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. 2012 Oct 1;30(32):4011–4016. doi: 10.1200/JCO.2011.41.4946

Table A1.

Related Adverse Events During Bolus IV Injection or 1-Hour IV Infusion of EC145 (all cycles)*

System Organ Class/Preferred Term Bolus IV Injection (n = 16)
1-Hour IV Infusion (n = 16)
All Grades
Grades 1-2
Grade 3
All Grades
Grades 1-2
Grade 3
No. % No. % No. % No. % No. % No. %
Blood and lymphatic system disorders
    Anemia 0 0 0 0 0 0 2 13 1 6 1 6
GI disorders
    Abdominal pain 0 0 0 0 0 0 3 19 2 13 1 6
    Constipation 5 31 5 31 0 0 7 44 5 31 2 13
    Diarrhea 0 0 0 0 0 0 2 13 2 13 0 0
    Nausea 2 13 2 13 0 0 5 31 5 31 0 0
    Vomiting 2 13 2 13 0 0 2 13 2 13 0 0
General disorders and administration site conditions
    Fatigue 2 13 1 6 1 6 5 31 5 31 0 0
Metabolism and nutrition disorders
    Anorexia 0 0 0 0 0 0 2 13 2 13 0 0
Musculoskeletal and connective tissue disorders
    Pain in jaw 1 6 1 6 0 0 2 13 2 13 0 0
Nervous system disorders
    Peripheral neuropathy 2 13 2 13 0 0 0 0 0 0 0 0
    Peripheral sensory neuropathy 4 25 4 25 0 0 5 31 4 25 1 6

Abbreviation: IV, intravenous.

*

Reported in ≥ 10% of patients.

Medical Dictionary for Regulatory Activities system organ classes and preferred terms were used and are listed in alphabetic order. Adverse events are listed with presumed relationship to the study medication of possibly, probably, or definitely related. All adverse events that were reported in ≥ 10% of patients who were either treated by bolus IV injection or continuous 1-hour IV infusion are included in the tabulation.