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NCT02158975 · OUTCOME

Objective Response Rate

Open-label, Phase II Study of MLN9708 in Patients With Relapsed/Refractory Cutaneous and Peripheral T-cell Lymphomas · Source last updated 2017-11-13

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
Up to 24 months after initiation of study treatment

What was measured

The percentage of patients with an objective response rate will be determined. The overall response will be based on response in each compartment (skin, blood, lymph nodes and viscera) using a global composite scoring system. Objective response is considered (CR) Complete Response (Complete disappearance of all clinical evidence of disease), CRu (Complete Response Unconfirmed), or (PR) Partial Response (Regression of measurable disease).

Analysis population: 12 analyzable patients

Groups in this outcome

MLN9708

MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days. MLN9708

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

Analysis denominator · Participants

GroupSource count
MLN970812

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MLN97088Not reported1.535Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.5
        upper Limit
        35
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
The percentage of patients with an objective response rate will be determined. The overall response will be based on response in each compartment (skin, blood, lymph nodes and viscera) using a global composite scoring system. Objective response is considered (CR) Complete Response (Complete disappearance of all clinical evidence of disease), CRu (Complete Response Unconfirmed), or (PR) Partial Response (Regression of measurable disease).
dispersion Type
95% Confidence Interval
groups
  1. description
    MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days. MLN9708
    id
    OG000
    title
    MLN9708
param Type
NUMBER
population Description
12 analyzable patients
reporting Status
POSTED
time Frame
Up to 24 months after initiation of study treatment
title
Objective Response Rate
type
PRIMARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice