Category:CTCAE4 Ear and labyrinth disorders

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Adverse Event Grade1 Grade2 Grade3 Grade4 Grade5
Ear and labyrinth disorders - Other, specify Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self care ADL Life-threatening consequences; urgent intervention indicated Death
Ear pain Mild pain Moderate pain; limiting instrumental ADL Severe pain; limiting self care ADL - -
External ear inflammation External otitis with erythema or dry desquamation External otitis with moist desquamation, edema, enhanced cerumen or discharge; tympanic membrane perforation; tympanostomy External otitis with mastoiditis; stenosis or osteomyelitis; necrosis of soft tissue or bone Urgent operative intervention indicated Death
External ear pain Mild pain Moderate pain; limiting instrumental ADL Severe pain; limiting self care ADL - -
Hearing impaired Adults enrolled on a monitoring program (a 1, 2, 3, 4, 6 and 8 kHz audiogram): threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear or subjective change in the absence of a Grade 1 threshold shift

Pediatrics (a 1, 2, 3, 4, 6 and 8 kHz audiogram): >20 dB at any frequency tested and does not meet criteria for >Grade 2

Adults enrolled in monitoring program (a 1, 2, 3, 4, 6 and 8 kHz audiogram): threshold shift of >25 dB averaged at 2 contiguous test frequencies in at least one ear

Adult not enrolled in monitoring program: hearing loss but hearing aid or intervention not indicated; limiting instrumental ADL

Pediatrics (a 1, 2, 3, 4, 6 and 8 kHz audiogram): >20 dB at >4 kHz

Adults enrolled in monitoring program (a 1, 2, 3, 4, 6 and 8 kHz audiogram): threshold shift of >25 dB averaged at 3 contiguous test frequencies in at least one ear; therapeutic intervention indicated

Adults not enrolled in monitoring program: hearing loss with hearing aid or intervention indicated; limiting self care ADL

Pediatrics (a 1, 2, 3, 4, 6 and 8 kHz audiogram): hearing loss sufficient to indicate therapeutic intervention, including hearing aids; >20 dB at 3 kHz and above in one ear; additional speech-language related services indicated

Adults: profound bilateral hearing loss (>80 dB at 2 kHz and above); non-serviceable hearing

Pediatric: audiologic indication for cochlear implant and additional speech-language related services indicated

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Middle ear inflammation Serous otitis Serous otitis, medical intervention indicated Mastoiditis; necrosis of canal soft tissue or bone Life-threatening consequences; urgent intervention indicated Death
Tinnitus Mild symptoms; intervention not indicated Moderate symptoms; limiting instrumental ADL Severe symptoms; limiting self care ADL - -
Vertigo Mild symptoms Moderate symptomatic; limiting instrumental ADL Severe symptoms; limiting self care ADL - -
Vestibular disorder - Symptomatic; limiting instrumental ADL Severe symptoms; limiting self care ADL - -
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