Safety Signals Observed in QUADRA Were Consistent With Those Found in NOVA1,2
However, rates of most common adverse reactions observed in QUADRA were different from NOVA, and fatal adverse reactions occurred in 2% of patients, including cardiac arrest. In QUADRA, serious adverse reactions occurred in 43% of patients receiving ZEJULA. Serious adverse reactions in >3% of patients were small intestinal obstruction (7%), vomiting (6%), nausea (5%), and abdominal pain (4%).
Adverse reactions in QUADRA led to3:
Dose reduction or interruption, 73%
Most frequently from:
- Thrombocytopenia, 40%
- Anemia, 21%
- Fatigue, 9%
- Nausea, 13%
- Vomiting, 11%
- Neutropenia, 11%
- Abdominal pain, 5%
*Monitor periodically. Schedule provided as an example.
Common lab abnormalities (Grades 1–4) in ≥25% of patients who received ZEJULA in QUADRA included3:
Decreased hemoglobin (83%), increased glucose (66%), decreased platelets (60%), decreased lymphocytes (57%), decreased leukocytes (53%), decreased magnesium (46%), increased alkaline phosphatase (40%), increased gamma glutamyl transferase (40%), increased creatinine (36%), decreased sodium (34%), decreased neutrophils (34%), increased aspartate aminotransferase (29%), and decreased albumin (27%).