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NCT00592319 · OUTCOME

Number of Case With Papilloma Recurrence During a 12-month Follow up

Celebrex (Celecoxib) Treatment of Laryngeal Papilloma · Source last updated 2012-08-31

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

Measure
NUMBER
Unit
case
Interval / dispersion
Not reported
Time frame
12-month follow up

What was measured

Criteria for the recurrence: the site scoring \>4, plus visible lesion found in \>50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.

Analysis population: The paticipants for analysis were those who had the recurrence or completed follow-up period. The analysis was per protocol, and follow-up period was 12 months.

Groups in this outcome

Control

treated with once-time routine surgery (CO2 laser or "cold" microsurgery)

Experienment

treated with once-time PDL, followed by oral taking of Celebrex (100mg,BID) for 9 months

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

Analysis denominator · Participants

GroupSource count
Control2
Experienment5

Reported measurements

Source class 1
Values in case · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Control2Not reported00Not reported
Experienment5Not reported00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        2
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Criteria for the recurrence: the site scoring \>4, plus visible lesion found in \>50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.
groups
  1. description
    treated with once-time routine surgery (CO2 laser or "cold" microsurgery)
    id
    OG000
    title
    Control
  2. description
    treated with once-time PDL, followed by oral taking of Celebrex (100mg,BID) for 9 months
    id
    OG001
    title
    Experienment
param Type
NUMBER
population Description
The paticipants for analysis were those who had the recurrence or completed follow-up period. The analysis was per protocol, and follow-up period was 12 months.
reporting Status
POSTED
time Frame
12-month follow up
title
Number of Case With Papilloma Recurrence During a 12-month Follow up
type
PRIMARY
unit Of Measure
case

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

Preserved source evidence · Not medical advice