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NCT01945775 · OUTCOME

Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) · Source last updated 2022-01-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months

What was measured

Criteria for potentially clinically significant changes in vital signs included a) Systolic blood pressure: 1) absolute results (AB) greater than (\>) 180 millimeter of mercury (mmHg) and increase from baseline (IFB) greater than or equal to (\>=) 40 mmHg, 2) absolute results less than (\<) 90 mmHg and decrease from baseline (DFB) \>30 mmHg; b) Diastolic blood pressure: 1) absolute results \>110 mmHg and \>=30 mmHg increase from baseline, 2) absolute results \<50 mmHg and \>20 mmHg decrease from baseline 3) \>=20 mmHg increase from baseline; c) Heart rate: 1) absolute results\>120 beats per minute \[bpm\] and \>30 bpm increase from baseline, 2) absolute results \<50 bpm and \>20 bpm decrease from baseline and d) Weight: \>10 percent \[%\] decrease from baseline.

Analysis population: Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).

Groups in this outcome

Talazoparib

Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.

Physician's Choice Treatment

Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\^2 (equivalent to eribulin 1.23 mg/ m\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Talazoparib286
Physician's Choice Treatment126

Reported measurements

SBP: AB>180 mmHg and IFB >=40 mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib3Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment2Not reportedNot reportedNot reportedNot reported
SBP: AB<90 mmHg and DFB >30 mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib8Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment2Not reportedNot reportedNot reportedNot reported
DBP: AB>110 mmHg and IFB >=30 mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib0Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment0Not reportedNot reportedNot reportedNot reported
DBP: AB<50 mmHg and DFB>20 mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib15Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment7Not reportedNot reportedNot reportedNot reported
DBP: IFB>=20 mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib39Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment13Not reportedNot reportedNot reportedNot reported
Heart rate: AB >120 bpm and IFB >30 bpm
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib6Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment2Not reportedNot reportedNot reportedNot reported
Heart rate: AB <50 bpm and DFB >20 bpm
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib2Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment0Not reportedNot reportedNot reportedNot reported
Weight: >10% DFB
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib23Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
    title
    SBP: AB>180 mmHg and IFB >=40 mmHg
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        2
    title
    SBP: AB<90 mmHg and DFB >30 mmHg
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    DBP: AB>110 mmHg and IFB >=30 mmHg
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        7
    title
    DBP: AB<50 mmHg and DFB>20 mmHg
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        13
    title
    DBP: IFB>=20 mmHg
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
    title
    Heart rate: AB >120 bpm and IFB >30 bpm
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Heart rate: AB <50 bpm and DFB >20 bpm
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        13
    title
    Weight: >10% DFB
denoms
  1. counts
    1. group Id
      OG000
      value
      286
    2. group Id
      OG001
      value
      126
    units
    Participants
description
Criteria for potentially clinically significant changes in vital signs included a) Systolic blood pressure: 1) absolute results (AB) greater than (\>) 180 millimeter of mercury (mmHg) and increase from baseline (IFB) greater than or equal to (\>=) 40 mmHg, 2) absolute results less than (\<) 90 mmHg and decrease from baseline (DFB) \>30 mmHg; b) Diastolic blood pressure: 1) absolute results \>110 mmHg and \>=30 mmHg increase from baseline, 2) absolute results \<50 mmHg and \>20 mmHg decrease from baseline 3) \>=20 mmHg increase from baseline; c) Heart rate: 1) absolute results\>120 beats per minute \[bpm\] and \>30 bpm increase from baseline, 2) absolute results \<50 bpm and \>20 bpm decrease from baseline and d) Weight: \>10 percent \[%\] decrease from baseline.
groups
  1. description
    Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
    id
    OG000
    title
    Talazoparib
  2. description
    Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\^2 (equivalent to eribulin 1.23 mg/ m\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
    id
    OG001
    title
    Physician's Choice Treatment
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).
reporting Status
POSTED
time Frame
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
title
Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice