Cellular Therapy Data Collection - Castor

21/11/2022 11:15 Cellular Therapy data collection - Castor
Cellular Therapy data collection -

Castor - version 24.0
Printed on 21-11-2022 11:15:10 by Narimane MEGUEDAD
1. Pre-infusion Registration - Informed consent

Number Question Answers
1.1 Consent to sharing data with EBMT?
No
Exclude patient if field's value is equal to No with message:
Yes
'Informed consent not signed, no further data entry should be
performed.'
1.1.1 If 'Consent to sharing data with EBMT?' is equal to 'Yes' (dd-mm-yyyy)

answer this question:
Date informed consent
Warning shown if field's value is larger than NOW: 'Date

cannot be set in the future'
1.1.2 If 'Consent to sharing data with EBMT?' is equal to 'Yes'

Informed consent date validation check
Warning shown if field's value is equal to Check successful:

No: 'Date of consent cannot be previous to date of
Diagnosis.'
1.2 Did the patient sign the updated Consent form for sharing No
data with the EBMT and EBMT collaboration partners (used
Yes
since 2020)?
1.2.1 If 'Did the patient sign the updated Consent form for No
sharing data with the EBMT and EBMT collaboration
Yes
partners (used since 2020)?' is equal to 'Yes' answer this
question:
Unknown
Consent to data sharing with health authorities/researchers?
Yes
question:
Unknown
Consent to data sharing with HTA?
Yes
question:
Unknown
Consent to data sharing with MAH?
Yes
question:
Unknown
Consent to review medical records?
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2. Pre-infusion Registration - Centre identification

2.1 EBMT Code (CIC)
2.2 Hospital
2.3 Unit
2.4 Contact person
3. Pre-infusion Registration - Patient data

3.1 EBMT Unique Identification Code
3.2 Date of this report
(dd-mm-yyyy)
3.3 Hospital Unique Patient Number or Code
3.4 Other type of patient identification code
3.5 Date of birth
(dd-mm-yyyy)
Warning shown if field's value is larger than or equal to NOW:
'Birth date cannot be set in the future or after diagnosis.'
3.6 Date of birth validation check

No: 'Date of birth cannot be posterior to date of diagnosis.'
3.7 Sex
Male
Female
3.8 Initials (first name)
3.9 Initials (family name)
3.10 Patient ABO Blood group
Group A
Group B
Group AB
Group O
3.11 Patient Rhesus factor
Absent
Present
Not Evaluated
Unknown
4. Pre-infusion Registration - Indication for Cellular therapy

4.1 Main indication for the therapy
Treatment of a primary disease

Treatment or prevention of complications
Both, treatment of primary disease and
complications
4.2 Primary disease
Primary acute leukemia

Chronic leukemia
Lymphoma
Myeloma/plasma cell disorder
Solid tumour
Myelodysplastic syndrome and/or
myeloproliferative neoplasm
Aplastic anaemia and other bone marrow
failure syndrome
Inherited disorders
Histiocytic disorders
Autoimmune disease
Haemoglobinopathy
Infections
Other primary disease
4.2.1 If 'Primary disease' is equal to 'Other primary disease'

Indicate other diagnosis/indication
4.3 Date of diagnosis
(dd-mm-yyyy)
4.4 Date of diagnosis validity check

No: 'Date of diagnosis cannot be prior to date of birth'
5. Pre-infusion Registration - Basic information on planned

cellular therapy
5.1 Clinical setting
Clinical trial/Investigational drug product

Marketing approval/Standard of
care/Institutional guidelines
Hospital exemption
Compassionate use/Accelerated access
Unknown
5.1.1 If 'Clinical setting' is equal to 'Clinical trial/Investigational 1

drug product' answer this question:
1/2
Phase
2
2/3
3
5.1.2 If 'Clinical setting' is equal to 'Clinical trial/Investigational No

Yes
Blind trial
5.1.3 If 'Clinical setting' is equal to 'Clinical trial/Investigational No

Yes
Randomised trial
5.1.4 If 'Clinical setting' is equal to 'Clinical trial/Investigational

EudraCT number

USA CT number

UMIN CT number
5.2 Cell origin
Allogeneic
Autologous
5.2.1 If 'Cell origin' is equal to 'Allogeneic' answer this A known donor never used before to treat
question:
this patient
This product is manufactured from
A donor that is already registered as part of a

previous treatment
An unknown donor with no available data
6. Pre-infusion Registration - Donor information

6.1 If 'This product is manufactured from' is equal to 'A (dd-mm-yyyy)

known donor never used before to treat this patient'
Donor date of birth

6.2 If 'This product is manufactured from' is equal to 'A

Donor age at time of donation (years)

Donor age at time of donation (months)
6.4 If 'This product is manufactured from' is equal to 'A Male

Female
Donor sex

Donor ID given by the centre

Global registration identifier for donors

Donor ID given by the Donor Registry

Donor ID given by the Cord Blood Bank

ION code of the Donor Registry or Cord Blood Bank

Eurocord code for the Cord Blood Bank

Name of donor registry

Name of the Cord Blood Bank
7. Pre-infusion Registration - Planned Cellular therapy infusion

product
7.1 Is the planned cell infusion product a commercial product?
No
Yes
7.2 Is it planned to manufacture more than one cell infusion No

product?
Yes
7.3 Name of the manufacturer
Novartis
Kite Gilead
Celgene/Bristol-Meyers Squibb
Autolus
Miltenyi
Janssen
Local hospital or university
Bluebird Bio
Vertex
Orchard
Other
7.3.1 If 'Name of the manufacturer' is equal to 'Other' answer

this question:
Product manufacturer other: Specify
7.4 Name of the product
Kymriah
Yescarta
Tecartus
Breyanzi
Abecma
Cilta-cel
Strimvelis
Libmeldy
Eli-cel
Other
7.4.1 If 'Name of the product' is equal to 'Other' answer this

question:
Name of product other: Specify
7.5 Tissue source
Bone marrow
Peripheral blood
Tumour
Other
7.5.1 If 'Tissue source' is equal to 'Other' answer this question:

Other: Specify
7.6 Cell collection date
(dd-mm-yyyy)
7.7 Cell collection date validity check

No: 'Date of cell collection inconsistent with previously
entered data.'
7.8 Number of collections
8. Day 0 - Patient identification

8.1 Person responsible for filling the form
(dd-mm-yyyy)
8.3 Date of this report validity check.

No: 'Date of this report cannot be prior to date of pre-
registration report.'
8.5 Date of birth
8.6 Sex
9. Day 0 - Previous therapies

9.1 Has the information requested in this section been submitted No
with a previous HSCT/Cellular Therapy registration for this
Yes
patient?
9.1.1 If 'Has the information requested in this section been No

submitted with a previous HSCT/Cellular Therapy
Yes
registration for this patient?' is equal to 'No' answer this
question:
Unknown
Was the patient treated before this cellular therapy
procedure?
9.1.1.1 If 'Was the patient treated before this cellular therapy (dd-mm-yyyy)
procedure?' is equal to 'Yes' answer this question:
Date started

9.1.1.2 If 'Was the patient treated before this cellular therapy

Sequential number of this treatment (counted from diagnosis)
9.2 Radiotherapy
No
Yes
Unknown
9.2.1 If 'Radiotherapy' is equal to 'Yes' answer this question:
Radiotherapy details
9.3 Other treatment
No
Yes
Unknown
9.3.1 If 'Other treatment' is equal to 'Yes' answer this question:

Other treatment details
10. Day 0 - Status at Cellular therapy

10.1 Performance system used
Karnofsky
Lansky
ECOG
Not evaluated
10.1.1 If 'Performance system used' is not equal to 'ECOG' Dead (0)

Moribund (10)
Karnofsky/Lansky score
Very sick (20)

Severely disabled (30)
Disabled (40)
Requires assistance (50)
Requires occasional assistance (60)
Care for self (70)
Normal with effort (80)
Normal activity with minor restrictions (90)
Normal (100)
10.1.2 If 'Performance system used' is equal to 'ECOG' answer Fully active (0)
this question:
Restricted (1)
ECOG score
Ambulatory (2)
Capable (3)
Completely disabled (4)
Dead (5)
10.2 Patient weight at cellular therapy (kg)
10.3 Patient height at cellular therapy (cm)
10.4 Was B-cell aplasia present at the time of the treatment?
No
Yes
Unknown
10.4.1 If 'Was B-cell aplasia present at the time of the

treatment?' is equal to 'Yes' answer this question:
Percentage of B-Cells
10.5 Disease status at Cellular Therapy
Disease status
Acute Leukaemias ---
Chronic Leukaemias ---
Solid Tumours ---
Lymphomas ---
MDS, MPN and MDS/MPN ---
Plasma cell disorders incl.
---
Multiple Myeloma
Other Diagnosis ---
11. Day 0 - Comorbidity index

11.1 Were there any comorbid conditions present at time of patient No
assessment prior to the preparative regimen?
Yes
11.1.1 If 'Were there any comorbid conditions present at time of No

patient assessment prior to the preparative regimen?' is
Yes
equal to 'Yes' answer this question:
Solid tumour, previously present
Not Evaluated
11.1.1.1 If 'Solid tumour, previously present' is equal to 'Yes'

If Solid tumor was present, please indicate type.

Yes
Inflammatory bowel disease, previously present
Not Evaluated

Yes
Rheumatologic comorbidity
Not Evaluated
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Yes
Infections present before the treatment
Not Evaluated

Yes
Diabetes (requiring treatment other than diet alone)
Not Evaluated

Yes
Renal comorbidity (moderate to severe)
Not Evaluated

Mild
Hepatic comorbidity
Moderate/Severe
Not evaluated

Yes
Arrythmia / conduction blocks
Not Evaluated

Yes
Cardiac comorbidity
Not Evaluated

Yes
Cerebrovascular disease: Stroke/CNS haemorrhage
Not Evaluated

Yes
Heart valve disease
Not Evaluated
11.1.12 If 'Were there any comorbid conditions present at time of Moderate

Severe
Pulmonary comorbidity
Absent
Not evaluated

Yes
Obesity
Not Evaluated

Yes
Peptic ulcer requiring treatment
Not Evaluated

Yes
Psychiatric disturbance
Not Evaluated
11.1.16 If 'Were there any comorbid conditions present at time of

Specify other additional major clinical abnormalities not listed

above and present prior to the preparative regimen:
12. Day 0 - Cellular Therapy treatment

12.1 Was the cell product infused during this treatment or No
procedure?
Yes
12.1.1 If 'Was the cell product infused during this treatment or Production failure
procedure?' is equal to 'No' answer this question:
Out-of-specification product refused by

Reason why the treatment did not take place
physician
Disease progression
Patient condition worsened (ineligible for
treatment) or patient died
Other
12.1.1.1 If 'Reason why the treatment did not take place' is equal
to 'Other' answer this question:
Other: Specify
12.1.2 If 'Was the cell product infused during this treatment or (dd-mm-yyyy)
Date of cell infusion

12.1.3 If 'Was the cell product infused during this treatment or

Date of cell infusion validity check

No: 'Date of cell infusion cannot be earlier than date of cell
collection.'
12.1.4 If 'Was the cell product infused during this treatment or (dd-mm-yyyy)
Date of last assessment

12.1.5 If 'Was the cell product infused during this treatment or

Date of last assessment validity check

No: 'Date of last assessment must be before date of data
entry.'
13. Day 0 - Cell therapy infusion unit(s)

13.1 Was there more than one cell infusion unit administered No
during this treatment?
Yes
13.1.1 If 'Was there more than one cell infusion unit

administered during this treatment?' is equal to 'Yes'
Number of different cell infusion units that form part of this

treatment
13.2 Cell therapy infusion unit(s)
14. Day 0 - Cellular Therapy Infusion Unit – Manipulation

14.1 Important Information
14.2 Identification of the Cell Infusion Unit given by the Centre
14.3 Ex-vivo Manipulation of the products contained in the cellular No

therapy infusion unit
Yes
Unknown
14.4 Manipulation
15. Day 0 - Therapy and cell infusion(s)

15.1 Chronological number of cell therapy treatment for this

patient
15.1.1 If 'Chronological number of cell therapy treatment for No

this patient' is bigger than
'1' answer this question:
Yes
Same package/product as for the previous cell therapy
treatment?
15.1.2 If 'Chronological number of cell therapy treatment for (dd-mm-yyyy)

Date of last cell therapy treatment before this one

15.1.3 If 'Chronological number of cell therapy treatment for

Date of last cell therapy treatment validity check

No: 'Date of last cell therapy treatment must be earlier than
current date of cell infusion.'
15.1.4 If 'Chronological number of cell therapy treatment for Allogeneic

Autologous
Type of last cell therapy treatment before this one
15.1.4.1 If 'Type of last cell therapy treatment before this one' is No
equal to 'Allogeneic' answer this question:
Yes
Was the same donor used for all prior and current cell
therapy treatments?

Yes
Was the last cell therapy at another institution?
15.1.5.1 If 'Was the last cell therapy at another institution?' is

CIC if known

Name of institution

City
15.1.6 If 'Chronological number of cell therapy treatment for Primary treatment/Treatment of primary
this patient' is bigger or equal than '1' answer this diagnosis
question:
Prevention of disease relapse

Reason for the cellular therapy treatment
Rescue after relapse/progression

Minimal residual disease reduction
Refractory disease
Other reason
15.1.6.1 If 'Reason for the cellular therapy treatment' is equal to

'Other reason' answer this question:
Other reason, specify
15.2 If 'Main indication for the therapy' is equal to 'Treatment Unrelated to GvHD
or prevention of complications' answer this question:
Prevention/Prophylaxis of GvHD
GVHD
Treatment
15.3 If 'Main indication for the therapy' is equal to 'Treatment Unrelated to graft function
Prevention of rejection/promotion
Graft function
engraftment
Graft enhancement
15.4 If 'Main indication for the therapy' is equal to 'Treatment Unrelated to immune reconstitution
Obtain immune reconstitution

Immune reconstitution

this patient' is equal to '1' answer this question:
Yes
Patient preparative treatment
15.5 Patient preparative treatment
15.1.8 If 'Chronological number of cell therapy treatment for

this patient' is bigger or equal than '1' answer this
question:
Other drug

this patient' is bigger or equal than '1' answer this
Yes
question:
Other type of treatment
15.1.9.1 If 'Other type of treatment' is equal to 'Yes' answer this

question:
Other specify
16. Day 0 - Cell infusion episode(s)

16.1 Was there more than one cell infusion episode during this No
treatment or procedure?
Yes
16.1.1 If 'Was there more than one cell infusion episode during
this treatment or procedure?' is equal to 'Yes' answer
this question:
Number of different cell infusion episodes during this

treatment/procedure
16.2 Cell infusion episodes
16.3 Combined/concomitant therapies planned before this Cellular No

Therapy treatment to optimize efficency
Yes
16.3.1 If 'Combined/concomitant therapies planned before this

Cellular Therapy treatment to optimize efficency' is equal
to 'Yes' answer this question:
Specify
16.3.2 If 'Combined/concomitant therapies planned before this No

Yes
Given simultaneously to the CT
16.3.3 If 'Combined/concomitant therapies planned before this No

Yes
Given after CT was finished
17. Day 0 - Survival status

17.1 Survival status
Dead
Notice shown if field's value is equal to Dead: 'The current
Alive
patient is dead. Please, fill the Death report and do not
continue with further data entry.'
17.1.1 If 'Survival status' is equal to 'Dead' answer this

question:
Death report
18. Day 100 - Follow up - Patient identification

(dd-mm-yyyy)
18.3 Date of this report validity check

No: 'Date of this report cannot be prior to date of Day 0
assessment.'
18.5 Date of birth
18.6 Sex
19. Day 100 - Follow up - Recovery

19.1 Absolute neutrophil count (ANC) recovery
No
Yes
Never below
Unknown
19.1.1 If 'Absolute neutrophil count (ANC) recovery' is equal to (dd-mm-yyyy)

'No' answer this question:

19.1.2 If 'Absolute neutrophil count (ANC) recovery' is equal to


No: 'Date of last assessment cannot be prior to date of cell
infusion.'
19.1.3 If 'Absolute neutrophil count (ANC) recovery' is equal to (dd-mm-yyyy)

'Yes' answer this question:
Date of ANC recovery

19.1.4 If 'Absolute neutrophil count (ANC) recovery' is equal to

ANC recovery date validity check

No: 'Date of ANC recovery cannot be prior to date of cell
infusion.'
19.2 Platelets >20 10^9/l
No
Yes - Date available
Yes - Date unknown - Patient discharged
beforehand
Yes - Date unknown - Outpatient
Never Below
Unknown
19.2.1 If 'Platelets >20 10^9/l' is equal to 'Yes - Date available' (dd-mm-yyyy)

Date platelets >20

19.2.2 If 'Platelets >20 10^9/l' is equal to 'Yes - Date available'

Date platelets > 20 validity check

No: 'Date of platelets > 20 cannot be prior to date of cell
infusion.'
19.2.3 If 'Platelets >20 10^9/l' is equal to 'No' answer this (dd-mm-yyyy)

question:

19.3 Platelets >50 10^9/l
No
beforehand
Never Below
Unknown
19.3.1 If 'Platelets >50 10^9/l' is equal to 'Yes - Date available' (dd-mm-yyyy)

Date platelets >50

19.3.2 If 'Platelets >50 10^9/l' is equal to 'Yes - Date available'


infusion or prior to platelets > 20'
19.3.3 If 'Platelets >50 10^9/l' is equal to 'No' answer this (dd-mm-yyyy)

question:

19.4 Date last platelet transfusion
(dd-mm-yyyy)
19.5 Date last platelet transfusion validity check

No: 'Date of last platelet transfusion cannot be prior to date of
cell infusion.'
20. Day 100 - Follow up - Response to Cellular therapy

20.1 Best clinical/biological response after the entire cell therapy Complete remission
treatment
Partial remission
CRi
No response
Disease progression
Not evaluated
20.2 Date response evaluated
(dd-mm-yyyy)
20.3 Date response evaluation validity check

No: 'Date response evaluated cannot be prior to date of cell
collection.'
20.4 Last assessment for this report
(dd-mm-yyyy)
20.5 Date of last assessment for this report validity check

No: 'Date of last assessment for this report cannot be prior to
date of cell apheresis.'
21. Day 100 - Follow up - Current hematological findings

21.1 Was a hematological investigation performed?

No
Yes
21.1.1 If 'Was a hematological investigation performed?' is

Hb (g/dL)

Platelets (10^9/L)
21.1.3 If 'Was a hematological investigation performed?' is No

Yes
Were platelets transfused within 7 days before date of the
test?

White blood cells (10^9/L)

% haematocrit

Yes
Was RBC transfused within 30 days before the date of the
test?

% Lymphocytes

% Neutrophils

Yes
Was B-cell aplasia present during this period?
Unknown
21.1.9.1 If 'Was B-cell aplasia present during this period?' is

22. Day 100 - Follow up - Performance score

22.1 Performane system used
Karnofsky
Lansky
ECOG
Not evaluated
22.1.1 If 'Performane system used' is not equal to 'ECOG' Dead (0)

Moribund (10)
Very sick (20)

Disabled (40)
Care for self (70)
Normal (100)
22.1.2 If 'Performane system used' is equal to 'ECOG' answer Fully active (0)
this question:
Restricted (1)
ECOG score
Ambulatory (2)
Capable (3)
Dead (5)
23. Day 100 - Follow up - Complications since last report -

GvHD
23.1 Did GvHD occur?
No
Yes
23.1.1 If 'Did GvHD occur?' is equal to 'Yes' answer this Acute graft versus host disease
question:
Chronic graft versus host disease

Type of GvHD
Acute & Chronic
23.1.1.1 If 'Type of GvHD' is not equal to 'Chronic graft versus Grade I

host disease' answer this question:
Grade II
aGVHD maximum grade
Grade III
Grade IV
Present/Grade unknown
No aGvHD present
Not evaluated
23.1.2 If 'Did GvHD occur?' is equal to 'Yes' answer this New onset
question:
Recurrent
Indicate type
Persistent
23.1.3 If 'Did GvHD occur?' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset

23.1.4 If 'Did GvHD occur?' is equal to 'Yes' answer this

question:
Date response evaluation validity check

No: 'Date of onset cannot be prior to date of diagnosis.'
23.1.5 If 'Did GvHD occur?' is equal to 'Yes' answer this 0

question:
1
Skin stage
2
3
4

question:
1
Liver stage
2
3
4

question:
1
Lower GI stage
2
3
4

question:
1
Upper GI stage
2
3
4
23.1.9 If 'Did GvHD occur?' is equal to 'Yes' answer this No

question:
Yes
Other site affected

question:
Yes
Related to cell therapy

question:
Yes
Resolved?

question:
Yes
Treatment for acute GvHD?
23.1.12.1 If 'Treatment for acute GvHD?' is equal to 'Yes' answer Corticoesteroid

this question:
Monoclonal Antibodies (MoAB)

aGvHD treatment
ATG/ALG
Extra-corporeal photopheresis (ECP)
Other
23.1.12.1.1 If 'aGvHD treatment' is equal to 'Other' answer this

question:
Other, specify

question:
Yes
Presence of cGvHD during this period
23.1.13.1 If 'Presence of cGvHD during this period' is equal to No

First episode
Chronic GvHD episode
Recurrence
Continuous since last reported episode
Yes, but resolved
Yes, but resolved and recurred again
23.1.13.2 If 'Presence of cGvHD during this period' is equal to (dd-mm-yyyy)

Onset date

23.1.13.1.1 If 'Chronic GvHD episode' is not equal to 'No' answer

this question:
Date onset validity check

23.1.13.3 If 'Presence of cGvHD during this period' is equal to Limited

Extensive
Maximum extent during this period
Unknown
23.1.13.4 If 'Presence of cGvHD during this period' is equal to Mild

Moderate
Maximum NIH score during this period
Severe
Not calculated
24. Day 100 - Follow up - Complications since last report -

toxicities
24.1 Complications or toxicities during this period (within the 100 No
days)?
Yes
Not applicable
Unknown
24.1.1 If 'Complications or toxicities during this period (within

the 100 days)?' is equal to 'Yes' answer this question:
Date of onset remark
24.1.2 If 'Complications or toxicities during this period (within No

Yes
CRS
Not applicable
Unknown
24.1.2.1 If 'CRS' is equal to 'Yes' answer this question:

(dd-mm-yyyy)
CRS: Onset date

CRS: Grade

ASBMT/ASTCT grading system
Select scale/criteria was used to determine the Grade of CRS
Penn grading system
CTCAE grading system
2014 Lee grading system
MDACC
CARTOX grading system
Other grading system
Unknown
24.1.2.3.1 If 'Select scale/criteria was used to determine the Grade

of CRS' is equal to 'Other grading system' answer this
question:
If other scale/criteria, please specify

No
CRS: treated?
Yes
Not applicable
Unknown

No
CRS: Resolved?
Yes
Not applicable
Unknown

Yes
Neurotoxicity
Not applicable
Unknown
24.1.3.1 If 'Neurotoxicity' is equal to 'Yes' answer this question:

No
Neurotoxicity: Altered mental status
Yes
Not applicable
Unknown
24.1.3.1.1 If 'Neurotoxicity: Altered mental status' is equal to 'Yes' (dd-mm-yyyy)

Date of onset neurotoxicity: Altered mental status

24.1.3.1.2 If 'Neurotoxicity: Altered mental status' is equal to 'Yes'

Grade neurotoxicity: Altered mental status
24.1.3.1.3 If 'Neurotoxicity: Altered mental status' is equal to 'Yes' No

Yes
Neurotoxicity Altered mental status: treated?
Not applicable
Unknown

Yes
Neurotoxicity Altered mental status: resolved?
Not applicable
Unknown

No
Neurotoxicity: Aphasia
Yes
Not applicable
Unknown
24.1.3.2.1 If 'Neurotoxicity: Aphasia' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset neurotoxicity: Aphasia

24.1.3.2.2 If 'Neurotoxicity: Aphasia' is equal to 'Yes' answer this

question:
Grade neurotoxicity: Aphasia
24.1.3.2.3 If 'Neurotoxicity: Aphasia' is equal to 'Yes' answer this No

question:
Yes
Neurotoxicity Aphasia: treated?
Not applicable
Unknown

question:
Yes
Neurotoxicity Aphasia: resolved?
Not applicable
Unknown

No
Neurotoxicity: Hemiparesis or other focal motor deficit
Yes
Not applicable
Unknown
24.1.3.3.1 If 'Neurotoxicity: Hemiparesis or other focal motor (dd-mm-yyyy)

deficit' is equal to 'Yes' answer this question:
Date of onset neurotoxicity: Hemiparesis or other focal motor

deficit

24.1.3.3.2 If 'Neurotoxicity: Hemiparesis or other focal motor

Grade neurotoxicity: Hemiparesis or other focal motor deficit
24.1.3.3.3 If 'Neurotoxicity: Hemiparesis or other focal motor No

Yes
Neurotoxicity Hemiparesis or other focal motor deficit:
treated?
Not applicable
Unknown

Yes
resolved?
Not applicable
Unknown

No
Neurotoxicity: Seizures
Yes
Not applicable
Unknown
24.1.3.4.1 If 'Neurotoxicity: Seizures' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset neurotoxicity: Seizures

24.1.3.4.2 If 'Neurotoxicity: Seizures' is equal to 'Yes' answer this

question:
Grade neurotoxicity: Seizures
24.1.3.4.3 If 'Neurotoxicity: Seizures' is equal to 'Yes' answer this No

question:
Yes
Neurotoxicity Seizures: treated?
Not applicable
Unknown

question:
Yes
Neurotoxicity Seizures: resolved?
Not applicable
Unknown

No
Neurotoxicity: Tremors
Yes
Not applicable
Unknown
24.1.3.5.1 If 'Neurotoxicity: Tremors' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset neurotoxicity: Tremors

24.1.3.5.2 If 'Neurotoxicity: Tremors' is equal to 'Yes' answer this

question:
Grade neurotoxicity: Tremors
24.1.3.5.3 If 'Neurotoxicity: Tremors' is equal to 'Yes' answer this No

question:
Yes
Neurotoxicity Tremors: treated?
Not applicable
Unknown

question:
Yes
Neurotoxicity Tremors: resolved?
Not applicable
Unknown

No
Neurotoxicity: Visual hallucinations
Yes
Not applicable
Unknown
24.1.3.6.1 If 'Neurotoxicity: Visual hallucinations' is equal to 'Yes' (dd-mm-yyyy)

Date of onset neurotoxicity: Visual hallucinations

24.1.3.6.2 If 'Neurotoxicity: Visual hallucinations' is equal to 'Yes'

Grade neurotoxicity: Visual hallucinations
24.1.3.6.3 If 'Neurotoxicity: Visual hallucinations' is equal to 'Yes' No

Yes
Neurotoxicity Visual hallucinations: treated?
Not applicable
Unknown

Yes
Neurotoxicity Visual hallucinations: resolved?
Not applicable
Unknown

No
Neurotoxicity: Encephalopathy
Yes
Not applicable
Unknown
24.1.3.7.1 If 'Neurotoxicity: Encephalopathy' is equal to 'Yes' (dd-mm-yyyy)

Date of onset neurotoxicity: Encephalopathy

24.1.3.7.2 If 'Neurotoxicity: Encephalopathy' is equal to 'Yes'

Grade neurotoxicity: Encephalopathy
24.1.3.7.3 If 'Neurotoxicity: Encephalopathy' is equal to 'Yes' No

Yes
Neurotoxicity Encephalopathy: treated?
Not applicable
Unknown

Yes
Neurotoxicity Encephalopathy: resolved?
Not applicable
Unknown

No
Neurotoxicity: Cerebral edema
Yes
Not applicable
Unknown
24.1.3.8.1 If 'Neurotoxicity: Cerebral edema' is equal to 'Yes' (dd-mm-yyyy)

Date of onset neurotoxicity: Cerebral edema

24.1.3.8.2 If 'Neurotoxicity: Cerebral edema' is equal to 'Yes'

Grade neurotoxicity: Cerebral edema
24.1.3.8.3 If 'Neurotoxicity: Cerebral edema' is equal to 'Yes' No

Yes
Neurotoxicity Cerebral edema: treated?
Not applicable
Unknown

Yes
Neurotoxicity Cerebral edema: resolved?
Not applicable
Unknown

No
Neurotoxicity: other
Yes
Not applicable
Unknown
24.1.3.9.1 If 'Neurotoxicity: other' is equal to 'Yes' answer this

question:
Neurotoxicity: other, please specify
24.1.3.9.2 If 'Neurotoxicity: other' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset neurotoxicity: other


question:
Grade neurotoxicity: other
24.1.3.9.4 If 'Neurotoxicity: other' is equal to 'Yes' answer this No

question:
Yes
Neurotoxicity other: treated? add details in d100-post-
treatment sheet
Not applicable
Unknown

question:
Yes
Neurotoxicity other: resolved?
Not applicable
Unknown

Yes
Did Grade 3 and 4 organ toxicity as per CTCAE occur?
Not applicable
Unknown
24.1.4.1 If 'Did Grade 3 and 4 organ toxicity as per CTCAE No

occur?' is equal to 'Yes' answer this question:
Yes
Organ toxicity: skin
Not applicable
Unknown
24.1.4.1.1 If 'Organ toxicity: skin' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: skin

24.1.4.1.2 If 'Organ toxicity: skin' is equal to 'Yes' answer this

question:
Grade organ toxicity: skin
24.1.4.1.3 If 'Organ toxicity: skin' is equal to 'Yes' answer this No

question:
Yes
Organ toxicity skin: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity skin: resolved?
Not applicable
Unknown

Yes
Organ toxicity: liver
Not applicable
Unknown
24.1.4.2.1 If 'Organ toxicity: liver' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: liver

24.1.4.2.2 If 'Organ toxicity: liver' is equal to 'Yes' answer this

question:
Grade organ toxicity: liver
24.1.4.2.3 If 'Organ toxicity: liver' is equal to 'Yes' answer this No

question:
Yes
Organ toxicity liver: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity liver: resolved?
Not applicable
Unknown

Yes
Organ toxicity: lungs
Not applicable
Unknown
24.1.4.3.1 If 'Organ toxicity: lungs' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: lungs

24.1.4.3.2 If 'Organ toxicity: lungs' is equal to 'Yes' answer this

question:
Grade organ toxicity: lungs
24.1.4.3.3 If 'Organ toxicity: lungs' is equal to 'Yes' answer this No

question:
Yes
Organ toxicity lungs: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity lungs: resolved?
Not applicable
Unknown

Yes
Organ toxicity: Heart
Not applicable
Unknown
24.1.4.4.1 If 'Organ toxicity: Heart' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: heart

24.1.4.4.2 If 'Organ toxicity: Heart' is equal to 'Yes' answer this

question:
Grade organ toxicity: heart
24.1.4.4.3 If 'Organ toxicity: Heart' is equal to 'Yes' answer this No

question:
Yes
Organ toxicity heart: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity heart: resolved?
Not applicable
Unknown

Yes
Organ toxicity: kidney
Not applicable
Unknown
24.1.4.5.1 If 'Organ toxicity: kidney' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: kidney

24.1.4.5.2 If 'Organ toxicity: kidney' is equal to 'Yes' answer this

question:
Grade organ toxicity: kidney
24.1.4.5.3 If 'Organ toxicity: kidney' is equal to 'Yes' answer this No

question:
Yes
Organ toxicity kidney: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity kidney: resolved?
Not applicable
Unknown

Yes
Organ toxicity: gastrointestinal
Not applicable
Unknown
24.1.4.6.1 If 'Organ toxicity: gastrointestinal' is equal to 'Yes' (dd-mm-yyyy)

Date of onset organ toxicity: gastrointestinal

24.1.4.6.2 If 'Organ toxicity: gastrointestinal' is equal to 'Yes'

Grade organ toxicity: gastrointestinal
24.1.4.6.3 If 'Organ toxicity: gastrointestinal' is equal to 'Yes' No

Yes
Organ toxicity gastrointestinal: treated?
Not applicable
Unknown

Yes
Organ toxicity gastrointestinal: resolved?
Not applicable
Unknown

Yes
Organ toxicity: other
Not applicable
Unknown
24.1.4.7.1 If 'Organ toxicity: other' is equal to 'Yes' answer this

question:
Please specify other organ toxicities
24.1.4.7.2 If 'Organ toxicity: other' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: other


question:
Grade organ toxicity: other
24.1.4.7.4 If 'Organ toxicity: other' is equal to 'Yes' answer this No

question:
Yes
Organ toxicity other: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity other: resolved?
Not applicable
Unknown

Yes
Complication: TLS
Not applicable
Unknown
24.1.5.1 If 'Complication: TLS' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
TLS: onset date

24.1.5.2 If 'Complication: TLS' is equal to 'Yes' answer this

question:
TLS: grade
24.1.5.3 If 'Complication: TLS' is equal to 'Yes' answer this No

question:
Yes
TLS: treated?
Not applicable
Unknown

question:
Yes
TLS: resolved?
Not applicable
Unknown

Yes
Complication: hemorrhagic stroke
Not applicable
Unknown
24.1.6.1 If 'Complication: hemorrhagic stroke' is equal to 'Yes' (dd-mm-yyyy)

hemorrhagic stroke: onset date

24.1.6.2 If 'Complication: hemorrhagic stroke' is equal to 'Yes'

hemorrhagic stroke: grade
24.1.6.3 If 'Complication: hemorrhagic stroke' is equal to 'Yes' No

Yes
hemorrhagic stroke: treated?
Not applicable
Unknown

Yes
hemorrhagic stroke: resolved?
Not applicable
Unknown

Yes
Complication: Bone marrow aplasia/failure
Not applicable
Unknown
24.1.7.1 If 'Complication: Bone marrow aplasia/failure' is equal to (dd-mm-yyyy)

Bone marrow aplasia/failure: onset date

24.1.7.2 If 'Complication: Bone marrow aplasia/failure' is equal to

Bone marrow aplasia/failure: please specify

Bone marrow aplasia/failure: grade
24.1.7.4 If 'Complication: Bone marrow aplasia/failure' is equal to No

Yes
Bone marrow aplasia/failure: treated?
Not applicable
Unknown

Yes
Bone marrow aplasia/failure: resolved?
Not applicable
Unknown

Yes
Complication: Hypogammaglobulinemia
Not applicable
Unknown
24.1.8.1 If 'Complication: Hypogammaglobulinemia' is equal to (dd-mm-yyyy)

Hypogammaglobulinemia: onset date

24.1.8.2 If 'Complication: Hypogammaglobulinemia' is equal to No

Yes
Was hypogammaglobulinemia present before the cellular
therapy?
Not applicable
Unknown
24.1.8.2.1 If 'Was hypogammaglobulinemia present before the No

cellular therapy?' is equal to 'Yes' answer this question:
Yes
Was it worsened by the cellular therapy?
Not applicable
Unknown

Yes
Hypogammaglobulinemia: treated?
Not applicable
Unknown

Yes
Hypogammaglobulinemia: resolved?
Not applicable
Unknown

Yes
Complication: Insertional mutagenesis
Not applicable
Unknown
24.1.9.1 If 'Complication: Insertional mutagenesis' is equal to (dd-mm-yyyy)

Insertional mutagenesis: onset date

24.1.9.2 If 'Complication: Insertional mutagenesis' is equal to

Insertional mutagenesis: grade

Yes
Complication: exacerbation of existing neurological disorder
Not applicable
Unknown
24.1.10.1 If 'Complication: exacerbation of existing neurological (dd-mm-yyyy)

disorder' is equal to 'Yes' answer this question:
Exacerbation of existing neurological disorder: onset date

24.1.10.2 If 'Complication: exacerbation of existing neurological

Exacerbation of existing neurological disorder: please specify

Exacerbation of existing neurological disorder: grade
24.1.10.4 If 'Complication: exacerbation of existing neurological No

Yes
Exacerbation of existing neurological disorder: treated?
Not applicable
Unknown

Yes
Exacerbation of existing neurological disorder: resolved?
Not applicable
Unknown

Yes
Complication: other
Not applicable
Unknown
24.1.11.1 If 'Complication: other' is equal to 'Yes' answer this

question:
Other Complication
25. Day 100 - Follow up - Complications - Infections

25.1 Important information
25.2 Infection related complications?
No
Yes
Not applicable
Unknown
25.2.1 If 'Infection related complications?' is equal to 'Yes' No

Yes
Bacteremia
Not applicable
Unknown

Yes
Invasive fungal disease
Not applicable
Unknown

Yes
CNS infection
Not applicable
Unknown

Yes
Pneumonia
Not applicable
Unknown

Yes
C. difficile infection
Not applicable
Unknown

Yes
Abdominal infection
Not applicable
Unknown

Yes
Hepatitis
Not applicable
Unknown

Yes
Retinitis
Not applicable
Unknown

Yes
Cystitis
Not applicable
Unknown

Yes
Skin infection
Not applicable
Unknown

Yes
Upper respiratory tract infection
Not applicable
Unknown

Yes
CMV reactivation
Not applicable
Unknown

Yes
EBV reactivation
Not applicable
Unknown

Yes
HHV6 reactivation
Not applicable
Unknown

Yes
Adenovirus reactivation
Not applicable
Unknown

Yes
Other virus reactivation
Not applicable
Unknown

Yes
Other infectious complications
Not applicable
Unknown
25.2.18 If 'Infection related complications?' is equal to 'Yes'

Infections during this period of time
26. Day 100 - Follow up - Secondary malignancies

26.1 Did a secondary malignancy, lymphoproliferative, No

myeloproliferative or autoimmune disorder occur?
Yes
26.1.1 If 'Did a secondary malignancy, lymphoproliferative,

myeloproliferative or autoimmune disorder occur?' is
Diagnosis
26.1.2 If 'Did a secondary malignancy, lymphoproliferative, (dd-mm-yyyy)

Date of diagnosis


Date of diagnosis validity check

No: 'Date of diagnosis cannot be prior to date of cell infusion.'

Histologic Type

Location
26.1.6 If 'Did a secondary malignancy, lymphoproliferative, No

Yes
Secondary malignancy material preserved?
27. Day 100 - Follow up - Post-therapy treatment

27.1 Did the patient undergo additional treatment during or after No
the CT?
Yes
Unknown
27.1.1 If 'Did the patient undergo additional treatment during or (dd-mm-yyyy)

after the CT?' is equal to 'Yes' answer this question:
Start date of the additional treatment since last report
27.1.2 If 'Did the patient undergo additional treatment during or

Start date of additional treatment since last report validity

check

No: 'Start of additional treatment date cannot be prior to Day
0 report date.'
27.1.3 If 'Did the patient undergo additional treatment during or No

Yes
Unplanned treatment for complications/CT failure
Yes, not planned

Yes, reason unknown
Unknown

Yes
Drugs or chemotherapy
27.1.4.1 If 'Drugs or chemotherapy' is equal to 'Yes' answer this

question:
Drugs/Treatments

question:
Drug/Treatments for Complications & Infections

Yes
Unknown

question:
Other, specify
27.2 Is patient getting any medications not related to cell therapy No
or its indications?
Yes
Unknown
28. Day 100 - Follow up - First relapse/Progression or significant

worsening after cell therapy
28.1 First relapse or progression or significant worsening of organ No

function of the primary disease?
Yes
Continuous progression
28.1.1 If 'First relapse or progression or significant worsening (dd-mm-yyyy)

of organ function of the primary disease?' is equal to
Date of relapse

28.1.2 If 'First relapse or progression or significant worsening

Date of relapse validity check

No: 'Date of relapse cannot be prior to date of cell infusion.'
29. Day 100 - Follow up - Last disease status

29.1 Last disease status
Complete remission
Partial remission
No response
Disease progression
Not evaluated
29.2 If 'Primary disease' is equal to 'Lymphoma' answer this No

question:
Yes
For lymphoma patient only: histological verification of
relapse?
29.3 If 'Primary disease' is equal to 'Haemoglobinopathy' No transfusions required

Transfusions required
For haemoglobinopathy patient only: transfusion status
29.3.1 If 'For haemoglobinopathy patient only: transfusion (dd-mm-yyyy)

status' is equal to 'Transfusions required' answer this
question:
Date of first transfusion

29.3.2 If 'For haemoglobinopathy patient only: transfusion

question:
Date of first transfusion validity check

No: 'Date of first transfusion cannot be prior to date of cell
infusion.'
29.4 Disease burden: LDH level
Normal
Elevated
Not evaluated
29.5 Inflammatory state (C-reactive protein [CPR] concentration)
Normal
Elevated
Not evaluated
29.5.1 If 'Inflammatory state (C-reactive protein [CPR]

concentration)' is equal to 'Elevated' answer this
question:
Maximum CRP concentration
29.5.2 If 'Inflammatory state (C-reactive protein [CPR] mg/dL

mg/L
question:
Unit
29.6 Date of C-reactive protein level assessment
(dd-mm-yyyy)
30. Day 100 - Follow up - Hospital admission

30.1 Was inpatient admission and care needed? (not ICU)
No
Yes
Unknown
30.2 Was the patient transferred to the Intensive Care Unit?
No
Yes
Unknown
31. Day 100 - Follow up - Persistence of the Infused cells

31.1 Were tests performed to detect the persistence of the cellular No
products during this period?
Yes
31.1.1 If 'Were tests performed to detect the persistence of the (dd-mm-yyyy)

cellular products during this period?' is equal to 'Yes'
Date of the last test

31.1.2 If 'Were tests performed to detect the persistence of the

Date of last test validity check

No: 'Date of last test cannot be prior to date of cell infusion.'
31.1.3 If 'Were tests performed to detect the persistence of the Bone marrow
Peripheral blood
Source of cells used for the test
Tumour
Other
31.1.3.1 If 'Source of cells used for the test' is equal to 'Other'

Other source, specify
31.1.4 If 'Were tests performed to detect the persistence of the No

Yes
Technique used: molecular (PCR)
Unknown

Yes
Technique used: flow cytometry
Unknown

Yes
Technique used: chimaerism
Unknown

Yes
Technique used: imaging
Unknown

Yes
Technique used: immunohistochemistry
Unknown

Yes
Technique used: other
Unknown
31.1.9.1 If 'Technique used: other' is equal to 'Yes' answer this

question:
Other, specify

Yes
Were cells detected?
32. Day 100 - Follow up - Survival status

Dead
Alive
32.2 Survival status validity check

No: 'Performance score is reported to be dead. Please, check
performance score and survival status and adjust where
necessary.'

question:
Death report
33. 6 Months - Follow up - Patient identification

(dd-mm-yyyy)
33.3 Date of this report validity check

No: 'Date of this report cannot be prior to date of Day 100
assessment.'
33.5 Date of birth
33.6 Sex
34. 6 Months - Follow up - Recovery

34.1 ANC Recovery check
34.1.1 If 'ANC Recovery check' is not equal to 'Recovery already No

achieved.' answer this question:
Yes
Absolute neutrophil count (ANC) recovery
Never below
Unknown
34.1.1.1 If 'Absolute neutrophil count (ANC) recovery' is equal to (dd-mm-yyyy)


34.1.1.2 If 'Absolute neutrophil count (ANC) recovery' is equal to


No: 'Date of last assessment cannot be prior to date of cell
infusion.'
34.1.1.3 If 'Absolute neutrophil count (ANC) recovery' is equal to (dd-mm-yyyy)

Date of ANC recovery

34.1.1.4 If 'Absolute neutrophil count (ANC) recovery' is equal to

ANC recovery date validity check

No: 'Date of ANC recovery cannot be prior to date of cell
infusion.'


Platelets >20 10^9/l

beforehand
Never Below
Unknown
34.1.2.1 If 'Platelets >20 10^9/l' is equal to 'Yes - Date available' (dd-mm-yyyy)

Date platelets >20

34.1.2.2 If 'Platelets >20 10^9/l' is equal to 'Yes - Date available'


infusion.'
34.1.2.3 If 'Platelets >20 10^9/l' is equal to 'No' answer this (dd-mm-yyyy)

question:



Platelets >50 10^9/l

beforehand
Never Below
Unknown
34.1.3.1 If 'Platelets >50 10^9/l' is equal to 'Yes - Date available' (dd-mm-yyyy)

Date platelets >50

34.1.3.2 If 'Platelets >50 10^9/l' is equal to 'Yes - Date available'


infusion or prior to platelets > 20'
34.1.3.3 If 'Platelets >50 10^9/l' is equal to 'No' answer this (dd-mm-yyyy)

question:

34.1.4 If 'ANC Recovery check' is not equal to 'Recovery already (dd-mm-yyyy)

Date last platelet transfusion

34.1.5 If 'ANC Recovery check' is not equal to 'Recovery already

Date last platelet transfusion validity check

No: 'Date of last platelet transfusion cannot be prior to date of
cell infusion.'
35. 6 Months - Follow up - Response to Cellular therapy

35.1 Best clinical/biological response after the entire cell therapy Complete remission
treatment
Partial remission
CRi
No response
Disease progression
Not evaluated
35.2 Date response evaluated
(dd-mm-yyyy)
35.3 Date response evaluation validity check

No: 'Date response evaluated cannot be prior date of cell
infusion.'
35.4 Last assessment for this report
(dd-mm-yyyy)
35.5 Date of last assessment for this report validity check

No: 'Date of last assessment for this report cannot be prior
date of last assessment for the previous follow up.'
36. 6 Months - Follow up - Current hematological findings

36.1 Was a hematological investigation performed?

No
Yes

Hb (g/dL)

Platelets (10^9/L)

Yes
Were platelets transfused within 7 days before date of the
test?

White blood cells (10^9/L)

% haematocrit

Yes
Was RBC transfused within 30 days before the date of the
test?

% Lymphocytes

% Neutrophils

Yes
Was B-cell aplasia present during this period?
Unknown
36.1.9.1 If 'Was B-cell aplasia present during this period?' is

37. 6 Months - Follow up - Performance score

37.1 Performane system used
Karnofsky
Lansky
ECOG
Not evaluated
37.1.1 If 'Performane system used' is not equal to 'ECOG' Dead (0)

Moribund (10)
Very sick (20)

Disabled (40)
Care for self (70)
Normal (100)
37.1.2 If 'Performane system used' is equal to 'ECOG' answer Fully active (0)
this question:
Restricted (1)
ECOG score
Ambulatory (2)
Capable (3)
Dead (5)
38. 6 Months - Follow up - Complications since last report -

GvHD
38.1 Did GvHD occur?
No
Yes
38.1.1 If 'Did GvHD occur?' is equal to 'Yes' answer this Acute graft versus host disease
question:
Chronic graft versus host disease

Type of GvHD
Acute & Chronic
38.1.1.1 If 'Type of GvHD' is not equal to 'Chronic graft versus Grade I

host disease' answer this question:
Grade II
aGVHD maximum grade
Grade III
Grade IV
Present/Grade unknown
No aGvHD present
Not evaluated
38.1.2 If 'Did GvHD occur?' is equal to 'Yes' answer this New onset
question:
Recurrent
Indicate type
Persistent
38.1.3 If 'Did GvHD occur?' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset

38.1.4 If 'Did GvHD occur?' is equal to 'Yes' answer this

question:
Date response evaluation validity check


question:
1
Skin stage
2
3
4

question:
1
Liver stage
2
3
4

question:
1
Lower GI stage
2
3
4

question:
1
Upper GI stage
2
3
4

question:
Yes
Other site affected

question:
Yes
Related to cell therapy

question:
Yes
Resolved?

question:
Yes
Treatment for acute GvHD?
38.1.12.1 If 'Treatment for acute GvHD?' is equal to 'Yes' answer Corticoesteroid

this question:
Monoclonal Antibodies (MoAB)

aGvHD treatment
ATG/ALG
Extra-corporeal photopheresis (ECP)
Other
38.1.12.1.1 If 'aGvHD treatment' is equal to 'Other' answer this

question:
Other, specify

question:
Yes
Presence of cGvHD during this period
38.1.13.1 If 'Presence of cGvHD during this period' is equal to No

First episode
Chronic GvHD episode
Recurrence
Continuous since last reported episode
Yes, but resolved
Yes, but resolved and recurred again
38.1.13.2 If 'Presence of cGvHD during this period' is equal to (dd-mm-yyyy)

Onset date

38.1.13.1.1 If 'Chronic GvHD episode' is not equal to 'No' answer

this question:
Date onset validity check

38.1.13.3 If 'Presence of cGvHD during this period' is equal to Limited

Extensive
Maximum extent during this period
Unknown
38.1.13.4 If 'Presence of cGvHD during this period' is equal to Mild

Moderate
Maximum NIH score during this period
Severe
Not calculated
39. 6 Months - Follow up - Complications since last report -

toxicities
39.1 Complications or toxicities during this period (within the 6 No

months)?
Yes
Not applicable
Unknown
39.1.1 If 'Complications or toxicities during this period (within

the 6 months)?' is equal to 'Yes' answer this question:
Date of onset remark

Yes
CRS
Not applicable
Unknown

(dd-mm-yyyy)
CRS: Onset date

CRS: Grade

ASBMT/ASTCT grading system
Select scale/criteria was used to determine the Grade of CRS
Penn grading system
CTCAE grading system
2014 Lee grading system
MDACC
CARTOX grading system
Other grading system
Unknown
39.1.2.3.1 If 'Select scale/criteria was used to determine the Grade

of CRS' is equal to 'Other grading system' answer this
question:
If other scale/criteria, please specify

No
CRS: treated?
Yes
Not applicable
Unknown

No
CRS: Resolved?
Yes
Not applicable
Unknown

Yes
Neurotoxicity
Not applicable
Unknown

No
Neurotoxicity: Altered mental status
Yes
Not applicable
Unknown
39.1.3.1.1 If 'Neurotoxicity: Altered mental status' is equal to 'Yes' (dd-mm-yyyy)

Date of onset neurotoxicity: Altered mental status

39.1.3.1.2 If 'Neurotoxicity: Altered mental status' is equal to 'Yes'

Grade neurotoxicity: Altered mental status

Yes
Neurotoxicity Altered mental status: treated?
Not applicable
Unknown

Yes
Neurotoxicity Altered mental status: resolved?
Not applicable
Unknown

No
Neurotoxicity: Aphasia
Yes
Not applicable
Unknown
39.1.3.2.1 If 'Neurotoxicity: Aphasia' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset neurotoxicity: Aphasia

39.1.3.2.2 If 'Neurotoxicity: Aphasia' is equal to 'Yes' answer this

question:
Grade neurotoxicity: Aphasia

question:
Yes
Neurotoxicity Aphasia: treated?
Not applicable
Unknown

question:
Yes
Neurotoxicity Aphasia: resolved?
Not applicable
Unknown

No
Neurotoxicity: Hemiparesis or other focal motor deficit
Yes
Not applicable
Unknown
39.1.3.3.1 If 'Neurotoxicity: Hemiparesis or other focal motor (dd-mm-yyyy)

Date of onset neurotoxicity: Hemiparesis or other focal motor

deficit

39.1.3.3.2 If 'Neurotoxicity: Hemiparesis or other focal motor

Grade neurotoxicity: Hemiparesis or other focal motor deficit

Yes
treated?
Not applicable
Unknown

Yes
resolved?
Not applicable
Unknown

No
Neurotoxicity: Seizures
Yes
Not applicable
Unknown
39.1.3.4.1 If 'Neurotoxicity: Seizures' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset neurotoxicity: Seizures

39.1.3.4.2 If 'Neurotoxicity: Seizures' is equal to 'Yes' answer this

question:
Grade neurotoxicity: Seizures

question:
Yes
Neurotoxicity Seizures: treated?
Not applicable
Unknown

question:
Yes
Neurotoxicity Seizures: resolved?
Not applicable
Unknown

No
Neurotoxicity: Tremors
Yes
Not applicable
Unknown
39.1.3.5.1 If 'Neurotoxicity: Tremors' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset neurotoxicity: Tremors

39.1.3.5.2 If 'Neurotoxicity: Tremors' is equal to 'Yes' answer this

question:
Grade neurotoxicity: Tremors

question:
Yes
Neurotoxicity Tremors: treated?
Not applicable
Unknown

question:
Yes
Neurotoxicity Tremors: resolved?
Not applicable
Unknown

No
Neurotoxicity: Visual hallucinations
Yes
Not applicable
Unknown
39.1.3.6.1 If 'Neurotoxicity: Visual hallucinations' is equal to 'Yes' (dd-mm-yyyy)

Date of onset neurotoxicity: Visual hallucinations

39.1.3.6.2 If 'Neurotoxicity: Visual hallucinations' is equal to 'Yes'

Grade neurotoxicity: Visual hallucinations

Yes
Neurotoxicity Visual hallucinations: treated?
Not applicable
Unknown

Yes
Neurotoxicity Visual hallucinations: resolved?
Not applicable
Unknown

No
Neurotoxicity: Encephalopathy
Yes
Not applicable
Unknown
39.1.3.7.1 If 'Neurotoxicity: Encephalopathy' is equal to 'Yes' (dd-mm-yyyy)

Date of onset neurotoxicity: Encephalopathy

39.1.3.7.2 If 'Neurotoxicity: Encephalopathy' is equal to 'Yes'

Grade neurotoxicity: Encephalopathy

Yes
Neurotoxicity Encephalopathy: treated?
Not applicable
Unknown

Yes
Neurotoxicity Encephalopathy: resolved?
Not applicable
Unknown

No
Neurotoxicity: Cerebral edema
Yes
Not applicable
Unknown
39.1.3.8.1 If 'Neurotoxicity: Cerebral edema' is equal to 'Yes' (dd-mm-yyyy)

Date of onset neurotoxicity: Cerebral edema

39.1.3.8.2 If 'Neurotoxicity: Cerebral edema' is equal to 'Yes'

Grade neurotoxicity: Cerebral edema

Yes
Neurotoxicity Cerebral edema: treated?
Not applicable
Unknown

Yes
Neurotoxicity Cerebral edema: resolved?
Not applicable
Unknown

No
Neurotoxicity: other
Yes
Not applicable
Unknown

question:
Neurotoxicity: other, please specify
39.1.3.9.2 If 'Neurotoxicity: other' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset neurotoxicity: other


question:
Grade neurotoxicity: other

question:
Yes
Neurotoxicity other: treated? add details in d100-post-
treatment sheet
Not applicable
Unknown

question:
Yes
Neurotoxicity other: resolved?
Not applicable
Unknown

Yes
Did Grade 3 and 4 organ toxicity as per CTCAE occur?
Not applicable
Unknown

Yes
Organ toxicity: skin
Not applicable
Unknown
39.1.4.1.1 If 'Organ toxicity: skin' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: skin

39.1.4.1.2 If 'Organ toxicity: skin' is equal to 'Yes' answer this

question:
Grade organ toxicity: skin

question:
Yes
Organ toxicity skin: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity skin: resolved?
Not applicable
Unknown

Yes
Organ toxicity: liver
Not applicable
Unknown
39.1.4.2.1 If 'Organ toxicity: liver' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: liver

39.1.4.2.2 If 'Organ toxicity: liver' is equal to 'Yes' answer this

question:
Grade organ toxicity: liver

question:
Yes
Organ toxicity liver: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity liver: resolved?
Not applicable
Unknown

Yes
Organ toxicity: lungs
Not applicable
Unknown
39.1.4.3.1 If 'Organ toxicity: lungs' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: lungs

39.1.4.3.2 If 'Organ toxicity: lungs' is equal to 'Yes' answer this

question:
Grade organ toxicity: lungs

question:
Yes
Organ toxicity lungs: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity lungs: resolved?
Not applicable
Unknown

Yes
Organ toxicity: Heart
Not applicable
Unknown
39.1.4.4.1 If 'Organ toxicity: Heart' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: heart

39.1.4.4.2 If 'Organ toxicity: Heart' is equal to 'Yes' answer this

question:
Grade organ toxicity: heart

question:
Yes
Organ toxicity heart: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity heart: resolved?
Not applicable
Unknown

Yes
Organ toxicity: kidney
Not applicable
Unknown
39.1.4.5.1 If 'Organ toxicity: kidney' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: kidney

39.1.4.5.2 If 'Organ toxicity: kidney' is equal to 'Yes' answer this

question:
Grade organ toxicity: kidney

question:
Yes
Organ toxicity kidney: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity kidney: resolved?
Not applicable
Unknown

Yes
Organ toxicity: gastrointestinal
Not applicable
Unknown
39.1.4.6.1 If 'Organ toxicity: gastrointestinal' is equal to 'Yes' (dd-mm-yyyy)

Date of onset organ toxicity: gastrointestinal

39.1.4.6.2 If 'Organ toxicity: gastrointestinal' is equal to 'Yes'

Grade organ toxicity: gastrointestinal

Yes
Organ toxicity gastrointestinal: treated?
Not applicable
Unknown

Yes
Organ toxicity gastrointestinal: resolved?
Not applicable
Unknown

Yes
Organ toxicity: other
Not applicable
Unknown

question:
Please specify other organ toxicities
39.1.4.7.2 If 'Organ toxicity: other' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
Date of onset organ toxicity: other


question:
Grade organ toxicity: other

question:
Yes
Organ toxicity other: treated?
Not applicable
Unknown

question:
Yes
Organ toxicity other: resolved?
Not applicable
Unknown

Yes
Complication: TLS
Not applicable
Unknown
39.1.5.1 If 'Complication: TLS' is equal to 'Yes' answer this (dd-mm-yyyy)

question:
TLS: onset date

39.1.5.2 If 'Complication: TLS' is equal to 'Yes' answer this

question:
TLS: grade

question:
Yes
TLS: treated?
Not applicable
Unknown

question:
Yes
TLS: resolved?
Not applicable
Unknown

Yes
Complication: hemorrhagic stroke
Not applicable
Unknown
39.1.6.1 If 'Complication: hemorrhagic stroke' is equal to 'Yes' (dd-mm-yyyy)

hemorrhagic stroke: onset date

39.1.6.2 If 'Complication: hemorrhagic stroke' is equal to 'Yes'

hemorrhagic stroke: grade

Yes
hemorrhagic stroke: treated?
Not applicable
Unknown

Yes
hemorrhagic stroke: resolved?
Not applicable
Unknown

Yes
Complication: Bone marrow aplasia/failure
Not applicable
Unknown
39.1.7.1 If 'Complication: Bone marrow aplasia/failure' is equal to (dd-mm-yyyy)

Bone marrow aplasia/failure: onset date


Bone marrow aplasia/failure: please specify

Bone marrow aplasia/failure: grade

Yes
Bone marrow aplasia/failure: treated?
Not applicable
Unknown

Yes
Bone marrow aplasia/failure: resolved?
Not applicable
Unknown

Yes
Complication: Hypogammaglobulinemia
Not applicable
Unknown
39.1.8.1 If 'Complication: Hypogammaglobulinemia' is equal to (dd-mm-yyyy)

Hypogammaglobulinemia: onset date


Yes
Was hypogammaglobulinemia present before the cellular
therapy?
Not applicable
Unknown
39.1.8.2.1 If 'Was hypogammaglobulinemia present before the No

Yes
Was it worsened by the cellular therapy?
Not applicable
Unknown

Yes
Hypogammaglobulinemia: treated?
Not applicable
Unknown

Yes
Hypogammaglobulinemia: resolved?
Not applicable
Unknown

Yes
Complication: Insertional mutagenesis
Not applicable
Unknown
39.1.9.1 If 'Complication: Insertional mutagenesis' is equal to (dd-mm-yyyy)

Insertional mutagenesis: onset date

39.1.9.2 If 'Complication: Insertional mutagenesis' is equal to

Insertional mutagenesis: grade

Yes
Complication: exacerbation of existing neurological disorder
Not applicable
Unknown
39.1.10.1 If 'Complication: exacerbation of existing neurological (dd-mm-yyyy)

Exacerbation of existing neurological disorder: onset date


Exacerbation of existing neurological disorder: please specify

Exacerbation of existing neurological disorder: grade

Yes
Exacerbation of existing neurological disorder: treated?
Not applicable
Unknown

Yes
Exacerbation of existing neurological disorder: resolved?
Not applicable
Unknown

Yes
Complication: other
Not applicable
Unknown
39.1.11.1 If 'Complication: other' is equal to 'Yes' answer this

question:
Other Complication
40. 6 Months - Follow up - Complications - Infections

40.1 Important information
40.2 Infection related complications?
No
Yes
Not applicable
Unknown

Yes
Bacteremia
Not applicable
Unknown

Yes
Invasive fungal disease
Not applicable
Unknown

Yes
CNS infection
Not applicable
Unknown

Yes
Pneumonia
Not applicable
Unknown

Yes
C. difficile infection
Not applicable
Unknown

Yes
Abdominal infection
Not applicable
Unknown

Yes
Hepatitis
Not applicable
Unknown

Yes
Retinitis
Not applicable
Unknown

Yes
Cystitis
Not applicable
Unknown

Yes
Skin infection
Not applicable
Unknown

Yes
Upper respiratory tract infection
Not applicable
Unknown

Yes
CMV reactivation
Not applicable
Unknown

Yes
EBV reactivation
Not applicable
Unknown

Yes
HHV6 reactivation
Not applicable
Unknown

Yes
Adenovirus reactivation
Not applicable
Unknown

Yes
Other virus reactivation
Not applicable
Unknown

Yes
Other infectious complications
Not applicable
Unknown
40.2.18 If 'Infection related complications?' is equal to 'Yes'

Infections during this period of time
41. 6 Months - Follow up - Secondary malignancy

41.1 Did a secondary malignancy, lymphoproliferative, No

myeloproliferative or autoimmune disorder occur?
Yes

Diagnosis
41.1.2 If 'Did a secondary malignancy, lymphoproliferative, (dd-mm-yyyy)

Date of diagnosis


Date of diagnosis validity check

No: 'Date of diagnosis cannot be prior to date of cell infusion.'

Histologic Type

Location
41.1.6 If 'Did a secondary malignancy, lymphoproliferative, No

Yes
Secondary malignancy material preserved?
42. 6 Months - Follow up - Post therapy treatment

42.1 Did the patient undergo additional treatment during or after No
the CT?
Yes
Unknown
42.1.1 If 'Did the patient undergo additional treatment during or (dd-mm-yyyy)

Start date of the additional treatment since last report
42.1.2 If 'Did the patient undergo additional treatment during or

Start date of additional treatment since last report validity

check

No: 'Start of additional treatment date cannot be prior to Day
0 report date.'

Yes
Unplanned treatment for complications/CT failure
Yes, not planned

Yes, reason unknown
Unknown

Yes
Drugs or chemotherapy

question:
Drugs/Treatments

question:
Drug/Treatments for Complications & Infections

Yes
Unknown

question:
Other, specify
42.2 Is patient getting any medications not related to cell therapy No
or its indications?
Yes
Unknown
43. 6 Months - Follow up - First relapse/ Progression or

significant worsening after cell therapy
43.1 First relapse or progression or significant worsening of organ No

function of the primary disease?
Yes
Continuous progression
43.1.1 If 'First relapse or progression or significant worsening (dd-mm-yyyy)

Date of relapse

43.1.2 If 'First relapse or progression or significant worsening

Date of relapse validity check

No: 'Date of relapse cannot be prior to date of cell infusion.'
44. 6 Months - Follow up - Last disease status

44.1 Last disease status
Complete remission
Partial remission
No response
Disease progression
Not evaluated
44.2 If 'Primary disease' is equal to 'Lymphoma' answer this No

question:
Yes
For lymphoma patient only: histological verification of
relapse?
44.3 If 'Primary disease' is equal to 'Haemoglobinopathy' No transfusions required

Transfusions required
For haemoglobinopathy patient only: transfusion status
44.3.1 If 'For haemoglobinopathy patient only: transfusion (dd-mm-yyyy)

question:
Date of first transfusion

44.3.2 If 'For haemoglobinopathy patient only: transfusion

question:
Date of first transfusion validity check

No: 'Date of first transfusion cannot be prior to date of cell
infusion.'
44.4 Disease burden: LDH level
Normal
Elevated
Not evaluated
44.5 Inflammatory state (C-reactive protein [CPR] concentration)
Normal
Elevated
Not evaluated
44.5.1 If 'Inflammatory state (C-reactive protein [CPR]

question:
Maximum CRP concentration
44.5.2 If 'Inflammatory state (C-reactive protein [CPR] mg/dL

mg/L
question:
Unit
44.6 Date of C-reactive protein level assessment
(dd-mm-yyyy)
45. 6 Months - Follow up - Hospital admission

45.1 Was inpatient admission and care needed? (not ICU)
No
Yes
Unknown
45.2 Was the patient transferred to the Intensive Care Unit?
No
Yes
Unknown
46. 6 Months - Follow up - Pregnancy

46.1 Has patient or partner become pregnant after this cellular No
therapy?
Yes
Unknown
46.1.1 If 'Has patient or partner become pregnant after this No

Yes
Did the pregnancy result in a live birth?
Unknown
46.1.1.1 If 'Did the pregnancy result in a live birth?' is equal to Abortion

Stillbirth
Pregnancy outcome
46.1.1.2 If 'Did the pregnancy result in a live birth?' is equal to Healthy

Affected by a disease
Live birth: new born status
Information not provided
46.1.1.3 If 'Did the pregnancy result in a live birth?' is equal to Full-term

Premature
Live birth: length of term
Information not provided
47. 6 Months - Follow up - Persistence of the Infused cells

47.1 Were tests performed to detect the persistence of the cellular No
products during this period?
Yes
47.1.1 If 'Were tests performed to detect the persistence of the (dd-mm-yyyy)

Date of the last test

47.1.2 If 'Were tests performed to detect the persistence of the

Date of last test validity check

No: 'Date of last test cannot be prior to date of last test in
previous follow up.'
47.1.3 If 'Were tests performed to detect the persistence of the Bone marrow
Peripheral blood
Source of cells used for the test
Tumour
Other
47.1.3.1 If 'Source of cells used for the test' is equal to 'Other'

Other source, specify

Yes
Technique used: molecular (PCR)
Unknown

Yes
Technique used: flow cytometry
Unknown

Yes
Technique used: chimaerism
Unknown

Yes
Technique used: imaging
Unknown

Yes
Technique used: immunohistochemistry
Unknown

Yes
Technique used: other
Unknown
47.1.9.1 If 'Technique used: other' is equal to 'Yes' answer this

question:
Other, specify

Yes
Were cells detected?
48. 6 Months - Follow up - Survival status

Dead
Alive
48.2 Survival status validity check

No: 'Performance score is reported to be dead. Please, check
performance score and survival status and adjust where
necessary.'

question:
Death report
49. Annual - Follow up - Annual follow up selection

49.1 Add annual follow up to the patient

Cellular Therapy Data Collection - Castor

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21/11/2022 11:15 Cellular Therapy data collection - Castor

Cellular Therapy data collection -

1. Pre-infusion Registration - Informed consent

1.1 Consent to sharing data with EBMT?

1.1.1 If 'Consent to sharing data with EBMT?' is equal to 'Yes' (dd-mm-yyyy)

Date informed consent

Warning shown if field's value is larger than NOW: 'Date

1.1.2 If 'Consent to sharing data with EBMT?' is equal to 'Yes'

Informed consent date validation check

Warning shown if field's value is equal to Check successful:

2. Pre-infusion Registration - Centre identification

2.1 EBMT Code (CIC)

2.4 Contact person

3. Pre-infusion Registration - Patient data

3.1 EBMT Unique Identification Code

3.2 Date of this report

3.3 Hospital Unique Patient Number or Code

3.4 Other type of patient identification code

3.5 Date of birth

3.6 Date of birth validation check

Warning shown if field's value is equal to Check successful:

3.8 Initials (first name)

3.9 Initials (family name)

3.10 Patient ABO Blood group

3.11 Patient Rhesus factor

4. Pre-infusion Registration - Indication for Cellular therapy

4.1 Main indication for the therapy

Treatment of a primary disease

4.2 Primary disease

Primary acute leukemia

4.2.1 If 'Primary disease' is equal to 'Other primary disease'

Indicate other diagnosis/indication

4.3 Date of diagnosis

4.4 Date of diagnosis validity check

Warning shown if field's value is equal to Check successful:

5. Pre-infusion Registration - Basic information on planned

5.1 Clinical setting

Clinical trial/Investigational drug product

5.1.1 If 'Clinical setting' is equal to 'Clinical trial/Investigational 1

5.1.2 If 'Clinical setting' is equal to 'Clinical trial/Investigational No

5.1.3 If 'Clinical setting' is equal to 'Clinical trial/Investigational No

5.1.4 If 'Clinical setting' is equal to 'Clinical trial/Investigational

5.1.5 If 'Clinical setting' is equal to 'Clinical trial/Investigational

5.1.6 If 'Clinical setting' is equal to 'Clinical trial/Investigational

5.2 Cell origin

A donor that is already registered as part of a

6. Pre-infusion Registration - Donor information

6.1 If 'This product is manufactured from' is equal to 'A (dd-mm-yyyy)

Donor date of birth

Warning shown if field's value is larger than NOW: 'Date

6.2 If 'This product is manufactured from' is equal to 'A

Donor age at time of donation (years)

6.3 If 'This product is manufactured from' is equal to 'A

Donor age at time of donation (months)

6.4 If 'This product is manufactured from' is equal to 'A Male

6.5 If 'This product is manufactured from' is equal to 'A

Donor ID given by the centre

6.6 If 'This product is manufactured from' is equal to 'A

Global registration identifier for donors

6.7 If 'This product is manufactured from' is equal to 'A

Donor ID given by the Donor Registry

6.8 If 'This product is manufactured from' is equal to 'A

Donor ID given by the Cord Blood Bank