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NCT01209325 · OUTCOME

Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants

Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males · Source last updated 2020-08-11

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

Measure
NUMBER
Unit
per 100 person years
Interval / dispersion
Not reported
Time frame
Post month 7 through month 24

What was measured

Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

Analysis population: Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.

Groups in this outcome

Naive to HPV 18

HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.

Prior Exposure to HPV 18

HPV 18 positive based on serum at visit 0.

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

Analysis denominator · Participants

GroupSource count
Naive to HPV 1876
Prior Exposure to HPV 1844

Reported measurements

Source class 1
Values in per 100 person years · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Naive to HPV 180.7Not reportedNot reportedNot reportedNot reported
Prior Exposure to HPV 182.3Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.423
    p Value Comment
    Two-sided p-value.
    statistical Method
    Exact Poisson calculation
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.423
    p Value Comment
    Two-sided p-value.
    statistical Method
    Exact Poisson calculation
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.7
      2. group Id
        OG001
        value
        2.3
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    2. group Id
      OG001
      value
      44
    units
    Participants
description
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
groups
  1. description
    HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
    id
    OG000
    title
    Naive to HPV 18
  2. description
    HPV 18 positive based on serum at visit 0.
    id
    OG001
    title
    Prior Exposure to HPV 18
param Type
NUMBER
population Description
Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.
reporting Status
POSTED
time Frame
Post month 7 through month 24
title
Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants
type
PRIMARY
unit Of Measure
per 100 person years

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

Preserved source evidence · Not medical advice