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NCT02187783 · OUTCOME

Number of Days for Duration of Response for Responders

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
Days
Interval / dispersion
Not reported
Time frame
Baseline up to approximately 36 months

What was measured

Duration of response (DOR) is defined as time from the first documented response to the date first documented disease progression or relapse or death due to any cause. For patients with solid tumors the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR.

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 mg3

Reported measurements

Patient 1
Values in Days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib 600 mg254Not reportedNot reportedNot reportedNot reported
Patient 2
Values in Days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib 600 mg330Not reportedNot reportedNot reportedNot reported
Patient 3
Values in Days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib 600 mg985Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        254
    title
    Patient 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        330
    title
    Patient 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        985
    title
    Patient 3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
Duration of response (DOR) is defined as time from the first documented response to the date first documented disease progression or relapse or death due to any cause. For patients with solid tumors the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR.
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 up to approximately 36 months
title
Number of Days for Duration of Response for Responders
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice