Information:
Error:
ID
16069
Description
ODM form derived from 15pp EBMT Multiple Sclerosis 13MS please refer to: http://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Pages/MED-AB-data-collection-forms.aspx
Link
Keywords
Versions (1)
- 6/27/16 6/27/16 -
Uploaded on
June 27, 2016
DOI
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License
Creative Commons BY-NC 3.0
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EBMT Multiple Sclerosis follow up form
15pp EBMT Multiple Sclerosis Follow up form
- StudyEvent: ODM
Similar models
15pp EBMT Multiple Sclerosis Follow up form
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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
C0008976 (UMLS CUI [1])
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])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
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])
PATIENT LAST SEEN
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) - Maximum grade
text
C0441799 (UMLS CUI [1,1])
C0856825 (UMLS CUI [1,2])
C0856825 (UMLS CUI [1,2])
CL Item
grade I (grade I)
CL Item
grade II (grade II)
CL Item
grade III (grade III)
CL Item
grade IV (grade IV)
CL Item
not evaluated (not evaluated)
CL Item
grade 0 (absent) (grade 0 (absent))
Item
If present GvHD, Maximum grade
integer
C0856825 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
CL Item
New onset (1)
C0746890 (UMLS CUI-1)
CL Item
Recurrent (2)
C2945760 (UMLS CUI-1)
CL Item
Persistent (3)
C0205322 (UMLS CUI-1)
Item
Reason Maximum grade
integer
C0441800 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Tapering (1)
C0441640 (UMLS CUI-1)
CL Item
DLI (2)
C1512034 (UMLS CUI-1)
CL Item
Unexplained (3)
C0439673 (UMLS CUI-1)
Date onset of this episode
Item
Date onset of this episode (if new or recurrent)
date
C0574845 (UMLS CUI [1])
Item
Date onset of this episode
integer
C0574845 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Not applicable (1)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
Not evaluated (6)
CL Item
unknown (7)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
Not evaluated (6)
CL Item
unknown (7)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
Not evaluated (6)
CL Item
unknown (7)
CL Item
No (1)
CL Item
Yes (2)
aGvHD Date of resolutions
Item
aGvHD Date of resolutions
date
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)
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
CL Item
limited (1)
CL Item
Extensive (2)
CL Item
Skin (1)
C1123023 (UMLS CUI-1)
CL Item
Gut (2)
C0021853 (UMLS CUI-1)
CL Item
Liver (3)
C0023884 (UMLS CUI-1)
CL Item
Mouth (4)
C0230028 (UMLS CUI-1)
CL Item
Eyes (5)
C0015392 (UMLS CUI-1)
CL Item
Lung (6)
C0024109 (UMLS CUI-1)
CL Item
Other, specify (7)
CL Item
Unknown (8)
C0439673 (UMLS CUI-1)
Organs affected
Item
If other organs affected, please specify
integer
C0178784 (UMLS CUI [1])
cGvHD Resolved: Date of resolution
Item
cGvHD Resolved: Date of resolution
date
C0867389 (UMLS CUI [1,1])
C2985858 (UMLS CUI [1,2])
C2985858 (UMLS CUI [1,2])
Item
INFECTION RELATED COMPLICATIONS
integer
C0009450 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,2])
CL Item
No complications (1)
CL Item
Yes (2)
Item
Bacteremia / fungemia / viremia / parasites
integer
C0004610 (UMLS CUI [1,1])
C0085082 (UMLS CUI [1,2])
C0042749 (UMLS CUI [1,3])
C0030498 (UMLS CUI [1,4])
C0085082 (UMLS CUI [1,2])
C0042749 (UMLS CUI [1,3])
C0030498 (UMLS CUI [1,4])
CL Item
Pathogen (1)
CL Item
Date (2)
CL Item
Pathogen (1)
CL Item
Date (2)
CL Item
Pathogen (1)
CL Item
Date (2)
Item
Multiorgan failure due to infection
integer
C0026766 (UMLS CUI [1])
CL Item
Pathogen (1)
CL Item
Date (2)
CL Item
Pathogen (1)
CL Item
Date (2)
CL Item
Pathogen (1)
CL Item
Date (2)
CL Item
Pathogen (1)
CL Item
Date (2)
CL Item
Pathogen (1)
CL Item
Date (2)
CL Item
Pathogen (1)
C0450254 (UMLS CUI-1)
CL Item
Date (2)
C0011008 (UMLS CUI-1)
CL Item
Pathogen (Pathogen)
CL Item
Date (Date)
CL Item
Pathogen (Pathogen)
CL Item
Date (Date)
Other pathogen specified
Item
Other pathogen specified
integer
C0450254 (UMLS CUI [1])
Item
NON INFECTION RELATED COMPLICATIONS
integer
C0009566 (UMLS CUI [1])
CL Item
No complications (1)
CL Item
Yes (2)
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
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)
Item
Multiorgan failure, non infectious
integer
C0026766 (UMLS CUI [1])
CL Item
yes (yes )
CL Item
no (no )
CL Item
unknown (unknown)
Item
HSCT-associated microangiopathy
integer
C0155765 (UMLS CUI [1])
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Date (4)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Date (Date)
Item
Haemolytic anaemia due to blood group
integer
C0002878 (UMLS CUI [1])
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Date (4)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Date (Date)
Other type of NON INFECTION RELATED COMPLICATIONS
Item
Other type of NON INFECTION RELATED COMPLICATIONS, please specify
text
Idiopathic pneumonia syndrome
Item
Idiopathic pneumonia syndrome
date
C1504431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Not evaluated (Not evaluated)
CL Item
Full (donor >95%) (1)
C0443225 (UMLS CUI-1)
CL Item
Mixed (partial) (2)
C0205430 (UMLS CUI-1)
CL Item
Autologuos reconstitution (recipient > 95%) (3)
C0301944 (UMLS CUI-1)
CL Item
Aplasia (4)
C0243065 (UMLS CUI-1)
CL Item
Not evaluated (5)
C3846720 (UMLS CUI-1)
Date of test
Item
Date of test (Indicate the date(s) and results of all tests done for all donors. Split the results by donor and by the cell type on which the test was performed if applicable. Copy this table as many times as necessary.)
date
C2826247 (UMLS CUI [1])
Identification
Item
Identification of donor or Cord Blood Unit given by the centre
text
C1718162 (UMLS CUI [1])
Number in the infusion order
Item
Number in the infusion order (if applicable)
text
C0237753 (UMLS CUI [1])
Item
Cell type on which test was performed % Donor cells B-Cells
integer
C0004561 (UMLS CUI [1])
Code List
Cell type on which test was performed % Donor cells B-Cells
CL Item
BM (1)
C0005953 (UMLS CUI-1)
CL Item
PB mononuclear cells (PBMC) (2)
C1321301 (UMLS CUI-1)
CL Item
T-cell (3)
C0039194 (UMLS CUI-1)
CL Item
B-cells (4)
C0004561 (UMLS CUI-1)
CL Item
Red blood cells (5)
C0014772 (UMLS CUI-1)
CL Item
Monocytes (6)
C0026473 (UMLS CUI-1)
CL Item
PMNs (neutrophils) (7)
C0200633 (UMLS CUI-1)
CL Item
Lymphocytes, NOS (8)
C0024264 (UMLS CUI-1)
CL Item
Myeloid cells, NOS (9)
C0887899 (UMLS CUI-1)
CL Item
Other, specify (10)
C1707811 (UMLS CUI-1)
C3840932 (UMLS CUI-2)
C3840932 (UMLS CUI-2)
CL Item
FISH (FISH)
C0162789 (UMLS CUI-1)
CL Item
Molecular (Molecular)
C0026376 (UMLS CUI-1)
CL Item
Cytogenetic (Cytogenetic)
C0010802 (UMLS CUI-1)
CL Item
ABO group (ABO group)
C0000778 (UMLS CUI-1)
CL Item
Other (Other)
C0205394 (UMLS CUI-1)
CL Item
unknown (unknown)
C0439673 (UMLS CUI-1)
Specification other labaratory tests
Item
Test used: If other, specify:
text
C0022885 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
SECONDARY MALIGNANCY, LYMPHOPROLIFERATIVE OR MYELOPROLIFRATIVE DISORDER DIAGNOSED
text
Code List
SECONDARY MALIGNANCY, LYMPHOPROLIFERATIVE OR MYELOPROLIFRATIVE DISORDER DIAGNOSED
CL Item
Previously reported (Previously reported)
CL Item
Yes (Yes)
CL Item
No at date of this follow-up (No at date of this follow-up)
Date of Diagnosis
Item
Date of Diagnosis
date
C2316983 (UMLS CUI [1])
Item
Diagnosis OTHER COMPLICATIONS SINCE LAST REPORT
text
C0011900 (UMLS CUI [1])
CL Item
AML (AML)
C0023467 (UMLS CUI-1)
CL Item
MDS (MDS)
C3463824 (UMLS CUI-1)
CL Item
Lymphoproliferative disorder (Lymphoproliferative disorder)
C0024314 (UMLS CUI-1)
CL Item
Other (Other)
C0205394 (UMLS CUI-1)
Other diagnosis
Item
Diagnosis, other:
text
C0205394 (UMLS CUI [1])
Item
Additional treatment given since last report
integer
C1706712 (UMLS CUI [1])
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Unknown (Unknown)
CL Item
Date (4)
Treatment given since last report
Item
If treatment given since last report
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
C0012634 (UMLS CUI [1])
CL Item
CR (CR)
C0677874 (UMLS CUI-1)
CL Item
Not in CR (Not in CR)
C0677874 (UMLS CUI-1)
CL Item
Not evaluated (Not evaluated)
C3846720 (UMLS CUI-1)
CL Item
Donor lymphocyte infusion (DLI) (1)
C1512034 (UMLS CUI-1)
CL Item
Mesenchymal cells (2)
C1257975 (UMLS CUI-1)
CL Item
Other (3)
C0205394 (UMLS CUI-1)
CL Item
Unknown (4)
C0439673 (UMLS CUI-1)
Type of cells
Item
If other
text
Chronological number
Item
Chronological number of this cell therapy for this patient
float
C2348184 (UMLS CUI [1])
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
Evaluated (Evaluated)
CL Item
Not Evaluated (Not Evaluated)
CL Item
Unknown (Unknown)
Item
Cell therapy indication
integer
C3146298 (UMLS CUI [1,1])
C0302189 (UMLS CUI [1,2])
C0302189 (UMLS CUI [1,2])
CL Item
Planned/protocol (1)
CL Item
Treatment for disease (2)
CL Item
Prophylactic (3)
CL Item
Mixed chimaerism (4)
CL Item
Treatment of GvHD (5)
CL Item
Treatment viral infection (6)
CL Item
Loss/decreased chimaerism (7)
CL Item
Treatment PTLD, EBV lymphoma (8)
CL Item
Other, specify (9)
Infusion count
Item
Number of infusions within 10 weeks (count only infusions that are part of same regimen and given for the same indication)
float
C0574032 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
Item
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)
Datestarted
Item
Date started
date
C3173309 (UMLS CUI [1])
Item
Overall main reason ADDITIONAL THERAPIES
integer
C1706712 (UMLS CUI [1,1])
C1443309 (UMLS CUI [1,2])
C1443309 (UMLS CUI [1,2])
CL Item
Relapse/progression (1)
C0449438 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
C0678257 (UMLS CUI-2)
CL Item
Continued from pre-HSCT (2)
CL Item
unknow (3)
C0439673 (UMLS CUI-1)
CL Item
Planned per protocol (4)
CL Item
Other (5)
Overall main reason
Item
Of Other, please specify
text
CL Item
no (no)
CL Item
yes (yes)
CL Item
unknown (unknown)
CL Item
Cyclophosphamide (Cyclophosphamide)
C0010583 (UMLS CUI-1)
CL Item
Mitoxantron (Mitoxantron)
C0026259 (UMLS CUI-1)
CL Item
Anti-lymphocyte antibodies (Anti-lymphocyte antibodies)
C0003369 (UMLS CUI-1)
CL Item
Corticosteroids (Corticosteroids)
C0001617 (UMLS CUI-1)
CL Item
low dose (Chronic low dose)
C0001617 (UMLS CUI-1)
C1708745 (UMLS CUI-2)
C1708745 (UMLS CUI-2)
CL Item
high dose (Pulse high dose)
C2065041 (UMLS CUI-1)
C0444956 (UMLS CUI-2)
C0444956 (UMLS CUI-2)
CL Item
Azathioprine (Azathioprine)
C0004482 (UMLS CUI-1)
CL Item
CopI (Cop-I)
C0887887 (UMLS CUI-1)
CL Item
Alpha interferon (Alpha interferon)
C0002199 (UMLS CUI-1)
CL Item
Interferon Beta (Beta Interferon)
C0015980 (UMLS CUI-1)
Item
Total lymph node (TLI)
integer
C0024204 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
CL Item
NO (NO)
CL Item
YES (YES)
CL Item
UNKNOWN (UNKNOWN)
CL Item
no (no)
CL Item
yes (yes)
CL Item
unknown (unknown)
CL Item
no (no)
CL Item
yes (yes )
CL Item
unknown (unknown)
Other modality
Item
if other modality please specify:
integer
C0695347 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Item Group
FIRST EVIDENCE OF DISEASE WORSENING SINCE LAST HSCT
CL Item
Previously reported (Previously reported)
C0205309 (UMLS CUI-1)
CL Item
No (No)
C1298908 (UMLS CUI-1)
CL Item
Yes (Yes)
C1705108 (UMLS CUI-1)
CL Item
Continuous worsening since HSCT (Continuous worsening since HSCT)
C0332271 (UMLS CUI-1)
EventDiseaseResponseDate
Item
Date First Noted (mm-dd-yyyy)
date
C0011008 (UMLS CUI [1,1])
C0871261 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0871261 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
Number of relapses/progressions since last HSCT
Item
Number of relapses/progressions since last HSCT
float
C0035020 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,2])
Scripps neurological rating scale
Item
Scripps neurological rating scale Score
float
C0451180 (UMLS CUI [1])
Kurtzke functional systems
Item
Kurtzke functional systems Overall score
float
C3826987 (UMLS CUI [1])
Kurtzke Expanded Disability Status
Item
Kurtzke Expanded Disability Status Scale (EDSS)
float
C3887783 (UMLS CUI [1])
Composite Scale
Item
Composite Scale Score
float
C4066222 (UMLS CUI [1])
CL Item
Not done (Not done)
CL Item
Yes (Yes)
Date of most recent MRI scan of brain
Item
Date of most recent MRI scan of brain
date
C0412675 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Results, Are new lesions present on the MRI?
text
C0412675 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
no (no)
CL Item
yes (yes)
CL Item
unknown (unknown)
CL Item
Gadolinium-enhancing (Gadolinium-enhancing)
CL Item
Unenhancing (Unenhancing)
CL Item
Both (Both)
CL Item
Unknown (Unknown)
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 (1)
C0206065 (UMLS CUI-1)
CL Item
Lansky (2)
C1522275 (UMLS CUI-1)
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 (1)
CL Item
Secondary malignancy (including lymphoproliferative disease) (2)
CL Item
HSCT related cause (3)
CL Item
Unknown (4)
CL Item
Other (5)
Item
HSCT related cause
integer
C0007465 (UMLS CUI [1,1])
C0472699 (UMLS CUI [1,2])
C0472699 (UMLS CUI [1,2])
CL Item
GvHD (1)
C0018133 (UMLS CUI-1)
CL Item
Interstitial pneumonitis (2)
C0206061 (UMLS CUI-1)
CL Item
Pulmonary toxicity (3)
C0919924 (UMLS CUI-1)
CL Item
Infection bacterial (4)
C0004623 (UMLS CUI-1)
CL Item
Infection viral (5)
C0042769 (UMLS CUI-1)
CL Item
Infection fungal (6)
C0026946 (UMLS CUI-1)
CL Item
Infection parasitic (7)
C0030498 (UMLS CUI-1)
CL Item
Infection unknown (8)
C0009450 (UMLS CUI-1)
CL Item
Rejection / poor graft function (9)
C0018129 (UMLS CUI-1)
CL Item
Veno-occlusive disease (VOD) (10)
C0948441 (UMLS CUI-1)
CL Item
Haemorrhage (11)
C0019080 (UMLS CUI-1)
CL Item
Cardiac toxicity (12)
C0876994 (UMLS CUI-1)
CL Item
Central nervous system toxicity (13)
C3160947 (UMLS CUI-1)
CL Item
Gastro intestinal toxicity (14)
C1142499 (UMLS CUI-1)
CL Item
Skin toxicity (15)
C1167791 (UMLS CUI-1)
CL Item
Renal failure (16)
C1533077 (UMLS CUI-1)
CL Item
Multiple organ failure (17)
C0026766 (UMLS CUI-1)
CL Item
Other (18)
C0205394 (UMLS CUI-1)
COMMENTS
Item
COMMENTS
integer
C0947611 (UMLS CUI [1])
Identification
Item
Identification
text
C0205396 (UMLS CUI [1])