XTANDI demonstrated a statistically significant improvement in OS vs placebo.1
Median duration of treatment in AFFIRM1
- Patients receiving XTANDI stayed on treatment more than twice as long as those receiving placebo1
The most common adverse drug reactions (≥ 5%) were asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema,
musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection,
spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 3 and higher adverse
reactions were reported among 47% of XTANDI-treated patients and 53% of placebo-treated patients. Discontinuations due to adverse
events were reported for 16% of XTANDI-treated patients and 18% of placebo-treated patients.
Please see Full Prescribing Information for number of patients at risk at each time point.
*NR = not reached.
CI = confidence interval; HR = hazard ratio.