Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER and Time to Onset

Area of Science:

• Oncology
• Pharmacovigilance
• Clinical Pharmacology

Background:

• Poly (ADP-ribose) polymerase (PARP) inhibitors are crucial in treating cancers with BRCA mutations.
• Hematologic and gastrointestinal toxicities are known class effects of PARP inhibitors.
• Data on adverse events (AEs) in Japanese patient cohorts receiving PARP inhibitors are limited.

Purpose of the Study:

• To comprehensively survey the AEs of olaparib and niraparib in a Japanese clinical cohort.
• To analyze the onset and progression of AEs associated with these PARP inhibitors.
• To provide insights for managing PARP inhibitor-related side effects in clinical practice.

Main Methods:

• Utilized the Japanese Adverse Reaction Reporting (JADER) database from the Pharmaceuticals and Medical Devices Agency (PMDA).
• Conducted a signal detection analysis for AEs associated with olaparib and niraparib.
• Analyzed the temporal patterns, including time to onset, for identified AEs.

Main Results:

• Detected 15 significant AE signals for olaparib and 11 for niraparib.
• The majority of detected AEs occurred within the first month of treatment for both agents.
• Identified specific adverse event profiles for olaparib and niraparib in the Japanese population.

Conclusions:

• Early monitoring and response are critical following the initiation of PARP inhibitor therapy.
• The findings underscore the importance of understanding the specific AE profiles of olaparib and niraparib.
• This study provides valuable data for optimizing supportive care and managing side effects in patients receiving PARP inhibitors.