Trial Outcomes & Findings for Open-Label Extension and Safety Study of Talazoparib (NCT NCT02921919)
NCT ID: NCT02921919
Last Updated: 2022-08-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
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)
Results posted on
2022-08-24
Participant Flow
Eligible participants who received talazoparib as a single agent or in combination with another agent in following qualifying studies: PRP-001(NCT01286987), MDV3800-01(NCT02997163), MDV3800-02(NCT02997176), MDV3800-03(NCT03070548), MDV3800-04(NCT03077607), MDV3800-14(NCT03042910) continued therapy with talazoparib as single agent in this extended treatment study.
A total of 120 participants were enrolled in the study of which 118 participants received the study treatment and 2 participants did not receive any study treatment as they were withdrawn before treatment initiation. Hence those 2 participants were not reported under any reporting arms.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
52
|
|
Overall Study
Treated
|
66
|
52
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
66
|
52
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Other
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Disease Progression
|
47
|
38
|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Adverse Event
|
6
|
4
|
Baseline Characteristics
Open-Label Extension and Safety Study of Talazoparib
Baseline characteristics by cohort
| Measure |
Initial Dose Talazoparib: < 1 mg/Day
n=66 Participants
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.
|
Initial Dose Talazoparib: 1 mg/Day
n=52 Participants
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.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 50 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Customized
50 to <65 years
|
30 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Customized
Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Safety population included all participants who received any amount of talazoparib.
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.
Outcome measures
| Measure |
Initial Dose Talazoparib: < 1 mg/Day
n=66 Participants
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.
|
Initial Dose Talazoparib: 1 mg/Day
n=52 Participants
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.
|
|---|---|---|
|
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
TEAE
|
63 Participants
|
47 Participants
|
|
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
SAE
|
27 Participants
|
18 Participants
|
|
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
Treatment-related TEAEs
|
45 Participants
|
31 Participants
|
|
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
Treatment-related SAEs
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Safety population included all participants who received any amount of talazoparib.
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.
Outcome measures
| Measure |
Initial Dose Talazoparib: < 1 mg/Day
n=66 Participants
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.
|
Initial Dose Talazoparib: 1 mg/Day
n=52 Participants
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.
|
|---|---|---|
|
Number of Participants With Grade 3 or 4 TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4
|
38 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Safety population included all participants who received any amount of talazoparib.
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.
Outcome measures
| Measure |
Initial Dose Talazoparib: < 1 mg/Day
n=66 Participants
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.
|
Initial Dose Talazoparib: 1 mg/Day
n=52 Participants
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.
|
|---|---|---|
|
Number of Participants With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death
TEAE leading to dose reduction
|
6 Participants
|
7 Participants
|
|
Number of Participants With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death
TEAE leading to permanent study drug discontinuation
|
5 Participants
|
4 Participants
|
|
Number of Participants With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death
TEAE leading to death
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Initial Dose Talazoparib: < 1 mg/Day
n=61 Participants
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.
|
Initial Dose Talazoparib: 1 mg/Day
n=50 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests
ALT or AST >= 3*ULN
|
5 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests
ALT or AST > 5*ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests
ALT or AST > 10*ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests
ALT or AST > 20*ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests
TBL > 2*ULN
|
4 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests
ALT or AST >= 3*ULN and TBL > 2*ULN (any visit date)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests
ALT or AST >= 3*ULN and TBL > 2*ULN and ALP < 2*ULN (any visit date)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Safety population included all participants who received any amount of talazoparib.
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.
Outcome measures
| Measure |
Initial Dose Talazoparib: < 1 mg/Day
n=66 Participants
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.
|
Initial Dose Talazoparib: 1 mg/Day
n=52 Participants
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.
|
|---|---|---|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
Hemoglobin (low): Grade 3
|
7 Participants
|
16 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
Hemoglobin (low): Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
Leukocytes (low): Grade 3
|
5 Participants
|
2 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
Leukocytes (low): Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
Lymphocytes (low): Grade 3
|
11 Participants
|
8 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
Lymphocytes (low): Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
Neutrophils (low): Grade 3
|
9 Participants
|
4 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
Neutrophils (low): Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
Platelets (low): Grade 3
|
4 Participants
|
4 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
Platelets (low): Grade 4
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Safety population included all participants who received any amount of talazoparib.
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.
Outcome measures
| Measure |
Initial Dose Talazoparib: < 1 mg/Day
n=66 Participants
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.
|
Initial Dose Talazoparib: 1 mg/Day
n=52 Participants
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.
|
|---|---|---|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters
Creatinine (high): Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters
Alkaline Phosphatase (high): Grade 3
|
5 Participants
|
1 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters
Alkaline Phosphatase (high): Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters
Bilirubin (high): Grade 3
|
3 Participants
|
0 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters
Bilirubin (high): Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters
Creatinine (high): Grade 3
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Safety population included all participants who received any amount of talazoparib.
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.
Outcome measures
| Measure |
Initial Dose Talazoparib: < 1 mg/Day
n=66 Participants
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.
|
Initial Dose Talazoparib: 1 mg/Day
n=52 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Weight
SBP: absolute results >180 mmHg and increase from baseline >=40 mmHg
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Weight
SBP: absolute results <90 mmHg and decrease from baseline >30 mmHg
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Weight
DBP: absolute results >110 mmHg and increase from baseline >=30 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Weight
DBP: absolute results <50 mmHg and decrease from baseline >20 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Weight
DBP: increase from baseline >=20 mmHg
|
6 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Weight
Heart rate: absolute results >120 bpm and increase from baseline >30 bpm
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Weight
Heart rate: absolute results <50 bpm and decrease from baseline >20 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Weight
Temperature: <=34.5 or >=38 degree Celsius
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and Weight
Weight: >10% decrease from baseline
|
7 Participants
|
2 Participants
|
Adverse Events
Initial Dose Talazoparib: < 1 mg/Day
Serious events: 27 serious events
Other events: 54 other events
Deaths: 7 deaths
Initial Dose Talazoparib: 1 mg/Day
Serious events: 18 serious events
Other events: 46 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Initial Dose Talazoparib: < 1 mg/Day
n=66 participants at risk
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.
|
Initial Dose Talazoparib: 1 mg/Day
n=52 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
2/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
3.8%
2/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
2/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Cardiac disorders
Bradycardia
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.0%
2/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Oesophagitis
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
General disorders
Death
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
General disorders
Disease Progression
|
6.1%
4/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
General disorders
Gait Disturbance
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Hepatobiliary disorders
Jaundice
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Infections and infestations
Abdominal Abscess
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Infections and infestations
Cellulitis
|
3.0%
2/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Infections and infestations
Endocarditis Bacterial
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Infections and infestations
Sepsis
|
3.0%
2/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Infections and infestations
Streptococcal Sepsis
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Infections and infestations
Urinary Tract Infection
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Infections and infestations
Urosepsis
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Metabolism and nutrition disorders
Gout
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
3.8%
2/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
5.8%
3/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial Effusion Malignant
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Nervous system disorders
Cauda Equina Syndrome
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Nervous system disorders
Paraesthesia
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.5%
3/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
Other adverse events
| Measure |
Initial Dose Talazoparib: < 1 mg/Day
n=66 participants at risk
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.
|
Initial Dose Talazoparib: 1 mg/Day
n=52 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.8%
19/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
34.6%
18/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
5.8%
3/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.2%
10/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
7.7%
4/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.2%
10/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
9.6%
5/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.1%
4/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.6%
9/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
9.6%
5/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.6%
5/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
3.8%
2/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Constipation
|
12.1%
8/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
3.8%
2/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.1%
8/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
5.8%
3/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Nausea
|
27.3%
18/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
19.2%
10/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
12/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
7.7%
4/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
General disorders
Asthenia
|
9.1%
6/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
11.5%
6/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
General disorders
Fatigue
|
25.8%
17/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
21.2%
11/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
General disorders
Oedema Peripheral
|
10.6%
7/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
7.7%
4/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
General disorders
Pain
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
5.8%
3/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
12.1%
8/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
5.8%
3/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Infections and infestations
Urinary Tract Infection
|
9.1%
6/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
3.8%
2/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
6/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Investigations
Blood Creatinine Increased
|
4.5%
3/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
5.8%
3/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Investigations
Neutrophil Count Decreased
|
6.1%
4/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
7.7%
4/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Investigations
Platelet Count Decreased
|
3.0%
2/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
17.3%
9/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Investigations
Weight Decreased
|
4.5%
3/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
5.8%
3/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Investigations
White Blood Cell Count Decreased
|
9.1%
6/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
5.8%
3/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
10.6%
7/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
13.5%
7/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.6%
5/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.5%
1/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
5.8%
3/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
6/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
7.7%
4/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
15.2%
10/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
3.8%
2/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
4/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
1.9%
1/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Ascites
|
0.00%
0/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
5.8%
3/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Nervous system disorders
Dizziness
|
7.6%
5/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Nervous system disorders
Headache
|
10.6%
7/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
0.00%
0/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.6%
7/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
7.7%
4/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.1%
8/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
11.5%
6/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
6/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
9.6%
5/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
|
Vascular disorders
Hypertension
|
6.1%
4/66 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
3.8%
2/52 • 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)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population included all participants who received any amount of talazoparib.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER