SUBJECT ID ______________

Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

UNSCHEDULED VISIT

Unscheduled Visit 1

Unscheduled Visit 2
Please record the number of this
unscheduled visit Unscheduled Visit 3

Unscheduled Visit 4

Reason why unscheduled visit was

performed

Date of visit (dd/mmm/yyyy) / /

____________________ _____________
Date (DD-MMM-YYYY) Initials

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 SUBJECT ID ______________
Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

ADVERSE EVENTS
Has the subject been experiencing any adverse events since last visit?

No

Yes, Please complete the Adverse Events Log

____________________ _____________
Date (DD-MMM-YYYY) Initials
CONCOMITANT MEDICATION
Has there been any new or changes to ongoing concomitant medication since last visit?

No

Yes, Please complete the Prior and Concomitant Medication Form

____________________ _____________
Date (DD-MMM-YYYY) Initials
CONCOMITANT THERAPY
Has there been any new or changes to ongoing concomitant therapy since last visit?

No

Yes, Please complete the Prior and Concomitant Therapy Form

____________________ _____________
Date (DD-MMM-YYYY) Initials

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 SUBJECT ID ______________
Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

ANALGESIC MEDICATION WASHOUT

No
Did the subject used any analgesics within 12 hours to visit?
Yes*

*Please complete the Prior and Conconitant Medication Form

____________________ _____________
Date (DD-MMM-YYYY) Initials

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 SUBJECT ID ______________
Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

VITAL SIGNS
Were vital signs measured?
Yes Please complete date (dd/mmm/yyyy) and time (hh:mm 24-hour clock) of assessment

/ / __ __ : __ __

No Please specify why not done ______________________________________________

Assessment Evaluation
Parameter Result Unit performed by Evaluation performed by
Date/Initials Date/Initials
 Normal
Weight . Kg  Abnormal, NCS
 Abnormal, CS
Systolic Blood  Normal
Pressure* mmHg  Abnormal, NCS
 Abnormal, CS
 Normal
Diastolic Blood  Abnormal, NCS
Pressure* mmHg  Abnormal, CS
 Not done
Reason _________
 Normal
 Abnormal, NCS
Heart Rate*
beats/min  Abnormal, CS
 Not done
Reason _________
 Normal
 Abnormal, NCS
Respiratory
beats/min  Abnormal, CS
Rate
 Not done
Reason _________
beats/min  Normal
Arm used for  Right Arm  Abnormal, NCS
BP/HR  Left Arm  Abnormal, CS
measurment  Not done
Reason _________
NCS: Not Clinically Significant, CS: Clinically Significant.
Please record all CS findings in the AE log
*BP/HR to be measured on the non-dominant arm after 5 minutes in the supine rest. If any value is outside the reference range presented in the
Protocol, the measurement will be repeated at the investigator’s discretion, and the final measurement will be reported in the eCRF.
.

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 SUBJECT ID ______________
Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

ELECTROCARDIOGRAM
Was ECG conducted?*
Yes Please complete date (dd/mmm/yyyy) and time (hh:mm 24-hour clock) of assessment

/ / __ __ : __ __

No Please specify reason not done ______________________________________________

Normal If abnormal, please specifiy:

Rhythm Abnormal, not clinically significant

_________________________________

_________________________________
Abnormal, clinically significant
_______ beats/min
RR Interval

_______ msec
PR Interval

_______ msec
QRS Duration

_______ msec
QT Interval

_______ msec
QTcF Interval

* Subject must have been resting quietly for at least 10 minutes before ECG is performed

Assessment performed by: ____________________ _____________

Date (DD-MMM-YYYY) Initials
If interpretation is not present on the ECG Report, please complete the section below:
Normal
Overall Interpretation of ECG Report
Abnormal, not clinically significant
Abnormal, clinically significant
Unable to Evaluate
Description of abnormal clinical significants findings:
___________________________________________
_____________________________________________
_________________________________________
Please record all clinically significant findings in the AE Log.

Evaluation performed by: ____________________ _____________

Date (DD-MMM-YYYY) Initials

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 SUBJECT ID ______________
Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

PHYSICAL EXAMINATION
Was the physical examination performed?
Yes Please complete date of assessment (dd/mmm/yyyy)

/ /

No Please specify why not done ______________________________________________

Abnormal
Not
Body Systems Normal Description if result is Not clinically Clinically examined
abnormal significant significant
1. General
appearance

2. Dermatological

3. Thyroid

4. Head, Neck, Throat

5. Heart / Lungs

6. Abdomen

7. Lymph Nodes

8. Musculoskeletal

9. Cardiovascular

10. Neurological

11. Joints

Please record all clinically significant findings at screening in the Medical History Forms.

____________________ _____________
Date (DD-MMM-YYYY) Initials

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 SUBJECT ID ______________
Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

LABORATORY TESTS

Yes

Was sampling for local laboratory performed? No Please specify reason not done and tests
not performed:
___________________________________
__________________________________

Date and time of collection / /

(dd/mmm/yyyy hh:mm 24 hour clock) __:__

Sampling performed by: ____________________ _____________

Date (DD-MMM-YYYY) Initials

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 SUBJECT ID ______________
Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

URINANALYSIS
Yes
Was the urine sample collected for analysis
No, please specify: ________________
___________________________________

Date and time of collection / /

(dd/mmm/yyyy hh:mm 24 hour clock) __:__

Results
Analysis Un S Te Results (please indicate with a circle) *Clinical
it ec st Assessme
U- Leu .12 LE Neg 15 70 125 500 nt *
Leucocytes /µL 0 U (0)

U-Nitrile 60 NIT Neg. Pos.

U-Protein g/L 60 PR Neg 0.15 0.3 1 3 ≥20

O (0)

U-pH 60 pH 5.0 6.0 6.5 7.0 7.5 8.0 9.0

U-Blood Ery/ 60 BL Neg ± + ++ +++ 5-10 50

(Erythrocyt µL O (0)
es)
U-Ketones mm 40 KE Neg 0.5 1.5 4 8 ≥16
ol/L T (0)

U-Glucose mm 30 GL Neg 5 15 30 60 ≥11

ol/L U (0) 1
If any of the results are positive and clinically significant abnormal, a urine sample must be sent for culture at
the local laboratory

Sampling/Read performed by ____________________ _____________

Date (DD-MMM-YYYY) Initials

Clinincal assessment performed by ____________________ _____________

Date (DD-MMM-YYYY) Initials

No
If abnormal, clinical significant, was the sample sent for urine culture at local lab?
Yes

Please record all clinically significant findings in the Medical History Form.

____________________ _____________
Date (DD-MMM-YYYY) Initials

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 SUBJECT ID ______________
Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

URINE PREGNANCY TEST

Yes

No Please specify: ________________

Was the urine pregnancy test performed?

NA

Date and time of collection / /

(dd/mmm/yyyy hh:mm 24 hour clock) __:__

Please complete the result Negative

Positive Please specify: _____________

___________________________________

If POSITIVE, please complete the Pregnancy Report Form within 24h.

____________________ _____________
Date (DD-MMM-YYYY) Initials

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 SUBJECT ID ______________
Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

MTX Treatment

Yes
If Yes, please update Concomitant Medication Log
Was the MTX dose changed?
No
If No, please explain _________________________

Yes Please describe

Was the patient instructed on MTX

administration?

No
If No, please explain _________________________

____________________ _____________
Date (DD-MMM-YYYY) Initials

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 SUBJECT ID ______________
Unscheduled Visit SUBJECT INITIALS ______________

SynAct-CS002

REMINDERS

Yes No

If YES, specify date:

________________________

Yes No
If No, specify:
________________________

Yes No
If No, specify:
________________________

Yes No
If No, specify:
________________________

____________________ _____________
Date (DD-MMM-YYYY) Initials

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