Trial Outcomes & Findings for A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors (NCT NCT03077607)
NCT ID: NCT03077607
Last Updated: 2021-06-30
Results Overview
T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID".
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23
Results posted on
2021-06-30
Participant Flow
Study was conducted in 4 countries from 07-Nov-2016 to 18 Dec 2017.
Participant milestones
| Measure |
A: Talazoparib 0.5 mg + Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 milligram (mg) on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of itraconazole 200 mg (100 mg twice daily \[BID\]) from Day 16 to Day 36 and a single oral dose of talazoparib 0.5 mg on Day 23. Participants were followed up to 23 days after last dose of study drug.
|
B: Talazoparib 1 mg + Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of rifampin 600 mg once daily (QD) from Day 16 to Day 38 and a single oral dose of talazoparib 1.0 mg on Day 25. Participants were followed up to 23 days after last dose of study drug.
|
|---|---|---|
|
Period 1 (15 Days)
STARTED
|
19
|
17
|
|
Period 1 (15 Days)
Treated (With Any Study Drug)
|
19
|
17
|
|
Period 1 (15 Days)
Received Talazoparib
|
19
|
17
|
|
Period 1 (15 Days)
COMPLETED
|
17
|
17
|
|
Period 1 (15 Days)
NOT COMPLETED
|
2
|
0
|
|
Period 2 (Arm A:21 Days; Arm B:23 Days)
STARTED
|
17
|
17
|
|
Period 2 (Arm A:21 Days; Arm B:23 Days)
Treated (With Any Study Drug)
|
17
|
17
|
|
Period 2 (Arm A:21 Days; Arm B:23 Days)
Received Talazoparib
|
15
|
15
|
|
Period 2 (Arm A:21 Days; Arm B:23 Days)
COMPLETED
|
14
|
15
|
|
Period 2 (Arm A:21 Days; Arm B:23 Days)
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
A: Talazoparib 0.5 mg + Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 milligram (mg) on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of itraconazole 200 mg (100 mg twice daily \[BID\]) from Day 16 to Day 36 and a single oral dose of talazoparib 0.5 mg on Day 23. Participants were followed up to 23 days after last dose of study drug.
|
B: Talazoparib 1 mg + Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of rifampin 600 mg once daily (QD) from Day 16 to Day 38 and a single oral dose of talazoparib 1.0 mg on Day 25. Participants were followed up to 23 days after last dose of study drug.
|
|---|---|---|
|
Period 1 (15 Days)
Adverse Event
|
1
|
0
|
|
Period 1 (15 Days)
Death
|
1
|
0
|
|
Period 2 (Arm A:21 Days; Arm B:23 Days)
Death
|
1
|
0
|
|
Period 2 (Arm A:21 Days; Arm B:23 Days)
Adverse Event
|
2
|
2
|
Baseline Characteristics
A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
A: Talazoparib 0.5 mg + Itraconazole 100 mg BID
n=19 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 36 and a single oral dose of talazoparib 0.5 mg on Day 23. Participants were followed up to 23 days after last dose of study drug.
|
B: Talazoparib 1 mg + Rifampin 600 mg QD
n=17 Participants
Participants received a single oral dose of talazoparib 1.0 mg on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of rifampin 600 mg QD from Day 16 to Day 38 and a single oral dose of talazoparib 1.0 mg on Day 25. Participants were followed up to 23 days after last dose of study drug.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23Population: Pharmacokinetic (PK) analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=19 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Itraconazole
|
2092.00 Picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 50
|
2936.82 Picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=19 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Itraconazole
|
98532.30 Hour*picogram per milliliter (hr*pg/mL)
Geometric Coefficient of Variation 38
|
145944.59 Hour*picogram per milliliter (hr*pg/mL)
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "Overall number of participants analyzed" (N) signifies those participants who were evaluable for this outcome measure.
T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=18 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=12 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Talazoparib: Alone and in Combination With Itraconazole
|
109762.10 hr*pg/mL
Geometric Coefficient of Variation 42
|
151919.63 hr*pg/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Rifampin
|
6007.01 pg/mL
Geometric Coefficient of Variation 53
|
8336.83 pg/mL
Geometric Coefficient of Variation 71
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Rifampin
|
196631.34 hr*pg/mL
Geometric Coefficient of Variation 32
|
196100.69 hr*pg/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=12 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Talazoparib: Alone and in Combination With Rifampin
|
209521.62 hr*pg/mL
Geometric Coefficient of Variation 34
|
194307.67 hr*pg/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=19 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Itraconazole
|
1.00 Hours
Interval 0.5 to 24.1
|
1.02 Hours
Interval 0.5 to 4.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half. T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=18 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=12 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Itraconazole
|
101.26 Hours
Standard Deviation 26.315
|
118.47 Hours
Standard Deviation 23.600
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Clearance of talazoparib was measure of the rate at which it was metabolized or eliminated by normal biological processes. T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=18 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=12 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Itraconazole
|
4.55 Liter per hour
Geometric Coefficient of Variation 42
|
3.29 Liter per hour
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Apparent volume of distribution was defined as the theoretical volume in which the total amount of talazoparib would need to be uniformly distributed to produce its desired plasma concentration. T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=18 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=12 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Itraconazole
|
644.81 Liter
Geometric Coefficient of Variation 42
|
552.01 Liter
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Rifampin
|
1.00 Hours
Interval 0.5 to 24.0
|
1.00 Hours
Interval 0.5 to 8.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half. T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=12 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Rifampin
|
92.05 Hours
Standard Deviation 17.679
|
80.61 Hours
Standard Deviation 16.540
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Apparent volume of distribution was defined as the theoretical volume in which the total amount of talazoparib would need to be uniformly distributed to produce its desired plasma concentration. T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=12 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Rifampin
|
623.89 Liter
Geometric Coefficient of Variation 30
|
588.14 Liter
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25Population: PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Clearance of talazoparib was measure of the rate at which it was metabolized or eliminated by normal biological processes. T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD".
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=12 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Rifampin
|
4.77 Liter per hour
Geometric Coefficient of Variation 34
|
5.15 Liter per hour
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of study (up to 61 days)Population: Safety analysis set included all participants who received at least 1 dose of talazoparib. Here, 1 participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A TEAE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. AEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=19 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=16 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
n=17 Participants
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
n=15 Participants
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
AEs
|
12 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of study (up to 61 days)Population: Safety analysis set included all participants who received at least 1 dose of talazoparib.
Chemistry:(sodium135-146,potassium3.5-5.5,chloride95-109,glucose3.3-5.5,urea2.8-7.2,calcium2.2-2.65,phosphate0.8-1.45,triglyceride0.4-1.7,cholesterol2.6-5.2)millimoles/L, (bilirubin\[direct0-3,total2-21\],creatinine53- 110)micromole/L, (albumin35-52,protein65-83)g/L,(alkaline phosphatase30-120, aspartate amino\[A\]transferase\[T\]4-46, alanine AT4-49, lactic acid dehydrogenase200-460, gammaglutamylT7-50,creatinine kinase24-170)U/L. Hematology: hemoglobin(Hb)120-177, hematocrit0.35-0.49L/L, RBC4-5.9T/L, (platelet150- 400,WBC4-10,basophil\<0.10,eosinophil\<0.40, neutrophil1.50-7.00,monocyte\<1.20,lymphocyte1.0 -3.70)G/L. Urine:(glucose,protein,ketone,Hb:negative/positive), specific gravity1.010-1.030g/cm\^3, pH4.8-7.8, pale yellow-deep amber, microscopy\[WBC0-5,leukocyte0-5,Hb0-3,cast0-1,bacteria0-500,epithelial0-6\])Pcs/area. Coagulation:(activated partial thromboplastine time25-43,prothrombin time13.7-15.6) seconds,international normalized ratio0.89-1.1. Investigator judged clinical significance.
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=19 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=16 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
n=17 Participants
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
n=15 Participants
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Significance Abnormalities in Laboratory Parameters
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of study (up to 61 days)Population: Safety analysis set included all participants who received at least 1 dose of talazoparib.
Vital sign abnormalities: a) systolic blood pressure (SBP): 1) minimum less than (\<) 90 millimeter of mercury (mmHg), 2) change from baseline maximum decrease greater than equal to (\>=) 30 mmHg, 3) change from baseline maximum increase \>=30 mmHg; b) diastolic blood pressure (DBP): 1) minimum \<50 mmHg, 2) change from baseline maximum decrease \>=20 mmHg, 3) change from baseline maximum increase \>=20 mmHg; c) supine pulse rate: 1) minimum \<40 beats per minute (bpm), 2) maximum \>120 bpm; d) standing pulse rate: 1) minimum \<40 bpm and 2) maximum \>140 bpm. Clinical significance of vital signs abnormalities was judged by investigator.
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=19 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=16 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
n=17 Participants
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
n=15 Participants
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of study (up to 61 days)Population: Safety analysis set included all participants who received at least 1 dose of talazoparib.
ECG abnormalities: a) QT Interval: new absolute values greater than (\>) 450, \>480, \>500 milliseconds (msec), increase from baseline \>30 and \>60 msec, b) QT interval using Fridericia's correction (QTcF) Interval: new absolute values \>450, \>480, \>500 msec, increase from baseline \>30 and \> 60 msec, c) Heart rate: increase from baseline \>25 percentage (%) and to a value \>100 bpm, decrease from baseline \>25% and to a value \<50 bpm, d) PR Interval: increase from baseline \> 25% and to a value \>200 msec, e) QRS duration: increase from baseline \> 25% and to a value \>100 msec. Clinical significance of ECG abnormalities was judged by investigator.
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=19 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=16 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
n=17 Participants
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
n=15 Participants
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of study (up to 61 days)Population: Safety analysis set included all participants who received at least 1 dose of talazoparib.
Physical examination included examination of abdomen, cardiovascular, eyes, ears, nose, throat, general appearance, head, neck, thyroid, lymph nodes, musculoskeletal, neurological, skin / subcutaneous tissue, thorax / lungs, abdomen including spleen size, breasts (female only) and respiratory. Clinical significance of physical examination was judged by investigator.
Outcome measures
| Measure |
Talazoparib 0.5 mg Alone
n=19 Participants
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=16 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 Participants
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg Alone
n=17 Participants
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
n=17 Participants
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
n=15 Participants
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Physical Examination Findings
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Talazoparib 0.5 mg Alone
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
Itraconazole 100 mg BID Alone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Talazoparib 1.0 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Rifampin 600 mg QD Alone
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Talazoparib 0.5 mg Alone
n=19 participants at risk
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Itraconazole 100 mg BID Alone
n=16 participants at risk
Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 participants at risk
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg
n=17 participants at risk
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
n=17 participants at risk
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
n=15 participants at risk
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Mouth haemorrhage
|
5.3%
1/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
10.5%
2/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
Other adverse events
| Measure |
Talazoparib 0.5 mg Alone
n=19 participants at risk
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
|
Itraconazole 100 mg BID Alone
n=16 participants at risk
Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2.
|
Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
n=15 participants at risk
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
|
Talazoparib 1.0 mg
n=17 participants at risk
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
|
Rifampin 600 mg QD Alone
n=17 participants at risk
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
|
Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
n=15 participants at risk
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.5%
2/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
3/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
13.3%
2/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
11.8%
2/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
1/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.2%
1/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.2%
1/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
1/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
3/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Constipation
|
15.8%
3/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.2%
1/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.5%
2/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.2%
1/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Gastritis
|
5.3%
1/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
General disorders
Oedema peripheral
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
5.3%
1/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.3%
1/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.3%
1/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
11.8%
2/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
General disorders
Fatigue
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
11.8%
2/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
17.6%
3/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
23.5%
4/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Reproductive system and breast disorders
Breast inflammation
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
5.9%
1/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/19 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/16 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
0.00%
0/17 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
6.7%
1/15 • Baseline up to end of study (up to 61 days)
One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
|
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