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NCT01647711 · OUTCOME

Maximum Tolerated Dose

A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations · Source last updated 2017-01-31

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

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
28 days

What was measured

Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).

Analysis population: Treated set including patients eligible for MTD determination

Groups in this outcome

Afatinib

Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Afatinib30

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib160Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        160
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).
groups
  1. description
    Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    OG000
    title
    Afatinib
param Type
NUMBER
population Description
Treated set including patients eligible for MTD determination
reporting Status
POSTED
time Frame
28 days
title
Maximum Tolerated Dose
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice