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NCT02639546 · OUTCOME

PFS as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II)

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors · Source last updated 2022-09-16

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)

What was measured

Tumor assessment was performed using RANO criteria for Participants with LGG.

Analysis population: The safety evaluable population was defined as all participants who received at least one dose of study drug. For phase II, only one tumor type cohort was opened (LGG).

Groups in this outcome

Low Grade Glioma

Participants with Low Grade Glioma.

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

Analysis denominator · Participants

GroupSource count
Low Grade Glioma12

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low Grade Glioma18.4Not reported3.6NAThe upper limit could not be calculated from the data due to insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit could not be calculated from the data due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        3.6
        upper Limit
        NA
        value
        18.4
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Tumor assessment was performed using RANO criteria for Participants with LGG.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with Low Grade Glioma.
    id
    OG000
    title
    Low Grade Glioma
param Type
MEDIAN
population Description
The safety evaluable population was defined as all participants who received at least one dose of study drug. For phase II, only one tumor type cohort was opened (LGG).
reporting Status
POSTED
time Frame
From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)
title
PFS as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice