Table 3.

Treatment-emergent adverse reactions (≥20%) in patients with pLGG who received tovorafenib in FIREFLY-1 (Arms 1 and 2)

	Tovorafenib N=137
Adverse Reaction	All Grades (%)	Grade 3 or 4 (%)
Skin and Subcutaneous Tissue Disorders
Rasha	77	12
Hair color changes	76	0
Dry skin	36	0
Dermatitis acneiform	31	1
Pruritus	26	1
General Disorders
Fatigue	55	4
Pyrexia	39	4
Edemab	26	0
Infections and Infestations
Viral infectionc	55	7
Upper respiratory tract infection	31	1.5
Paronychia	26	1.5
Gastrointestinal Disorders
Vomitingd	50	4
Constipation	33	0
Nausea	33	0
Abdominal pain	28	0
Diarrheae	22	1.5
Stomatitisf	20	0
Nervous system disorders
Headache	45	1
Vascular Disorders
Hemorrhageg	42	5*

Source: OJEMDA (tovorafenib; package insert; ref. 15)

^aIncludes terms erythema multiforme, eczema, rash erythematous, rash macular, rash follicular, rash pruritic, rash maculopapular, rash, rash papular, rash pustular, skin exfoliation, drug eruption, dermatitis, dermatitis bullous.

^bIncludes terms lip edema, periorbital edema, edema peripheral, localized edema, face edema, vulval edema.

^cIncludes terms viral infection, rhinovirus infection, enterovirus infection, viral upper respiratory tract infection, enterocolitis viral, oral herpes, gastroenteritis viral, influenza, influenza like illness, respiratory syncytial virus infection, enterovirus infection, coronavirus infection, COVID-19, SARS-COV-2 test positive, herpes simplex, parainfluenza virus infection, adenoviral upper respiratory infection, viraemia, adenovirus infection, conjunctivitis viral, eye infection viral, metapneumovirus infection, parvovirus infection, respiratory syncytial virus bronchiolitis, respiratory tract infection viral, viral pharyngitis, viral rhinitis, viral tonsillitis.

^dIncludes terms retching, hematemesis.

^eIncludes terms colitis, enterocolitis.

^fIncludes terms mouth ulceration, mucosal inflammation, aphthous ulcer, cheilitis.

^gIncludes terms tumor hemorrhage, gastrointestinal hemorrhage, subdural hemorrhage, epistaxis, intracranial tumor hemorrhage, upper gastrointestinal hemorrhage, lower gastrointestinal hemorrhage, vaginal hemorrhage, gingival bleeding, post procedural hemorrhage, hemoptysis, anal hemorrhage.

^*Includes one Grade 5 event.