CTCAE RápidoAdverse event grades · CTCAE v6.0

Eye disorders

The 26 CTCAE v6.0 adverse events in Eye disorders, with grades 1 to 5.

  1. G1Intervention not indicated
  2. G2Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by visual perception of unclear or fuzzy images.

Navigational noteConsider: Eye disorders: Uveitis.

MedDRA code (LLT): 10005886 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); glare symptoms affecting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by partial or complete opacity of the crystalline lens of one or both eyes. This results in a decrease in visual acuity and eventual blindness if untreated.

MedDRA code (LLT): 10007739 · CTCAE v6.0 (NCI), original English text.

  1. G1Not applicable
  2. G2Not applicable
  3. G3Corneal ulcer without perforation in the affected eye
  4. G4Perforation in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an area of epithelial tissue loss on the surface of the cornea. It is associated with inflammatory cells in the cornea and anterior chamber.

MedDRA code (LLT): 10048492 · CTCAE v6.0 (NCI), original English text.

  1. G1Symptomatic
  2. G2Moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an inability to see clearly in dim light.

MedDRA code (LLT): 10011974 · CTCAE v6.0 (NCI), original English text.

  1. G1Clinical or diagnostic observations only; symptoms relieved by lubricants
  2. G2Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
  3. G3Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); 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 dryness of the cornea and conjunctiva.

Navigational noteIf corneal ulcer is present, grade under Eye disorders: Corneal ulcer. If related to syndromes not present in CTCAE (ex. Sjogren's syndrome, etc.), report as Other, specify in the most representative SOC.

MedDRA code (LLT): 10013774 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only
  2. G2Unilateral paresis without double vision
  3. G3Bilateral paresis or unilateral paresis causing double vision in peripheral gaze, but not in central gaze
  4. G4Bilateral paresis requiring head turning to see beyond central 60 degrees or double vision in central gaze
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by incomplete paralysis of an extraocular muscle.

MedDRA code (LLT): 10015829 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; no change in vision
  2. G2Moderate; minimal, local or noninvasive intervention indicated; best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe or medically significant but not immediately sight-threatening; decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Sight-threatening consequences; urgent intervention indicated; best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

MedDRA code (LLT): 10015919 · CTCAE v6.0 (NCI), original English text.

  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 eye.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10015958 · CTCAE v6.0 (NCI), original English text.

  1. G1Clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; nonoperative intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Operative intervention indicated requiring hospitalization; 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 impaired eyelid function.

MedDRA code (LLT): 10061145 · CTCAE v6.0 (NCI), original English text.

  1. G1Symptomatic
  2. G2Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Limiting 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 sudden or brief burst of light.

Navigational noteConsider Eye disorders: Retinal tear, Retinal detachment.

MedDRA code (LLT): 10016757 · CTCAE v6.0 (NCI), original English text.

  1. G1Symptomatic
  2. G2Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Limiting 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 an individual seeing spots before their eyes. The spots are shadows of opaque cell fragments in the vitreous humor or lens.

Navigational noteConsider Eye disorders: Retinal tear, Retinal detachment.

MedDRA code (LLT): 10016778 · CTCAE v6.0 (NCI), original English text.

  1. G1Less than 8 mmHg of elevated intraocular pressure (EIOP); no visual field deficit
  2. G2Topical medication indicated
  3. G3EIOP causing visual field deficits
  4. G4Visual field deficit within the central 10 degrees of the visual field in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an increase in pressure in the eyeball due to obstruction of the aqueous humor outflow.

MedDRA code (LLT): 10018304 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
  3. G3Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); corneal ulcer; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Perforation; best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by inflammation to the cornea of the eye.

Navigational noteConsider Eye disorders: Corneal ulcer.

MedDRA code (LLT): 10023332 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only
  2. G2Moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
  3. G3Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by involvement of the optic nerve (second cranial nerve).

MedDRA code (LLT): 10061322 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; no visual field deficit
  2. G2Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
  3. G3Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by swelling around the optic disc.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10033703 · CTCAE v6.0 (NCI), original English text.

  1. G1Soft or non-pitting
  2. G2Indurated or pitting edema; topical intervention indicated
  3. G3Edema associated with visual disturbance; increased intraocular pressure, glaucoma or retinal hemorrhage; diuretics indicated; operative intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by swelling due to an excessive accumulation of fluid around the orbits of the face.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10054541 · CTCAE v6.0 (NCI), original English text.

  1. G1Symptomatic
  2. G2Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Limiting 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 fear and avoidance of light.

MedDRA code (LLT): 10034960 · CTCAE v6.0 (NCI), original English text.

  1. G1Not applicable
  2. G2Not applicable
  3. G3Macular sparing rhegmatogenous detachment
  4. G4Macula-off rhegmatogenous retinal detachment
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by the separation of the inner retina layers from the underlying pigment epithelium.

MedDRA code (LLT): 10038848 · CTCAE v6.0 (NCI), original English text.

  1. G1No retinal detachment and treatment not indicated
  2. G2No retinal detachment and treatment indicated
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a small laceration of the retina. Symptoms include flashes and floaters.

Navigational noteIf retinal detachment is present, grade under Eye disorders: Retinal detachment.

MedDRA code (LLT): 10038897 · CTCAE v6.0 (NCI), original English text.

  1. G1Not applicable
  2. G2Retinal vascular disorder without neovascularization
  3. G3Retinal vascular disorder with neovascularization
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by pathological retinal blood vessels that adversely affects vision.

Navigational noteIf vitreous hemorrhage is present, report under Eye disorders: Vitreous hemorrhage.

MedDRA code (LLT): 10038901 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only
  2. G2Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder involving the retina.

Navigational noteIf vitreous hemorrhage is present, report under Eye disorders: Vitreous hemorrhage.

MedDRA code (LLT): 10038923 · CTCAE v6.0 (NCI), original English text.

  1. G1No change in vision from baseline
  2. G2Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by involvement of the sclera of the eye.

MedDRA code (LLT): 10061510 · CTCAE v6.0 (NCI), original English text.

  1. G1Anterior uveitis with trace cells
  2. G2Anterior uveitis with 1+ or 2+ cells
  3. G3Anterior uveitis with 3+ or greater cells; intermediate posterior or pan-uveitis
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by inflammation to the uvea of the eye.

MedDRA code (LLT): 10046851 · CTCAE v6.0 (NCI), original English text.

  1. G1Not applicable
  2. G2Moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
  3. G3Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a decrease in visual acuity.

Navigational noteIf etiology is known, use a more specific CTCAE term. Consider: Eye disorders: Uveitis

MedDRA code (LLT): 10047516 · CTCAE v6.0 (NCI), original English text.

  1. G1Intervention not indicated
  2. G2Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Symptomatic with marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200); vitrectomy indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by bleeding into the vitreous humor.

MedDRA code (LLT): 10047656 · CTCAE v6.0 (NCI), original English text.

  1. G1Intervention not indicated
  2. G2Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline)
  3. G3Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or more than 3 lines of decreased vision from known baseline, up to 20/200)
  4. G4Best corrected visual acuity of 20/200 or worse in the affected eye
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by excessive tearing in the eyes; it can be caused by overproduction of tears or impaired drainage of the tear duct.

MedDRA code (LLT): 10047848 · CTCAE v6.0 (NCI), original English text.

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