Annex 1.

Table of the NCI proposed classification Common Terminology Criteria for Adverse Events (CTCAE) (2003) Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events Version 3.0 DCTD, NCI, NIH, DHHS. March31, 2003 (http://ctep.cancer.gov) Publishing date, 10 June 2003

Hearing / Ear
Auditory Adverse Event	Name	1	2	3	4	5
patient with or with no baseline audiogram and non-monitored patients	Hearing: (monitoring program)	Thresholds or 15 – 25dB decrease relative to the baseline audiogram at two or more adjacent frequencies in at least one ear, or subjective change in the absence of grade 1	Thresholds or 25 in two or more adjacent frequencies in at least one ear	ADULTS: thresholds over 25 – 90 dB at 3 adjacent frequencies in at least one ear.	ADULTS: profound bilateral hearing loss (> 90dB)
				CHILDREN: Hearing loss sufficient to require treatment including AASI (loss > 20dB at speech frequencies, bilateral or > 30dB unilateral and that require special phonoaudiological care)	CHILDREN: Audiological indication for cochlear implants, requiring special phonoaudiological care.	–
OBS: pediatric recommendations are similar to those of adults unless otherwise specified. For children and teenagers (< or equals; 18 years) with no pre-treatment baseline audiogram, hearing is considered as below 5dB.
Hearing: patients with no baseline audiogram and not included in a monitoring program	Hearing: no monitoring program		Hearing loss with no need to use AASI (no effect on activities of daily life)	Hearing loss with no deed to use AASI (affecting activities of daily life)	Profound bilateral hearing loss (> 90dB)	–
Otitis, outer ear (non– infectious)	Otitis media	Otitis external with erythema or dry desquamation	Otitis external with desquamation, ear wax or effusion, tympanic perforation, tympanoplasty	Otitis external with mastoiditis, stenosis or osteomyelitis	Necrosis of bone or soft tissues	Death
OBS: patients with or with no baseline audiogram, included or not in a monitoring program.
Otitis, middle ear (non– infectious)	Otitis media	Otitis serous	Otitis serous with indication for medical intervention	Otitis with effusion, mastoiditis	Necrosis of canal, of bone or soft tissues	Death
Tinnitus	Tinnitus	–	Tinnitus not affecting activities of daily life	Tinnitus affecting activities of daily life	Disability Loss of function	–
OBS: patients with or with no baseline audiogram, included or not in a monitoring program.
Hearing / Ear Others	Hearing / Ear Others	mild	moderate	severe	life risk / loss of function	Death