Management and Dose Modification Guidelines Sample Clauses

Management and Dose Modification Guidelines. If a patient develops ocular symptoms of any grade, the patient is required to have a complete examination by an ophthalmologist. If a patient develops ≥ CTCAE Grade 2 ocular symptoms, treatment with MIRV must be interrupted. Treatment should not be interrupted solely for Grade 2 ocular signs (eg, Grade 2 keratopathy) unless they are also associated with Grade 2 ocular symptoms. Treatment with MIRV may resume if ocular symptoms improve to Grade 1 or baseline within 28 days of the next scheduled MIRV dose (refer to Table 8 for details). If ocular symptoms last longer than 28 days, resumption of MIRV may be considered for those patients who have experienced clinical benefit if agreed upon between the Sponsor and the Investigator. Subsequent eye examinations will be scheduled to occur in every other cycle going forward, from the time that the AE was initially reported, and at either the EOT visit or 30-day follow-up visit after treatment discontinuation, even if the results of the patient’s ocular exam shows no obvious clinical findings. Management of treatment-emergent ocular AEs with inflammatory characteristics should include corticosteroid eye drops and/or other measures as indicated by an ophthalmologist. Table 8: Management of Ocular Symptoms Severity Grade (CTCAE v5.0 Grade) Management Guidelines for MIRV Dose Modifications Grade 1 Complete eye exam as outlined in Schedule of Assessments (Table 2, Table 3, Table 4) Monitor for worsening symptoms Continue MIRV dosing Grade 2 Complete eye exam as outlined in Schedule of Assessments (Table 2, Table 3, Table 4) Repeat complete exam as clinically indicated Patients should have weekly symptomatic ocular assessments by the Investigator until the symptoms resolve to Grade 1 or baseline or are deemed to be irreversible by the Investigator Hold MIRV dosing until AE has resolved to Grade 1 or better Patients with ocular symptoms lasting < 14 days may be allowed to resume MIRV at the same dose level Patients with ocular symptoms lasting ≥ 14 days but no more than 28 days may resume MIRV at one lower dose level a Recurrence of Grade 2 toxicity on subsequent cycles despite best supportive care will require a MIRV dose reduction of one dose level Grade 3 Complete eye exam as outlined in Schedule of Assessments (Table 2, Table 3, Table 4). Repeat complete exam as clinically indicated Patients should have weekly symptomatic ocular assessments by the Investigator until the symptoms resolve to Grade 1 or baseline or are ...
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