Table 4 List of filters/rules which trigger error flags

Patient information/

Physical examination form

Date of First Visit

1. The field Date of First Visit is mandatory and cannot be blank.

2. The Date of First Visit cannot be after the Date of today

Date of Birth

1. The patient Date of Birth cannot be blank

2. The patient Date of Birth cannot be after the current date.

3. The Date of birth you entered is before 1-1-1900, the patient is too old to participate in this study

Date of Signed informed consent

1. The field "Date of Signed informed consent" is mandatory and cannot be left blank

2. The Date of First Visit cannot be after the Date of today

1. The field Heart Rate cannot be blank.

2. The field "heart rate" cannot be more than 220 p/m

3. The field "heart rate" cannot be less than 40 p/m

Temperature

1. Patient Temperature should be between 35 and 41.5 degrees

WHO performance rate"

1. The field "performance rate" is mandatory and cannot be left blank

2. During First Visit, the "WHO performance rate" cannot be either 3 or 4.

Radiology Diagnostics form

CT/MRI- scan Date Sample Taken

1. The field CT/MRI- scan Date Sample Taken is mandatory and cannot be blank.

2. The Date of sample taken, CT/MRI-scan, cannot be before the Date of Visit, as specified on the General Patient Information form (belonging to this Event/Visit).

3. The Date Sample Taken CT/MRI- scan cannot be before the Date of First Visit.

4. The Date Sample Taken CT/MRI- scan during PDT Assessment should be about 12 weeks after the Date of Foscan Administration and no less than 10 weeks after that date.

5. The Date of CT/MRI- scan cannot be later than today.

T-stage

1. The T-stage (0,1,2A and 2B,3,4) in the field "CT-MRI T-stage" has to be the same as the T (0,1,2A and 2B,3,4) in the field "T-stage" on the Pathology form.

2. The T- stage cannot be "0" if patient has been included in this study because of a recurrent or persistent disease

field CT/MRI Lesion Size

1. The field CT/MRI Lesion Size (length) cannot be blank when the field T-stage has been entered.

2. The field CT/MRI Lesion Size (length) cannot be more than 200 mm

CT/MRI site

1. The field "CT/MRI site" is mandatory and cannot be left blank

2. The tumour site CT/MRI- scan selected here differs from the Suspicious site as specified on the Endoscopy form during this Visit. Are you sure this is correct? If yes, please provide explanation in Audit Trail entry after Validation

3. The tumour site CT/MRI- scan selected here differs from the Tumour site as specified on the Endoscopy form during this Visit. Are you sure this is correct? If yes, please provide explanation in Audit Trail entry after Validation

endoscopy

1. If Nose endoscopy has been performed, the field Date of Endoscopy cannot be blank

2. During (visit) Positive Test, the Date of Endoscopy should be after the Date of Endoscopy of the PDT Assessment.

3. The Date of Endoscopy should be after the Date of Endoscopy of the last PDT Follow Up

4. The Date of Endoscopy should be after the Date of Endoscopy of the PDT Visit(s)

5. The Date of Endoscopy should be after the Date of Endoscopy of the previous Follow Up visit.

6. The Date of Endoscopy should be after the Date of Endoscopy of the First Visit.

7. The Date of Endoscopy should be 3 months after the Date of Endoscopy of the Therapy Assessment