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NCT02187783 · OUTCOME

Overall Response Rate (ORR) ≥ 16 Weeks. FAS

LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) · Source last updated 2019-07-18

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

Measure
NUMBER
Unit
participant
Interval / dispersion
95% Confidence Interval
Time frame
Baseline and ≥ 16 weeks up to approximately 36 months

What was measured

ORR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR+PR ≥ 16 weeks. FAS

Groups in this outcome

Ribociclib 600 mg

LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.

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 600 mg105

Reported measurements

Source class 1
Values in participant · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ribociclib 600 mg3Not reported0.68.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        8.1
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    units
    Participants
description
ORR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR+PR ≥ 16 weeks. FAS
dispersion Type
95% Confidence Interval
groups
  1. description
    LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
    id
    OG000
    title
    Ribociclib 600 mg
param Type
NUMBER
reporting Status
POSTED
time Frame
Baseline and ≥ 16 weeks up to approximately 36 months
title
Overall Response Rate (ORR) ≥ 16 Weeks. FAS
type
PRIMARY
unit Of Measure
participant

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice