NOVA Trial Dosing
Side Effects of ZEJULA May Be Managed With Dose Interruption and Modification1,2
In the NOVA trial, adverse reactions led to dose reduction or interruption in 69% of patients, most frequently from thrombocytopenia (41%) and anemia (20%). Discontinuation due to hematologic adverse reactions was uncommon for thrombocytopenia (3%), neutropenia (2%), and anemia (1%).
aThrombocytopenia includes reports of thrombocytopenia and decreased platelet count.
bAnemia includes reports of anemia and decreased hemoglobin counts.
cNeutropenia includes reports of neutropenia, decreased neutrophil count, and febrile neutropenia.
- The incidence of grade 3/4 thrombocytopenia by dose at onset was 2.3%, 5.9%, and 33.2% for patients receiving ZEJULA doses of 100 mg, 200 mg, and 300 mg, respectively2
The analysis is exploratory in nature; it does not control for type 1 error and is not powered to determine treatment effect in any subgroup.
- Interrupt and reduce dose at the first sign of unacceptable toxicity1
†Censored subjects are indicated by circles.
The Side Effect Profile of ZEJULA Is Well Characterized1
- No on-treatment deaths were reported during the trial5