CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Ear and labyrinth disorders

The 8 CTCAE v6.0 adverse events in Ear and labyrinth disorders, with grades 1 to 5.

Ear and labyrinth disorders - Other, specify

Ear and labyrinth disorders
  1. G1Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

MedDRA code (LLT): 10013993 · CTCAE v6.0 (NCI), original English text.

Ear pain

Ear and labyrinth disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the ear.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10014020 · CTCAE v6.0 (NCI), original English text.

External ear pain

Ear and labyrinth disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the external ear region.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10065785 · CTCAE v6.0 (NCI), original English text.

Hearing impaired

Ear and labyrinth disorders
  1. G1Adult: Subjective change in hearing in the absence of documented hearing loss; threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear (on a 1, 2, 4, 3, 6, and 8 kHz audiogram); Pediatric (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift >20 dB hearing loss (HL) (i.e., 25 dB HL or greater); sensorineural hearing loss (SNHL) above 4 kHz (i.e., 6 or 8 kHz) in at least one ear
  2. G2Adult: Hearing loss not requiring hearing aid; intervention not indicated; limiting instrumental ADL; threshold shift of >25 dB averaged at 2 contiguous test frequencies in at least one ear (on a 1, 2, 3, 4, 6, and 8 kHz audiogram); Pediatric (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift >20 dB at 4 kHz in at least one ear; mild/moderate impact on age-appropriate normal daily activity
  3. G3Adult: Hearing loss requiring hearing aid; intervention indicated; limiting self-care ADL; threshold shift of >25 dB averaged at 3 contiguous test frequencies in at least one ear(on a 1, 2, 3, 4, 6, and 8 kHz audiogram); Pediatric (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Hearing loss sufficient to indicate therapeutic intervention, including hearing aids; threshold shift >20 dB at 2 to <4 kHz in at least one ear; severe impact on age-appropriate normal daily activity
  4. G4Adult: Nonservicable hearing; decrease in hearing to profound bilateral loss (absolute threshold >80 dB HL at 2 kHz and above); Pediatric: Audiologic indication for cochlear implant; >40 dB HL (i.e., 45 dB HL or more); SNHL at 2 kHz and above
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by partial or complete loss of the ability to detect or understand sounds resulting from damage to ear structures.

MedDRA code (LLT): 10019245 · CTCAE v6.0 (NCI), original English text.

Middle ear inflammation

Ear and labyrinth disorders
  1. G1Serous otitis
  2. G2Serous otitis, medical intervention indicated
  3. G3Mastoiditis; necrosis of canal soft tissue or bone
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation (physiologic response to irritation), swelling and redness to the middle ear.

MedDRA code (LLT): 10065838 · CTCAE v6.0 (NCI), original English text.

Tinnitus

Ear and labyrinth disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by noise in the ears, such as ringing, buzzing, roaring or clicking.

MedDRA code (LLT): 10043882 · CTCAE v6.0 (NCI), original English text.

Vertigo

Ear and labyrinth disorders
  1. G1Mild symptoms
  2. G2Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation as if the external world were revolving around the patient (objective vertigo) or as if he himself were revolving in space (subjective vertigo).

MedDRA code (LLT): 10047340 · CTCAE v6.0 (NCI), original English text.

Vestibular disorder

Ear and labyrinth disorders
  1. G1Not applicable
  2. G2Symptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by dizziness, imbalance, nausea, and vision problems.

MedDRA code (LLT): 10047386 · CTCAE v6.0 (NCI), original English text.

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