-ANZMTG XX.XX [Trial Name] Trial-

-Follow Up Form: FORM FU Page 3 of 3-

Date form completed / /

Date of assessments / /

Weight . kg

Temperature . °C

Pulse rate bpm

Blood pressure mmHg

ECOG performance status 0 or 1

Investigations / Performed / Date of Results / Results / Clinically Significant
If Yes
complete FORM AE
Investigation 1 / / / / / /
If Abnormal (Result) please specify
|______|
Investigation 2 / / / / / /
If Abnormal (Result) please specify
|______|
Investigation 3 / / / / / /
If Abnormal (Result) please specify
|______|
Other |______| / / / / / /
If Abnormal (Result) please specify
|______|


Laboratory Tests / Performed / Date of Results / Results / Clinically Significant
If Yes
complete FORM AE
Test 1 / / / / / /
If Abnormal (Result) please specify
|______|
Test 2 / / / / / /
If Abnormal (Result) please specify
|______|
If patient is a woman of childbearing potential, please provide the following details (tick N/A otherwise)
Laboratory Test / Performed / Date of Result / Result / If Positive
complete FORM SAE
Pregnancy test N/A / / / / /

[Imaging]

All patients entered onto the trial are required to have a CT scan of chest, abdomen and pelvis, and optional MRI/CT scan of the brain, whole body PET/CT scan, bone scan and plain X-ray at Follow Up

Since the last visit, has the patient had any imaging performed? Yes No

If Yes please indicate imaging performed below and complete Imaging Form (FORM I)

Please indicate imaging which is compulsory investigation

CT scan of chest, abdomen and pelvis Yes No

Please indicate imaging which are optional investigations

MRI scan of the brain Yes No OR CT scan of the brain Yes No

Whole body PET/CT scan Yes No

Bone scan Yes No

Plain X-ray Yes No

[Tumour Assessment]

Since the last visit, have the index lesions and other lesions (target and non-target) Yes No

and RECIST responses been assessed?

If Yes please complete Tumour Assessment Form (FORM TA)

[Questionnaire]

Is the patient willing to participate in pain measurement component of this study? Yes No

If Yes please complete [Questionnaire] (FORM [Questionnaire Abbreviation])

Adverse Events/Pre-existing Conditions

Since the last visit, did the patient have any adverse events or pre-existing conditions Yes No

related to melanoma?

If Yes please complete Adverse Event Form (FORM AE)

Serious Adverse Events

Since the last visit, did the patient have any serious adverse events? Yes No

If Yes please complete Serious Adverse Event Form (FORM SAE)

Concomitant Medications

Since the last visit, has the patient commenced any new medication(s) N/A Yes No

or has there been a change in existing medication(s) for any of

the adverse events/pre-existing conditions noted on FORM AE or

serious adverse events on FORM SAE related to melanoma?

If Yes please complete Concomitant Medication Form (FORM CM)

Melanoma Medications

Since the last visit, has there been a change in systemic therapies; including Yes No

chemotherapy, immunotherapy, vaccine, targeted therapy and intra-lesion infusion

and/or clinical trials participation in relation to their melanoma?

If Yes please complete Melanoma Medication Form (FORM MM)

ANZMTG XX.XX [Trial Name] Follow Up Form [Version: vX.X] – [Date Form Created: DD/MM/YYYY]