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NCT01945775 · OUTCOME

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

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 National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key hematology parameters included hemoglobin (gram per liter \[g/L\]), leukocytes (10\^6 cells per liter), lymphocytes (10\^6 cells per liter), neutrophils (10\^6 cells per liter), and platelets (10\^9 cells per liter). Low value indicated lower values than the baseline values and high value indicated higher 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

Hemoglobin: Low value
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib115Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment8Not reportedNot reportedNot reportedNot reported
Leukocytes: Low value
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib43Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment31Not reportedNot reportedNot reportedNot reported
Lymphocytes: Low value
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib54Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment11Not reportedNot reportedNot reportedNot reported
Neutrophils: Low value
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib65Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment48Not reportedNot reportedNot reportedNot reported
Platelets: Low value
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Talazoparib44Not reportedNot reportedNot reportedNot reported
Physician's Choice Treatment2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        115
      2. group Id
        OG001
        value
        8
    title
    Hemoglobin: Low value
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        31
    title
    Leukocytes: Low value
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        11
    title
    Lymphocytes: Low value
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        48
    title
    Neutrophils: Low value
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        2
    title
    Platelets: Low 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 National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key hematology parameters included hemoglobin (gram per liter \[g/L\]), leukocytes (10\^6 cells per liter), lymphocytes (10\^6 cells per liter), neutrophils (10\^6 cells per liter), and platelets (10\^9 cells per liter). Low value indicated lower values than the baseline values and high value indicated higher 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: Hematology
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice