Table 4:

Adverse Reactions (≥10%) in Patients with ROS1-positive NSCLC Who Received Repotrectinib in TRIDENT-1

Adverse Reaction1	Repotrectinib N=264
	All Grades (%)	Grade 3 or 4 (%)
Nervous System Disorders
Dizzinessa	63	1.9
Dysgeusiab	48	0
Peripheral neuropathyc	47	1.9
Ataxiad	28	0.4
Cognitive disorderse	23	0.8
Headachef	19	0
Gastrointestinal Disorders
Constipation	36	0
Nausea	19	0.4
Diarrhea	13	0.4
Vomiting	10	0.8
Respiratory, Thoracic, and Mediastinal Disorders
Dyspneag	30	7
Coughh	14	0
General Disorders
Fatiguei	24	1.1
Edemaj	12	0.8
Musculoskeletal and Connective Tissue Disorders
Muscular weakness	21	1.5
Myalgiak	12	0.4
Metabolism and Nutritional
Increased weight	14	1.9
Eye Disorders
Vision disordersl	11	0

¹Based on NCI CTCAE v4.03

Source: U.S. Food and Drug Administration Repotrectinib Label (USPI).¹⁵

^aIncludes terms dizziness, vertigo, dizziness postural, dizziness exertional, vertigo positional

^bIncludes terms dysgeusia, ageusia, anosmia, hypogeusia

^cIncludes terms neuralgia, neuropathy peripheral, peripheral sensory neuropathy, dysesthesia, peripheral motor neuropathy, polyneuropathy, paresthesia, hypoesthesia, hyperesthesia

^dIncludes terms ataxia, gait disturbance, balance disorder, cerebellar ataxia

^eIncludes terms memory impairment, disturbance in attention, cognitive disorder, confusional state, amnesia, attention deficit hyperactivity disorder, delirium, altered state of consciousness, aphasia, delusion, depressed level of consciousness, hallucination, mental status changes, neurological decompensation

^fIncludes terms headache, migraine, tension headache

^gIncludes terms dyspnea and dyspnea exertional

^hIncludes terms productive cough, cough, and upper-airway cough syndrome

ⁱIncludes terms fatigue and asthenia

^jIncludes terms generalized edema, periorbital edema, localized edema, face edema, edema peripheral, edema, eye edema, scrotal edema

^kIncludes terms myalgia, myositis, musculoskeletal discomfort, musculoskeletal pain

^lIncludes terms vision blurred, dry eye, visual impairment, visual field defect, cataract, conjunctivitis, eye pain, photophobia, photosensitivity reaction, visual acuity reduced, vitreous floaters, blepharospasm, color blindness, diplopia, eye hematoma, eye swelling, eyelid disorder, eyelid injury, eyelids pruritus, glaucoma, night blindness, ophthalmic herpes zoster