Table 2.

Toxicity profile of TIER

AEEvents
Grade 3Grade 4
Hematologic   
 Anemia 24 (10)  
 Decreased white blood cell count 28 (7) 17 (8) 
 Decreased neutrophil count 39 (14) 36 (16) 
 Decreased lymphocyte count 29 (8) 11 (6) 
 Decreased platelet count 40 (12) 28 (11) 
 Febrile neutropenia 5 (4)  
 Other investigations (cytopenia) 1 (1)  
Neurologic or ophthalmologic   
 Seizure 2 (2) 1 (1) 
 Confusion 2 (2)  
 Dysphasia 2 (2)  
 Agitation 1 (1)  
 Psychosis 1 (1)  
 Encephalopathy 1 (1)  
 Headache 2 (2)  
 Somnolence 1 (1)  
 Fatigue 1 (1)  
 Depression 1 (1)  
 Left-sided muscle weakness 1 (1)  
 Syncope 1 (1)  
 Vasovagal reaction 1 (1)  
 Ataxia 1 (1)  
 Nervous system disorders ( drowsiness) 1 (1)  
 Keratitis 1 (1)  
 Eye disorders ( right eye vision loss) 1 (1)  
Metabolic   
 Hypophosphatemia 4 (2) 2 (1) 
 Hypokalemia 4 (1)  
 Hypomagnesemia  3 (1) 
 Hyponatremia 1 (1)  
 Hypoalbuminemia 2 (1)  
 Hypoglycemia 1 (1)  
Infective   
 Bronchial infection 1 (1)  
 Infections and infestations ( lower respiratory tract infection) 1 (1)  
 Upper respiratory infection 1 (1)  
 General disorders and administration site conditions ( influenza) 1 (1)  
 Urinary tract infection 1 (1)  
 Infections and infestations   
  Neutropenic sepsis 1 (1)  
  Other infection 1 (1)  
Gastrointestinal   
 Dysphagia 2 (2)  
 Diarrhea 1 (1)  
 Oral mucositis 1 (1)  
Other   
 Hypertension 1 (1)  
 Urinary incontinence 1 (1)  
 Increased lipase 1 (1)  
 Increased alanine aminotransferase 1 (1)  
AEEvents
Grade 3Grade 4
Hematologic   
 Anemia 24 (10)  
 Decreased white blood cell count 28 (7) 17 (8) 
 Decreased neutrophil count 39 (14) 36 (16) 
 Decreased lymphocyte count 29 (8) 11 (6) 
 Decreased platelet count 40 (12) 28 (11) 
 Febrile neutropenia 5 (4)  
 Other investigations (cytopenia) 1 (1)  
Neurologic or ophthalmologic   
 Seizure 2 (2) 1 (1) 
 Confusion 2 (2)  
 Dysphasia 2 (2)  
 Agitation 1 (1)  
 Psychosis 1 (1)  
 Encephalopathy 1 (1)  
 Headache 2 (2)  
 Somnolence 1 (1)  
 Fatigue 1 (1)  
 Depression 1 (1)  
 Left-sided muscle weakness 1 (1)  
 Syncope 1 (1)  
 Vasovagal reaction 1 (1)  
 Ataxia 1 (1)  
 Nervous system disorders ( drowsiness) 1 (1)  
 Keratitis 1 (1)  
 Eye disorders ( right eye vision loss) 1 (1)  
Metabolic   
 Hypophosphatemia 4 (2) 2 (1) 
 Hypokalemia 4 (1)  
 Hypomagnesemia  3 (1) 
 Hyponatremia 1 (1)  
 Hypoalbuminemia 2 (1)  
 Hypoglycemia 1 (1)  
Infective   
 Bronchial infection 1 (1)  
 Infections and infestations ( lower respiratory tract infection) 1 (1)  
 Upper respiratory infection 1 (1)  
 General disorders and administration site conditions ( influenza) 1 (1)  
 Urinary tract infection 1 (1)  
 Infections and infestations   
  Neutropenic sepsis 1 (1)  
  Other infection 1 (1)  
Gastrointestinal   
 Dysphagia 2 (2)  
 Diarrhea 1 (1)  
 Oral mucositis 1 (1)  
Other   
 Hypertension 1 (1)  
 Urinary incontinence 1 (1)  
 Increased lipase 1 (1)  
 Increased alanine aminotransferase 1 (1)  

All data are n (%). All grade 3 and 4 AEs are listed. Terms from Common Terminology Criteria for Adverse Events version 4.0 are arranged into clinically related groups. Total number of patients, 36.

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