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An additional analysis aimed at separating the effect of psychological distress alone from physical or sexual abuse showed that most effects dropped below the level of statisticalignificance, except for the relationship between physical abuse and nausea/vomiting.
In clinical trials in China, patients did not exhibit the side effects such as hypertension, headache, rapid heart rate, nausea/vomiting and clotted vascular access commonly associated with Western therapies used in conjunction with chemotherapy.
The most common adverse events for combination therapy included flu-like symptoms, such as fever, chills, fatigue, headache, myalgia/arthralgia, nausea/vomiting, anorexia, diarrhea and abdominal pain, injection site reactions, partial alopecia, depression, irritability, insomnia and dizziness.
Mild (grade 1 or 2) adverse events consisted primarily of constitutional symptoms such as fever/chills, asthenia (weakness and loss of strength), nausea/vomiting, and headache; skin reactions including generalized pruritus (itching) and rash; pain; and increases in transaminase levels, with the highest frequency and severity at the 5 mcg/kg/day dose.
The most common adverse events include fatigue, headache, myalgia/arthralgia, flu-like symptoms, nausea/vomiting, injection site reactions, fever, chills, diarrhea, partial alopecia, abdominal pain, depression, irritability, insomnia, dizziness and anorexia.
Fewer and less severe adverse events, including nausea/vomiting, alopecia, peripheral sensory neuropathy and neutropenia (<1000 cells/mm3), were reported in the DOXIL arm relative to ABV, with the exception of mucositis, which was more frequent among DOXIL patients.
In clinical trials, the most frequently reported adverse events with EPOGEN (R) were hypertension, headache, tachycardia (rapid heart rate), nausea/vomiting and clotted vascular access.