YMI - Toxicity
Table 5 summarizes drug-related adverse events, which occurred in 10% of patients in
either arm. As expected, patients who received DPPE plus DOX had more vomiting,
ataxia, dizziness, extrapyramidal effects, and hallucinations; interestingly, they also had
less stomatitis. There was no difference in grade 3 or 4 neutropenia (68% v 63%) or
febrile neutropenia (7% v 8%) between DPPE plus DOX and DOX arms, respectively.
There were no clinically significant adverse effects on liver or renal function. The use of
blood transfusions (8% v 4%), growth factors (6% v 4%), and prophylactic antibiotics
(2% v 1%) was similar for DPPE plus DOX and DOX arms, respectively. There were
seven deaths within 30 days of protocol therapy. These included three patients receiving
DPPE plus DOX in whom death was considered related to drug (febrile neutropenia,
myelosuppression, and hypertension with possible pulmonary embolism). One patient
receiving DOX died as a result of febrile neutropenia after receiving a subsequent salvage
regimen of chemotherapy (Table 6). Two patients receiving DOX had clinical evidence of
cardiomyopathy, four patients receiving DPPE plus DOX had at least one report of
cardiac failure, and 18 patients in each arm had at least one documented decrease in left
ventricular ejection fraction (by 20% of baseline value or to a value of < 40%).
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