*Fatigue, abdominal pain, hypertension, and proteinuria are consolidated terms.
†Includes 1 patient with nephrotic syndrome in the CYRAMZA arm.
‡Includes 1 fatal event in the CYRAMZA arm.
Laboratory abnormalities worsening from baseline in ≥15% (all grades) of patients receiving CYRAMZA with a difference between arms of ≥2% in REACH‑21
§ The denominator used to calculate the incidence varied based on the number of patients with a baseline and at least 1 on study laboratory measurement: CYRAMZA-treated patients (range 179 to 193 patients) and placebo-treated patients (range 84 to 92 patients).
|| Laboratory abnormalities were not included if the Grade ≥3 percentage was less than placebo-treated patients.
- Clinically relevant adverse drug reactions reported in ≥1% and <10% of CYRAMZA-treated patients in REACH‑2 were:
- Infusion-related reactions (9%)
- Hepatic encephalopathy (5%), including 1 fatal event
- Hepatorenal syndrome (2%), including 1 fatal event
- The most common serious adverse reactions with CYRAMZA were ascites (3%) and pneumonia (3%).
- Treatment discontinuations due to adverse reactions occurred in 18% of CYRAMZA-treated patients, with proteinuria being the most frequent (2%).