Evaluation of the new medication Kalydeco to treat cystic fibrosis (Kalydeco)

Version:
Status: inactive
Unique ID: patient ID
How to create a CSV file for this data collection?

Start date: 26/06/2017
End date creation: 12/08/2024
End date submission: 12/08/2024
End date comments: 12/08/2024

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

1 General

list

Treating physician

This is a container for multiple answers. See the reference documentation for more details. Below you can find the information about the fields of the container

Help

The RIZIV/INAMI code of the treating physician. If there are multiple treating physicians, multiple codes can be added. This information is encoded upon storage and can be decoded for two purposes only: 1) for individual and personalised feedback based on the collected data 2) for the award of the telematics premium by the RIZIV/INAMI (agreement medical doctors-health insurers).

List items

Section help

text

RIZIV/INAMI-code of the treating physician

Technical specs

CSV column name:

treating_physician|rizivinamicode_of_the_treating_physician

Length:

100

Reference list:

PHYSICIAN

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.HealthProfessional

Data element:

HealthProfessionalIdentificationNumber

patient identificator

National registry ID of the patient

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

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

PatientIdentificationNumber

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

Length:

Required:

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

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

LastName

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

Length:

Required:

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

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

FirstNames

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)

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

DateOfBirth

Validation

The difference between the Kalydeco treatment start date and the date of birth must be at least two years (error)

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

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

Gender

text

Place of residence

Technical specs

CSV column name:

patient_id|place_of_residence

Length:

Reference list:

POSTAL_CODE

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

Place of residence

boolean

Deceased?

Technical specs

CSV column name:

patient_id|deceased

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

DeathIndicator

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:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

DateOfDeath

date

Date of CF diagnosis

Technical specs

Format:

DD/MM/YYYY

CSV column name:

date_of_clinical_diagnosis

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatusDate

choice

Diagnosis confirmed

Technical specs

CSV column name:

diagnosis_confirmed

Required:

true

Options

Label	Value
No	1
Yes	2
To be confirmed	3
Unknown	4
Missing data	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatus

fieldset

Genotype

Fields

date

Date of genotype

Technical specs

Format:

DD/MM/YYYY

CSV column name:

legacy_name|date_of_genotype

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestDateTime

text

Mutation CFTR allele 1

Technical specs

CSV column name:

legacy_name|chromosome_1

Length:

Reference list:

CHROMOSOME

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

Result

Validation

Only the following mutations are registered for Kalydeco: G1244E, G1349D, G178R, G551D, G551S, S1251N, S1255P, S549N en S549R (error)

text

Mutation CFTR allele 2

Technical specs

CSV column name:

legacy_name|chromosome_2

Length:

Reference list:

CHROMOSOME

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

Result

Validation

Only the following mutations are registered for Kalydeco: G1244E, G1349D, G178R, G551D, G551S, S1251N, S1255P, S549N en S549R (error)

2 T0 - Baseline

fieldset

Transplants

Fields

choice

Transplant status

Technical specs

CSV column name:

transplants|transplant_status

Required:

true

Options

Label	Value
Not evaluated	1
Refused by transplant center	2
Waiting list	3
Received transplant	4
Evaluated but not on waiting list	5
Refused by patient	6
Missing Data	999

date

Precise date of first entering the Tx waiting list

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants|precise_date_of_first_entering_the_tx_waiting_list

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStartDate

date

Precise date of the most recent Tx

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants|precise_date_of_the_most_recent_tx

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureStartDate

fieldset

Anthropometry

Fields

number

Weight (kg)

Technical specs

CSV column name:

anthropometry|weight

Length:

3,3

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyWeight

Data element:

WeightValue

Validation

Weight cannot contain more than 3 decimals (error)
Weight cannot contain more than 3 decimals (error)
Weight cannot contain more than 3 decimals (error)
Weight cannot contain more than 3 decimals (error)
Weight cannot contain more than 3 decimals (error)
Weight cannot contain more than 3 decimals (error)
Weight cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Height (cm)

Technical specs

CSV column name:

anthropometry|height

Length:

3,3

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyHeight

Data element:

HeightValue

Validation

Height cannot contain more than 3 decimals (error)
Height cannot contain more than 3 decimals (error)
Height cannot contain more than 3 decimals (error)
Height cannot contain more than 3 decimals (error)
Height cannot contain more than 3 decimals (error)
Height cannot contain more than 3 decimals (error)
Height cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

BMI

Not to be included in the CSV.

Technical specs

CSV column name:

anthropometry|bmi

Length:

3,3

Computed:

Required:

false

number

Number of hospitalisation days for CF in last 12 months

Technical specs

CSV column name:

days_in_hospital

Length:

Required:

true

Validation

Number of hospitalisation days cannot contain any decimals (error)
Number of hospitalisation days cannot contain any decimals (error)
Number of hospitalisation days cannot contain any decimals (error)
Number of hospitalisation days cannot contain any decimals (error)
Number of hospitalisation days cannot contain any decimals (error)
Number of hospitalisation days cannot contain any decimals (error)
Number of hospitalisation days cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Number of exacerbations requiring IV antibiotics or hospitalisation in last 12 months

Help

Please provide most recent value prior to start of Kalydeco use

Technical specs

CSV column name:

number_of_exacerbations_requiring_iv_antibiotics_or_hospitalisation_in_last_12_months

Length:

Required:

true

Validation

Number of exacerbations cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of % predicted FEV1

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of__predicted_fev1

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultDateTime

number

% predicted FEV1

Help

Please provide most recent value prior to start of Kalydeco use

Technical specs

CSV column name:

_predicted_fev1

Length:

3,3

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultType

Validation

% predicted FEV1 cannot contain more than 3 decimals (error)
% predicted FEV1 cannot contain more than 3 decimals (error)
% predicted FEV1 cannot contain more than 3 decimals (error)
% predicted FEV1 cannot contain more than 3 decimals (error)
% predicted FEV1 cannot contain more than 3 decimals (error)
% predicted FEV1 cannot contain more than 3 decimals (error)
% predicted FEV1 cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of sweat test

Technical specs

Format:

DD/MM/YYYY

CSV column name:

date_of_sweat_test

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestDateTime

number

Sweat chloride (mmol/l)

Help

Please provide most recent value prior to start of Kalydeco use

Technical specs

CSV column name:

chloride

Length:

3,3

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

Result

Validation

Sweat chloride cannot contain more than 3 decimals (error)
Sweat chloride cannot contain more than 3 decimals (error)
Sweat chloride cannot contain more than 3 decimals (error)
Sweat chloride cannot contain more than 3 decimals (error)
Sweat chloride cannot contain more than 3 decimals (error)
Sweat chloride cannot contain more than 3 decimals (error)
Sweat chloride cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

choice

CF diabetes

Technical specs

CSV column name:

cf_diabetes

Required:

true

Options

Label	Value
No	1
IGT	2
CFRD	3
CFRD without fasting hyperglycemia	4
CFRD with fasting hyperglycemia	5
Missing data	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

OGTT done this year

Technical specs

CSV column name:

ogtt_done_this_year

Required:

true

Options

Label	Value
No	1
Yes	2
Missing	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestName

date

Kalydeco treatment start date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_start_date

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

Validation

The difference between the Kalydeco treatment start date and the date of birth must be at least two years (error)

3 T1 - 6 months

fieldset

Transplants

Fields

choice

Transplant status

Technical specs

CSV column name:

transplants_1|transplant_status

Only when:

Required:

true

Options

Label	Value
Not evaluated	1
Refused by transplant center	2
Waiting list	3
Received transplant	4
Evaluated but not on waiting list	5
Refused by patient	6
Missing Data	999

date

Precise date of first entering the Tx waiting list

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_1|precise_date_of_first_entering_the_tx_waiting_list_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStartDate

date

Precise date of the most recent Tx

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_1|precise_date_of_the_most_recent_tx_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureStartDate

fieldset

Anthropometry

Fields

number

Weight (kg)

Technical specs

CSV column name:

anthropometry_1|weight

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyWeight

Data element:

WeightValue

Validation

Weight cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Height (cm)

Technical specs

CSV column name:

anthropometry_1|height

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyHeight

Data element:

HeightValue

Validation

Height cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

BMI

Not to be included in the CSV.

Technical specs

CSV column name:

anthropometry_1|bmi

Length:

3,3

Computed:

Only when:

Required:

true

boolean

Treatment adherent

Technical specs

CSV column name:

treatment_adherent

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

boolean

Was the Kalydeco treatment stopped in the last 6 months?

Technical specs

CSV column name:

was_the_kalydeco_treatment_stopped_in_the_last_6_months

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment stop date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_stop_date_t1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

choice

Reason stop Kalydeco

Technical specs

CSV column name:

reason_stop_kalydeco_t1

Only when:

Required:

true

Options

Label	Value
Lack of efficacy	lack_of_efficacy
Safety	safety
Other CFTR treatment	other_cftr_treatment
Other	other

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

ReasonMedicationAgreement

Nested option fields

When other Is selected:
text
Specify
Technical specs
CSV column name:
reason_stop_kalydeco_t1|specify
Length:
200
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicationAgreement
Data element:
ReasonMedicationAgreement

boolean

Kalydeco treatment re-started

Technical specs

CSV column name:

kalydeco_treatment_restarted_t1

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment re-start date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_restart_date

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

number

Number of hospitalisation days for CF in last 6 months

Technical specs

CSV column name:

days_in_hospital_1

Length:

Only when:

Required:

true

Validation

Number of hospitalisation days cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Number of exacerbations requiring IV antibiotics or hospitalisation since start of Kalydeco use

Technical specs

CSV column name:

number_of_exacerbations_requiring_iv_antibiotics_or_hospitalisation_since_start_of_kalydeco_use_1

Length:

Only when:

Required:

true

Validation

Number of exacerbations cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of % predicted FEV1

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of__predicted_fev1_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultDateTime

number

% predicted FEV1

Technical specs

CSV column name:

_predicted_fev1_1

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultType

Validation

% predicted FEV1 cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of sweat test

Technical specs

Format:

DD/MM/YYYY

CSV column name:

date_of_sweat_test_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestDateTime

number

Sweat chloride (mmol/l)

Technical specs

CSV column name:

chloride_1

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

Result

Validation

Sweat chloride cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

choice

Clinical status

Technical specs

CSV column name:

clinical_status

Only when:

Required:

true

Options

Label	Value
Improved	improved
Stable	stable
Deteriorated	deteriorated

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatus

choice

CF diabetes

Technical specs

CSV column name:

cf_diabetes_1

Only when:

Required:

true

Options

Label	Value
No	1
IGT	2
CFRD	3
CFRD without fasting hyperglycemia	4
CFRD with fasting hyperglycemia	5
Missing data	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

OGTT done this year

Technical specs

CSV column name:

ogtt_done_this_year_1

Only when:

Required:

true

Options

Label	Value
No	1
Yes	2
Missing	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestName

boolean

Other CFTR treatment started

Technical specs

CSV column name:

other_cftr_treatment_started

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

Options

Label	Value
Yes	TRUE
No	FALSE

4 T2 - 12 months

fieldset

Transplants

Fields

choice

Transplant status

Technical specs

CSV column name:

transplants_2|transplant_status

Only when:

Required:

true

Options

Label	Value
Not evaluated	1
Refused by transplant center	2
Waiting list	3
Received transplant	4
Evaluated but not on waiting list	5
Refused by patient	6
Missing Data	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemType

date

Precise date of first entering the Tx waiting list

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_2|precise_date_of_first_entering_the_tx_waiting_list_2

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStartDate

date

Precise date of the most recent Tx

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_2|precise_date_of_the_most_recent_tx_2

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureStartDate

fieldset

Anthropometry

Fields

number

Weight (kg)

Technical specs

CSV column name:

anthropometry_2|weight

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyWeight

Data element:

WeightValue

Validation

Weight cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Height (cm)

Technical specs

CSV column name:

anthropometry_2|height

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyHeight

Data element:

HeightValue

Validation

Height cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

BMI

Not to be included in the CSV.

Technical specs

CSV column name:

anthropometry_2|bmi

Length:

3,3

Computed:

Only when:

Required:

true

boolean

Treatment adherent

Technical specs

CSV column name:

treatment_adherent_2

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

boolean

Was the Kalydeco treatment stopped in the last 6 months?

Technical specs

CSV column name:

was_the_kalydeco_treatment_stopped_in_the_last_6_months_2

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment stop date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_stop_date_t2

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

choice

Reason stop Kalydeco

Technical specs

CSV column name:

reason_stop_kalydeco_t2

Only when:

Required:

true

Options

Label	Value
Lack of efficacy	lack_of_efficacy
Safety	safety
Other CFTR treatment	other_cftr_treatment
Other	other

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

ReasonMedicationAgreement

Nested option fields

When other Is selected:
text
Specify
Technical specs
CSV column name:
reason_stop_kalydeco_t2|specify
Length:
200
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicationAgreement
Data element:
ReasonMedicationAgreement

boolean

Kalydeco treatment re-started

Technical specs

CSV column name:

kalydeco_treatment_restarted_t2

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment re-start date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_restart_date_2

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

number

Number of hospitalisation days for CF in last 6 months

Technical specs

CSV column name:

days_in_hospital_2

Length:

Only when:

Required:

true

Validation

Number of hospitalisation days cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Number of exacerbations requiring IV antibiotics or hospitalisation since start of Kalydeco use

Technical specs

CSV column name:

number_of_exacerbations_requiring_iv_antibiotics_or_hospitalisation_since_start_of_kalydeco_use_2

Length:

Only when:

Required:

true

Validation

Number of exacerbations cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of % predicted FEV1

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of__predicted_fev1_2

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultDateTime

number

% predicted FEV1

Technical specs

CSV column name:

_predicted_fev1_2

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultType

Validation

% predicted FEV1 cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of sweat test

Technical specs

Format:

DD/MM/YYYY

CSV column name:

date_of_sweat_test_2

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestDateTime

number

Sweat chloride (mmol/l)

Technical specs

CSV column name:

chloride_2

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

Result

Validation

Sweat chloride cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

choice

Clinical status

Technical specs

CSV column name:

clinical_status_2

Only when:

Required:

true

Options

Label	Value
Improved	improved
Stable	stable
Deteriorated	deteriorated

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatus

choice

CF diabetes

Technical specs

CSV column name:

cf_diabetes_2

Only when:

Required:

true

Options

Label	Value
No	1
IGT	2
CFRD	3
CFRD without fasting hyperglycemia	4
CFRD with fasting hyperglycemia	5
Missing data	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

OGTT done this year

Technical specs

CSV column name:

ogtt_done_this_year_2

Only when:

Required:

true

Options

Label	Value
No	1
Yes	2
Missing data	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestName

boolean

Other CFTR treatment started

Technical specs

CSV column name:

other_cftr_treatment_started_2

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

Options

Label	Value
Yes	TRUE
No	FALSE

5 T3 – 18 months

fieldset

Transplants

Fields

choice

Transplant status

Technical specs

CSV column name:

transplants_3|transplant_status

Only when:

Required:

true

Options

Label	Value
Not evaluated	1
Refused by transplant center	2
Waiting list	3
Received transplant	4
Evaluated but not on waiting list	5
Refused by patient	6
Missing Data	999

date

Precise date of first entering the Tx waiting list

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_3|precise_date_of_first_entering_the_tx_waiting_list_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStartDate

date

Precise date of the most recent Tx

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_3|precise_date_of_the_most_recent_tx_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureStartDate

fieldset

Anthropometry

Fields

number

Weight (kg)

Technical specs

CSV column name:

anthropometry_3|weight

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyWeight

Data element:

WeightValue

Validation

Weight cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Height (cm)

Technical specs

CSV column name:

anthropometry_3|height

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyHeight

Data element:

HeightValue

Validation

Height cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

BMI

Not to be included in the CSV.

Technical specs

CSV column name:

anthropometry_3|bmi

Length:

3,3

Computed:

Only when:

Required:

true

boolean

Treatment adherent

Technical specs

CSV column name:

treatment_adherent_1

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

boolean

Was the Kalydeco treatment stopped in the last 6 months?

Technical specs

CSV column name:

was_the_kalydeco_treatment_stopped_in_the_last_6_months_1

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment stop date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_stop_date_t3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

choice

Reason stop Kalydeco

Technical specs

CSV column name:

reason_stop_kalydeco_t3

Only when:

Required:

true

Options

Label	Value
Lack of efficacy	lack_of_efficacy
Safety	safety
Other CFTR treatment	other_cftr_treatment
Other	other

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

ReasonMedicationAgreement

Nested option fields

When other Is selected:
text
Specify
Technical specs
CSV column name:
reason_stop_kalydeco_t3|specify
Length:
200
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicationAgreement
Data element:
ReasonMedicationAgreement

boolean

Kalydeco treatment re-started

Technical specs

CSV column name:

kalydeco_treatment_restarted_t3

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment re-start date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_restart_date_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

number

Number of hospitalisation days for CF in last 6 months

Technical specs

CSV column name:

days_in_hospital_3

Length:

Only when:

Required:

true

Validation

Number of hospitalisation days cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Number of exacerbations requiring IV antibiotics or hospitalisation since start of Kalydeco use

Technical specs

CSV column name:

number_of_exacerbations_requiring_iv_antibiotics_or_hospitalisation_since_start_of_kalydeco_use

Length:

Only when:

Required:

true

Validation

Number of exacerbations cannot contain any decimals (error)
Number of exacerbations cannot contain any decimals (error)
Number of exacerbations cannot contain any decimals (error)
Number of exacerbations cannot contain any decimals (error)
Number of exacerbations cannot contain any decimals (error)
Number of exacerbations cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of % predicted FEV1

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of__predicted_fev1_3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultDateTime

number

% predicted FEV1

Technical specs

CSV column name:

_predicted_fev1_3

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultType

Validation

% predicted FEV1 cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of sweat test

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of_sweat_test

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestDateTime

number

Sweat chloride (mmol/l)

Technical specs

CSV column name:

chloride_3

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

Result

Validation

Sweat chloride cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

choice

Clinical status

Technical specs

CSV column name:

clinical_status_1

Only when:

Required:

true

Options

Label	Value
Improved	improved
Stable	stable
Deteriorated	deteriorated

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatus

choice

CF diabetes

Technical specs

CSV column name:

cf_diabetes_3

Only when:

Required:

true

Options

Label	Value
No	1
IGT	2
CFRD	3
CFRD without fasting hyperglycemia	4
CFRD with fasting hyperglycemia	5
Missing data	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

OGTT done this year

Technical specs

CSV column name:

ogtt_done_this_year_3

Only when:

Required:

true

Options

Label	Value
No	1
Yes	2
Missing	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestName

boolean

Other CFTR treatment started

Technical specs

CSV column name:

other_cftr_treatment_started_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

Options

Label	Value
Yes	TRUE
No	FALSE

6 T4 – 24 months

fieldset

Transplants

Fields

choice

Transplant status

Technical specs

CSV column name:

transplants_4|transplant_status

Only when:

Required:

true

Options

Label	Value
Not evaluated	1
Refused by transplant center	2
Waiting list	3
Received transplant	4
Evaluated but not on waiting list	5
Refused by patient	6
Missing Data	999

date

Precise date of first entering the Tx waiting list

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_4|precise_date_of_first_entering_the_tx_waiting_list_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStartDate

date

Precise date of the most recent Tx

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_4|precise_date_of_the_most_recent_tx_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureStartDate

fieldset

Anthropometry

Fields

number

Weight (kg)

Technical specs

CSV column name:

anthropometry_4|weight

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyWeight

Data element:

WeightValue

Validation

Weight cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Height (cm)

Technical specs

CSV column name:

anthropometry_4|height

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyHeight

Data element:

HeightValue

Validation

Height cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

BMI

Not to be included in the CSV.

Technical specs

CSV column name:

anthropometry_4|bmi

Length:

3,3

Computed:

Only when:

Required:

true

boolean

Treatment adherent

Technical specs

CSV column name:

treatment_adherent_3

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

boolean

Was the Kalydeco treatment stopped in the last 6 months?

Technical specs

CSV column name:

was_the_kalydeco_treatment_stopped_in_the_last_6_months_3

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment stop date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_stop_date_t4

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

choice

Reason stop Kalydeco

Technical specs

CSV column name:

reason_stop_kalydeco_t4

Only when:

Required:

true

Options

Label	Value
Lack of efficacy	lack_of_efficacy
Safety	safety
Other CFTR treatment	other_cftr_treatment
Other	other

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

ReasonMedicationAgreement

Nested option fields

When other Is selected:
text
Specify
Technical specs
CSV column name:
reason_stop_kalydeco_t4|specify
Length:
200
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicationAgreement
Data element:
ReasonMedicationAgreement

boolean

Kalydeco treatment re-started

Technical specs

CSV column name:

kalydeco_treatment_restarted_t4

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment re-start date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_restart_date_3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

number

Number of hospitalisation days for CF in last 6 months

Technical specs

CSV column name:

days_in_hospital_4

Length:

Only when:

Required:

true

Validation

Number of hospitalisation days cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Number of exacerbations requiring IV antibiotics or hospitalisation since start of Kalydeco use

Technical specs

CSV column name:

number_of_exacerbations_requiring_iv_antibiotics_or_hospitalisation_since_start_of_kalydeco_use_3

Length:

Only when:

Required:

true

Validation

Number of exacerbations cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of % predicted FEV1

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of__predicted_fev1_4

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultDateTime

number

% predicted FEV1

Technical specs

CSV column name:

_predicted_fev1_4

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultType

Validation

% predicted FEV1 cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of sweat test

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of_sweat_test_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestDateTime

number

Sweat chloride (mmol/l)

Technical specs

CSV column name:

chloride_4

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

Result

Validation

Sweat chloride cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

choice

Clinical status

Technical specs

CSV column name:

clinical_status_3

Only when:

Required:

true

Options

Label	Value
Improved	improved
Stable	stable
Deteriorated	deteriorated

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatus

choice

CF diabetes

Technical specs

CSV column name:

cf_diabetes_4

Only when:

Required:

true

Options

Label	Value
No	1
IGT	2
CFRD	3
CFRD without fasting hyperglycemia	4
CFRD with fasting hyperglycemia	5
Missing data	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

OGTT done this year

Technical specs

CSV column name:

ogtt_done_this_year_4

Only when:

Required:

true

Options

Label	Value
No	1
Yes	2
Missing	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestName

boolean

Other CFTR treatment started

Technical specs

CSV column name:

other_cftr_treatment_started_3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

Options

Label	Value
Yes	TRUE
No	FALSE

7 T5 – 30 months

fieldset

Transplants

Fields

choice

Transplant status

Technical specs

CSV column name:

transplants_5|transplant_status

Only when:

Required:

true

Options

Label	Value
Not evaluated	1
Refused by transplant center	2
Waiting list	3
Received transplant	4
Evaluated but not on waiting list	5
Refused by patient	6
Missing Data	999

date

Precise date of first entering the Tx waiting list

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_5|precise_date_of_first_entering_the_tx_waiting_list_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStartDate

date

Precise date of the most recent Tx

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_5|precise_date_of_the_most_recent_tx_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureStartDate

fieldset

Anthropometry

Fields

number

Weight (kg)

Technical specs

CSV column name:

anthropometry_5|weight

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyWeight

Data element:

WeightValue

Validation

Weight cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Height (cm)

Technical specs

CSV column name:

anthropometry_5|height

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyHeight

Data element:

HeightValue

Validation

Height cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

BMI

Not to be included in the CSV.

Technical specs

CSV column name:

anthropometry_5|bmi

Length:

3,3

Computed:

Only when:

Required:

true

boolean

Treatment adherent

Technical specs

CSV column name:

treatment_adherent_4

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

boolean

Was the Kalydeco treatment stopped in the last 6 months?

Technical specs

CSV column name:

was_the_kalydeco_treatment_stopped_in_the_last_6_months_4

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment stop date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_stop_date_t5

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

choice

Reason stop Kalydeco

Technical specs

CSV column name:

reason_stop_kalydeco_t5

Only when:

Required:

true

Options

Label	Value
Lack of efficacy	lack_of_efficacy
Safety	safety
Other CFTR treatment	other_cftr_treatment
Other	other

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

ReasonMedicationAgreement

Nested option fields

When other Is selected:
text
Specify
Technical specs
CSV column name:
reason_stop_kalydeco_t5|specify
Length:
200
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicationAgreement
Data element:
ReasonMedicationAgreement

boolean

Kalydeco treatment re-started

Technical specs

CSV column name:

kalydeco_treatment_restarted_t5

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment re-start date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_restart_date_4

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

number

Number of hospitalisation days for CF in last 6 months

Technical specs

CSV column name:

days_in_hospital_5

Length:

Only when:

Required:

true

Validation

Number of hospitalisation days cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Number of exacerbations requiring IV antibiotics or hospitalisation since start of Kalydeco use

Technical specs

CSV column name:

number_of_exacerbations_requiring_iv_antibiotics_or_hospitalisation_since_start_of_kalydeco_use_4

Length:

Only when:

Required:

true

Validation

Number of exacerbations cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of % predicted FEV1

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of__predicted_fev1_5

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultDateTime

number

% predicted FEV1

Technical specs

CSV column name:

_predicted_fev1_5

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultType

Validation

% predicted FEV1 cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of sweat test

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of_sweat_test_2

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestDateTime

number

Sweat chloride (mmol/l)

Technical specs

CSV column name:

chloride_5

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

Result

Validation

Sweat chloride cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

choice

Clinical status

Technical specs

CSV column name:

clinical_status_4

Only when:

Required:

true

Options

Label	Value
Improved	improved
Stable	stable
Deteriorated	deteriorated

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatus

choice

CF diabetes

Technical specs

CSV column name:

cf_diabetes_5

Only when:

Required:

true

Options

Label	Value
No	1
IGT	2
CFRD	3
CFRD without fasting hyperglycemia	4
CFRD with fasting hyperglycemia	5
Missing data	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

OGTT done this year

Technical specs

CSV column name:

ogtt_done_this_year_5

Only when:

Required:

true

Options

Label	Value
No	1
Yes	2
Missing	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestName

boolean

Other CFTR treatment started

Technical specs

CSV column name:

other_cftr_treatment_started_4

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

Options

Label	Value
Yes	TRUE
No	FALSE

8 T6 – 36 months

fieldset

Transplants

Fields

choice

Transplant status

Technical specs

CSV column name:

transplants_6|transplant_status

Only when:

Required:

true

Options

Label	Value
Not evaluated	1
Refused by transplant center	2
Waiting list	3
Received transplant	4
Evaluated but not on waiting list	5
Refused by patient	6
Missing Data	999

date

Precise date of first entering the Tx waiting list

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_6|precise_date_of_first_entering_the_tx_waiting_list_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStartDate

date

Precise date of the most recent Tx

Technical specs

Format:

DD/MM/YYYY

CSV column name:

transplants_6|precise_date_of_the_most_recent_tx_1

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureStartDate

fieldset

Anthropometry

Fields

number

Weight (kg)

Technical specs

CSV column name:

anthropometry_6|weight

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyWeight

Data element:

WeightValue

Validation

Weight cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Height (cm)

Technical specs

CSV column name:

anthropometry_6|height

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.BodyHeight

Data element:

HeightValue

Validation

Height cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

BMI

Not to be included in the CSV.

Technical specs

CSV column name:

anthropometry_6|bmi

Length:

3,3

Computed:

Only when:

Required:

true

boolean

Treatment adherent

Technical specs

CSV column name:

treatment_adherent_5

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

boolean

Was the Kalydeco treatment stopped in the last 6 months?

Technical specs

CSV column name:

was_the_kalydeco_treatment_stopped_in_the_last_6_months_5

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment stop date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_stop_date_t6

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

choice

Reason stop Kalydeco

Technical specs

CSV column name:

reason_stop_kalydeco_t6

Only when:

Required:

true

Options

Label	Value
Lack of efficacy	lack_of_efficacy
Safety	safety
Other CFTR treatment	other_cftr_treatment
Other	other

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

ReasonMedicationAgreement

Nested option fields

When other Is selected:
text
Specify
Technical specs
CSV column name:
reason_stop_kalydeco_t6|specify
Length:
200
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicationAgreement
Data element:
ReasonMedicationAgreement

boolean

Kalydeco treatment re-started

Technical specs

CSV column name:

kalydeco_treatment_restarted_t6

Only when:

Required:

true

Options

Label	Value
Yes	TRUE
No	FALSE

date

Kalydeco treatment re-start date

Technical specs

Format:

DD/MM/YYYY

CSV column name:

kalydeco_treatment_restart_date_5

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

number

Number of hospitalisation days for CF in last 6 months

Technical specs

CSV column name:

days_in_hospital_6

Length:

Only when:

Required:

true

Validation

Number of hospitalisation days cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

number

Number of exacerbations requiring IV antibiotics or hospitalisation since start of Kalydeco use

Technical specs

CSV column name:

number_of_exacerbations_requiring_iv_antibiotics_or_hospitalisation_since_start_of_kalydeco_use_5

Length:

Only when:

Required:

true

Validation

Number of exacerbations cannot contain any decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of % predicted FEV1

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of__predicted_fev1_6

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultDateTime

number

% predicted FEV1

Technical specs

CSV column name:

_predicted_fev1_6

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TextResult

Data element:

TextResultType

Validation

% predicted FEV1 cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

date

Most recent date of sweat test

Technical specs

Format:

DD/MM/YYYY

CSV column name:

most_recent_date_of_sweat_test_3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestDateTime

number

Sweat chloride (mmol/l)

Technical specs

CSV column name:

chloride_6

Length:

3,3

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

Result

Validation

Sweat chloride cannot contain more than 3 decimals (error)
cannot be negative (error)
cannot be higher than 1000 (error)

choice

Clinical status

Technical specs

CSV column name:

clinical_status_5

Only when:

Required:

true

Options

Label	Value
Improved	improved
Stable	stable
Deteriorated	deteriorated

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatus

choice

CF diabetes

Technical specs

CSV column name:

cf_diabetes_6

Only when:

Required:

true

Options

Label	Value
No	1
IGT	2
CFRD	3
CFRD without fasting hyperglycemia	4
CFRD with fasting hyperglycemia	5
Missing data	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

OGTT done this year

Technical specs

CSV column name:

ogtt_done_this_year_6

Only when:

Required:

true

Options

Label	Value
No	1
Yes	2
Missing	999

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.LaboratoryTestResult

Data element:

TestName

boolean

Other CFTR treatment started

Technical specs

CSV column name:

other_cftr_treatment_started_5

Only when:

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicationAgreement

Data element:

PeriodOfUse

Options

Label	Value
Yes	TRUE
No	FALSE