Besponsa - 2 cycles (Besponsa - 2 cycles)

Version:
Status: active
Unique ID: Identificatienummer van het Rijksregister
How to create a CSV file for this data collection?

Start date: 11/05/2020

Full view CSV column names Validation rules Reference lists Computed expressions Additional information CSV extract

1 Patient

Section help

According to our information, your patient was administered with Besponsa in cycle 1 and cycle 2, after which treatment was ended. If this information is not correct, please complete CIVARS for §9830300 and disregard this data request. A new request form will be send after completion of §9830300 in CIVARS.

patient identificator

Patient identificator

Help

Please encode a social security identification number (SSIN). Please note that the patient ID is always pseudonymised before being transferred to Healthdata.

Technical specs

CSV column name:

patient_id

Required:

true

Validation

The validity of the national register number is checked with the mod97 check.

Fields

Section help

Please encode a social security identification number (SSIN). Please note that the patient ID is always pseudonymised before being transferred to Healthdata.

text

Internal patient ID

Help

This field can be used to enter an internal ID or reference number. It is available for internal use only and is not transferred to Healthdata. If there is an integration between HD4DP and your organisation's patient administration system, additional patient identification information such as date of birth, sex and SSIN can be automatically enriched based on this internal patient ID. Please do not encode the social security identification number (SSIN) in this field. The SSIN must be encoded in the field 'National registry ID of the patient'.

Technical specs

CSV column name:

patient_id|internal_patient_id

Required:

false

boolean

Generated

Help

The patient_id|generated column can be set to 'TRUE' for an automatically generated patient_id.This column should only be added in case the patient_id is empty. If the column is set to 'TRUE', a patient_id is automatically generated based on the name, first name, date of birth and sex of the patient.

Technical specs

CSV column name:

patient_id|generated

Required:

false

Options

Label	Value
Yes	TRUE
No	FALSE

text

Name

Help

The name of the patient is never transferred to Healthdata and is available for your information only.

Technical specs

CSV column name:

patient_id|name

Required:

noSSIN(Needed only if no national register number is entered)

text

First name

Help

The first name of the patient is never transferred and is available for your information only.

Technical specs

CSV column name:

patient_id|first_name

Required:

noSSIN(Needed only if no national register number is entered)

date

Date of birth

Technical specs

Format:

DD/MM/YYYY

CSV column name:

patient_id|date_of_birth

Required:

noSSIN(Needed only if no national register number is entered)

choice

Sex

Technical specs

CSV column name:

patient_id|sex

Required:

noSSIN(Needed only if no national register number is entered)

Options

Label	Value
Female	F
Male	M
Unknown	U

text

Place of residence

Technical specs

CSV column name:

patient_id|place_of_residence

Reference list:

POSTAL_CODE

Only when:

Required:

false

boolean

Deceased?

Technical specs

CSV column name:

patient_id|deceased

Only when:

Required:

false

Options

Label	Value
Yes	TRUE
No	FALSE

date

Date of death

Technical specs

Format:

DD/MM/YYYY

CSV column name:

patient_id|date_of_death

Only when:

Required:

false

2 Physician

text

Treating physician

Technical specs

CSV column name:

CD_RIZIV_TREAT_PHYS

Reference list:

PHYSICIAN

Required:

true

3 Disease characteristics and treatment history

choice

Your patient was diagnosed with R/R B-cell ALL

Technical specs

CSV column name:

CD_C2_CD22_POS_BCP_ALL

Required:

true

Options

Label	Value
Philadelphia chromosome negative	1
Philadelphia chromosome positive	2

choice

In which salvage line has the patient been treated with Besponsa?

Technical specs

CSV column name:

CD_C2_PCP_SALV_THERPY

Only when:

Required:

true

Options

Label	Value
S1	1
S2	2
S3 or later	3

choice

What prior treatment did your patient receive in S1?

Technical specs

CSV column name:

CD_C2_PCP_S1_TREAT

Only when:

Required:

true

Options

Label	Value
TKI +/- chemotherapy	1
Other	99

choice

What prior treatment did your patient receive in S2?

Technical specs

CSV column name:

CD_C2_PCP_S2_TREAT

Only when:

Required:

true

Options

Label	Value
TKI +/- chemotherapy	1
Other	99

choice

What prior treatment did your patient receive in S3 (optional)?

Technical specs

CSV column name:

CD_C2_PCP_S3_TREAT

Only when:

Required:

false

Options

Label	Value
TKI +/- chemotherapy	1
Other	99

choice

In which salvage line has the patient been treated with Besponsa?

Technical specs

CSV column name:

CD_C2_PCN_SALV_THERPY

Only when:

Required:

true

Options

Label	Value
S1	1
S2	2
S3 or later	3

choice

What prior treatment did your patient receive in S1?

Technical specs

CSV column name:

CD_C2_PCN_S1_TREAT

Only when:

Required:

true

Options

Label	Value
Blinatumomab	1
Chemotherapy	2
Other	99

choice

What prior treatment did your patient receive in S2?

Technical specs

CSV column name:

CD_C2_PCN_S2_TREAT

Only when:

Required:

true

Options

Label	Value
Blinatumomab	1
Chemotherapy	2
Other	99

choice

What prior treatment did your patient receive in S3 (optional)?

Technical specs

CSV column name:

CD_C2_PCN_S3_TREAT

Only when:

Required:

false

Options

Label	Value
Blinatumomab	1
Chemotherapy	2
Other	99

4 HSCT eligibility

choice

At the start of Besponsa treatment did you intend to bring your patient to HSCT?

Technical specs

CSV column name:

CD_C2_HSCT_PLAN

Required:

true

Options

Label	Value
Yes	1
No	0

Validation

"Patient was ineligible for a HSCT at start of the treatment" is not in line with your previous response to the question “At the start of Besponsa treatment did you intend to bring your patient to HSCT?”. Please verify. (error)

5 Treatment outcomes

date

At which date was the first cycle of Besponsa treatment initiated?

Technical specs

Format:

DD/MM/YYYY

CSV column name:

DT_C2_TREAT_START

Required:

true

choice

Was CR/CRi achieved?

Technical specs

CSV column name:

CD_C2_CR

Required:

true

Options

Label	Value
Yes	1
No	0

Validation

"Insufficient response to Besponsa treatment" is not in line with your previous response to the question “Was CR/CRi obtained?”. Please verify. (error)
"CR/CRi achieved and intention to start follow-up treatment (other than HSCT)" is not in line with your previous response to the question “Was CR/CRi obtained?”. Please verify. (error)

choice

CR/CRi was obtained

Technical specs

CSV column name:

CD_C2_TM

Only when:

Required:

true

Options

Label	Value
During or after cycle 1	1
During or after cycle 2	2

choice

Did the patient reach MRD negativity?

Technical specs

CSV column name:

CD_C2_MRD_NEG

Only when:

Required:

true

Options

Label	Value
Yes	1
No	0
Unknown	99

choice

Did the patient undergo a HSCT following the Besponsa treatment?

Technical specs

CSV column name:

CD_C2_HSCT

Required:

true

Options

Label	Value
Yes	1
No	0

Validation

"Patient was ineligible for a HSCT at start of the treatment" is not in line with your previous response to the question “At the start of Besponsa treatment did you intend to bring your patient to HSCT?”. Please verify. (error)

date

What was the date of HSCT?

Technical specs

Format:

DD/MM/YYYY

CSV column name:

DT_C2_HSCT

Only when:

Required:

true

choice

Why didn't the patient undergo a HSCT?

Technical specs

CSV column name:

CD_C2_NO_HSCT_REAS

Only when:

Required:

true

Options

Label	Value
No donor available (or not compatible)	1
General health status of the patient did not allow for a HSCT	2
Patient received donor lymfocyte infusion	3
At patient request	4
Patient was ineligible for a HSCT at start of the treatment	5
Patient died before planned HSCT	6
Other	99

Validation

"Patient was ineligible for a HSCT at start of the treatment" is not in line with your previous response to the question “At the start of Besponsa treatment did you intend to bring your patient to HSCT?”. Please verify. (error)

multichoice

What is the reason for treatment discontinuation (multiple answers possible)?

Technical specs

CSV column name:

CD_C2_REAS_STOP

Only when:

Required:

true

Options

Label	Value
CR/CRi achieved and intention to start follow-up treatment (other than HSCT)	FL_C2_REAS_STOP_CR_FLLWUP
Insufficient response to Besponsa treatment	FL_C2_REAS_STOP_INSUFF_RESP
Global deterioration of health status	FL_C2_REAS_STOP_HEALTH_DETOR
Adverse event requiring discontinuation of treatment	FL_C2_REAS_STOP_AE
Patient refused continued treatment	FL_C2_REAS_STOP_REFUSAL
Patient died	FL_C2_REAS_STOP_DEAD
Other	FL_C2_REAS_STOP_OTH

Validation

"Insufficient response to Besponsa treatment" is not in line with your previous response to the question “Was CR/CRi obtained?”. Please verify. (error)
"CR/CRi achieved and intention to start follow-up treatment (other than HSCT)" is not in line with your previous response to the question “Was CR/CRi obtained?”. Please verify. (error)

6 Vial use

number

How many vials were used to treat the patient in paragraph 9830100?

Help

Please contact your hospital pharmacist to request the exact number of BESPONSA vials that were invoiced to RIZIV/INAMI for cycle 1.

Technical specs

CSV column name:

MS_VIALS_C1

Required:

true

number

How many vials were used to treat the patient in paragraph 9830200?

Help

Please contact your hospital pharmacist to request the exact number of BESPONSA vials that were invoiced to RIZIV/INAMI for cycle 2.

Technical specs

CSV column name:

MS_VIALS_C2

Required:

true