Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)

Lynparza Tablets 100mg, 150mg Clinical Experience Investigation (All Case Investigation) in Patients With Platinum-sensitive Relapsed Ovarian Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03505307

Enrollment

846

Registered

2018-04-23

Start date

2018-05-21

Completion date

2020-12-07

Last updated

2022-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results