MedDRA Preferred Term Placebo N 126 DYLOJECT N 187 Any Reaction 104 83 146 78 Nausea 50 40 45 24 Constipation 14 11 25 13 Headache 20 16 19 10 Infusion Site Pain 10 8 19 10 Dizziness 2 2 15 8 Flatulence 20 16 15 8 Vomiting 23 18 12 6 Insomnia 12 10 11 6 Pruritus 10 8 9 5 Hypotension 6 5 9 5 Pyrexia 13 10 8 4 Anemia 9 7 8 4 Infusion Site Extravasation 1 1 6 3 Intravenous morphine was permitted as rescue medication for pain management
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