Open-Label Extension and Safety Study of Talazoparib | NCT02921919

NCT02921919

ID	Type	Description	Link
C3441010	Other Identifier	Alias Study Number
2016-001972-31	EudraCT Number

Status Module

Sponsor/Collaborators Module

Name	Class
Medivation, Inc.	INDUSTRY

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Talazoparib	Experimental		Drug: Talazoparib

Name	Type	Description	Arm Group Labels	Other Names
Talazoparib	Drug	Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol	Talazoparib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs	An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug without regard to possibility of a causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death; inpatient hospitalization or prolongation of existing hospitalization; was life-threatening (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or was considered as an important medical event. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. AE included both SAEs and all non-SAEs. Treatment-related TEAEs were defined as any TEAE with at least a possible relationship to the study drug as assessed by the investigator or that was missing the assessment of causal relationship whose relationship to the study drug could not be ruled out.	From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
Number of Participants With Grade 3 or 4 TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4	An AE was any untoward medical occurrence in a participant administered a study drug without regard to possibility of a causal relationship. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. Severity was graded using NCI-CTCAE version 4 where, Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 3 or 4 TEAEs were reported.	From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
Number of Participants With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UCLA Hematology/Oncology - Alhambra		Alhambra	California	91801	United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Initial Dose Talazoparib: < 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of less than (<) 1 milligram (mg) orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 14, 2018	Jun 7, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Baseline analysis population included the participants who received any amount of talazoparib in this study.

Arm/Group Information

ID	Title	Description
BG000	Initial Dose Talazoparib: < 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.
BG001	Initial Dose Talazoparib: 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 50 years	BG00010 BG0019 BG00219
50 to <65 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00046 BG00137 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0006 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs

An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug without regard to possibility of a causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death; inpatient hospitalization or prolongation of existing hospitalization; was life-threatening (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or was considered as an important medical event. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. AE included both SAEs and all non-SAEs. Treatment-related TEAEs were defined as any TEAE with at least a possible relationship to the study drug as assessed by the investigator or that was missing the assessment of causal relationship whose relationship to the study drug could not be ruled out.

Safety population included all participants who received any amount of talazoparib.

Posted

Count of Participants

Participants

From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)

ID	Title	Description
OG000	Initial Dose Talazoparib: < 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.
OG001	Initial Dose Talazoparib: 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

Units	Counts
Participants	OG00066 OG00152

Title

Denominators

Categories

TEAE

Title	Measurements
	OG00063 OG00147

SAE

Title	Measurements
	OG000

Primary

Number of Participants With Grade 3 or 4 TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4

An AE was any untoward medical occurrence in a participant administered a study drug without regard to possibility of a causal relationship. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. Severity was graded using NCI-CTCAE version 4 where, Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 3 or 4 TEAEs were reported.

Safety population included all participants who received any amount of talazoparib.

Posted

Count of Participants

Participants

From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)

ID	Title	Description
OG000	Initial Dose Talazoparib: < 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

Primary

Number of Participants With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death

An AE was any untoward medical occurrence in a participant administered a study drug without regard to possibility of a causal relationship. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. Number of participants with TEAEs leading to dose reduction, permanent study drug discontinuation and death were reported.

Safety population included all participants who received any amount of talazoparib.

Posted

Count of Participants

Participants

From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)

ID	Title	Description
OG000	Initial Dose Talazoparib: < 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.
OG001	Initial Dose Talazoparib: 1 mg/Day

Primary

Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests

The following liver parameters were analyzed: aspartate transaminase (AST), alanine aminotransferase (ALT), total bilirubin (TBL) and alkaline phosphatase (ALP). The criteria for clinically significant abnormalities for liver parameters included AST or ALT greater than or equal to (>=) 3 times upper limit of normal (ULN); ALT or AST greater than (>) 5 times ULN; ALT or AST > 10 times ULN; ALT or AST > 20 times ULN; total TBL >2 times ULN; ALT or AST >= 3 times ULN and TBL > 2 times ULN and ALT or AST >= 3 times ULN and TBL > 2 times ULN and ALP < 2 times ULN.

Safety population included all participants who received any amount of talazoparib. Here, "overall number of participants analyzed" signifies number of participants who were evaluable for this outcome measure.

Posted

Count of Participants

Participants

From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)

ID	Title	Description
OG000	Initial Dose Talazoparib: < 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

Primary

Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters

The following hematology parameters were analyzed: hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. Laboratory toxicities were graded using NCI-CTCAE version 4 where, grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death) for each parameter. Number of participants with Grade 3 and 4 toxicities were reported. Low indicates values lower than the normal range.

Safety population included all participants who received any amount of talazoparib.

Posted

Count of Participants

Participants

From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)

ID	Title	Description
OG000	Initial Dose Talazoparib: < 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.
OG001	Initial Dose Talazoparib: 1 mg/Day

Primary

Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters

The following chemistry parameters were analyzed: alkaline phosphatase, bilirubin and creatinine. Laboratory toxicities were graded using NCI-CTCAE version 4 where, grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death) for each parameter. Number of participants with Grade 3 or 4 toxicities were reported. High indicates values higher than the normal range.

Safety population included all participants who received any amount of talazoparib.

Posted

Count of Participants

Participants

From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)

ID	Title	Description
OG000	Initial Dose Talazoparib: < 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.
OG001	Initial Dose Talazoparib: 1 mg/Day

Primary

Number of Participants With Clinically Significant Changes in Vital Signs and Weight

Criteria for clinically significant changes in vital signs included a) Systolic blood pressure (SBP): 1) absolute results >180 millimeter of mercury (mmHg) and increase from baseline >=40 mmHg, 2) absolute results <90 mmHg and decrease from baseline >30 mmHg; b) Diastolic blood pressure (DBP): 1) absolute results >110 mmHg and increase from baseline >=30 mmHg , 2) absolute results <50 mmHg and decrease from baseline >20 mmHg , 3) increase from baseline >=20 mmHg; c) Heart rate: 1) absolute results >120 beats per minute (bpm) and increase from baseline >30 bpm, 2) absolute results <50 bpm and >20 bpm decrease from baseline; d) Temperature: <=34.5 or >=38 degree Celsius. Criteria for clinically significant changes in weight: >10 percent (%) decrease from baseline.

Safety population included all participants who received any amount of talazoparib.

Posted

Count of Participants

Participants

From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)

ID	Title	Description
OG000	Initial Dose Talazoparib: < 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Initial Dose Talazoparib: < 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.	7	66	27	66	54	66
EG001	Initial Dose Talazoparib: 1 mg/Day	Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.	8	52	18	52	46	52

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 affected66 at risk EG0012 affected52 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected52 at risk
Bradycardia	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected52 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Ileus	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected52 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Large Intestinal Obstruction	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Death	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Disease Progression	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 affected66 at risk EG0010 affected52 at risk
Gait Disturbance	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
General Physical Health Deterioration	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Jaundice	Hepatobiliary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Abdominal Abscess	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Cellulitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected52 at risk
Endocarditis Bacterial	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Sepsis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected52 at risk
Streptococcal Sepsis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Urosepsis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Platelet Count Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Failure To Thrive	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Gout	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected52 at risk
Intraductal Proliferative Breast Lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Malignant Pleural Effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0013 affected52 at risk
Pericardial Effusion Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Aphasia	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Cauda Equina Syndrome	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected52 at risk
Paraesthesia	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0003 affected66 at risk EG0011 affected52 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected52 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected52 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG00019 affected66 at risk EG00118 affected52 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0013 affected52 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG00010 affected66 at risk EG0014 affected52 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Non-systematic Assessment	EG00010 affected66 at risk EG0015 affected52 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 affected66 at risk EG0011 affected52 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0009 affected66 at risk EG0015 affected52 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0005 affected66 at risk EG0012 affected52 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0008 affected66 at risk EG0012 affected52 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0008 affected66 at risk EG0013 affected52 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG00018 affected66 at risk EG00110 affected52 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG00012 affected66 at risk EG0014 affected52 at risk
Asthenia	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0006 affected66 at risk EG0016 affected52 at risk
Fatigue	General disorders	MedDRA 24.0	Non-systematic Assessment	EG00017 affected66 at risk EG00111 affected52 at risk
Oedema Peripheral	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0007 affected66 at risk EG0014 affected52 at risk
Pain	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0013 affected52 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0008 affected66 at risk EG0013 affected52 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0006 affected66 at risk EG0012 affected52 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	EG0006 affected66 at risk EG0011 affected52 at risk
Blood Creatinine Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0003 affected66 at risk EG0013 affected52 at risk
Neutrophil Count Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0004 affected66 at risk EG0014 affected52 at risk
Platelet Count Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 affected66 at risk EG0019 affected52 at risk
Weight Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0003 affected66 at risk EG0013 affected52 at risk
White Blood Cell Count Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0006 affected66 at risk EG0013 affected52 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0007 affected66 at risk EG0017 affected52 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0005 affected66 at risk EG0011 affected52 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 affected66 at risk EG0013 affected52 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0006 affected66 at risk EG0014 affected52 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG00010 affected66 at risk EG0012 affected52 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 affected66 at risk EG0011 affected52 at risk
Malignant Ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0000 affected66 at risk EG0013 affected52 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0005 affected66 at risk EG0010 affected52 at risk
Headache	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0007 affected66 at risk EG0010 affected52 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0007 affected66 at risk EG0014 affected52 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0008 affected66 at risk EG0016 affected52 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0006 affected66 at risk EG0015 affected52 at risk
Hypertension	Vascular disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 affected66 at risk EG0012 affected52 at risk

ID	Term
D009369	Neoplasms

ID	Term
C586365	talazoparib

Participants were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of 1 mg orally once daily. Participants received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Participants were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.