Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01958021 · OUTCOME

All Collected Deaths

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer · Source last updated 2025-03-07

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Pre-treatment: Up to 21 days. On-treatment: Up to 99 months. Crossover on-treatment: Up to 12 months after crossing-over.Post-treatment survival FU: Up to 99 months.Crossover post-treatment survival FU: Up to 12 months after crossing-over

What was measured

Pre-treatment deaths were collected from randomization 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 survival follow-up (FU) deaths were collected from day 31 after last dose of study treatment to end of study. Crossover post-treatment survival FU 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 + Letrozole

Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral

Placebo + Letrozole

Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole

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 + Letrozole334
Placebo + Letrozole334

Reported measurements

Pre-treatment

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole334
Placebo + Letrozole334
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole0Not reportedNot reportedNot reportedNot reported
Placebo + Letrozole0Not reportedNot reportedNot reportedNot reported
On-treatment

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole334
Placebo + Letrozole330
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole8Not reportedNot reportedNot reportedNot reported
Placebo + Letrozole3Not reportedNot reportedNot reportedNot reported
Crossover On-treatment

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole0
Placebo + Letrozole4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Letrozole0Not reportedNot reportedNot reportedNot reported
Post-treatment survival follow-up

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole278
Placebo + Letrozole298
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole178Not reportedNot reportedNot reportedNot reported
Placebo + Letrozole218Not reportedNot reportedNot reportedNot reported
Crossover post-treatment survival follow-up

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole0
Placebo + Letrozole4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Letrozole0Not reportedNot reportedNot reportedNot reported
All deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole334
Placebo + Letrozole334
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole186Not reportedNot reportedNot reportedNot reported
Placebo + Letrozole221Not 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
        334
      2. group Id
        OG001
        value
        334
      units
      Participants
    title
    Pre-treatment
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        334
      2. group Id
        OG001
        value
        330
      units
      Participants
    title
    On-treatment
  3. categories
    1. measurements
      1. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Crossover On-treatment
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        178
      2. group Id
        OG001
        value
        218
    denoms
    1. counts
      1. group Id
        OG000
        value
        278
      2. group Id
        OG001
        value
        298
      units
      Participants
    title
    Post-treatment survival follow-up
  5. categories
    1. measurements
      1. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Crossover post-treatment survival follow-up
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        221
    denoms
    1. counts
      1. group Id
        OG000
        value
        334
      2. group Id
        OG001
        value
        334
      units
      Participants
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      334
    2. group Id
      OG001
      value
      334
    units
    Participants
description
Pre-treatment deaths were collected from randomization 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 survival follow-up (FU) deaths were collected from day 31 after last dose of study treatment to end of study. Crossover post-treatment survival FU deaths were collected from day 31 after last dose of crossover treatment to end of study
groups
  1. description
    Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
    id
    OG000
    title
    Ribociclib + Letrozole
  2. description
    Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
    id
    OG001
    title
    Placebo + Letrozole
param Type
NUMBER
population Description
FAS including all randomized participants
reporting Status
POSTED
time Frame
Pre-treatment: Up to 21 days. On-treatment: Up to 99 months. Crossover on-treatment: Up to 12 months after crossing-over.Post-treatment survival FU: Up to 99 months.Crossover post-treatment survival FU: Up to 12 months after crossing-over
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