4
(%)
Abbreviations: NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; SOC=System organ class.
*
Adverse reactions were graded using NCI CTCAE version 4.0.
†
Mood effects (including affective disorder, affect lability, aggression, agitation, anxiety, depressed mood, depression, euphoric mood, irritability, mania, mood altered, mood swings, personality change, stress, suicidal ideation).
‡
Peripheral neuropathy (including burning sensation, carpal tunnel syndrome, dysesthesia, formication, gait disturbance, hypoesthesia, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity, paresthesia, peripheral sensory neuropathy, sensory disturbance).
§
Cognitive effects (including events from SOC Nervous system disorders: amnesia, cognitive disorder, dementia, disturbance in attention, memory impairment, mental impairment; and also including events from SOC Psychiatric disorders: attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder).
¶
Speech effects (including aphasia, dysarthria, slow speech, speech disorder)
#
Sleep effects (including abnormal dreams, insomnia, nightmare, sleep disorder, sleep talking, somnambulism)
Þ
Vision disorder (including blindness, diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters).
ß
Myalgia (including musculoskeletal pain, myalgia).
à
Edema (including edema, edema peripheral, eyelid edema, face edema, generalized edema, localized edema, periorbital edema, peripheral swelling, swelling).
è
Fatigue (including asthenia, fatigue).
ð
Upper respiratory infection (including fungal upper respiratory infection, upper respiratory infection, viral upper respiratory infection).
ø
Rash (including dermatitis acneiform, maculopapular rash, pruritic rash, rash).
Psychiatric
Mood effects† 23 1.7
Nervous system
Peripheral neuropathy‡ 47 2.7
Cognitive effects§ 27 2.0
Headache 18 0.7
Dizziness 16 0.7
Speech effects¶ 12 0.3
Sleep effects# 10 0
Respiratory
Dyspnea 27 5.4
Cough 18 0
Ocular
Vision disorderÞ 15 0.3
Gastrointestinal
Diarrhea 22 0.7
Nausea 18 0.7
Constipation 15 0
Vomiting 12 1
Musculoskeletal and connective tissue
Arthralgia 23 0.7
Myalgiaß 17 0
Back pain 13 0.7
Pain in extremity 13 0.3
General
Edemaà 57 3.1
Fatigueè 26 0.3
Weight gain 24 4.4
Pyrexia 12 0.7
Infections
Upper respiratory tract infectionð 12 0
Skin
Rashø 14 0.3
Additional clinically significant adverse reactions occurring at an incidence between 1% and 10% were hallucinat |
