Table 3:

Adverse Reactions (≥15%) in Study TAS-120–101.

	Futibatinib N = 103
Adverse Reaction	All Gradesa (%)	Grade 3 (%)
Skin and subcutaneous tissue disorders
Nail toxicityb	47	1.9
Alopecia	34	0
Dry skin	29	0
Palmar-plantar erythrodysesthesia syndrome	21	4.9
Gastrointestinal disorders
Constipation	39	0
Diarrheac	39	1
Dry mouth	35	0
Stomatitisd	30	6
Abdominal paine	30	2.9
Nausea	24	1.9
Vomitingf	20	1
General disorders
Fatigueg	37	8
Metabolism and nutrition disorders
Decreased appetite	23	2.9
Musculoskeletal and connective tissue disorder
Musculoskeletal painh	43	3.9
Arthralgiai	25	0
Eye disorders
Dry eyej	25	1
Nervous system disorders
Dysgeusiak	25	0
Infections
Urinary tract infectionl	23	2.9
Investigations
Weight decreased	18	3.9

Source: LYTGOBI USPI (13).

^aGraded per NCI CTCAE 4.03.

^bIncludes nail toxicity, nail disorder, nail discoloration, nail dystrophy, nail hypertrophy, nail infection, nail pigmentation, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomycosis, and paronychia.

^cIncludes diarrhea, colitis, and gastroenteritis.

^dIncludes stomatitis, glossitis, mouth ulceration, mucosal inflammation, pharyngeal inflammation, and tongue ulceration.

^eIncludes abdominal pain, abdominal discomfort, abdominal pain upper, gastrointestinal pain, and hepatic pain.

^fIncludes vomiting and hematemesis.

^gIncludes fatigue and asthenia.

^hIncludes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, non-cardiac chest pain, pain in extremity, and spinal pain.

ⁱIncludes arthralgia and arthritis.

^jIncludes dry eye, keratitis, lacrimation increased, photokeratitis, punctate keratitis, and ulcerative keratitis.

^kIncludes dysgeusia, ageusia, and taste disorder.

^lIncludes urinary tract infection, cystitis, and dysuria.