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NCT02422615 · OUTCOME

All Collected Deaths

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. · Source last updated 2023-11-30

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
Pre-treatment: Up to 28 days prior to treatment. On-treatment: Up to 82 months. Crossover on-treatment: Up to 3.5 months. Post-treatment efficacy/survival follow-up: Up to 82 months. Crossover post-treatment efficacy/survival follow-up: Up to 1 year

What was measured

Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication. On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment or one day before first administration of crossover treatment (for crossover participants), whichever came first Crossover on-treatment deaths were collected from start of crossover treatment up to 30 days after last dose of crossover treatment. Post-treatment efficacy/survival follow-up deaths were collected from day 31 after last dose of study treatment to end of study. Crossover post-treatment efficacy/survival follow-up deaths were collected from day 31 after last dose of crossover treatment to end of study.

Analysis population: FAS including all randomized participants

Groups in this outcome

Ribociclib + Fulvestrant

Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.

Placebo + Fulvestrant

Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and 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
Ribociclib + Fulvestrant484
Placebo + Fulvestrant242

Reported measurements

Pre-treatment deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant484
Placebo + Fulvestrant242
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant0Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant0Not reportedNot reportedNot reportedNot reported
On-treatment deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant483
Placebo + Fulvestrant241
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant13Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant8Not reportedNot reportedNot reportedNot reported
Crossover on-treatment deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Placebo + Fulvestrant3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Fulvestrant0Not reportedNot reportedNot reportedNot reported
Post-treatment efficacy/survival deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant380
Placebo + Fulvestrant210
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant264Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant153Not reportedNot reportedNot reportedNot reported
Crossover post-treatment efficacy/survival deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Placebo + Fulvestrant1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Fulvestrant1Not reportedNot reportedNot reportedNot reported
All deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant484
Placebo + Fulvestrant242
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant277Not reportedNot reportedNot reportedNot reported
Placebo + Fulvestrant162Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        484
      2. group Id
        OG001
        value
        242
      units
      Participants
    title
    Pre-treatment deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        483
      2. group Id
        OG001
        value
        241
      units
      Participants
    title
    On-treatment deaths
  3. categories
    1. measurements
      1. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Crossover on-treatment deaths
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        264
      2. group Id
        OG001
        value
        153
    denoms
    1. counts
      1. group Id
        OG000
        value
        380
      2. group Id
        OG001
        value
        210
      units
      Participants
    title
    Post-treatment efficacy/survival deaths
  5. categories
    1. measurements
      1. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Crossover post-treatment efficacy/survival deaths
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        277
      2. group Id
        OG001
        value
        162
    denoms
    1. counts
      1. group Id
        OG000
        value
        484
      2. group Id
        OG001
        value
        242
      units
      Participants
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      484
    2. group Id
      OG001
      value
      242
    units
    Participants
description
Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication. On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment or one day before first administration of crossover treatment (for crossover participants), whichever came first Crossover on-treatment deaths were collected from start of crossover treatment up to 30 days after last dose of crossover treatment. Post-treatment efficacy/survival follow-up deaths were collected from day 31 after last dose of study treatment to end of study. Crossover post-treatment efficacy/survival follow-up deaths were collected from day 31 after last dose of crossover treatment to end of study.
groups
  1. description
    Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
    id
    OG000
    title
    Ribociclib + Fulvestrant
  2. description
    Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant.
    id
    OG001
    title
    Placebo + Fulvestrant
param Type
COUNT_OF_PARTICIPANTS
population Description
FAS including all randomized participants
reporting Status
POSTED
time Frame
Pre-treatment: Up to 28 days prior to treatment. On-treatment: Up to 82 months. Crossover on-treatment: Up to 3.5 months. Post-treatment efficacy/survival follow-up: Up to 82 months. Crossover post-treatment efficacy/survival follow-up: Up to 1 year
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice