FLACTIV

Table Description: Digital Biomarker Full Active Test

1.0 Data Dictionary

ITM_NAME

DSCR_1.0

COMM

Comments

FATFDT

Full Active Test OFF date performed

FATFDVST

Full Active Test OFF device set

FATFPRF

Full Active Test OFF performed

FATNDT

Full Active Test ON date performed

FATNDVST

Full Active Test ON device set

FATNPRF

Full Active Test ON performed

LSTDSMIN

How long since last dose - minutes

NOFNFRSN

Reason Full Active not done ON and OFF

ONOFFBN

Capture (medication state)

1.0 Code Book

ITM_NAME

CODE

DECODE_1.0

FATFDVST

1

Subject’s device set

FATFDVST

2

Site’s demo device set

FATFPRF

0

No

FATFPRF

1

Yes

FATNDVST

1

Subject’s device set

FATNDVST

2

Site’s demo device set

FATNPRF

0

No

FATNPRF

1

Yes

NOFNFRSN

1

Not applicable(interim vis/unaff/no med)

NOFNFRSN

2

Disease severity prevent withholding med

NOFNFRSN

3

Technical difficulties

NOFNFRSN

4

No smartphone available

NOFNFRSN

5

Not enough time at visit

NOFNFRSN

6

Other, specify in comments

ONOFFBN

1

Off medication

ONOFFBN

2

On medication

ONOFFBN

3

Both off and on medication

ONOFFBN

4

Neither off or on medication