Alkem

Date of Assessment *

Subject Initials *

OPD *

IPD *

Age (Completed years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Patients with confirmed case of HNSCC *

Yes No

Clinical Signs and Symptoms *

Clinical Diagnosis *

Duration of current illness *

Primary Tumor Location *

Oral Cavity Oropharynx Larynx Other

Concurrent Treatment Modality *

EXTREME Regimen (Erbitux (cetuximab) + Taxane (commonly docetaxel)/Platinum (cisplatin or carboplatin) + 5-FU (fluorouracil)) TPEx Regimen (Taxane (docetaxel) + Platinum (cisplatin) + Cetuximab) Radiotherapy Other

History of prior malignancies (if any)

History of tobacco or alcohol use *

Yes No

Therapy Type *	Received *	Agent/Regimen (if known)
Chemotherapy	Yes No
Radiotherapy	Yes No
Targeted Therapy	Yes No
Immunotherapy	Yes No
Surgery (for tumor)	Yes No

Cetuximab prescribed *

Yes No

Brand Name *

Marketing Company Name *

Dose *

Frequency *

Duration *

Choice of cetuximab as line of therapy *

First line Second line

Other medications prescribed for T/t

Medication	Dose	Frequency	Duration

Disease Control Rate (DCR) (based on investigator's clinical judgment) *

Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) Not Evaluable

Has the patient demonstrated an appropriate response to cetuximab therapy (based on investigator's clinical judgment)? *

Yes No

Adverse events noted due to study medication *

Yes No

If yes, add details
AE. No	Adverse Event Term	Date of onset (DD/MM/YYYY)	Date of resolution (DD/MM/YYYY)	Severity	Action Taken (Specify)	Treatment given	Relationship with Study Drug	Outcome	Serious Adverse Event
1						Yes No			Yes No
2						Yes No			Yes No
3						Yes No			Yes No
4						Yes No			Yes No
Severity: 1- Mild; 2- Moderate; 3- Severe; +Action Taken: 1- No Change in IP, 2- IP Temporarily Interrupted, 3- IP Permanently Discontinued, 4- Other, specify *If 'Treatment given 'is ticked as 'Yes' then relevant information should be captured on Prior and concomitant Medication Form. † Relationship: 1= Related, 2= Not Related ++Outcome: 1 = Resolved, 2= Recovered/ Resolved with Sequelae, 3= Recovering/ Resolving, 4=Not Recovered/ Not Resolved, 5= Fatal/ result in death, 6= Unknown

Cetuximab

ASSESSMENT 1 - THERAPY EVALUATION

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

Previous Cancer Therapies (Prior to Cetuximab Initiation)

TREATMENT OF CURRENT MEDICAL ILLNESS

CLINICAL RESPONSE

ADVERSE EVENTS