Table A1.
System Organ Class/Preferred Term† | Bolus IV Injection (n = 16) |
1-Hour IV Infusion (n = 16) |
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---|---|---|---|---|---|---|---|---|---|---|---|---|
All Grades |
Grades 1-2 |
Grade 3 |
All Grades |
Grades 1-2 |
Grade 3 |
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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.