Table 2.

Treatment-related grade 3/4 toxicities during the first six courses of induction therapy

ToxicityCourse 1 (n = 43)Course 2 (n = 43)Course 3 (n = 43)Course 4 (n = 43)Course 5 (n = 42)aCourse 6 (n = 42)a
Abdominal distension1
Abdominal pain321225
Acidosis245521
Acute kidney injury1
Agitation1
Alanine aminotransferase increased334111
Alkalosis11
Allergic reaction1
Anaphylaxis1
Anemia414035403842
Anorexia1112
Apnea1
Aspartate aminotransferase increased4111
Asystole1
Atelectasis1
Back pain11
Bladder infection12
Blood antidiuretic hormone abnormal1
Blood bilirubin increased41214
Bone pain11
Bronchospasm2
Buttock pain1
Catheter-related infection121316
Chest pain, cardiac1
Colitis11211
Constipation1
Cough111
Cystitis noninfective2111
Dehydration1111
Device-related infection12
Diarrhea112131
Enterocolitis5251057
Epistaxis2232
Erythema multiforme1
Esophagitis116
Febrile neutropenia199223820
Fever112346
GGT increased55115
Gum infection1
Headache11
Hearing impaired2216
Hematuria1
Hypercalcemia1
Hyperglycemia246542
Hyperkalemia112
Hypermagnesemia1
Hypertension1111
Hypoalbuminemia21121
Hypocalcemia53133
Hypoglycemia21
Hypokalemia133168159
Hyponatremia6111645
Hypophosphatemia4161166
Hypotension11112
Hypoxia821
Ileus1
Infections and infestations12
Infusion-related reaction3211
Injection site reaction1
Left ventricular systolic dysfunction1
Lung infection1
Lymphocyte count decreased384142434142
Lymphocyte count increased331346
Malabsorption1
Metabolism and nutrition disorders1
Mucositis, oral117118
Nausea1331
Neutrophil count decreased434235434142
Pain1034311
Photophobia1
Platelet count decreased343741434142
Pleural effusion41
Pneumonitis1
Pruritus1
Rash acneiform2
Rash, maculopapular2
Respiratory failure1
Scrotal infection1
Sepsis13
Sinus tachycardia1
Skin infection122
Sore throat1
Stridor1
Syncope1
Thromboembolic event11
Tracheitis1
Tumor lysis syndrome1
Typhlitis1
Upper gastrointestinal hemorrhage1
Upper respiratory infection8937615
Urethral infection1
Urinary retention1
Urinary tract infection34525
Urostomy obstruction1
Vascular access complication1
Vomiting4513
Vulval infection1
Weight loss1
White blood cell decreased433931434142
Wound infection1
  • NOTE: Entries in the table represent patient numbers. If a patient experienced multiple episodes of a particular toxicity during a course of therapy, only the highest observed grade of a toxicity was reported.

  • Abbreviation: GGT, gamma-glutamyltransferase.

  • aOne patient withdrew after course 4 of therapy (parental preference).