Adverse events

Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas · Source last updated 2026-03-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame

All-cause mortality (death due to any cause) and Treatment emergent adverse events during randomised period, which is from the first dose of study intervention until the first date when selumetinib kit(s) are dispensed at Cycle 12 Day 28 (about 1 year), or 30 days after study intervention discontinuation, or up to one day prior to start of subsequent therapy, whichever occurs first. The medians of total treatment duration were 336 days for Selumetinib group and 335 days for Placebo group.

Other-event reporting threshold

5%

All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug and include AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose. All TESAE, and non-serious TEAEs for a preferred term at a frequency of \> 5% in any treatment group during the randomized period are presented.

Group identifiers: EG000: Selumetinib 25 mg/m2 · EG001: Placebo

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Preserved source evidence · Not medical advice