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NCT01871805 · OUTCOME

Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2018-08-21

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

What was measured

CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RECIST v1.1. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

Analysis population: Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

Groups in this outcome

Alectinib 600 mg (Fed): Phase II

Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.

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

Analysis denominator · Participants

GroupSource count
Alectinib 600 mg (Fed): Phase II16

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Alectinib 600 mg (Fed): Phase II0Not reported0.0020.59Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        20.59
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RECIST v1.1. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    OG000
    title
    Alectinib 600 mg (Fed): Phase II
param Type
NUMBER
population Description
Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
title
Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice