In the full study population
Combination therapy: Safety and tolerability in the PROpel trial1
Adverse reactions reported in ≥10% of patients who received LYNPARZA® (with a difference of ≥5% vs placebo)1
*Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.1
†Includes anemia, anemia macrocytic, and red blood cell count decreased.1
‡Includes lymphocyte count decreased and lymphopenia.1
§Includes abdominal discomfort, abdominal pain, abdominal pain upper, and abdominal pain lower.1
||Includes dizziness and vertigo.1
Fatal adverse reactions occurred in 6% of patients, including COVID-19 (3%) and pneumonias (0.5%)
Serious adverse reactions occurred in 39% of patients.1
Serious adverse reactions reported in >2% of patients included anemia (6%), COVID-19 (6%), pneumonia (4.5%), pulmonary embolism (3.5%), and urinary tract infection (3%)1
Venous thromboembolism (VTE), including severe or fatal pulmonary embolism (PE), occurred in patients treated with LYNPARZA. In the combined data of two randomised, placebo-controlled clinical studies (PROfound and PROpel) in patients with metastatic castration-resistant prostate cancer (N=1180), VTE occurred in 8% of patients who received LYNPARZA, including pulmonary embolism in 6%. In the control arms, VTE occurred in 2.5% including pulmonary embolism in 1.5%.1
Laboratory abnormalities reported in ≥20% of patients in PROpel1
*This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.1
abi/pred, abiraterone plus prednisone or prednisolone; COVID-19, coronavirus disease 2019.
Reference: 1. LYNPARZA® (olaparib). Prescribing information.