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NCT01208103 · OUTCOME

Number of Participants With Progression-free Survival (PFS) at Six Months

Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma · Source last updated 2020-09-03

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
6 months

What was measured

A Bayesian sequential monitoring design will be used. PFS will be estimated using the Kaplan-Meier method.The length of time interval in months from date of first treatment, during and after the treatment a participant lives without progression.

Groups in this outcome

Bevacizumab + Capecitabine + Oxaliplatin

Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-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
Bevacizumab + Capecitabine + Oxaliplatin30

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bevacizumab + Capecitabine + Oxaliplatin68Not reported5288Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52
        upper Limit
        88
        value
        68
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
A Bayesian sequential monitoring design will be used. PFS will be estimated using the Kaplan-Meier method.The length of time interval in months from date of first treatment, during and after the treatment a participant lives without progression.
dispersion Type
95% Confidence Interval
groups
  1. description
    Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
    id
    OG000
    title
    Bevacizumab + Capecitabine + Oxaliplatin
param Type
NUMBER
reporting Status
POSTED
time Frame
6 months
title
Number of Participants With Progression-free Survival (PFS) at Six Months
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice