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NCT02639546 · OUTCOME

Percentage of Participants With Objective Response (CR or PR) 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)

What was measured

Tumor assessment will be performed using RANO criteria for 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 Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Low Grade Glioma8.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8.3
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Tumor assessment will be performed using RANO criteria for LGG.
groups
  1. description
    Participants with Low Grade Glioma.
    id
    OG000
    title
    Low Grade Glioma
param Type
NUMBER
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
Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)
title
Percentage of Participants With Objective Response (CR or PR) as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II)
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice