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NCT01945775 · OUTCOME

Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Chemistry

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

Toxicity grades were evaluated based on as NCI CTCAE v4.03. NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe) and grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key chemistry parameters included alanine aminotransferase (units per liter), alkaline phosphatase (units per liter), aspartate aminotransferase (units per liter) and bilirubin (micromole per liter). High value indicated higher values than the baseline values and low value indicated lower values than the baseline values. Only those categories in which at least 1 participant had data were reported.

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

Alanine Aminotransferase: High Value
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib5Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment3Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase: High Value
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib6Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment2Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase: High Value
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib7Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment4Not reportedNot reportedNot reportedNot reported
Bilirubin: High Value
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib4Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
    title
    Alanine Aminotransferase: High Value
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
    title
    Alkaline Phosphatase: High Value
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
    title
    Aspartate Aminotransferase: High Value
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
    title
    Bilirubin: High Value
denoms
  1. counts
    1. group Id
      OG000
      value
      286
    2. group Id
      OG001
      value
      126
    units
    Participants
description
Toxicity grades were evaluated based on as NCI CTCAE v4.03. NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe) and grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key chemistry parameters included alanine aminotransferase (units per liter), alkaline phosphatase (units per liter), aspartate aminotransferase (units per liter) and bilirubin (micromole per liter). High value indicated higher values than the baseline values and low value indicated lower values than the baseline values. Only those categories in which at least 1 participant had data were reported.
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 Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Chemistry
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice