FOR REGISTRY USE ONLY:
Core Insert
I.D.
P
–
–
Date received:
IUBMID:
Log:_______
(Institutional Unique Blood or Marrow
Transplant Identification Number)
1. Date of HSCT for
which this form is
being completed:
Registry (circle one):
2.
Month
Day
PC:_______
IBMTR
ABMTR
Date of report:
Year
Month
Day
Year
on
TEAM:
(Use same date on Graft Insert & Disease Insert for this transplant.)
Series 2002
Reporting Forms
si
Statistical Center
Medical College of Wisconsin
bm
is
P.O. Box 26509, 8701 Watertown Plank Road
Milwaukee, WI 53226
Telephone: 414-456-8325 Fax: 414-456-6530
Email: [email protected]
Day 100 posttransplant:
4.
Date of last actual contact (LCD) with patient
to determine medical status for this report:
(See Qs.vii-xi on pg 40 for help determining date of last contact.)
Day
Year
——(if patient died prior to
Day 100 with no further
infusions, enter date of
death and check here .)
D
at
a
Month
Su
3.
Demographics*
,
fo
r
* If this is a report of a second (or subsequent) transplant check here
complete Disease Insert and go to Q.13
Institutional protocol number (if applicable):
6.
Sex:
7.
Date of birth:
Male
Female
2
N
1
ot
5.
Day
–
Month
Hispanic or Latino
Year
Non Hispanic or non-Latino
Unknown
8.
Ethnicity:
9.
Race: (If patient’s parents are from two separate groups of the following, check both)
2
8
ire
d
1
R
et
22
African Black (both parents
60
Native Pacific Islander, NOS
Caucasian/White
born in Africa)
61
Guamanian
10
White, NOS
21
African American
62
Hawaiian
16
Eastern European
23
Caribbean Black
63
Samoan
11
European, NOS
24
South or Central American Black Native American
13
Mediterranean
82
North Coast of Africa
Asian/Pacific Islander
50
Native American, NOS
83
Middle Eastern
30
Asian, NOS
51
Native Alaskan/Eskimo/Aleut
14
White North American
31
Asian Indian/South Asian
52
American Indian
17
Northern European
36
Chinese
53
North American Indian
18
Western European
32
Filipino
54
South or Central American Indian
81
White Caribbean
34
Japanese
55
Caribbean Indian
15
White South or Central American 35
Korean
Other
38
Vietnamese
Black
88
Unknown
37
Other Southeast Asian
20
Black, NOS
90
Other, 10. specify:_______________
Cust Fig A-59
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 1 of 40
TEAM:
DRAFT
IUBMID:
Disease
11. What was the primary disease for which transplant was performed? (Appropriate Disease Insert must be
submitted with this form. Subsequent transplants: complete same disease insert as for transplant #1.)
12
13
14
15
16
17
19
10
42
43
44
45
46
47
48
40
Complete CML Insert and continue with Q.12 on Pg 6
50
Complete AML Insert and continue with Q.12 on Pg 6
23
24
21
126
27
134
29
20
B-lineage, NOS
T-cell
Null cell (early Pre-B)
cALLa (includes Pre-B)
Mature B-cell (L3)
Large granular lymphocytic leukemia
Aggressive NK-cell leukemia
Adult T-cell lymphoma/leukemia
(HTLV1 associated)
Other ALL, specify:________________________
ALL, NOS
51
55
52
53
54
fo
r
26
22
80
Complete AML Insert and continue with Q.12 on Pg 6
Other leukemia——
et
30
69
R
34
71
72
35
37
73
74
Chronic lymphocytic leukemia (CLL), NOS
CLL, B-cell/small cell lymphocytic lymphoma
CLL, T-cell
Hairy cell leukemia
Prolymphocytic leukemia (PLL)
PLL, B-cell
PLL, T-cell
Complete CLL Insert and continue with Q.12 on Pg 6
39
30
Refractory anemia (RA)
Acquired idiopathic sideroblastic anemia (RARS)
Refractory anemia with excess blasts (RAEB)
Refractory anemia with excess blasts in
transformation (RAEB-t)
Chronic myelomonocytic leukemia (CMMoL)
Other MDS, specify:________________________
MDS, NOS
MPS, NOS
Polycythemia vera
Essential or primary thrombocythemia
Myelofibrosis with myeloid metaplasia
Acute myelofibrosis or myelosclerosis
Other MFS/MPS, specify:
________________________
Complete MDS Insert and continue with Q.12 on Pg 6
–
ire
89
57
63
N
33
Acute undifferentiated leukemia
Biphenotypic, bilineage or hybrid leukemia
Acute mast cell leukemia
Other acute leukemia, specify:
________________________
Acute leukemia, NOS
60
36
d
32
50
59
Other acute leukemia——
31
67
58
Complete ALL Insert and continue with Q.12 on Pg 6
80
Myelodysplastic/myeloproliferative disorders (MDS)
(Please classify all preleukemias)
(If patient has transformed to AML, also complete AML
Insert and indicate AML as the primary disease)—
D
at
a
Acute lymphoblastic leukemia (ALL)——
ot
20
Ph1+; BCR/ABL+
Ph1+; BCR/ABL–
Ph1+; BCR/ABL unknown
Ph1–; BCR/ABL+
Ph1–; BCR/ABL–
Ph1–; BCR/ABL unknown
Ph1 unknown; BCR/ABL+
Ph1 unknown; BCR/ABL–
Ph1 unknown; BCR/ABL unknown
on
11
41
si
38
Transformed from MDS
~also tick AML subtype~
M0, stem cell
M1, myeloblastic
M2, myelocytic
M3, promyelocytic (APML, APL)
M4, myelomonocytic
M5, monocytic
M6, erythroblastic
M7, megakaryoblastic
Other AML, specify:________________________
AML or ANLL, NOS
Chronic myelogenous leukemia (CML)——
is
70
40
bm
Acute myelogenous leukemia (AML or ANLL)——
Su
10
Juvenile CML (JMML or JCML) (no evidence of
Philadelphia chromosome or BCR/ABL)
Complete JMM Insert and continue with Q.12 on Pg 6
170
Multiple myeloma/Plasma cell disorder (PCD)——
171
172
175
179
170
Multiple myeloma, NOS
Plasma cell leukemia
Solitary plasmacytoma
Other PCD, specify:________________________
Plasma cell disorders, NOS
Complete MYE Insert and continue with Q.12 on Pg 6
173
Waldenstrom macroglobulinemia (IgM)
Complete MAC Insert and continue with Q.12 on Pg 6
174
Amyloidosis
Complete AMY Insert and continue with Q.12 on Pg 6
Other leukemia, specify:
________________________
Other leukemia, NOS
Complete AML Insert and continue with Q.12 on Pg 6
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 2 of 40
104
164
115
107
111
135
129
127
137
133
145
146
113
147
130
131
148
139
100
ire
118
Complete LYM Insert and continue with Q.12 on Pg 6
Hodgkin lymphoma——
et
150
151
R
152
153
154
159
150
251
252
Breast cancer, NOS
Breast cancer inflammatory
Breast cancer non-inflammatory
Complete BC Insert and continue with Q.12 on Pg 6
203
230
Lung, small cell
Lung, non-small cell
Lung, NOS
on
202
Complete SCL Insert and continue with Q.12 on Pg 6
208
Kidney & urinary tract
Complete RC Insert and continue with Q.12 on Pg 6
225
210
si
103
250
Germ cell tumor, extragonadal
Testicular
is
102
Solid tumor——
Complete TC Insert and continue with Q.12 on Pg 6
214
Ovarian (epithelial)
Complete OV Insert and continue with Q.12 on Pg 6
216
244
Sarcoma NOS
Fibrosarcoma
Hemangiosarcoma
Leiomyosarcoma
Liposarcoma
Lymphangio sarcoma
Neurogenic sarcoma
Rhabdomyosarcoma
Synovial sarcoma
Soft tissue sarcoma, include Sarcoma PNET
Bone sarcoma (excluding Ewing sarcoma),
include Sarcoma PNET
Ewing sarcoma
246
242
243
247
D
at
a
123
fo
r
122
ot
124
N
121
Precursor B-lymphoblastic lymphoma/leukemia
(precursor B-cell acute lymphoblastic leukemia)
Small lymphoplasmacytic lymphoma
Splenic marginal zone B-cell lymphoma
Extranodal marginal zone B-cell lymphoma
of Mucosal Associated Lymphoid Tissue type
Nodal marginal zone B-cell lymphoma
(+/- monocytoid B-cells)
Follicular, predominantly small cleaved cell
(Grade I follicle center lymphoma)
Follicular, mixed, small cleaved and large cell
(Grade II follicle center lymphoma)
Follicular, predominantly large cell
(Grade III follicle center lymphoma)
Follicular (unknown grade)
Mantle cell
Diffuse large B-cell lymphoma, including Primary
mediastinal (thymic) large B-cell lymphoma (large
B-cell lymphoma subtype)
Burkitt lymphoma/Burkitt cell leukemia
High-grade B-cell lymphoma, Burkitt-like
(provisional entity)
Other B-cell lymphoma, specify:
________________________
Precursor T-lymphoblastic lymphoma/leukemia
(precursor T-cell acute lymphoblastic leukemia)
Extranodal NK/T-cell lymphoma, nasal type
Enteropathy-type T-cell lymphoma
Hepatosplenic gamma-delta T-cell lymphoma
Subcutaneous panniculitis-like T-cell lymphoma
Mycosis fungoides/Sezary syndrome
Anaplastic large-cell lymphoma, T/null cell,
primary cutaneous type
Peripheral T-cell lymphoma, NOS
Angioimmunoblastic T-cell lymphoma
Anaplastic large-cell lymphoma, T/null cell,
primary systemic type
Other T-cell/NK-cell lymphoma, specify:
________________________
Non-Hodgkin lymphoma, NOS
Primary CNS lymphoma
–
109
200
bm
Non-Hodgkin lymphoma——
d
100
DRAFT
IUBMID:
Su
TEAM:
Lymphocyte-rich
Nodular sclerosis
Mixed cellularity
Lymphocyte depleted
Other Hodgkin lymphoma, specify:____________
Hodgkin lymphoma, NOS
Complete LYM Insert and continue with Q.12 on Pg 6
248
232
245
217
218
224
Complete SAR Insert and continue with Q.12 on Pg 6
220
226
Central nervous system tumor, include CNS PNET
Medulloblastoma
Complete CNS Insert and continue with Q.12 on Pg 6
222
Neuroblastoma
Complete NEU Insert and continue with Q.12 on Pg 6
201
204
228
229
206
207
209
211
212
213
215
219
221
223
231
269
200
Head & neck
Mediastinal neoplasm, specify:________________
Colorectal
Gastric
Pancreatic
Hepatobiliary
Prostate
External genitalia
Cervical
Uterine
Vaginal
Melanoma
Wilm tumor
Retinoblastoma
Thymoma
Other solid tumor, specify:___________________
Solid tumor, NOS
Continue with Q.12 on Pg 6
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 3 of 40
302
303
304
306
309
56
Idiopathic
Secondary to hepatitis
Secondary to toxin/other drug
Amegakaryocytosis (not congenital)
Acquired Pure Red Cell Aplasia
Other acquired cytopenic syndrome,
specify:________________________
Paroxysmal nocturnal hemogloblinuria (PNH)
Disorders of the immune system—
401
402
403
404
405
406
410
Complete APL Insert and continue with Q.12 on Pg 6
419
451
452
454
455
457
Inherited abnormalities of erythrocyte differentiation
or function (If patient has developed leukemia, also complete Insert for appropriate leukemia diagnosis)——
305
312
458
459
Schwachmann-Diamond
Diamond-Blackfan anemia (pure red cell aplasia)
460
Su
310
Complete APL Insert and continue with Q.12 on Pg 6
311
461
462
Fanconi anemia
464
356
D
at
a
Complete FAN Insert and continue with Q.12 on Pg 6
355
470
Sickle Thalassemia
Sickle cell disease
474
479
Complete SCA Insert and continue with Q.12 on Pg 6
359
310
400
Thalassemia, NOS
Other hemoglobinopathy,
specify:_____________________________
Inherited abnormalities of erythrocyte differentiation
or function, NOS
Complete ID Insert and continue with Q.12 on Pg 6
456
fo
r
350
453
Wiskott Aldrich syndrome
Complete WAS Insert and continue with Q.12 on Pg 6
ot
Other constitutional anemia,
specify:_____________________________
500
502
d
509
500
Amegakaryocytosis/congenital thrombocytopenia
Glanzmann thrombasthenia
Other inherited abnormalities of platelets,
specify:__________________________
Inherited abnormalities of platelets, NOS
Continue with Q.12 on Pg 6
ire
et
Inherited abnormalities of platelets——
501
–
N
Complete APL Insert and continue with Q.12 on Pg 6
R
Chediak-Higashi syndrome
Complete CHS Insert and continue with Q.12 on Pg 6
Continue with Q.12 on Pg 6
319
ADA deficiency
severe combined immunodeficiency (SCID)
Absence of T and B cells SCID
Absence of T, normal B cell SCID
Omenn syndrome
Reticular dysgenesis
Bare lymphocyte syndrome
SCID, NOS
SCID other, specify:________________________
Ataxia telangiectasia
HIV infection
DiGeorge anomaly
Chronic granulomatous disease
Common variable immunodeficiency
X-linked lymphoproliferative syndrome
Leukocyte adhesion deficiencies, incl. GP180,
CD-18, LFA and WBC adhesion deficiencies
Kostmann agranulocytosis
(congenital neutropenia)
Neutrophil actin deficiency
Cartilage-hair hypoplasia
CD40 ligand deficiency
Combined immunodeficiency disease (CID), NOS
CID other, specify:_________________________
Other immunodeficiencies, specify:____________
Immune Deficiencies (ID), NOS
on
301
400
si
Severe aplastic anemia——
is
300
DRAFT
IUBMID:
bm
TEAM:
900
Other (Fax Pathology Report to 414-456-6530 before
using this designation or attach Pathology Report from
diagnosis and check here .)——
Specify:_______________________________________
Continue with Q.12 on Pg 6
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 4 of 40
Inherited disorders of metabolism——
521
600
Osteopetrosis (malignant infantile osteopetrosis)
Complete OST Insert and continue with Q.12 on Pg 6
Complete SLE Insert and continue with Q.12 on Pg 6
is
632
Su
636
637
638
639
Familial erythrohemophagocytic
lymphohistiocytosis (FELH)
Langerhans cell histiocytosis (Histiocytosis-X)
Complete LCH Insert and continue with Q.12 on Pg 6
573
574
579
570
Hemophagocytosis (reactive or viral associated)
Malignant histiocytosis
Other histiocytic disorder, specify:
_______________________________
Histiocytic disorder, NOS
Continue with Q.12 on Pg 6
611
D
at
a
fo
r
ot
N
–
d
ire
Other inherited metabolic disorders, specify:
_______________________________
Inherital disorders of metabolisms, NOS
et
R
572
Classical
Microscopic
Churg-Strauss
Giant cell arteritis
Takayasu
Behcet’s syndrome
Overlap necrotizing arteritis
Other vasculitis, specify:____________________
635
Histiocytic disorders——
571
634
631
Complete MUC Insert and continue with Q.12 on Pg 6
570
614
Vasculitis
610
Wegener granulomatosis
609
Polyarteritis nodosa
Polysaccharide hydrolase abnormalities
561
Aspartyl glucosaminuria
562
Fucosidosis
563
Mannosidosis
569
Other polysaccharide hydrolase abnorm., specify:
_______________________________
560
Polysaccharide hydrolase abnorm., NOS
520
606
si
Mucopolysaccharidoses
531
Hurler syndrome (IH)
532
Scheie syndrome (IS)
533
Hunter syndrome (II)
534
Sanfilippo (III)
535
Morquio (IV)
536
Maroteaux-Lamy (VI)
537
ß-glucuronidase dificiency (VII)
538
Mucopolysaccharidosis (V)
539
Other mucopolysaccharidosis, specify:
_______________________________
530
Mucopolysaccharidosis, NOS
529
Sjögren syndrome
Polymyositis-dermatomyositis
Antiphospholipid syndrome
Other connective tissue disease,
specify:____________________
608
Lesch-Nyhan (HGPRT deficiency)
Neuronal ceroid lipofuscinosis (Batten disease)
Mucolipidoses
541
Gaucher disease
545
Neimann-Pick disease
546
I-cell disease
547
Wolman disease
548
Glucose storage disease
549
Lysosomal storage disease
559
Other mucolipidoses, specify:
_______________________________
540
Mucolipidoses, NOS
Systemic lupus erythematosis (SLE)
605
Complete LDS Insert and continue with Q.12 on Pg 6
523
Connective Tissue Disease
607
Systemic Sclerosis (Scleroderma)
Complete SSC Insert and continue with Q.12 on Pg 6
Leukodystrophies
542
Metachromatic leukodystrophy (MLD)
543
Adrenoleukodystrophy (ALD)
544
Krabbe disease (globoid leukodystrophy)
522
Autoimmune diseases——
on
520
DRAFT
IUBMID:
bm
TEAM:
Arthritis
603
Rheumatoid arthritis
Complete RA Insert and continue with Q.12 on Pg 6
604
640
641
642
643
Psoriatic arthritis/psoriasis
JIA: Systemic (Stills Disease)
JIA: Oligoarticular
JIA: Polyarticular
JIA: Other, specify:____________________
Complete JRA Insert and continue with Q.12 on Pg 6
633
Other arthritis, specify:____________________
Complete JRA Insert and continue with Q.12 on Pg 6
Multiple Sclerosis
602
Multiple sclerosis
Complete MS Insert and continue with Q.12 on Pg 6
Other Neurological Autoimmune Disease
601
Myasthenia gravis
644
Other autoimmune neurological disorder,
specify:____________________
Hematological Autoimmune Disease
645
Idiopathic thrombocytopenic purpura (ITP)
646
Hemolytic anemia
647
Evan syndrome
648
Other autoimmune cytopenia,
specify:____________________
Bowel Disease
649
Crohn’s disease
650
Ulcerative colitis
651
Other autoimmune bowel disorder,
specify:____________________
629
Other autoimmune disease,
specify:____________________
Continue with Q.12 on Pg 6
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 5 of 40
RAFT
D
Clinical Status of Patient Prior to Conditioning*
TEAM:
IUBMID:
* Complete only if a disease-specific insert is not required
12. Allografts only: Patient's blood type:
1
A Rh positive
2
B Rh positive
3
AB Rh positive
4
O Rh positive
5
A Rh negative
6
B Rh negative
7
AB Rh negative
8
O Rh negative
9
A Rh unknown
10
B Rh unknown
11
AB Rh unknown
12
O Rh unknown
88
Unknown
is
si
Bone Marrow
Donor Cellular Infusion
Epstein-Barr Virus
Hematopoietic Stem Cell Transplant
Intrathecal
Last Contact Date
Not Otherwise Specified
Peripheral Blood
Polymerase Chain Reaction
Posttransplant Lymphoproliferative Disorder
Video Assisted Thorascopic Surgery
Veno-occlusive Disease
bm
=
=
=
=
=
=
=
=
=
=
=
=
Su
BM
DCI
EBV
HSCT
IT
LCD
NOS
PB
PCR
PTLD
VATS
VOD
on
Abbreviations Used in This Report Form
D
at
a
13. Functional status of patient prior to conditioning:
If patient is 16 years of age or older, complete the Karnofsky Scale.
If patient is younger than 16 years of age, complete the Lansky Scale.
Rate activity of patient immediately prior to initiation of conditioning.
Karnofsky Scale (age ≥16 yrs)
fo
r
Select the phrase in the Karnofsky Scale which
best describes the activity status of the patient
ot
Able to carry on normal activity; no special care is needed.
100
Normal; no complaints; no evidence of disease
90
Able to carry on normal activity
80
Normal activity with effort
ire
d
–
N
Unable to work; able to live at home, care for most personal needs; a varying amount of assistance is needed.
70
Cares for self; unable to carry on normal activity or
to do active work
60
Requires occasional assistance but is able to care
for most needs
50
Requires considerable assistance and frequent
medical care
R
et
Unable to care for self; requires equivalent of institutional
or hospital care; disease may be progressing rapidly.
40
Disabled; requires special care and assistance
30
Severely disabled; hospitalization indicated, although
death not imminent
20
Very sick; hospitalization necessary
10
Moribund; fatal process progressing rapidly
Lansky Scale (age <16 yrs)
Select the phrase in the Lansky Play-Performance Scale
which best describes the activity status of the patient
Normal range.
100
Fully active
90
Minor restruction in physically strenuous play
80
Restricted in strenuous play, tires more easily,
otherwise active
Mild to moderate restriction.
70
Both greater restrictions of, and less time spent in,
active play
60
Ambulatory up to 50% of time, limited active play with
assistance/supervision
50
Considerable assistance required for any active play;
fully able to engage in quiet play
Moderate to severe restriction.
40
Able to initiate quiet activities
30
Needs considerable assistance for quiet activity
20
Limited to very passive activity initiated by others
(i.e., TV)
10
Completely disabled, not even passive play
Stnd Fig A-54
If this is a report of a second (or subsequent) transplant, skip Q.14 and continue with Q.59
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 6 of 40
TEAM:
DRAFT
IUBMID:
14. Was there clinically significant coexisting disease or organ impairment anytime prior to conditioning?
1
Yes——— Specify diagnoses (check all that apply):
0
No
0
8
Significant hemorrhage (e.g. CNS or GI)
16. Specify site(s): _____________________________________________
17.
1
0
8
History of other malignancy
18. Specify: ___________________________________________________
19.
20.
21.
22.
23.
24.
1
0
8
1
0
8
1
0
8
1
0
8
1
0
8
1
0
8
26.
27.
28.
1
0
8
1
0
8
1
0
8
30.
31.
32.
1
0
8
1
0
8
1
0
8
0
8
1
0
8
1
0
8
38.
39.
40.
1
0
8
1
0
8
1
0
8
42.
44.
46.
1
0
8
1
0
8
1
0
8
48.
49.
50.
51.
52.
1
0
8
1
0
8
1
0
8
1
0
8
1
0
8
d
ire
et
R
si
is
bm
D
at
a
Su
Cardiovascular
Coronary artery disease
Hypertension
Other cardiac disease 29. Specify: ________________________________
Chromosomal
Down syndrome
Fanconi anemia
Other chromosomal disorders
33 . Specify: __________________________________________________
fo
r
1
Autoimmune disease
Multiple sclerosis (MS)
Polyarteritis nodosa
Psoriasis
Rheumatoid arthritis (RA)
Systemic lupus erythematosis (SLE)
Other autoimmune disease
25. Specify: ___________________________________________________
CNS/Psychiatric
Depression
Seizure disorder
Other 37. Specify: _____________________________________________
ot
34.
35.
36.
on
1
N
Unknown
–
8
Yes No Unknown
15.
54.
55.
1
0
8
1
0
8
57.
1
0
8
Endocrine
Diabetes mellitus
Thyroid disease
Other endocrine disease
41. Specify: ___________________________________________________
Gastriontestinal disease 43. Specify: ______________________________
Genitourinary disease 45. Specify: ________________________________
Hematologic disease 47. Specify: ________________________________
Liver disease
Drug toxicity
Hepatitis A virus
Hepatitis B virus
Hepatitis C virus
Other liver disease 53. Specify: __________________________________
Pulmonary
Asthma
Other pulmonary disease
56. Specify: ___________________________________________________
Other 58. Specify: _____________________________________________
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 7 of 40
AFT
R
D
Organ Function Values Just Prior to Conditioning (provide last lab values recorded prior to
TEAM:
IUBMID:
the first dose of the conditioning regimen) See Q.107 first
Specify Units
59. AST (SGOT):
.
1
61.
.
Upper limit of normal
62. Total serum bilirubin:
.
1
64.
.
Upper limit of normal
65. LDH:
.
1
67.
.
Upper limit of normal
68. Serum creatinine:
.
3
µkat/L
U/L
µmol/L 63.
µkat/L
2
mg/dL 2
mmol/L
on
2
7
66.
µmol/L 69.
Su
Hematologic Findings Just Prior to Conditioning
Date tested:
Month Day
Specify Units
Not
Tested
7
si
mg/dL
60.
is
2
Date tested:
Day
Year
bm
1
U/L
Month
Year
7
7
Not
Tested
70.
71. WBC:
.
1
72. Neutrophils:
%
73. Lymphocytes:
%
.
1
x 109/L (x103/mm3)
g/dl
fo
r
74. Hemoglobin:
D
at
a
CBC results:
g/L
3
8
mmol/L
1
Transfused
8
RBC <30 days from Q.70
Transfused
8
RBC <30 days from Q.70
x109/L (x103/mm3)
x106/L
Transfused
8
platelets <7 days from Q.70
2
N
76. Platelets:
8
8
%
ot
75. Hematocrit:
2
x 106/L
2
77. Does patient smoke cigarettes, or have a history of smoking cigarettes?
8
Yes No Unknown
78.
79.
–
0
Yes———
No
Unknown
d
1
ire
80.
81.
1
0
8
1
0
8
Smoked within past year
Smoked prior to but not during past year
Average number of packs per day:
.
Number of years:
8
Unknown
8
Unknown
R
et
82. Did patient have a history of clinically significant fungal infection (documented or suspected)
at any time prior to conditioning?
1
Yes——— Specify:
83. Date of onset:
0
No
Month
Day
Year
85. If 209, 219, 259, specify fungus:
8
Unknown 84. Organism (see codes
_____________________________
F
200-260, 503 on pg 28):
86. Site(s) (see codes
on pg 30):
087.
88. Was there more than one documented or suspected fungal infection anytime prior to
conditioning?
1
Yes———
Copy Qs.83-87 and complete for each fungal infection
0
No
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 8 of 40
TEAM:
DRAFT
IUBMID:
Tests for Serological Evidence of Prior Viral Exposure/Infection
Recipient:
Negative
Inconclusive
Not Tested
1
0
3
7
90. Cytomegalovirus antibody
1
0
3
7
91. Epstein-Barr antibody
1
0
3
7
92. Hepatitis B surface antibody
1
0
3
7
93. Hepatitis B core antibody
1
0
3
7
94. Hepatitis B surface antigen
1
0
3
95. Hepatitis C antibody
1
0
3
96. Hepatitis A antibody
1
0
3
97. Human immunodeficiency virus (HIV) antibody
1
0
7
is
7
bm
7
3
Not able to release information for HIV
7
Su
6
si
89. HTLV1 antibody
on
Positive
98. Was high-dose therapy (conditioning) given?
Yes———
0
No
99. Protocol requires (check only one):
0
All agents given as outpatient
2
Some, but not all agents given as inpatient
3
All agents given as inpatient
ot
fo
r
1
D
at
a
Pretransplant Antitumor and Immunosuppressive Conditioning
(Pretransplant conditioning)
Yes———
0
No
Yes No Unknown
101.
102.
103.
104.
105.
1
0
8
1
0
8
1
0
8
1
0
8
1
0
8
Conventional private room
Laminar air flow room
HEPA filtered room
Positive pressure
Other
106.
Specify: ___________________________
et
ire
d
–
1
N
100. Was patient treated in an isolation room during the peri-transplant period?
R
107. Date pretransplant conditioning (radiation or drugs) was begun:
(Use earliest date from Qs.113,127,134 radiation or
Month
Qs.163-289 chemotherapy dates)
Day
Year
108. Height at initiation of pretransplant conditioning
cm
or
inches
109. Actual weight at initiation of pretransplant conditioning:
kg
or
pounds
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 9 of 40
TEAM:
IUBMID:
110. Was irradiation performed as part of the pretransplant conditioning regimen?
DRAFT
1
Yes
0
No—— Go to Q.139
What was the radiation field?
cGy
(Q.115 x Q.117)
113.
Starting date:
114.
Was radiation fractionated?
1
Yes———
115. Dose per fraction:
0
No
8
Unknown 116. Number of days:
117.
118.
Year
on
Day
cGy
si
Month
——(includes “rest” days)
Total number of fractions:
Was shielding used?
Yes——— Specify:
Yes No
0
No
119.
1
0
Lungs
8
Unknown
1
0
Eyes
120.
1
0
Liver
121.
1
0
Kidney
122.
1
0
Other
123.
D
at
a
Su
1
is
Total Body Radiation
Yes———
112. Total dose:
0
No
1
bm
111.
124.
Total lymphoid or nodal regions
1
Yes———
126. Total dose:
0
No
127.
fo
r
125.
cGy
Specify: ______________________
(Q.129 x Q.131)
Starting date:
Day
Year
ot
Month
Was radiation fractionated?
1
Yes———
129. Dose per fraction:
0
No
8
Unknown 130. Number of days:
131. Total number of fractions:
Thoraco-abdominal region
Yes———
133. Total dose:
0
No
ire
132.
et
1
R
cGy
——(includes “rest” days)
d
–
N
128.
cGy
(Q.136 x Q.138)
134.
Starting date:
135.
Was radiation fractionated?
1
Yes———
136. Dose per fraction:
0
No
8
Unknown 137. Number of days:
Month
138.
Day
Year
cGy
——(includes “rest” days)
Total number of fractions:
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 10 of 40
TEAM:
DRAFT
IUBMID:
139. Was (additional) radiation given to other sites within 14 days of preparative regimen?
0
No
Yes No
Total Dose
Date Started: (Month
140.
CNS
1
0
141.
cGy
142.
143.
Gonadal
1
0
144.
cGy
145.
146.
Splenic
1
0
147.
cGy
148.
149.
Radiation to site of residual tumor
1
0
150.
cGy
151.
152.
153.
Specify site:__________________________________
Other
154.
0
cGy
155.
Specify site:__________________________________
Year)
is
156.
1
Day
on
Yes———
si
1
1
Yes
0
No
158. Were drugs given for pretransplant conditioning?
160.
1
Horse
0
162.
Rabbit
2
Date started:
(month day
m g 163.
3
year)
Unk
8
Other, 161. Specify:_________________
Anthracycline
1
0
165. Daunomycin
1
0
166.
m g 167.
8
168. Doxorubicin
(Adriamycin)
1
0
169.
m g 170.
8
171. Idarubicin
1
0
172.
m g 173.
8
174. Rubidazone
1
0
175.
m g 176.
8
177. Other anthracycline,
1
0
179.
m g 180.
8
182.
m g 183.
8
Oral & IV 186.
m g 187.
8
ot
164.
Source:
1
No—— Go to Q.290
Su
ALG, ALS, ATG, ATS
0
Total dose pre-marrow infusion
(not daily dose)
fo
r
159.
Yes No
Yes
D
at
a
Drug given
1
bm
157. Was the recipient transplanted on a protocol with a conditioning regimen intended to be non-myeloablative (NST)?
N
223. 178. Specify:______________________________
Bleomycin
184.
Busulfan (myleran)
–
181.
IV1
Carboplatin
ire
188.
Oral1
d
185.1
1
0
1
0
1
0
189.
m g 190.
8
Cisplatin
1
0
192.
m g 193.
8
194.
Cladribine
1
0
195.
m g 196.
8
1
0
IV 200.
m g 201.
8
et
191.
R
197.
Corticosteroids (excluding
antinausea medication)
198. Methylprednisolone 1
249. (Solumedrol)
199.1 Oral1
0
202. Prednisone
1
0
203.
m g 204.
8
205. Dexamethasone
1
0
206.
m g 207.
8
208. Other corticosteroids,
1
0
210.
m g 211.
8
223. 209. Specify:______________________________
Continued on next page
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 11 of 40
TEAM:
DRAFT
IUBMID:
Continued from previous page
Yes No
Drug given
Total dose pre-marrow infusion
(not daily dose)
Date started:
(month day
year)
Unk
1
0
213.
m g 214.
8
215. Cytarabine (Ara-C)
1
0
216.
m g 217.
8
218. Etoposide (VP-16)
1
0
219.
m g 220.
8
221. Fludarabine
1
0
222.
m g 223.
224. Ifosfamide
1
0
225.
m g 226.
227. Intrathecal chemotherapy
1
0
228. IT Cytarabine
1
0
229.
m g 230.
231. IT Methotrexate
1
0
232.
m g 233.
234. Other IT,
1
0
236.
m g 237.
0
241. Melphalan (L-PAM)
1
0
242.1
Oral1
1
0
248. Monoclonal antibody
1
0
1
0
249. Radio labeled Mab
8
bm
is
si
8
m g 240.
8
8
8
8
IV 243.
m g 244.
8
246.
m g 247.
8
251.
8
fo
r
245. Mitoxantrone
239.
D
at
a
1
Su
223. 235. Specify:______________________________
238. Gleevec (STI571,
imatinib mesylate)
on
212. Cyclophosphamide
m g 252.
0
254.
m g 255.
8
0
257.
m g 258.
8
1
0
260.
m g 261.
8
1
0
264.
m g 265.
8
223. 250. Specify:______________________________
1
256. Rituxan (Anti CD20)
1
259. Mylotarg
(Gemtuzumab)
N
–
262. Other Mab,
ot
253. Campath
223. 263. Specify:______________________________
d
266. Nitrosourea
0
267. BCNU
1
0
268.
m g 269.
8
270. CCNU
1
0
271.
m g 272.
8
1
0
275.
m g 276.
8
et
ire
1
R
273. Other nitrosourea,
223. 274. Specify:______________________________
277. Paclitaxel (Taxol)
1
0
278.
m g 279.
8
280. Teniposide (VM26)
1
0
281.
m g 282.
8
283. Thiotepa
1
0
284.
m g 285.
8
286. Other,
1
0
288.
m g 289.
8
287. Specify:__________________________________
End of Pretransplant Data
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 12 of 40
TEAM:
290.
DRAFT
IUBMID:
Was this the first HSCT for this recipient?
Yes——— 291. Is a second HSCT planned as part of treatment protocol?
No
1
0
1
Yes
No
0
Go to Q.304
Previous Transplants
292. Number of previous HSCT/DCI patient has had:
Date of most recent previous HSCT/DCI:
Month
Day
on
293.
Year
si
DCI Calculation Timeline
is
1st DCI
0
Weeks
4
8
This DCI would be reported
on a separate DCI Report
Form.
D
at
a
294.
12
Su
>14 days
These 3 DCI would be reported
on one DCI Report Form.
bm
HSCT
Some patients have cellular infusions on more than one day. A single DCI form should be completed for all infusions given
within a 4-week period starting from the date of the first DCI >14 days following a HSCT or >28 days post prior DCI.
Separate DCI Report Forms should be completed for subsequent infusion(s) given after this 4-week period. For example:
16
These 2 DCI would be reported
together on a separate DCI
Report Form.
Stnd Fig A-53
Was previous transplant performed at a different institution?
1
Yes—————– 295. Specify:
0
No
Name: _____________________________________________________
fo
r
City: ____________________________________ State: ______________
Country: ____________________________________________________
Indicate graft type of previous transplant (check only one):
1
Autologous
297. Was this transplant reported to the ABMTR?
1
Yes
0
No
8
Unknown
2
Allogeneic,
unrelated
298. Was same donor as current?
donor
1
Yes
0
No
Syngeneic or
allogeneic,
related donor
299.
Was this transplant reported to the IBMTR?
1
Yes
0
No
8
Unknown
ire
d
3
–
N
ot
296.
Reason for re-transplant (check only one):
91 No engraftment
92 Partial engraftment
93 Graft failure/rejection————301. Date of rejection/failure:
Month
Day
Year
94 Persistent malignancy
95 Recurrent malignancy———————302. Date of relapse:
96 Planned second HSCT/DCI, per protocol
98 Secondary malignancy (including PTLD, EBV Lymphoma)
Continue with disease insert for
(specify disease from lists on pgs 2-5):
disease of first transplant
99 Stable, mixed chimerism
10 Declining chimerism
90 Other, 303. specify:____________________________________
R
et
300.
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 13 of 40
TEAM:
304.
DRAFT
IUBMID:
What type of graft did patient receive (or was planned) for the current transplant (check only one)?
From where were stem cells obtained?
2
Yes No
Autologous
305.
1
0
Bone marrow
If yes, complete INSERT AUTOBM
306.
1
0
Blood
If yes, complete INSERT AUTOPB
on
1
From where were stem cells obtained?
Allogeneic
Yes No
Bone marrow
If yes, complete Inserts ALLOBM
308.
1
0
Peripheral blood
If yes, complete Inserts ALLOPB
309.
1
0
Umbilical cord blood
If yes, complete Inserts ALLOCB
310.
1
0
Fetal tissue
If yes, complete Inserts ALLOBM
311.
1
0
Other,
If yes, complete Inserts ALLOBM
si
0
is
Syngeneic
1
bm
3
307.
Donor Cellular Infusion
0
Did patient receive graft?
1
Yes
0
No———–
315.
If yes, complete Day 100 DCI Report Form,
not this Report Form
Reason (check only one):
1
Patient died between first dose or conditioning and HSCT
2
Transplant cancelled, but patient was alive, 316. specify reason: _______________
__________________________________________________________________
R
et
ire
d
–
N
ot
fo
r
314.
1
D
at
a
313.
Su
312. Specify: _______________________________________________
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 14 of 40
TEAM:
IUBMID:
Post-HSCT Information
317.
DRAFT
Did patient receive a subsequent HSCT after the HSCT for which this Report Form is being completed?
1
Yes———
0
No
8
Unknown
event = The reason for subsequent allo HSCT (planned, to treat relapse, for graft failure, etc.)
LCD = last contact date, also represents cut-off date for data included in the Report Form
Cond = Conditioning
on
>14 Days but <100 days between HSCT & Subsequent HSCT
is
si
Answers to Pgs 17-36 should reflect clinical status up to start of conditioning for HSCT minus 1 day.
Be sure to answer Qs.753-759 on pg 34 of this Report Form.
bm
Day 100
Report Form 2/+
fo
r
D
at
a
Su
1234567890123456789012345678901
1234567890123456789012345678901
1234567890123456789012345678901
Current HSCT Day 100
1234567890123456789012345678901
1234567890123456789012345678901
Report Form
1234567890123456789012345678901
The new R.F. starts with patient status
1234567890123456789012345678901
LCD for this HSCT is
evaluation just prior to conditioning
1234567890123456789012345678901
1234567890123456789012345678901
HSCT #2 conditioning
for subsequent HSCT
1234567890123456789012345678901
start date minus 1 day
1234567890123456789012345678901
1234567890123456789012345678901
100 Days
1234567890123456789012345678901
>14 Days <100
)
+
d T
t”
/+
nd 2/
n
2
o n SC
o
0
C H
C TX
ve
10 TX
0
y
s
“e
i
Da rom
ay
Th
D
(f
>100 days between HSCT & Subsequent HSCT
ot
Complete Follow-up Report Form to cover events occurring >100 days after HSCT up to
conditioning for HSCT minus 1 day.
Be sure to answer Qs.753-759 on pg 34 of this Report Form.
R
et
ire
d
–
N
Day 100
Report Form 2/+
Follow
Up
12345678901234567890123456789012 R.F.
12345678901234567890123456789012
12345678901234567890123456789012
Current HSCT Day 100
12345678901234567890123456789012
12345678901234567890123456789012
12345678901234567890123456789012
Report Form
12345678901234567890123456789012
TX
+
2/
0
12345678901234567890123456789012
12345678901234567890123456789012
nd ay
12345678901234567890123456789012
o
D
12345678901234567890123456789012
C
12345678901234567890123456789012
12345678901234567890123456789012
100 Days
100 Days
12345678901234567890123456789012
.
0 t”
)
d
T
nd ay
/+
10 e n
2
o n SC
o
0
d
C H
ay e v
10 TX
=C s 1
D
“
y
s
D
=
i
u
D
Da rom
LC in
Th
m
LC
(f
Stnd Fig A-60
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 15 of 40
TEAM:
318.
DRAFT
IUBMID:
Has patient received (from the original donor) a subsequent DCI that requires reporting on a separate DCI form
based on the DCI Calculation Timeline (see pg 13)?
1
Yes———
0
No
8
Unknown
event = The reason for subsequent DCI (planned, to treat relapse, etc.)
LCD = last contact date, also represents cut-off date for data included in the Report Form
>14 Days but <100 days between HSCT and DCI
si
on
Answers to Pgs 17-36 should reflect clinical status up to subsequent DCI minus 1 day.
Be sure to answer Qs.760-763 on pg 35 of this Report Form.
is
DCI Day 100
Report Form 2/+
Su
bm
1234567890123456789012345678901
1234567890123456789012345678901
1234567890123456789012345678901
+
Current HSCT Day 100
1234567890123456789012345678901
2/
1234567890123456789012345678901
1234567890123456789012345678901
Report
Form
X
1234567890123456789012345678901
1234567890123456789012345678901
IT
1234567890123456789012345678901
1234567890123456789012345678901 DC
1234567890123456789012345678901
1234567890123456789012345678901
1234567890123456789012345678901
>14 Days <100
1234567890123456789012345678901
y
”
d T
I
C da
nt
o n SC
D
e
C H
= 1
v
D us
s
“e
i
C
L in
Th
m
100 Days
D
at
a
y
Da
0
10
fo
r
>100 days between HSCT and DCI
ot
Complete Follow-up Report Form to cover events >100 days after current HSCT and up to first
infusion of subsequent DCI minus 1 day.
Be sure to answer Qs.760-763 on pg 35 of this Report Form.
N
DCI Day 100
Report Form 2/+
R
et
ire
d
–
Follow
Up
R.F.
12345678901234567890123456789012
12345678901234567890123456789012
12345678901234567890123456789012
Current HSCT Day 100
12345678901234567890123456789012
12345678901234567890123456789012
Report Form
12345678901234567890123456789012
12345678901234567890123456789012
12345678901234567890123456789012
12345678901234567890123456789012
12345678901234567890123456789012
12345678901234567890123456789012
12345678901234567890123456789012
12345678901234567890123456789012
100 Days
d T
o n SC
C H
is
Th
X
IT
C
D
0 t ” CI ay
d
10 e n
y v
=D s 1
a
e
D
D “
u
LC in
m
+
2/
100 Days
+)
0 2/
0
1 TX
y
a
D rom
(f
Stnd Fig A-61
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 16 of 40
TEAM:
Indicate survival status at last contact date (approximately Day 100 if no subsequent HSCT/DCI) for this Report
Form:
0
Alive——– 320.
1
Deceased – Recipient did not have a subsequent reportable HSCT/DCI
(Answers on Pgs 17-36 should reflect clinical status up to date of death)
on
Did recipient have a subsequent reportable HSCT/DCI before Day 100?
1
Yes, answers on pgs 17-35 should reflect clinical status up to 1 day prior to
conditioning/DCI
0
No, answers on pgs 17-33 should reflect clinical status on day of actual contact
for this report, at least 100 days post-DCI
is
si
319.
DRAFT
IUBMID:
321.
bm
Hematopoietic Reconstitution Posttransplant
Has patient received hematopoietic growth factors or cytokines post conditioning?
Su
Specify agents given:
Yes No
(month
1st Course this HSCT:
G-CSF
323.
1
1
Neupogen
2
1
329.
Erythropoietin
1
2
325.
0
327.
328.
0
331.
332.
Darbepoietin
1
0
334.
335.
1
0
337.
338.
Interleukin-2 (IL-2)
1
0
340.
341.
Interleukin-7 (IL-7)
1
0
343.
344.
Interferon-alpha
336.
Interferon-gamma
339.
342.
–
N
333.
345.
KGF (Kepivance)
1
0
346.
347.
348.
d
2
Indication Code*
(see below)
ot
Epogen
No— Go to Q.362
324.
fo
r
GM-CSF
1
Date Started
day
year)
0
Neulasta
326.
330.
Yes
0
D
at
a
322.
1
Stem Cell Factor (SCF)
1
0
349.
350.
Thrombopoietin
1
0
352.
353.
Blinded growth factor trial,
1
0
356.
357.
ire
351.
354.
et
355.
Other
R
358.
359.
0
1
2
3
=
=
=
=
Specify agent(s) being studied: ______________________________________________
1
0
360.
361.
Specify: _________________________________________________________________
*Coding for Indication of Therapy
Planned therapy per protocol to promote engraftment
4 = Intervention for delay/delcline in red blood cell counts
Intervention for delay/decline in Absolute Neutrophil Count (ANC)
5 = Anti-leukemic or tumor agent to prevent relapse
Intervention for delay/decline in platelets
6 = Anti-leukemic or tumor agent to treat relapse
Intervention for delay/decline in both ANC and platelets
7 = Other indication
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 17 of 40
TEAM:
IUBMID:
Granulopoiesis*
DRAFT
* All dates should reflect the first of 3 consecutive lab results on different days
Is/Was there evidence of hematopoietic recovery following the intial hematopoietic cell infusion?
(check only one)
365.
No,
ANC ≥500/mm3
was not achieved
and there was no
evidence of re366.
current disease in
the bone marrow 367.
Year
Date of decline in ANC to <500/mm3
for greater than 3 lab values* (first of
3 lab values* that ANC remained <500):
CBC on first day of decline:
WBC:
Neutrophils:
is
Month
Day
.
x109/L
x106/L
%
Did patient recover and maintain ANC ≥500/mm3 following
the decline without a subsequent allo transplant/infusion?
1
Yes—— 369. Date of ANC recovery:
0
No
Month
ot
Year
8
Day
Date unknown
Year
370.
WBC:
.
371.
Neutrophils:
%
x109/L
x106/L
N
No,
ANC ≥500/mm3
was not achieved
and there was
documented
persistent disease
in the bone
marrow
Date ANC ≥500/mm3
(first of 3 consecutive lab values*):
fo
r
368.
4
Day
Yes, ANC ≥500/mm3 for 3 consecutive lab values* with subsequent decline in ANC to
<500/mm3 for greater than 3 consecutive lab values*
364.
3
Month
bm
2
Date ANC ≥500/mm3
(first of 3 consecutive lab values*):
si
363.
on
Yes, ANC ≥500/mm3 achieved and sustained for 3 consecutive lab values* with no
subsequent decline
Su
1
D
at
a
362.
–
ANC never dropped
below 500/mm3
at anytime post
conditioning
R
et
ire
d
7
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 18 of 40
TEAM:
DRAFT
IUBMID:
Megakaryopoiesis*
* The following questions relate to initial platelet recovery. All dates should reflect no transfusions in previous 7 days,
and the first of 3 consecutive laboratory results tested on different days.
Yes————————————————— 373.
0
No
7
Never dropped below 20
8
Unknown
is
si
Go
to
Q.376
Date platelets ≥20 x 109/L (first of 3 consecutive labs,
no platelet transfusions 7 days prior):
8
Date estimated
8
Date
unknown
Month
Day
Year
on
1
Was a platelet count of ≥50 x 109/L achieved?
Yes————————————————— 375.
0
No
7
Never dropped below 50
8
Unknown
Date platelets ≥50 x 109/L (first of 3 consecutive labs,
no platelet transfusions 7 days prior):
8
Date estimated
8
Date unknown
Month
Day
Year
bm
1
Su
374.
Was a platelet count of ≥20 x 109/L achieved?
D
at
a
372.
Current Hematologic Findings
Date of most recent test:
Month Day
Year
Not
Tested
x 106/L
Transfused
8
%
Transfused
8
%
Transfused
8
Specify Units
376.
.
379.
Lymphocytes:
380.
Hemoglobin:
381.
Hematocrit:
382.
Platelets:
1
ot
Neutrophils:
.
N
378.
–
WBC:
1
x 109/L (x103/mm3)
g/dl
2
g/L
3
2
mmol/L
%
Transfused
8
RBC <30 days from Q.376
Transfused
8
RBC <30 days from Q.376
1
x109/L (x103/mm3)
2
x106/L
Transfused
8
platelets <7 days from Q.376
R
et
ire
d
377.
fo
r
CBC results:
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 19 of 40
RAFT
D
Acute Graft-vs-Host Disease (GVHD)
TEAM:
Was specific therapy used post conditioning to prevent or induce acute GVHD, or promote engraftment
(other than growth factors reported in Q.321)?
Allografts, go to Q.410
Autografts, go to Q.564
1
0
ALS, ALG, ATS, ATG
385. Source: 1 Horse
2
Rabbit
3
Other, 386. Specify:__________________
387.
388.
389.
390.
391.
1
0
1
0
1
0
1
0
1
0
Corticosteroids (systemic)
Cyclosporine (CSA) (e.g., Sandimmune, Neoral)
ECP (extra-corporeal photopheresis)
FK 506 (e.g., Tacrolimus, Prograf)
In vivo monoclonal antibody
on
No
Yes No
384.
si
0
Yes———————————
is
1
bm
383.
IUBMID:
Yes No
392.
1
0
Anti CD 25 (e.g., Zenapax, Daclizumab, AntiTAC)
1
0
1
0
Campath
Etanercept (Enbrel)
Infliximab (Remicade)
OKT3 (e.g., Orthoclone)
Other
D
at
a
394.
395.
396.
397.
398.
Su
393. Specify: ______________________
1
0
1
0
1
0
399. Specify: ______________________
In vivo immunotoxin
fo
r
400.
1
0
401.
1
0
1
0
1
0
1
0
1
0
Methotrexate (MTX) (e.g., Amethopterin)
Mycophenolate mofetil (MMF) (e.g., Cellcept)
Sirolimus (e.g., Rapamycin, Rapamune)
Ursodiol
Blinded randomized trial
407.
408.
1
0
Specify agent(s) being studied: __________________
___________________________________________
Other
409.
Specify: _____________________________________
R
et
ire
d
–
N
ot
402.
403.
404.
405.
406.
Specify: _____________________________________
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 20 of 40
TEAM:
Did acute GVHD occur?
1
Yes———————————————————————
2
Acute GVHD persists from prior HSCT/DCI
0
No
8
Unknown
411.
412.
Go to
Q.470
Maximum overall grade:
1
I
2
II
3
III
4
IV
on
410.
DRAFT
IUBMID:
What was diagnosis based on?
Histologic evidence
2
Clinical evidence
3
Both
8
Unknown
is
Date of onset:
Month
Day
Year
Is acute GVHD still present at last contact date for this Report Form?
1
Yes
0
No
2
Progressed to chronic GVHD
8
Unknown
D
at
a
Su
414.
bm
413.
si
1
List the maximum severity of organ involvement attributed to acute GVHD:
Stage 0
1
2
Maculopapular
rash,<25% of
body surface
3
Maculopapular
rash, 25-50% of
body surface
4
Stage 3
Generalized
erythroderma
Stage 4
5
Generalized
erythroderma with
bullae formation
and desquamation
5
Severe abdominal
pain, with or
without ileus
Intestinal tract (use ml/day for adult patients and ml/m2/day for pediatric patients):
No gut GVHD 2
Diarrhea
<500 ml/day or
<280 ml/m2/day 6
0
Diarrhea >500 but 3
<1000 ml/day or
280-555 ml/m2/day
ot
1
Liver:
0
Bilirubin evaluated, not attributed to GVHD (captured in Q.693)
Bilirubin
2
Bilirubin
3
Bilirubin
<2.0 mg/dL or
2.0-3.0 mg/dL or
3.1-6.0 mg/dL or
<34 µmol/L
34-52 µmol/L
53-103 µmol/L
4
Diarrhea
>1500 ml/day or
>833 ml/m2/day
4
Bilirubin
5
6.1-15.0 mg/dL or
104-256 µmol/L
Bilirubin
>15.0 mg/dL or
>256 µmol/L
ire
d
1
Diarrhea >1000 but
<1500 ml/day or
556-833 ml/m2/day
Persistent nausea
and vomiting
–
417.
Stage 2
fo
r
No skin GVHD
No rash
0
416.
Stage 1
Skin:
N
415.
Other organ involvement?
1
Yes———
Yes No
419. 1
0
Upper GI tract
0
No
0
Lung
420. 1
0
Other
421. 1
R
et
418.
422.
Specify: ____________________________________________
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 21 of 40
TEAM:
423.
DRAFT
IUBMID:
Was specific therapy used to treat acute GVHD?
Yes
1
0
No—— Go to Q.470
For each agent listed below, indicate whether or not it was used to treat acute GVHD:
424.
ALS, ALG, ATS, ATG
425. Source:
Drug continued at Yes, drug Yes, dose
prophylactic dose started increased*
0
Horse
1
1
2
Rabbit
3
2
Still taking?
Yes No
427.
3
1
0
Other, 426. Specify: ________________________
on
No, drug
not given
Corticosteroids (systemic)
0
1
2
3
429.
1
0
430.
Corticosteroids (topical)
0
1
2
3
431.
1
0
432.
Cyclosporine (CSA) (e.g.,
Sandimmune, Neoral)
0
1
2
3
433.
1
0
434.
ECP (extra-corporeal
photopheresis)
0
1
2
3
435.
1
0
FK 506 (e.g., Tacrolimus,
Prograf)
0
1
2
3
437.
1
0
3
441.
1
0
In vivo monoclonal antibody
Yes
1
0
No
439. Anti CD 25 (e.g., Zenapax,
Daclizumab, AntiTAC)
0
is
bm
Su
438.
D
at
a
436.
si
428.
1
2
440. Specify: _______________________________________________________________
0
1
2
3
443.
1
0
444. Etanercept (Enbrel)
0
1
2
3
445.
1
0
446. Infliximab (Remicade)
0
1
2
3
447.
1
0
448. OKT3 (e.g., Orthoclone)
0
1
2
3
449.
1
0
450. Other
0
1
2
3
452.
1
0
ot
fo
r
442. Campath
N
451. Specify antibody: ________________________________________________________
In vivo immunotoxin
–
453.
0
1
2
3
455.
1
0
Methotrexate (MTX) (e.g.,
Amethopterin)
0
1
2
3
457.
1
0
Mycophenolate mofetil (MMF)
(e.g., Cellcept)
0
1
2
3
459.
1
0
Sirolimus (e.g., Rapamycin,
Rapamune)
0
1
2
3
461.
1
0
462.
Ursodiol
0
1
2
3
463.
1
0
464.
Blinded randomized trial
0
1
2
3
466.
1
0
ire
456.
d
454. Specify: _______________________________________________________________
et
458.
R
460.
465.
467.
Other
Specify agent being studied: ______________________________________________
0
468.
1
2
3
469.
1
0
Specify: _______________________________________________________________
* for a therapeutic purpose
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 22 of 40
RAFT
D
Chronic Graft-vs-Host Disease (GVHD)
TEAM:
IUBMID:
470. Has patient developed clinical chronic GVHD?
1
Yes———————————————————————
0
No
8
Unknown
8
Day
Date unknown (Q.472 = #1)
Year
is
Month
si
471. Date of onset:
on
Go to
Q.564
Su
bm
472. Onset of chronic GVHD was (check only one):
1
Progressive (acute GVHD progressed directly to chronic GVHD)
2
Interrrupted (acute GVHD resolved, then chronic GVHD developed)
3
De novo (never developed acute GVHD)
4
Chronic GVHD flair (symptoms reactivate within 30 days of drug tapering or discontinuation)
473. Karnofsky/Lansky score at diagnosis of chronic GVHD:
474. Platelet count at diagnosis of chronic GVHD:
D
at
a
Specify units for platelet count:
1
x109/L (x103/mm3)
475. Total serum bilirubin at diagnosis of chronic GVHD:
Specify units for bilirubin:
2
x106/L
.
1
mg/dL
2
µmol/L
ot
fo
r
476. Diagnosis based on:
1
Histologic evidence
2
Clinical evidence
3
Both
8
Unknown
(see pg 6 for scores)
477. Maximum grade of chronic GVHD:
Limited – localized skin involvement and/or hepatic dysfunction due to chronic GVHD
Extensive – one or more of the following:
-generalized skin involvement; or,
-Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis; or,
-Involvement of eye: Schirmer's test with <5 mm wetting; or,
-Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy; or,
-Involvement of any other target organ
ire
d
–
2
N
1
478. Overall severity:
R
et
1
2
3
Mild – signs and symptoms of chronic GVHD do not interfere substantially with function
and do not progress once appropriately treated with local therapy or standard systemic
therapy (corticosteroids)
Moderate – signs and symptoms of chronic GVHD interfere somewhat with function
despite appropriate therapy or are progressive through first line systemic therapy
(corticosteroids)
Severe – signs and symptoms of chronic GVHD limit function substantially despite
appropriate therapy or are progressive through second line therapy
Continued on next page
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 23 of 40
TEAM:
DRAFT
IUBMID:
Continued from previous page
Indicate organ involvement with chronic GVHD from list below:
Unknown
0
1
8
0
1
8
0
1
8
0
1
8
0
1
8
487.
0
1
8
Eyes: 489.
490.
491.
492.
0
1
8
0
1
8
0
1
8
0
1
8
Mouth: 494.
495.
496.
0
1
8
0
1
8
0
1
Lung: 498.
499.
0
1
0
1
GI Tract: 501.
502.
503.
504.
505.
506.
0
1
8
1
8
1
8
1
8
0
8
8
1
8
0
1
8
1
8
0
1
8
0
1
8
Musculoskeletal: 513.
514.
515.
516.
517.
0
1
8
0
1
8
0
1
8
0
1
8
0
1
8
Hematologic: 519.
520.
521.
522.
0
1
8
0
1
8
0
1
8
0
1
8
Other: 524.
526.
527.
0
1
8
0
1
8
0
1
8
N
0
d
ot
0
8
fo
r
0
0
–
Liver: 508.
R
et
ire
GU Tract: 510.
511.
Subclinical (biopsy findings only)——See Q.476, #1
Rash
Scleroderma
Lichenoid skin changes
Dyspigmentation
Alopecia
Body surface area
486. Specific percent of BSA involved:
%
Other skin/hair involvement,
488. Specify: ____________________________________
Dry eyes
Abnormal Schirmer's test
Corneal erosion/conjunctivitis
Other eye involvement,
493. Specify: ____________________________________
Lichenoid changes
Mucositis/Ulcers
Other mouth involvement,
497. Specify: ____________________________________
Bronchiolitis obliterans (BO, BOOP)——See Q.673
Other lung involvement
500. Specify: ____________________________________
Esophageal involvement
Chronic nausea/Vomiting
Chronic diarrhea
Malabsorption
Abdominal pain/cramps
Other GI tract involvement
507. Specify: ____________________________________
Liver involvement
509. Specify: ____________________________________
Vaginitis/Stricture
Other GU involvement
512. Specify: ____________________________________
Arthritis
Contractures
Myositis
Myasthenia
Other musculoskeletal involvement
518. Specify: ____________________________________
Thrombocytopenia
Eosinophilia
Autoantibodies
Other hematologic involvement
523. Specify: ____________________________________
Serositis 525. Specify site: ________________________
Weight loss
Other 528. Specify: ______________________________
on
8
si
1
is
8
0
D
at
a
1
bm
Present
0
Su
Absent
Skin/Hair: 479.
480.
481.
482.
483.
484.
485.
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 24 of 40
Were specific agents used to treat chronic GVHD?
No, drug
not given
530.
Go to
Q.563
ALS, ALG, ATS, ATG
531. Source:
Drug continued from
Yes, drug
prophylaxis/aGVHD treatment started
0
Horse
1
2
1
Rabbit
3
Other, 532. Specify: _______________
533.
Azathioprine
0
1
534.
Corticosteroids (systemic)
0
1
535.
536.
Corticosteroids (topical)
Cyclosporine (CSA) (e.g.,
Sandimmune, Neoral)
0
1
0
1
537.
ECP (extra-corporeal photopheresis)
0
1
538.
Etretinate
0
539.
FK 506 (e.g., Tacrolimus, Prograf)
0
540.
Hydroxychloroquine (Plaquenil)
0
541.
In vivo monoclonal antibody
1 Yes 0 No
Anti CD 25 (e.g., Zenapax,
Daclizumab, AntiTAC)
2
2
2
2
1
0
D
at
a
542.
2
on
No
is
Yes——
0
bm
1
2
2
1
2
1
2
1
2
Su
529.
DRAFT
IUBMID:
si
TEAM:
543. Specify: ____________________________________________________
Campath
Etanercept (Enbrel)
Infliximab (Remicade)
OKT3 (e.g., Orthoclone)
Other
fo
r
544.
545.
546.
547.
548.
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
Pentostatin
0
1
2
–
552.
Lamprene (Clofazimine)
Mycophenolate mofetil (MMF)
(e.g., Cellcept)
N
550.
551.
ot
549. Specify: ____________________________________________________
PUVA (Psoralen and UVA)
0
1
2
554.
Sirolimus (e.g., Rapamycin, Rapamune)
0
1
2
555.
Thalidomide
0
1
2
556.
Ursodiol
0
1
2
557.
Blinded randomized trial
0
1
2
R
et
ire
d
553.
561.
563.
558.
559.
Specify agent being studied: _________________________________________
Other
560.
0
1
2
Specify: __________________________________________________________
Is patient still receiving immuno-suppressive agents (including PUVA) to treat/prevent cGVHD?
1
Yes
0
No———— 562.
8
Unknown
Date last treatment was administered:
Month
Are symptoms of chronic GVHD still present (or present at time of death)?
Day
1
8
Year
Yes
0
Unknown
No
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 25 of 40
RAFT
D
Other Treatment and Clinical Status After Start of Conditioning
TEAM:
Were transfusions given at any time after start of conditioning to 60 days post-HSCT or LCD, whichever comes
sooner?
Yes No
Unknown
1
Yes——— 565. RBC (from conditioning to 60 days post-HSCT):
Units
8
Platelet (from conditioning to 60 days post-HSCT):
566.
567.
Single donor
Number of aphereses
Random donor
Number of donors
(e.g., a 6 pack of donor platelets transfused at one time = 6)
568. Irradiated granulocyte infusions
(from conditioning to 60 days post-HSCT):
8
8
Number of infusions
8
1
Yes———
Yes No
0
No
570.
Unknown 571.
572.
573.
1
0
1
0
1
0
1
0
574.
575.
1
0
1
0
8
Su
Did patient receive any of the following agents for infection prophylaxis after start of conditioning?
Systemic antibacterial antibiotics
Nonabsorbable oral antibiotics
Polyclonal IV gamma globulin (e.g., IVIG, not ATG)
CMV/hyperimmune gamma globulin
D
at
a
569.
on
Unknown
si
No
8
is
0
bm
564.
IUBMID:
IV amphotericin (Fungizone)
IV amphotericin lipid formulation (e.g., Abelcet, AmBisome, Amphotec)
576. Specify: __________________________________________________
0
1
0
1
0
1
1
Caspofungin
Fluconazole
Itraconazole
Posiconazole
Voriconazole
Other systemic antifungal agent
fo
r
0
1
ot
1
0
0
N
577.
578.
579.
580.
581.
582.
583. Specify: __________________________________________________
1
0
1
0
R
et
ire
d
–
584.
585.
587.
588.
589.
Acyclovir
Ganciclovir (DHPG)
586. Specify:
1
0
1
0
1
0
1
IV
2
PO
Foscarnet
Valacyclovir
Other antiviral agent
590. Specify: __________________________________________________
591.
592.
593.
594.
595.
1
0
1
0
1
0
1
0
1
0
Trimethoprim-sulfamethoxazole (Bactrim/Septra)
Pentamidine inhaled
Pentamidine IV
Dapsone
Other pneumocystis prophylaxis
596. Specify: __________________________________________________
597.
1
0
Other
598. Specify: __________________________________________________
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 26 of 40
TEAM:
IUBMID:
599. Did patient develop clinically significant infection after start of conditioning?
1
Yes———
0
No
8
Unknown
DRAFT
Specify site of infection and organism as First and Second, if applicable:
(see definitions for Organisms Codes on pg 28 & Infection Sites Codes on pg 30)
Month
Date of Onset
Day
Year
Typical
First 601.
602.
Second 604.
605.
First 607.
608.
Second 610.
611.
Atypical
T
T
B
B
si
Bacterial
0
603.
606.
609.
is
1
Organism
bm
600.
Site
on
Yes No
612.
1
Fungal
0
First 615.
616.
Second 618.
619.
F
F
617.
620.
D
at
a
614.
Su
1613. If code 119, specify::____________________________
1621. If code 209,219 or 259, specify:____________________________
622.
1
Viral
0
Second 626.
624.
V
V
625.
fo
r
First 623.
627.
628.
1
Parasitic
0
First 631.
632.
Second 634.
635.
P
P
633.
636.
–
N
630.
ot
1629. If code 329, specify::______________________________________
1
0
Other infections (do not report fever in the absence of a specific site of infection)
ire
638.
d
637. If code 409, specify:____________________________________
640.
643.
O
O
641.
644.
R
et
First 639.
Second 642.
645.
Did patient develop more than 2 infections of any category post-DCI?
1
Yes———
0
No
For reporting more than 2 infections of any
category, copy this page and submit (do not
report in Qs.638-644)
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 27 of 40
TEAM:
DRAFT
IUBMID:
Commonly Reported Organisms Codes
Su
bm
is
si
on
164 = Staphylococcus (coag. positive)
165 = Staphylococcus, NOS
166 = Stomatococcus mucilaginosis
167 = Streptococcus (all sp., except Enterococcus)
168 = Treponema (syphilis)
169 = Vibrio (all sp.)
170 = Other bacteria
198 = Other bacteria, specify in Q.613
502 = Suspected bacterial infection
Fungal Infections
200 = Candida, NOS
201 = Candida albicans
202 = Candida krusei
203 = Candida parapsilosis
204 = Candida tropicalis
205 = Torulopsis glabrata (a subsp. of candida)
209 = Other Candida, specify in Q.621
210 = Aspergillus, NOS
211 = Aspergillus flavus
212 = Aspergillus fumigatus
213 = Aspergillus niger
219 = Other Aspergillus, specify in Q.621
220 = Cryptococcus sp.
230 = Fusarium sp.
240 = Mucormycosis (zygomycetes, rhizopus)
250 = Yeast, NOS
259 = Other fungus, specify in Q.621
260 = Pneumocystis (PCP)
503 = Suspected fungal infection
Viral Infections
301 = Herpes Simplex (HSV1, HSV2)
302 = Herpes Zoster (Chicken pox, Varicella)
303 = Cytomegalovirus (CMV)
304 = Adenovirus
305 = Enterovirus (Coxsackie, Echo, Polio)
306 = Hepatitis A (HAV)
307 = Hepatitis B (HBV, Australian antigen)
308 = Hepatitis C (HCV)
309 = HIV-1 (HTLV-III)
310 = Influenza
311 = Measles (Rubeola)
312 = Mumps
313 = Papovavirus
314 = Respiratory syncytial virus (RSV)
315 = Rubella (German Measles)
316 = Parainfluenza
317 = Human herpesvirus-6 (HHV-6)
318 = Epstein-Barr virus (EBV)
319 = Polyomavirus
320 = Rotavirus
321 = Rhinovirus
329 = Other viral, specify in Q.629
504 = Suspected viral infection
Parasite Infections
402 = Toxoplasma
403 = Giardia
404 = Cryptosporidium
409 = Other parasite (amebiasis, echinococcal cyst,
trichomonas – either vaginal or gingivitis),
specify in Q.637
505 = Suspected parasite infection
Other Infections
509 = No organism identified
R
et
ire
d
–
N
ot
fo
r
D
at
a
Atypical Bacteria
100 = Atypical bacteria, NOS
101 = Coxiella
102 = Legionella
103 = Leptospira
104 = Listeria
105 = Mycoplasma
106 = Nocardia
107 = Rickettsia
110 = Tuberculosis, NOS (AFB, acid fast bacillus, Koch
bacillus)
111 = Typical tuberculosis (TB, Tuberculosis)
112 = Mycobacteria (avium, bovium, intracellulare)
113 = Chlamydia
119 = Other atypical bacteria, specify in Q.613
501 = Suspected atypical bacterial infection
Typical Bacteria
120 = Typical bacteria, NOS
121 = Acinetobacter
122 = Actinomyces
123 = Bacillus
124 = Bacteroides (gracillis, uniformis, vulgaris, other sp.)
125 = Bordetella
126 = Borrelia (Lyme disease)
127 = Branhamelia or Moraxella catarrhalis (other sp.)
128 = Campylobacter (all sp.)
129 = Capnocytophaga
130 = Citrobacter (freundii, other sp.)
131 = Clostridium (all sp., except difficile)
132 = Clostridium difficile
133 = Corynebacterium (all non-diptheria sp.)
134 = Enterobacter
135 = Enterococcus (all sp.)
136 = Escherichia (also E. coli)
137 = Flavimonas oryzihabitans
138 = Flavobacterium
139 = Fusobacterium nucleatum
140 = Gram Negative Diplococci, NOS
141 = Gram Negative Rod, NOS
142 = Gram Positive Cocci, NOS
143 = Gram Positive Rod, NOS
144 = Haemophilus (all sp., including influenzae)
145 = Helicobacter pylori
146 = Klebsiella
147 = Lactobacillus (bulgaricus, acidophilus, other sp.)
148 = Leptotrichia buccalis
149 = Leuconostoc (all sp.)
150 = Methylobacterium
151 = Micrococcus, NOS
152 = Neisseria (gonorrhoea, meningitidis, other sp.)
153 = Pasteurella multocida
154 = Propionibacterium (acnes, avidum, granulosum,
other sp.)
155 = Proteus
156 = Pseudomonas (all sp., except cepacia & maltophilia)
157 = Pseudomonas or Burkholderia cepacia
158 = Pseudomonas or Stenotrophomonas or Xanthomonas
maltophilia
159 = Rhodococcus
160 = Salmonella (all sp.)
161 = Serratia marcescens
162 = Shigella
163 = Staphylococcus (coag. negative)
Cust Fig A-56
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 28 of 40
DRAFT
IUBMID:
Pulmonary function
646. Has patient developed interstitial pneumonitis (IPn or ARDS)?
1
Yes————
0
No
8
Unknown
Interstitial pneumonitis is characterized by hypoxia and diffuse
interstitial infiltrates on chest x-ray not caused by fluid overload.
Has patient had prior episode(s) of IPn?
1
Yes———
648. Total number of prior episodes since first HSCT:
0
No
649.
Date of onset:
Day
Year
is
Month
si
647.
on
TEAM:
653.
654.
655.
bm
Were diagnostic tests other than radiographic studies done?
1
Yes———
Yes No Unknown
0
No
651. 1
0
8
Bronchoalveolar lavage (BAL)
8
Unknown 652. 1
0
8
Transbronchial biopsy
1
0
8
1
0
8
1
0
8
Open/thorascopic (VATS) lung biopsy
Autopsy
Other
Su
650.
Specify: ___________________________
D
at
a
656.
Was an organism isolated?
1
Yes——————
Yes No Unknown
0
No (idiopathic,
658. 1
0
8
Pneumocystis carinii (PCP)
or no organism 659. 1
0
8
Aspergillus
isolated)
0
8
Candida
660. 1
0
8
Toxoplasma
661. 1
0
8
Respiratory syncytial virus (RSV)
662. 1
0
8
Cytomegalovirus (CMV)
663. 1
0
8
Herpes simplex (HSV1, HSV2)
664. 1
0
8
Adenovirus
665. 1
0
8
Human herpes virus 6 (HHV-6)
666. 1
0
8
Other virus
667. 1
R
et
ire
d
–
N
ot
fo
r
657.
671.
668. Specify: ___________________________
669.
1
0
8
Other
670. Specify: ___________________________
(Report bacterial pneumonia, Q.600)
Did patient develop more than 1 episode of IPn during this reporting period?
1
Yes——————
Copy this page and complete Qs.649-670 for each
0
No
subsequent episode
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 29 of 40
TEAM:
Did patient develop non-infectious pulmonary abnormalities other than interstitial pneumonitis/ARDS post-HSCT?
1
Yes——— 673. Did patient develop bronchiolitis obliterans?
0
No
1
Yes———
8
Unknown
0
No
8
Unknown 675.
674.
Date of onset:
Month
Day
Year
Were diagnostic tests done?
1
Yes———
Yes No Unknown
676. 1
0
8
Bronchoalveolar lavage (BAL)
0
No
0
8
Transbronchial biopsy
8
Unknown 677. 1
0
8
Open/thorascopic (VATS)
678. 1
lung biopsy
679. 1
0
8
Autopsy
0
8
Other
680. 1
1
Yes———
0
No
8
Unknown 684.
683.
Date of onset:
Su
682. Did patient develop pulmonary hemorrhage?
Specify: ______________________
bm
681.
is
si
on
672.
DRAFT
IUBMID:
Month
Day
Year
690.
Specify: ______________________
ot
fo
r
D
at
a
Were diagnostic tests done?
1
Yes———
Yes No Unknown
685. 1
0
8
Bronchoalveolar lavage (BAL)
0
No
0
8
Transbronchial biopsy
8
Unknown 686. 1
0
8
Open/thorascopic (VATS)
687. 1
lung biopsy
688. 1
0
8
Autopsy
0
8
Other
689. 1
N
691. Did patient develop other non-infectious pulmonary abnormalities?
1
Specify: _____________________________________________
–
0
Yes——— 692.
No
Unknown
ire
d
8
R
et
1 = Blood/ buffy coat
2 = Disseminated – generalized,
isolated at 3 or more distinct sites
3 = Central Nervous System, NOS
4 = Brain
5 = Spinal cord
6 = Meninges and CSF
10 = Gastrointestinal Tract, NOS
11 = Lips
12 = Tongue, oral cavity and oropharynx
13 = Esophagus
14 = Stomach
15 = Gallbladder and biliary tree (not
hepatitis), pancreas
16 = Small intestine
17 = Large intestine
18 = Feces/stool
Common Sites of Infection Codes
19 = Peritoneum
20 = Liver
30 = Respiratory, NOS
31 = Upper airway and nasopharynx
32 = Laryngitis / larynx
33 = Lower respiratory tract (lung)
34 = Pleural cavity, pleural fluid
35 = Sinuses
40 = Genito-Urinary Tract, NOS
41 = Kidneys, renal pelvis, ureters and
bladder
42 = Prostate
43 = Testes
44 = Fallopian tubes, uterus, cervix
45 = Vagina
50 = Skin, NOS
51 = Genital area
52 = Cellulitis
53 = Herpes Zoster
54 = Rash, pustules or abscesses not
typical of any of the above
60 = Central venous catheter, NOS
61 = Catheter insertion or exit site
62 = Catheter tip
70 = Eyes
75 = Ear
81 = Joints
82 = Bone marrow
83 = Bone cortex (osteomyelitis)
84 = Muscle (excluding cardiac)
85 = Cardiac (endocardium, myocardium, pericardium)
86 = Lymph nodes
87 = Spleen
Stnd Fig A-55
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 30 of 40
TEAM:
DRAFT
IUBMID:
Liver function
693. Did patient develop non-infectious liver toxicity after conditioning (excluding GVHD)?
1
Yes———
0
No
8
Unknown Etiology:
694.
Date of onset:
Month
Day
Year
Yes No Unknown
8
1
0
8
1
0
8
Veno-occlusive disease
Cirrhosis
Other
on
0
si
1
698.
Specify: _______________________________________________
is
695.
696.
697.
Diagnosis in Qs.695-698 was confirmed by:
1
0
Clinical signs and symptoms
8
Yes No Unknown
0
8
1
0
8
1
0
8
1
0
8
1
0
8
0
8
1
Jaundice
Hepatomegaly
Right upper quadrant pain
Ascites
Weight gain (>5%)
Other
Su
1
D
at
a
700.
701.
702.
703.
704.
705.
bm
Yes No Not Done/Unknown
699.
706. Specify: ____________________________
0
8
1
0
8
1
0
8
1
0
8
1
0
8
1
0
8
Elevated liver enzymes (e.g., Alk Phos, ALT, AST, LDH, GGT)
Biopsy
Autopsy
Ultrasonography
Doppler
Other
fo
r
1
ot
707.
708.
709.
710.
711.
712.
1
Yes———
0
No
8
Unknown
–
Did patient develop any other non-infectious clinically significant organ impairment or disorder after conditioning?
Yes No
715.
ire
et
R
1
0
d
714.
Specify: _______________________________________________
N
713.
Renal failure severe enough to warrant dialysis
716.
717.
1
0
718.
719.
720.
721.
722.
723.
724.
725.
726.
727.
1
0
1
0
1
0
1
0
1
0
1
0
1
0
1
0
1
0
1
0
Received dialysis?
1
Yes
0
No
Posttransplant microangiopathythrombotic thrombocytopenic purpura (TTP)
hemolytic uremic syndrome (HUS) or similar syndrome
Depression
Hemorrhage cystitis
Seizures
Avascular necrosis
Cataracts
Gonadal dysfunction
Hypothyroidism
Growth hormone deficiency/growth disturbance
Myocardial infarction
Other
728.
Specify: __________________________________________________
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 31 of 40
TEAM:
Did a new malignancy, lymphoproliferative or myeloproliferative disorder appear (not a relapse,
progression or transformation of the disease for which the original transplant was performed)?
Yes——— 730.
Did more than one new malignancy develop?
Yes—— 731. Has more than 1 new malignancy been diagnosed during this
reporting period?
0
No
1
Yes——— For reporting more than 1 new malignancy, copy
this page and complete Qs.732-746 for each
0
No
1
0
No
8
Unknown
732.
on
1
Date of diagnosis:
Month
Origin of cells:
1
Host
Year
Donor
2
Unknown
8
is
733.
Day
si
729.
DRAFT
IUBMID:
Diagnosis:
0
1
0
Clonal cytogenetic abnormality without leukemia or MDS
Acute myeloid leukemia (AML, ANLL)
Other leukemia
737.
738.
739.
1
0
1
0
1
0
1
0
Specify: __________________________________________________
Myelodysplasia (MDS)/myeloproliferative (MPS) disorder
Lymphoma or lymphoproliferative disease
740.
741.
742.
Su
0
1
D
at
a
1
bm
Yes No
734.
735.
736.
EBV positive:
1
Yes
0
No
8
Unknown
Hodgkin disease
Other cancer
fo
r
Please translate into English and print neatly
743.
Primary site: _____________________________________________
744.
Histologic type: ___________________________________________
Behavior:
Benign
ot
745.
1
In situ
3
Malignant/Invasive
8
Unknown
Is a Pathology/Autopsy Report or other documentation available?
Yes—— If Pathology/Autopsy Report or other documentation is available,
attach copy with all identifiers removed except
0
No
Team/IUBMID #s and birth dates, and reference Q.729
N
746.
2
R
et
ire
d
–
1
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 32 of 40
TEAM:
RAFT
D
Survival and Functional Status
Was patient discharged from hospital after transplant?
1
Yes———
0
No
8
Unknown
7
Not applicable (high-dose therapy and transplant/infusion given as outpatient)
Date first discharged from hospital after transplant:
Autografts only: Total number inpatient days in first 60 days posttransplant:
750.
Allografts only: Total number inpatient days in first 100 days posttransplant:
751.
Was patient alive on the day of last contact (Refer to pg 1 for date)?
Yes——— 752.
0
No
If patient is 16 years of age or older, complete the Karnofsky Scale.
If patient is younger than 16 years of age, complete the Lansky Scale.
Su
1
Karnofsky Scale (age ≥16 yrs)
Select the phrase in the Karnofsky Scale which
best describes the activity status of the patient
D
at
a
Go to Q.764
fo
r
Able to carry on normal activity; no special care is needed.
100
Normal; no complaints; no evidence of disease
90
Able to carry on normal activity
80
Normal activity with effort
–
N
ot
Unable to work; able to live at home, care for most personal
needs; a varying amount of assistance is needed.
70
Cares for self; unable to carry on normal activity or to
do active work
60
Requires occasional assistance but is able to care for
most needs
50
Requires considerable assistance and frequent medical
care
et
ire
d
Unable to care for self; requires equivalent of institutional
or hospital care; disease may be progressing rapidly.
40
Disabled; requires special care and assistance
30
Severely disabled; hospitalization indicated, although
death not imminent
20
Very sick; hospitalization necessary
10
Moribund; fatal process progressing rapidly
R
Year
bm
749.
Day
si
Month
on
748.
is
747.
IUBMID:
Lansky Scale (age <16 yrs)
Select the phrase in the Lansky Play-Performance Scale
which best describes the activity status of the patient
Normal range.
100
Fully active
90
Minor restruction in physically strenuous play
80
Restricted in strenuous play, tires more easily, otherwise active
Mild to moderate restriction.
70
Both greater restrictions of, and less time spent in,
active play
60
Ambulatory up to 50% of time, limited active play with
assistance/supervision
50
Considerable assistance required for any active play;
fully able to engage in quiet play
Moderate to severe restriction.
40
Able to initiate quiet activities
30
Needs considerable assistance for quiet activity
20
Limited to very passive activity initiated by others
(i.e., TV)
10
Completely disabled, not even passive play
Stnd Fig A-57
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 33 of 40
TEAM:
IUBMID:
Subsequent HSCT*
DRAFT
* Complete this section if a subsequent HSCT was received (see Q.317). Answers on pgs 16-32 of this report should
reflect clinical status immediately prior to start of conditioning for subsequent HSCT.
Year
si
Day
Reason for subsequent HSCT (check only one):
91
No engraftment
92
Partial engraftment
93
Late graft failure
94
Persistent malignancy
95
Relapse
96
Planned second HSCT, per protocol
98
Secondary/new malignancy
90
Other reason
bm
Autologous re-infusions for these
reasons do not require separate
Report Form completion
is
Month
Complete new malignancy Qs.729-746
D
at
a
754.
Date will be later than Q.4 unless HSCT
is autologous for treatment for graft failure
Date of subsequent HSCT:
Su
753.
on
A separate Day 100 Report Form must be submitted unless the
subsequent HSCT is autologous for treatment of graft failure
755. Specify: _____________________________________________________
Allogeneic, unrelated
93
Autologous
fo
r
92
757. Donor (check only one):
1
Same donor
2
Different donor
3
Not applicable, initial transplant was autologous
ot
Allogeneic, related
Was the subsequent HSCT performed at a different institution?
1
Yes——— 759.
0
No
N
758.
Type of graft (check only one):
91
Specify:
Name: ___________________________________________________
–
756.
d
City: ____________________________________ State: ___________
R
et
ire
Country: _________________________________________________
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 34 of 40
TEAM:
DRAFT
IUBMID:
Subsequent DCI*
* Complete this section if a subsequent DCI was received >14 days from the HSCT for this Report Form (see Q.318).
Answers on pgs 16-33 of this report should reflect clinical status immediately prior to subsequent DCI.
Month
Year
Was infusion performed at a different institution?
1
Yes——— 762. Specify:
0
bm
761.
Day
Date will be later than Q.4
(last contact date)
si
Date first subsequent DCI given:
is
760.
on
A separate Day 100 DCI Report Form must be submitted
Name: ___________________________________________________
No
City: ____________________________________ State: ___________
1
Yes———
0
No
D
at
a
If patient received a DCI >14 days post-HSCT, was therapy given to treat the patient’s disease between this
HSCT and the next reportable DCI?
Complete a Disease Supplement and
submit with the next DCI Report Form
R
et
ire
d
–
N
ot
fo
r
763.
Su
Country: _________________________________________________
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 35 of 40
TEAM:
IUBMID:
Death Information
764.
DRAFT
Date of death:
Month
Day
Year
si
Cause of Death Codes
——If code 29, 39, 88, 89, 109, 129
——or 900, specify:
10 Graft rejection or failure
______________________________ Infection (other than interstitial pneumonia)
——If code 29, 39, 88, 89, 109, 129
——or 900, specify:
______________________________
767.
——If code 29, 39, 88, 89, 109, 129
——or 900, specify:
______________________________
768.
——If code 29, 39, 88, 89, 109, 129
——or 900, specify:
______________________________
769.
——If code 29, 39, 88, 89, 109, 129
——or 900, specify:
______________________________
770.
——If code 29, 39, 88, 89, 109, 129
——or 900, specify:
______________________________
N
ot
fo
r
D
at
a
766.
–
Was cause of death confirmed by autopsy?
1
Yes——— 772. Is Autopsy Report available?
1
Yes——— If Autopsy Report
0
No
is available,
0
No
8
Unknown
attach
copy with
6
Pending
6
Pending
all identifiers
removed except
Team/IUBMID #s
and birth dates,
and reference
Q.771
R
et
ire
d
771.
120 Infection, organism not identified
121 Bacterial
122 Fungal
123 Viral
124 Protozoal
129 Other infection, specify
Interstitial pneumonia
130 IPn, idopathic
131 IPn, Cytomegalovirus (CMV)
132 IPn, Viral, other
133 IPn, Pneumocystis (PCP)
134 IPn, Fungal
139 Other IPn, specify
40 Adult Respiratory Distress Syndrome, ARDS
(other than IPn)
50 Acute GVHD
60 Chronic GVHD
70 Recurrence or persistence of primary disease
Organ failure (not due to GVHD or infection)
180 Organ failure, not otherwise specified
181 Liver (not VOD)
182 VOD
183 Cardiac (Cardiomyopathy)
184 Pulmonary
185 CNS
186 Renal
187 Gastrointestinal (not liver)
188 Multiple organ failure, specify
189 Other organ failure, specify
90 Secondary malignancy
(malignancy other than one for which the
patient's first transplant was performed;
secondary malignancy includes
posttransplant lymphoproliferative
disease and MDS)
Hemorrhage
100 Hemorrhage, not otherwise specified
101 Pulmonary
102 Intracranial
103 Gastrointestinal
104 Hemorrhagic cystitis
109 Other hemorrhage, specify
110 Accidental death
115 Suicide
Vascular
120 Vascular, not otherwise specified
121 Thromboembolic
122 Disseminated intravascular coagulation (DIC)
123 Thrombotic thrombocytopenic purpura (HUS/TTP)
129 Other vascular, specify
130 In utero death (for in utero transplants)
140 Prior malignancy
(malignancy existing before disease for which
transplant performed as reported in Q.17)
900 Other, specify
is
Contributing or secondary causes:
bm
Primary:
Su
765.
on
Cause(s) of death:
Enter appropriate cause of death (see Cause of Death Codes):
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 36 of 40
RAFT
D
Confidential/Socioeconomic Information*
TEAM:
IUBMID:
* Complete for the first transplant only
Patient's state of residence (US only):
on
773.
773.2 Patient's zip code (US only):
5
41
6
7
8
9
52
51
10
42
13
14
15
49
46
17
18
48
19
20
21
Is Patient ≥18 years old?
1
0
8
22
23
24
25
43
26
27
28
50
29
30
38
Japan
Jordan
Korea
Malaysia
Mexico
Netherlands
New Zealand
Norway
Peru
Poland
Portugal
Russia
Saudi Arabia
Scotland
31
32
33
34
35
36
South Africa
Spain
Sweden
Switzerland
Taiwan
Turkey
Uruguay
Venezuela
Wales
Yugoslavia
Unknown/Unspecified
Other Country, specify:
37
45
47
39
40
53
88
90
____________________________
Yes——— 776. Patient's marital status (check only one):
No
1
Single, never married
2
Married
Unknown
3
4
5
N
8
Separated
Divorced
Widowed
Unknown
fo
r
775.
12
Denmark
Egypt
England
Finland
France
Germany
Greece
Hong Kong
Hungary
India
Iran
Ireland
Israel
Italy
is
4
11
44
bm
3
United States
Argentina
Austria
Australia
Belgium
Bosnia
Brazil
Canada
Chile
China
Costa Rica
Croatia
Cuba
Czech Republic
Su
2
D
at
a
1
si
Country of residence (check only one):
ot
774.
–
777. Highest grade patient finished in school (check only one):
1
d
2
R
et
ire
3
4
5
6
7
8
88
1-8 grades
9-11 grades
High School graduate
Some college
Junior college degree
College degree (BA/BS)
Some post-college work
Advanced degree
Unknown
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 37 of 40
TEAM:
DRAFT
IUBMID:
Type of health insurance:
8
1
0
8
1
0
8
1
0
8
1
0
8
1
0
8
1
0
8
1
0
8
1
0
8
788.
US patients only: Type of fee reimbursement (check only one):
Capitation
7
Other, specify:_______________________________________
8
Unknown
D
at
a
Su
Fee for service
2
Which category best describes patient's occupation (check only one)?
If not currently employed, which best describes patient's last job?
1
Professional, Technical & Related Occupations (teacher/professor, nurse, lawyer, physician or engineer)
Manager, Administrator of Proprietor (sales manager, real estate agent or postmaster)
3
Clerical & Related Occupations (secretary, clerk or mail carrier)
4
Sales Occupation (salesperson, demonstrator, agent or broker)
5
Service Occupation (police, cook or hairdresser)
6
Skilled crafts & Related Occupations (carpenter, repairer or telephone line worker)
7
Equipment or Vehicle Operator & Related Occupations (driver, railroad brakeman or sewer worker)
8
Laborer (helper, longshoreman or warehouse worker)
9
Farmer (owner, manager, operator or tenant)
N
ot
fo
r
2
Member of the military
11
Homemaker
90
Other, specify description:_______________________________________
88
Unknown
d
–
10
US patients only: What is patient's yearly income, earned by all familly members living in household before taxes
(check only one)?
1
Less than $5,000
et
790.
1
ire
789.
No insurance
Medicaid
Medicare (US)
Disability insurance
HMO
Individual health insurance
Group health insurance
National health insurance (non-US)
V.A./Military
Other, specify:_______________________________________
si
8
0
is
0
1
bm
1
on
Yes No Unknown
778.
779.
780.
781.
782.
783.
784.
785.
786.
787.
$5,000-9,999
3
$10,000-19,999
4
$20,000-29,999
5
$30,000-39,999
6
$40,000-49,999
7
$50,000-59,999
8
$60,000-79,999
9
$80,000 and over
R
2
88
Unknown
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 38 of 40
AFT
R
D
Log of Appended Documents
Attach as many documents as indicated thoughout this form and describe
below. Remove all identifiers except Team/IUBMID #s and birth dates.
Copy this page for each additional ≤ 5 documents attached.
Type of Document
Month
Day
73
Year
74
75
76
77
78
77
793.
71
72
Month
Day
73
Year
74
75
76
77
78
77
794.
71
72
Month
Day
73
Year
74
75
Bone marrow biopsy/aspirate
Cytogenetics
FISH
HLA
Laboratory
Molecular tests
Pathology/Autopsy
Copied page of Day
100 R.F., specify page #
Other, specify: _________________
1
3
4
0
77
77
795.
–
71
Day
Year
73
74
75
76
77
et
ire
Month
d
72
78
796.
71
R
77
72
Month
Day
Year
73
74
75
76
77
78
77
Page________
Question________
4
0
Page________
Question________
3
4
CORE Insert
Graft Insert
Disease-specific Insert
0
Page________
Question________
Bone marrow biopsy/aspirate
Cytogenetics
FISH
HLA
Laboratory
Molecular tests
Pathology/Autopsy
Copied page of Day
100 R.F., specify page #
Other, specify: _________________
1
Bone marrow biopsy/aspirate
Cytogenetics
FISH
HLA
Laboratory
Molecular tests
Pathology/Autopsy
Copied page of Day
100 R.F., specify page #
Other, specify: _________________
1
Bone marrow biopsy/aspirate
Cytogenetics
FISH
HLA
Laboratory
Molecular tests
Pathology/Autopsy
Copied page of Day
100 R.F., specify page #
Other, specify: _________________
1
N
78
CORE Insert
Graft Insert
Disease-specific Insert
CORE Insert
Graft Insert
Disease-specific Insert
1
3
ot
76
Bone marrow biopsy/aspirate
Cytogenetics
FISH
HLA
Laboratory
Molecular tests
Pathology/Autopsy
Copied page of Day
100 R.F., specify page #
Other, specify: _________________
Su
72
D
at
a
71
fo
r
792.
Document Referenced To
si
Date of Document
on
Number of attached documents:
is
791.
IUBMID:
bm
TEAM:
4
CORE Insert
Graft Insert
Disease-specific Insert
0
Page________
Question________
3
4
CORE Insert
Graft Insert
Disease-specific Insert
0
Page________
Question________
3
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 39 of 40
FOR REGISTRY USE ONLY:
Institutional Information
I.D.
P
–
–
Date received:
IUBMID:
Log:_______
(Institutional Unique Blood or Marrow
Transplant Identification Number)
Date of transplant for which
this form is being completed:
PC:_______
Registry (circle one):
IBMTR
ABMTR
Day
Year
Date of report:
Month
Day
Year
Month
on
TEAM:
Signed:________________________________________ / ________________________________________
Person completing this form / Print name
ii.
Name of doctor for correspondence: __________________________________________________________
Address: _______________________________________________
Su
_______________________________________________
bm
Institution: ______________________________________________
is
si
i.
_______________________________________________
iii. Telephone:
Ext.:
Fax:
v.
Make reimbursement check payable to: ________________________________________________________
D
at
a
iv.
Payment for data forms is contingent on the availability of funds that have been obtained from
sources external to the Medical College of Wisconsin for purposes of these payments.
Patient or authorized family member/guardian is aware of, and has consented to, the fact that this case is being
entered into the Registry database:
_________________________(physician's initials)
fo
r
vi.
–
N
ot
vii. Determining cut-off for all parts of this report:
A complete report of transplant consists of the following three parts (all 3 parts should have the same date of report
and date of transplant):
¹ A (white) Day 100 CORE Insert
² An appropriate (blue or pink) graft-specific insert (Insert ALLOBM, ALLOPB, ALLOCB, AUTOPB or AUTOBM)
³ An appropriate (ivory) disease-specific insert
CORE
Insert
+
Graft
Insert
+
Disease
Insert
Was a subsequent reportable transplant or infusion, as defined on pgs 15 & 16 performed?
1
Yes——— ix. Was conditioning given for subsequent transplant?
1
Yes——— Cut off for this Report Form is one day prior to conditioning start date
0
No
R
et
viii.
ire
d
Report Form =
x.
0
No
Cut off for this Report Form is one day prior to the subsequent infusion
Enter date 100 days from transplant (e.g., Month, Day, Year):
Enter this date on pg 1 of the 002-CORE Insert.
NOTE: Report information in the CORE Insert and Disease-specific Insert only up to last contact date. Later information
should be reported in a Follow-up Report Form or Report Form for a subsequent transplant when it is due.
xi.
Was patient alive on Day 100 for this Report Form?
1
Yes——— The last contact date for all parts of this Report Form should be up to
Day 100 or slightly beyond if patient was not actually seen on Day 100
0
No
The last contact date for all parts of this Report Form should be the
date of death – No separate Follow-up Report Form is required
IBMTR/ABMTR Reporting Form 002COREc (3/05) Page 40 of 40