Table 3

No. of patients with acute nonhematological toxicity by grade

Grade 1Grade 2Grade 3Grade 4
Symptoms
Nausea11701
Cough3030
Diarrhea41044 (1 grade 5)
Vomiting8601
Tachycardia1300
Anorexia6812
Fever0410
Fatigue8940
Dyspnea0030
Dehydration2102
Headache1200
Taste changes3300
Stomatitis0101
Edema/ascites0010
Back pain2000
Abdominal cramping4001
Abdominal pain1201
Laboratory abnormalitiesa
Elev. BUNb4000
Elev. Creatininec2201d
Hypokalemia2831 (grade 5)e
LDHf0000
Alkaline phosphatase12440
SGOTg11320
SGPTh8310
GGTi10220
Bilirubin2123j
  • a Exclusive of baseline elevations (e.g., preexisting grade 1 toxicity).

  • b Blood urea nitrogen.

  • c Acute toxicity only [excludes two patients (no. 2 and 3) with elevated creatinine 7–8 months after treatment].

  • d Unrelated to study drug.

  • e Patient 10.

  • f Lactate dehydrogenase.

  • g Serum aspartate aminotransferase.

  • h Serum alanine aminotransferase.

  • i Gamma glutamyl transferase.

  • j Patients 5, 14, and 23.