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NCT01160458 · OUTCOME

Progression Free Survival (PFS)

Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy · Source last updated 2018-04-10

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
To study completion, an average of 3 years

What was measured

Progression Free Survival is defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study longest diameter (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).

Analysis population: One participant withdrew from the study and was excluded from the analysis.

Groups in this outcome

IMC-A12 Monotherapy in Patients

20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)

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

Analysis denominator · Participants

GroupSource count
IMC-A12 Monotherapy in Patients19

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMC-A12 Monotherapy in Patients1.8Not reported1.45.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        5.5
        value
        1.8
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
Progression Free Survival is defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study longest diameter (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).
dispersion Type
95% Confidence Interval
groups
  1. description
    20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
    id
    OG000
    title
    IMC-A12 Monotherapy in Patients
param Type
MEDIAN
population Description
One participant withdrew from the study and was excluded from the analysis.
reporting Status
POSTED
time Frame
To study completion, an average of 3 years
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice