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NCT01740427 · OUTCOME

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

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) · Source last updated 2024-11-14

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 date of randomization up to 28 days after last dose of study drug (final analysis till study completion, approximately up to 10.51 years)

What was measured

An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization; resulted in persistent or significant disability or in congenital anomaly/birth defect. TEAE were events that occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Severity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening and Grade 5 = death related to AE. Discontinuation included permanent, temporary discontinuation and dose reduction due to AEs.

Analysis population: AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.

Groups in this outcome

Palbociclib Plus Letrozole

Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

Placebo Plus Letrozole

Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

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 Plus Letrozole444
Placebo Plus Letrozole222

Reported measurements

Participants with AEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole99.1Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole96.4Not reportedNot reportedNot reportedNot reported
Participants with SAEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole28.2Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole17.1Not reportedNot reportedNot reportedNot reported
Participants with Grade 3 or 4 AEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole83.1Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole30.2Not reportedNot reportedNot reportedNot reported
Participants with Grade 5 AEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole3.6Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole2.3Not reportedNot reportedNot reportedNot reported
Permanently discontinued study due to AEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole4.1Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole2.3Not reportedNot reportedNot reportedNot reported
Permanently disc. palbociclib/placebo due to AEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole14.4Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole6.3Not reportedNot reportedNot reportedNot reported
Permanently discontinued letrozole due to AEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole9.2Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole5.9Not reportedNot reportedNot reportedNot reported
Temporarily disc. palbociclib/placebo due to AEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole79.7Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole17.1Not reportedNot reportedNot reportedNot reported
Temporarily discontinued letrozole due to AEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole23.0Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole11.3Not reportedNot reportedNot reportedNot reported
With palbociclib/placebo dose reduction due to AEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole41.9Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole2.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        99.1
      2. group Id
        OG001
        value
        96.4
    title
    Participants with AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        28.2
      2. group Id
        OG001
        value
        17.1
    title
    Participants with SAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        83.1
      2. group Id
        OG001
        value
        30.2
    title
    Participants with Grade 3 or 4 AEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3.6
      2. group Id
        OG001
        value
        2.3
    title
    Participants with Grade 5 AEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4.1
      2. group Id
        OG001
        value
        2.3
    title
    Permanently discontinued study due to AEs
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        14.4
      2. group Id
        OG001
        value
        6.3
    title
    Permanently disc. palbociclib/placebo due to AEs
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        9.2
      2. group Id
        OG001
        value
        5.9
    title
    Permanently discontinued letrozole due to AEs
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        79.7
      2. group Id
        OG001
        value
        17.1
    title
    Temporarily disc. palbociclib/placebo due to AEs
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        23.0
      2. group Id
        OG001
        value
        11.3
    title
    Temporarily discontinued letrozole due to AEs
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        41.9
      2. group Id
        OG001
        value
        2.3
    title
    With palbociclib/placebo dose reduction due to AEs
denoms
  1. counts
    1. group Id
      OG000
      value
      444
    2. group Id
      OG001
      value
      222
    units
    Participants
description
An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization; resulted in persistent or significant disability or in congenital anomaly/birth defect. TEAE were events that occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Severity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening and Grade 5 = death related to AE. Discontinuation included permanent, temporary discontinuation and dose reduction due to AEs.
groups
  1. description
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    OG000
    title
    Palbociclib Plus Letrozole
  2. description
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    OG001
    title
    Placebo Plus Letrozole
param Type
NUMBER
population Description
AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
reporting Status
POSTED
time Frame
From date of randomization up to 28 days after last dose of study drug (final analysis till study completion, approximately up to 10.51 years)
title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs): All Causalities
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice