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NCT01209325 · OUTCOME

Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Through Month 24

What was measured

Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine.

Analysis population: The safety population included eligible participants who received at least one vaccination.

Groups in this outcome

Vaccination

Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine laboratory biomarker analysis

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

Analysis denominator · Participants

GroupSource count
Vaccination144

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vaccination0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      144
    units
    Participants
description
Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine.
groups
  1. description
    Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine laboratory biomarker analysis
    id
    OG000
    title
    Vaccination
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety population included eligible participants who received at least one vaccination.
reporting Status
POSTED
time Frame
Through Month 24
title
Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice