item
Renal failure (16)
CL Item
Multiple organ failure (17)
CL Item
Other (18)
COMMENTS
Item
COMMENTS
text
Identification
Item
Identification
text
C0205396 (UMLS CUI [1])