Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01831726 · OUTCOME

Overall Response (OR) of Partial Response (PR) or Greater

Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib · Source last updated 2017-03-20

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

Measure
NUMBER
Unit
number of participants
Interval / dispersion
Not reported
Time frame
Week 16

What was measured

Overall Response (OR) of Partial Response (PR) or greater based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria will apply and are included in the appendices. ORR: CR+PR

Analysis population: Full Analysis Set (FAS) included all patients who received at least one dose of study drug. FAS was used for the analysis of efficacy endpoints.

Groups in this outcome

TKI258

Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.

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

Analysis denominator · Participants

GroupSource count
TKI25880

Reported measurements

Complete response (CR)
Values in number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TKI2580Not reportedNot reportedNot reportedNot reported
Partial response (PR)
Values in number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TKI2581Not reportedNot reportedNot reportedNot reported
Overall response rate (ORR)
Values in number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TKI2581Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Partial response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Overall response rate (ORR)
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    units
    Participants
description
Overall Response (OR) of Partial Response (PR) or greater based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria will apply and are included in the appendices. ORR: CR+PR
groups
  1. description
    Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
    id
    OG000
    title
    TKI258
param Type
NUMBER
population Description
Full Analysis Set (FAS) included all patients who received at least one dose of study drug. FAS was used for the analysis of efficacy endpoints.
reporting Status
POSTED
time Frame
Week 16
title
Overall Response (OR) of Partial Response (PR) or Greater
type
SECONDARY
unit Of Measure
number of participants

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

Preserved source evidence · Not medical advice