Metastatic colorectal cancer
Clinical trial safety: RAISE
Adverse reaction profile for CYRAMZA + FOLFIRI1,2
Adverse reactions occurring at incidence rate ≥5% and a ≥2% difference between arms in patients receiving CYRAMZA1
SELECT IMPORTANT SAFETY INFORMATION
MOST COMMON ADVERSE REACTIONS – CYRAMZA ADMINISTERED AS A SINGE AGENT (REGARD)
- The most common serious adverse events with CYRAMZA were anemia (3.8%) and intestinal obstruction (2.1%). Red blood cell transfusions were given to 11% of CYRAMZA-treated patients vs 8.7% of patients who received placebo.
- Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA-treated patients in REGARD were: neutropenia (4.7%), epistaxis (4.7%), rash (4.2%), intestinal obstruction (2.1%), and arterial thromboembolic events (1.7%).
- Across clinical trials of CYRAMZA administered as a single agent, clinically relevant adverse reactions (including Grade ≥3) reported in CYRAMZA-treated patients included proteinuria, gastrointestinal perforation, and IRRs. In REGARD, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria vs 3% of placebo-treated patients. Two patients discontinued CYRAMZA due to proteinuria. The rate of gastrointestinal perforation in REGARD was 0.8% and the rate of IRRs was 0.4%.