Adverse events
pulmonary embolism, death, vomiting, bronchopneumonia, dehydration, Numbness, vomiting, dehydration, deaths
PULMONARY EMBOLISM, DEEP VENOUS THROMBOSIS, ADVERSE EVENTS, BRONCHOPNEUMONIA, DEHYDRATION
Eleven patients (6.5%) had adverse events: 5 (8.8%), 3 (5.4%), and 3 (5.3%) in the neuroEPO plus 0.5 mg, 1.0 mg, and placebo group, respectively.The incidence of death was 1.8% in the neuroEPO plus 0.5 mg group and 1.8% in the placebo group. No deaths were considered by the investigators to be related to neuroEPO plus. Numbness in the upper right member was the only adverse events related with neuroEPO plus 0.5 mg (Table Summary of adverse events (AEs) by treatment groupThe analysis was performed in the safety population, which included participants who received at least one dose of neuroEPO or placebo
The incidence of serious adverse events was 5.3% in the neuroEPO plus 0.5 mg group and in the placebo group. In the neuroEPO plus 0.5 mg group, 1 participant with bronchopneumonia, deep venous thrombosis, and pulmonary embolism subsequently died. In the placebo group, 1 participant with vomiting, dehydration, and bronchopneumonia subsequently died.The most commonly reported serious adverse events were bronchopneumonia (1.8% in the neuroEPO plus 0.5 mg and in the placebo group), pulmonary embolism (1.8% in the neuroEPO plus 0.5 mg group), deep venous thrombosis (1.8% in the neuroEPO plus 0.5 mg group), vomiting (1.8% in the placebo group), and dehydration (1.8% in the placebo group).There were 21 adverse events, 10 in neuroEPO plus 0.5 mg, 5 in neuroEPO plus 1.0 mg, and 7 in placebo group. The most common adverse events were vomiting (1.8% each in neuroEPO plus 0.5 mg, 1.0 mg, and in placebo) and bronchopneumonia (1.8% in neuroEPO plus 0.5 mg and in placebo group). The overall incidence of adverse events was similar in the three groups (Table Treatment discontinuation due to adverse events was reported just in the two deceased subjects.NeuroEPO plus produced no clinically relevant changes in laboratory tests, specifically no clinically important hemoglobin variation was detected and no difference between groups were observed at 48 weeks (Table S5 and Fig. S5, The benefit-risk analysis showed striking evidence in favour of the benefit. The odds were greater than 400 for neuroEPO plus groups indicating that the probability of benefit is greater than the probability of risk; for placebo, the odds was greater than 70 (Fig. S6, 