Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02607124 · OUTCOME

Number of Adverse Events

A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy · Source last updated 2020-11-05

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

Measure
NUMBER
Unit
adverse event
Interval / dispersion
Not reported
Time frame
6 months

What was measured

Primary feasibility endpoint is the number of individual toxicities and incidence of significant delays

Analysis population: Number of participants receiving investigational agent.

Groups in this outcome

RB+ High Grade Glioma

Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib

Non-Biopsied Diffuse Instrinsic Pontine Glioma

Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib

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

Analysis denominator · Participants

GroupSource count
RB+ High Grade Glioma1
Non-Biopsied Diffuse Instrinsic Pontine Glioma9

Reported measurements

Source class 1
Values in adverse event · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RB+ High Grade Glioma9Not reportedNot reportedNot reportedNot reported
Non-Biopsied Diffuse Instrinsic Pontine Glioma144Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        144
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Primary feasibility endpoint is the number of individual toxicities and incidence of significant delays
groups
  1. description
    Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib
    id
    OG000
    title
    RB+ High Grade Glioma
  2. description
    Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib
    id
    OG001
    title
    Non-Biopsied Diffuse Instrinsic Pontine Glioma
param Type
NUMBER
population Description
Number of participants receiving investigational agent.
reporting Status
POSTED
time Frame
6 months
title
Number of Adverse Events
type
PRIMARY
unit Of Measure
adverse event

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

Preserved source evidence · Not medical advice