-ANZMTG XX.XX [Trial Name] Trial-

-Baseline Form: FORM B Page 1 of 7-

To be completed at baseline

Date of study visit / /

Country of birth |______|

Main language spoken at home |______|

Postcode of usual residence in Australia

Indigenous status

Ethnicity

Date of assessments / /

Height cm

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 / / / / /
If other laboratory tests were performed, please provide the following details (proceed to the next page otherwise)
Laboratory Tests / Performed / Date of Results / Results / Clinically Significant
If Yes
complete FORM AE
Other |______| / / / / / /
If Abnormal (Result) |______|
Other |______| / / / / / /
If Abnormal (Result) |______|

Is the primary cutaneous melanoma known? Yes No/unknown

If Yes site of primary melanoma known

1 = Forehead 10 = Neck – submental 19 = Leg – proximal & anterior

2 = Eyelid – upper 11 = Trunk – anterior & upper 20 = Leg – proximal & posterior

3 = Eyelid – lower 12 = Trunk – anterior & lower 21 = Leg – distal & anterior

4 = Nose 13 = Trunk – posterior & upper 22 = Leg – distal & posterior

5 = Cheek 14 = Trunk – posterior & lower 23 = Scalp

6 = Chin 15 = Arm – proximal & anterior 24 = Palm of hand

7 = Neck – anterior cervical 16 = Arm – proximal & posterior 25 = Sole of foot

8 = Neck – posterior cervical 17 = Arm – distal & anterior 26 = External ear skin

9 = Neck – supraclavicular 18 = Arm – distal & posterior 27 = Subungual skin

Side of primary melanoma

Melanoma subtype

Was tumour biopsy performed? Yes No

If Yes immunohistochemical staining performed

H&E S-100 HMB-45 MelanA MART-1 Not specified

Breslow thickness . mm Unknown or not reported

Mitotic rate per mm2 Unknown or not reported

Ulceration Present Absent Unknown or not reported

Lymphovascular space invasion Present Absent Unknown or not reported

Perineural spread Present Absent Unknown or not reported

Satellitosis Present Absent Unknown or not reported

Tumour-infiltrating lymphocytes Present Absent Unknown or not reported

If Present please indicate classification

Has a copy of histological or cytological report been provided to the Trial Yes No

Co-ordinating Centre?

What was the tissue sample of cutaneous melanoma? Primary Metastatic

Was the mutation status of cutaneous melanoma obtained? Yes No

If Yes BRAF status Positive Negative N/A

If Positive mutation identified V600E V600K Other |______|

NRAS status Positive Negative N/A

c-kit Positive Negative N/A

Other mutation |______| Positive Negative N/A

Other mutation |______| Positive Negative N/A

Has a copy of mutation report(s) been obtained and forwarded to the Trial Yes No

Co-ordinating Centre?

[Imaging]

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

Did the patient have any imaging performed? Yes No

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

Please indicate imaging which are compulsory investigations

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

CT scan of chest, abdomen and pelvis Yes No

Please indicate imaging which are optional investigations

Whole body PET/CT scan Yes No

Bone scan Yes No

Plain X-ray Yes No

[Tumour Assessment]

Since providing informed consent, were the index lesions and other lesions Yes No

(target and non-target) and RECIST responses assessed?

If Yes please complete Tumour Assessment Form (FORM TA)

[Questionnaire]

Is the patient willing to participate in [questionnaire] component of this study? Yes No

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

Adverse Events/Pre-existing Conditions

Since providing informed consent, did the patient have any adverse events or Yes No

pre-existing conditions related to melanoma?

If Yes please complete Adverse Event Form (FORM AE)

Serious Adverse Events

Since providing informed consent, did the patient have any serious adverse events? Yes No

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

Concomitant Medications

Is the patient currently taking medication for any of the adverse events/ N/A Yes No

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

Is the patient receiving systemic therapy; including chemotherapy, immunotherapy, Yes No

vaccine, targeted therapy and intra-lesion infusion and/or participating in another

clinical trial in relation to their melanoma?

If Yes please complete Melanoma Medication Form (FORM MM)

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