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NCT01942135 · OUTCOME

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) · Source last updated 2024-04-04

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).

What was measured

An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.

Analysis population: The as-treated (AT) population or safety analysis set included all participants who received at least 1 dose of study intervention, with treatment assignments designated according to actual study intervention received.

Groups in this outcome

Palbociclib + Fulvestrant

Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.

Placebo + Fulvestrant

Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.

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

Analysis denominator · Participants

GroupSource count
Palbociclib + Fulvestrant345
Placebo + Fulvestrant172

Reported measurements

With AEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib + Fulvestrant98.8Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant93.6Not reportedNot reportedNot reportedNot reported
With SAEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib + Fulvestrant22.6Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant19.2Not reportedNot reportedNot reportedNot reported
With Grade 3 or 4 AEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib + Fulvestrant80.6Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant26.7Not reportedNot reportedNot reportedNot reported
With Grade 5 AEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib + Fulvestrant2.3Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant1.7Not reportedNot reportedNot reportedNot reported
Discontinued palbociclib/placebo due to AEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib + Fulvestrant7.5Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant4.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        98.8
      2. group Id
        OG001
        value
        93.6
    title
    With AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        22.6
      2. group Id
        OG001
        value
        19.2
    title
    With SAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        80.6
      2. group Id
        OG001
        value
        26.7
    title
    With Grade 3 or 4 AEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2.3
      2. group Id
        OG001
        value
        1.7
    title
    With Grade 5 AEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        7.5
      2. group Id
        OG001
        value
        4.7
    title
    Discontinued palbociclib/placebo due to AEs
denoms
  1. counts
    1. group Id
      OG000
      value
      345
    2. group Id
      OG001
      value
      172
    units
    Participants
description
An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.
groups
  1. description
    Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
    id
    OG000
    title
    Palbociclib + Fulvestrant
  2. description
    Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
    id
    OG001
    title
    Placebo + Fulvestrant
param Type
NUMBER
population Description
The as-treated (AT) population or safety analysis set included all participants who received at least 1 dose of study intervention, with treatment assignments designated according to actual study intervention received.
reporting Status
POSTED
time Frame
From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).
title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice