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NCT02947685 · OUTCOME

Incidence of Grade 3 or Higher Adverse Events (as Graded by NCI CTCAE v 4.0)

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer · Source last updated 2026-02-12

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
Not reported
Time frame
24 months

What was measured

The proportion of patient by arm that experienced grade 3 or higher adverse events will be reported

Groups in this outcome

Arm A

Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)

Arm B

AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)

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

Analysis denominator · Participants

GroupSource count
Arm A261
Arm B257

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A0.797Not reportedNot reportedNot reportedNot reported
Arm B0.306Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.797
      2. group Id
        OG001
        value
        0.306
denoms
  1. counts
    1. group Id
      OG000
      value
      261
    2. group Id
      OG001
      value
      257
    units
    Participants
description
The proportion of patient by arm that experienced grade 3 or higher adverse events will be reported
groups
  1. description
    Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
    id
    OG000
    title
    Arm A
  2. description
    AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
    id
    OG001
    title
    Arm B
param Type
NUMBER
reporting Status
POSTED
time Frame
24 months
title
Incidence of Grade 3 or Higher Adverse Events (as Graded by NCI CTCAE v 4.0)
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice