Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)

AstraZeneca

Status: Completed

Conditions: Ovarian Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT03505307

D0816C00019

Details and patient eligibility

About

[Objectives] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use.

1. ADR development in actual clinical use
2. Factors which may affect safety and efficacy
3. ADRs not expected from "Precautions for Use"

Full description

The objective of the Clinical Experience Investigation (CEI) is to collect following data to characterise safety and efficacy of LYMPARZA Tablets 100mg and 150mg (LYMPARZA) in usual post-marketing use.

1. Development of adverse drug reactions (ADRs)
2. Factors which may affect safety and efficacy of LYMPARZA
3. Development of adverse drug reactions (ADRs) unexpected from "Precautions for Use" of the LYMPARZA JPI

Enrollment: 846 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Maintenance treatment for patients with recurrent ovarian cancer, who are sensitive to platinum based chemotherapy

Exclusion criteria