Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)

NCT ID: NCT03505307

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

846 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-21

Study Completion Date

2020-12-07

Brief Summary

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\[Objectives\] 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

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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

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toshimitsu Tokimoto

Role: STUDY_DIRECTOR

AstraZeneca KK

Other Identifiers

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D0816C00019

Identifier Type: -

Identifier Source: org_study_id

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