Table 3

Treatment-related adverse events (as-treated population, n=1066)

Event, n (%)Any gradeMaximum CTCAE
Grade 3Grade 4
Any AE1022 (96)345 (32)68 (6)
Adverse events in≥10% of patients
 Vision disorder 615 (58)1 (0.1)0
 Nausea547 (51)17 (2)0
 Diarrhoea499 (47)12 (1)0
 Vomiting496 (47)11 (1)0
 Oedema409 (38)15 (1)0
 Constipation369 (35)2 (0.2)0
 Elevated transaminases 321 (30)69 (7)13 (1)
 Neutropenia 226 (21)109 (10)28 (3)
 Fatigue225 (21)27 (3)0
 Decreased appetite224 (21)6 (0.6)1 (0.1)
 Dysgeusia206 (19)00
 Leucopenia 165 (16)32 (3)1 (0.1)
 Dizziness 161 (15)2 (0.2)0
 Neuropathy 137 (13)5 (0.5)0
 Abdominal pain 134 (13)2 (0.2)0
 Bradycardia 112 (11)3 (0.3)0
Other adverse events of special interest<10% frequency*
 QT prolongation37 (4)12 (1)0
 Renal cysts 30 (3)9 (0.8)0
 Interstitial lung disease 25 (2)4 (0.4)2 (0.2)
 Hepatotoxicity 21 (2)6 (0.6)4 (0.4)
  • *AEs of special interest for crizotinib were predefined based on their clinical significance or frequency of observation in previous clinical studies and potential attribution to treatment with crizotinib.

  • †Certain preferred terms were in aggregate using clustered terms, because the frequency of certain medical concepts or conditions may have been underestimated by reliance on single Medical Dictionary for Regulatory Activities (MedDRA) preferred terms. MedDRA Preferred Terms within each clustered term that were actually reported are marked with an asterisk: Abdominal pain (Abdominal discomfort* or Abdominal pain* or Abdominal pain lower* or Abdominal pain upper* or Abdominal tenderness*); Bradycardia (or Bradycardia* or Heart rate decreased* or Sinus arrest or Sinus bradycardia*); Dizziness (Balance disorder* or Dizziness* or Dizziness exertional or Dizziness postural* or Presyncope*); Elevated transaminases (Alanine aminotransferase or Alanine aminotransferase abnormal* or Alanine aminotransferase increased* or Aspartate aminotransferase or Aspartate aminotransferase abnormal* or Aspartate aminotransferase increased* or Gamma-glutamyltransferase abnormal or Gamma-glutamyltransferase increased* or Hepatic enzyme abnormal or Hepatic enzyme increased* or Hepatic function abnormal* or Hypertransaminasemia or Liver function test abnormal or Transaminases or Transaminases abnormal or Transaminases increased*); Hepatotoxicity (Acute hepatic failure or Cholestatic liver injury or Coma hepatic or Drug-induced liver injury* or Hepatic encephalopathy or Hepatic failure* or Hepatic necrosis or Hepatic steatosis* or Hepatitis fulminant or Hepatocellular injury* or Hepatorenal failure or Hepatorenal syndrome or Hepatotoxicity* or Liver disorder* or Liver injury* or Mixed liver injury or Subacute hepatic failure); Interstitial lung disease (Acute interstitial pneumonitis or Acute lung injury or Acute respiratory distress syndrome* or Alveolitis* or Alveolitis allergic or Alveolitis necrotising or Diffuse alveolar damage or Eosinophilic pneumonia or Eosinophilic pneumonia acute or Idiopathic pulmonary fibrosis or Interstitial lung disease* or Pneumonitis* or Pulmonary toxicity); (* or White blood cell count decreased*); Neuropathy (Acute polyneuropathy or Amyotrophy or Areflexia or Autoimmune neuropathy or Autonomic failure syndrome or Autonomic neuropathy or Axonal neuropathy or Biopsy peripheral nerve abnormal or Burning feet syndrome or Burning sensation* or Decreased vibratory sense or Demyelinating polyneuropathy or Dysaesthesia* or Electromyogram abnormal or Formication* or Gait disturbance* or Genital hypoaesthesia or Guillain-Barre syndrome or Hyperaesthesia* or Hypoaesthesia* or Hyporeflexia or Hypotonia* or Ischaemic neuropathy or Loss of proprioception or Miller Fisher syndrome or Mononeuritis or Mononeuropathy or Mononeuropathy multiplex or Motor dysfunction* or Multifocal motor neuropathy or Muscle atrophy* or Muscular weakness* or Myelopathy or Nerve conduction studies abnormal or Nerve degeneration or Neuralgia* or Neuritis* or Neuromuscular toxicity or Neuromyopathy or Neuropathy peripheral* or Neuropathy vitamin B6 deficiency or Neurotoxicity* or Paraesthesia* or Peripheral motor neuropathy* or Peripheral nerve lesion or Peripheral nerve palsy or Peripheral nervous system function test abnormal or Peripheral sensorimotor neuropathy* or Peripheral sensory neuropathy* or Peroneal muscular atrophy or Peroneal nerve palsy* or Phrenic nerve paralysis or Polyneuropathy* or Polyneuropathy chronic or Polyneuropathy idiopathic progressive or Radiation neuropathy or Sensorimotor disorder or Sensory disturbance* or Sensory loss or Skin burning sensation* or Temperature perception test decreased or Tinel's sign or Toxic neuropathy* or Ulnar neuritis); Neutropenia (Febrile neutropenia* or Neutropenia* or Neutrophil count decreased*); Renal cyst (Renal abscess* or Renal cyst* or Renal cyst excision or Renal cyst * or Renal cyst infection* or Renal cyst ruptured); Vision disorder (Chromatopsia or Diplopia* or Halo vision* or Photophobia* or Photopsia* or Vision blurred* or Visual acuity reduced* or Visual brightness or Visual impairment* or Visual perseveration* or Vitreous floaters*).

  • CTCAE, common terminology criteria for adverse events.