Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT03505307
• Lead Sponsor: AstraZeneca

Brief Summary

\[Objectives\] 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"

Detailed 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

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-23
• Study Start: 2018-05-21
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 846

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ADRs regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment	from baseline to 1 year	To be calculated incidence of ADRs related to LYMPARZA during the observation period regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment
Factors which may impact incidence of ADRs related to LYMPARZA during the observation period, analysed by patient demographic characteristics	from baseline to 1 year	Factors which may impact incidence of ADRs, analysed by patient demographic characteristic(past medical history, and concomitant disease etc)
Incidence of ADRs not expected from "Precautions for Use" of LYNPARZA JPI	from baseline to 1 year	To be calculated incidence of ADRs related to LYMPARZA during the observation period not expected from "Precautions for Use" of LYNPARZA JPI